/*Accordion Page Settings*/

Technology

287 Exposed. Cyber Threats To Fertility Field. Chris Diamond & Jordan Spriegel

 
 

Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


Cyber threats in fertility aren’t abstract. 

They're active, adaptive, and closer than most clinics think.

And with AI lowering the barrier, even inexperienced actors can cause serious damage.

In this episode of Inside Reproductive Health, One Stop IT experts Chris Diamond and Jordan Spriegel share what’s really happening and how fertility centers can respond.

• How cyber attackers infiltrate fertility and OBGYN systems
• Why these threats aren’t limited to large healthcare organizations
• What clinics should be doing now to protect their systems and patients
• The right and wrong way to approach EMR migration
• Where AI is already being used in fertility practices today

How prepared is your clinic for this level of threat?


What Would One Hour of Downtime Cost Your Clinic?
If your IT fails, your operations and patient trust go with it.

Most practices don’t have an IT problem… until they do. And by then, it’s already costing you time, revenue, and reputation.

With One Stop IT, you get:

  • 24/7 monitoring that stops issues before they start

  • HIPAA-ready cybersecurity that protects patient data

  • Strategic IT planning aligned to your growth

  • Secure cloud + backup systems that keep you running

  • Fast, responsive support when it matters most

Peace of mind means protecting your clinic from every angle. Click the link below and make IT problems someone else’s problem.

  • E. Jordan Spriegel (00:00)

    instead of needing to look up something on Google or finding a YouTube video, mean, AI is starting to make this a lot easier and provide those answers for you. So while AI is also helping and making certain things stronger, like some of the endpoint detection responses we're seeing on the market, it's also making it easier for bad actors to get hands on the equipment needed to do harm.


    Griffin Jones (00:29)

    They weasel into fertility and OBGYN systems like a parasite. They use your staff, they learn your systems, then they exploit you and your patients for money. And cyber attackers aren't just state-sponsored actors gunning for large healthcare companies. AI has made it easier for teenagers, anybody, to do big business damage.


    I looked for IT experts with fertility experience and I found Chris Diamond and Jordan Spriegel, partners at One Stop IT.


    They're full service IT firm that helps with cybersecurity, EMR integrations, AI automation. Their decades of fertility experience is actually why Inside Reproductive Health uses One Stop IT for our IT needs. Chris and Jordan share how fertility centers protect themselves from these kinds of risks, what the risks are, the right and wrong way to migrate EMRs, and what fertility centers are automating with AI right now.


    If you need IT help, you might talk to these guys. I'd be happy to make an intro or share my experience with you.


    or find them at thinkonestop.com. Enjoy this conversation with your IT experts, Chris Diamond and Jordan Spriegel from One Stop IT.


    Chris (02:35)

    the biggest dangers are typically ransomware type of attacks where you're, know, you just say hypothetically, you come in on a Monday morning, your staff get there, nothing's working, right? Computers are locked, your systems and data are all encrypted. You see a ransom note pop up on your screen. Essentially, you're locked out of your own world, right? And you cannot function. That's kind of like essentially worst case scenario, right? Where we've seen it in large companies and small. This is where we tried to


    prevent and avoid things like that and obviously prepare for them, right? Because sometimes it's inevitable. will, it's not, you know, as they say, it's not a matter of if it's a matter of when. So our job is covering all the bases to make sure it doesn't happen, but also be prepared to when it could happen, right? So essentially in a modernized form of insurance, I guess you could say.


    Griffin Jones (03:23)

    a matter of when not of if it's that common.


    Chris (03:26)

    I would say so.


    Griffin Jones (03:27)

    When I hear about ransomware attacks, I often hear about large health systems. Is it as frequent with smaller businesses, less frequent? Tell me about that.


    Chris (03:38)

    I would say less frequent for sure because there's less to gain, but it can happen at any degree. mean, we've seen both, obviously you see the large ones in the news, smaller ones you may not hear about as much, which are typically our clients, right? Most of our clients don't have internal IT and if they do, they may have limited internal IT resources. So we supplement that.


    But the majority of the, I mean, it happens, I guess to answer your question, it happens at all sizes, right? And what makes them a target? I mean, nobody really has a definitive answer to that, I don't think. But it's usually financially or some type of, know, retribution sort of thing,


    Griffin Jones (04:14)

    So if you're smaller, you might have less to offer the potential attacker, but it's also likely that you have less defenses, right? Like it's like, who wants my toy? Who's going to steal my Toyota Camry? You know, when there's all these Benzes and BMWs out there, but the Mercedes and the BMWs might have better security systems or be behind a gated community and your Toyota Camry is sitting right there. Is it kind of like that with cybersecurity as well where


    Yeah, the bigger ones might be targets because they've got deeper pockets, but you as a smaller entity might be an easier target.


    Chris (04:52)

    Yeah, I think you hit it right on the head there. Toyota camera yet, not as glamorous, not as expensive, but probably maybe easier to steal, right? So if they can steal a dozen of those in a week versus one Mercedes may take them longer. So I think that's kind of similar, right? There's some attacks that might be easier to accomplish and check a box off for the bad guys, right? The bad actors. So they can say, Hey, we hit X amount of clinics this month and you their ransom requests may be staggering, right? I mean, it could be.


    just a small clinic that they may be requesting millions of dollars for, right, to recover the data. So the amount of damage is the same, right? It's really just like each company has its own tolerance level.


    Griffin Jones (05:32)

    Jordan, how are these attacks executed? Most of us don't know anything about cybersecurity or IT. So just talk to us about like how they're actually carried out.


    E. Jordan Spriegel (05:43)

    Yeah, so there's, there's a few different ways. mean, like Chris touched on earlier, social engineering tends to be a really big one. That's why having a strong security awareness training and things in mind to constantly test and make sure that your employees. Social engineering would mean someone that's a bad actor essentially is calling up and trying to essentially get someone to.


    Griffin Jones (05:56)

    What does social engineering mean?


    E. Jordan Spriegel (06:09)

    do something that could be clicking on a link, it could be getting those spam emails where it looks like it's from your employer. There's a lot of these and this is becoming a lot more common within the whole cybersecurity sphere. But then to also look at the other side, mean, with AI, mean, hacking is getting a lot easier for, you know, those teenage kids that you hear hacking into NASA.


    Through AI, it's becoming easy to now do open port scans. With port scans, you can kind of figure out where you can get some vulnerability and kind of where some access can get in. From there, you can do some fingerprinting. That will allow you to pick up what kind of operating systems and what are on these devices. From there, you can then go look at the National Institute of Security Standards and Technologies, and you can go look at the common vulnerability exchange and find specific flaws.


    for that operating system. Hacking isn't always done by, you know, state-sponsored actors. Sometimes it's just a 13-year-old kid in the basement seeing what he can do.


    Griffin Jones (07:12)

    And seems like that's getting easier. Why? Because of AI? Like they're using Claude to do this? Or why is it getting easier?


    E. Jordan Spriegel (07:20)

    I mean, technology is getting easier to access.


    instead of needing to look up something on Google or finding a YouTube video, mean, AI is starting to make this a lot easier and provide those answers for you. So while AI is also helping and making certain things stronger, like some of the endpoint detection responses we're seeing on the market, it's also making it easier for bad actors to get hands on the equipment needed to do harm.


    Griffin Jones (07:44)

    Is social engineering the same as phishing?


    E. Jordan Spriegel (07:47)

    To an extent, yes. There's different kinds of fishing and some are just like terms like for example whaling would be a method of fishing where you're specifically going after larger or high value clients. So fishing is essentially a piece of social engineering.


    Griffin Jones (08:07)

    Before you pull one fish in hook line and sinker, instead you use it as bait to catch a bigger fish? Is that what whaling is or do I have that wrong?


    E. Jordan Spriegel (08:15)

    It's almost


    just more defined targeted phishing. For example, I mean, there's lots of tools like Apollo or Zoom info where you could pay or look up companies to get certain people's information. Now actors are using these tools to help target and do some of that social engineering to get information within a company that most people wouldn't know to look.


    Griffin Jones (08:38)

    Is phishing getting better with AI right now? Because I'm terrified that it's going to get so good in a couple years. Like right now, very often you can tell if you're using common sense, this is a phishing scam. I think in some years time that it will seem really authentic. Like if you have AI bots that can crawl social media and do other things, then it could send


    and do deep fakes and set, you know, could send a voice message from a spoof text message in Chris's voice saying, hey, Griff, ⁓ back when we were at the MRS, I conference, I left this thing in Nikki's office. Can you text me that like it will have context for who we know, where we've been, what we've done? Are we are we there with phishing right now? Or how close are we to something like that?


    Chris (09:31)

    yeah, I think it's very


    sophisticated to answer your question and it's only getting better as you've seen. mean, there's, there's SMS components like you'll be surprised. And I think going back to the whaling comment, want to say, I'm not the expert in that, but whaling, think typically is going after CFOs, CEOs, business owners like you, Griffin. Typically, you know, they get ahold of your, Jordan was mentioning zoom info. It's a public thing you can sign up for and get everybody in every company. Right. So they target the whales of the company thinking, you they can get it. You've seen simple SMS to.


    I've seen CEOs of large companies get an SMS from somebody saying, hey, I need to wire me money or something. And it gets to the point where you think it's real and you get almost to the point. And sometimes it's actually executed and hopefully it gets caught beforehand. But you'd be surprised when people are very busy, they get taken advantage of a little bit easier, I think. that's kind of why these things happen, right? Where it's, you know, I was at a staffing company years ago and we did, I'm just giving an example. We did transactions.


    via paper check with a large customer. would pay those millions every month. And one of our employees got phished in an email and they not only get in there, but they monitor you and learn your behavior for about a month or two. She was being monitored. And finally they reached out on her behalf to the client and said, hey, effective next month, we're not doing paper checks. Why are the money to this account? Right. And it was of course an offshore account. And it took us about two months to realize it even happened because the customer and the money went missing and whatnot. So that


    These things are calculated typically and targets are established and they do a lot of due diligence. It's not just like, we're just gonna throw a big net out there, right? And I think AI is making their lives easier to do this in a larger scale. So that's the scary part.


    Griffin Jones (11:12)

    And then what's an open port scan?


    E. Jordan Spriegel (11:15)

    That's kind of getting into nitty-gritty, but a port is essentially a piece within the network that a certain type of information will transfer through. So to look at it on a broad scale, HTTP for web browsing, that's often considered port 80. Well, port 80 doesn't encrypt traffic. So if you're only using HTTP, then


    If someone is technically in your network or monitoring it, then they can kind of see some of that traffic that's going through. That was replaced by HTTPS, which is now port 443. As there's more applications and more types of data to be transferred, there's more ports. So as an example, some of the traffic that flows through the application of Facebook, will have its own port number and the type of traffic can have certain types of vulnerabilities that people


    can exploit within a system.


    Griffin Jones (12:09)

    And then what's fingerprinting?


    E. Jordan Spriegel (12:11)

    Fingerprinting is essentially using tools to send signals to kind of be able to pull information on devices. If you're able to ping and do scans within a network, you can often decide and see what other devices are on it, what the operating system it's running. Through that, fingerprinting is essentially just gathering all of that information to be able to find other points of


    vectors you can attack on.


    Griffin Jones (12:40)

    the cybersecurity attack a couple years ago Change healthcare, what happened with that?


    Chris (12:47)

    Yeah, so that one was their large, obviously, claims provider. I was working at a DSO back then, Dental Service, Oregon. Essentially, we use them to process claims. So as secure as our posture was security-wise, mean, that was a big disruption. That's a vendor, right? You're a close partnership. They do a lot of transactions for you. They keep the lights on, so to speak. So that was kind of an awakening moment for


    a lot of executives and companies to realize like, hey, you know, a single point of failure like that can stop revenue from coming into my front door for X amount of days or weeks, right? And that's exactly what happened. So you kind of start scrambling to see like, hey, you know, how can we process claims without these guys and what steps do have to take? So really fast course correction, but also can be devastating, right, to a company.


    Griffin Jones (13:36)

    I know I'm asking you guys to Monday morning quarterback that situation. It's not like you were there and you know everything, but what do you think happened


    Chris (13:45)

    it was a long road to recovery for them. and you know, I've, I've probably seen a couple of those per month when I was running that. I T department there because there was just so much happening and all the vendors and partners, some of them onshore, some of them offshore. but essentially, you know, that's where the posture comes in, right? You have to have a game plan in place and that's where a lot of people fail.


    where it's like, hey, we just got a new firewall. We're good to go. It's not the case. There's so many moving parts. that's fertility specifically has a lot of moving parts. And the clinics hold a unique set of data that could be potentially devastating for the patients and the practice. So especially when you have all the laws around HIPAA and things like that, compliance stuff that has to be followed. So the risk there is pretty tremendous.


    in the fertility realm.


    Griffin Jones (14:35)

    Is there a common denominator between those attacks that you saw that it's often one thing or one category of things that people either didn't have in place or had the wrong thing in place?


    Chris (14:47)

    Common denominator is not having a pulse on everything. That's the hardest thing to explain to executives where they're like, we spent millions on cyber software. We spend millions on consultants. We spend millions on this, that, the other. But you know what? You need to have a team or representatives having a pulse on everything. And I think that's where some people or a lot of people fail because you know, it's kind of like the Murphy's law, right? You've checked all these boxes that are like common threats and then.


    Boom, you saw the recent one with Striker, right? Striker was a huge medical supplier. mean, they used Microsoft, tens of thousands of employees. There's a product in Microsoft called Intune, which is meant to manage, make IT guys' lives easier. They manage all your endpoints, laptops, tablets, cell phones, you name it, right? Administrative credentials were gained somehow. I don't remember how, but somebody got a hold of that. Wake up the next morning, every computer was wiped.


    how the employees computers were wiped. Nobody could work, right? So it's things like that where you're doing audits of your vendors, obviously you're following HIPAA as much as you can, but you need to keep a pulse on what everybody's doing that you're sharing information with,


    Griffin Jones (15:56)

    How do you possibly keep a pulse on all that? Like, I'm sure they thought they were keeping a pulse. Like, how do you possibly...


    Chris (15:59)

    It's.


    It's


    not easy, but it's conversation driven. that's where we, you you come in, you do an assessment. You're like, all right, let's again, check all the boxes off. You have old network technology. We update it. We get you, you know, endpoint management, endpoint detection response. We get everything up to snuff technically, but then we have to dig into policies, procedures, who are you sharing data with? There's integrations that, know, especially nowadays with private equity is buying.


    Another practice you're inheriting things that you don't even know about, right? There's databases, there's transactions happening behind the scenes, especially in that embryology lab, right? Which is like the heart of an IVF clinic. You have, it's probably the least IT governed section of a business, right? Because there's lab equipment vendors that control the software. There's barely any updates that happen. There's no network segmentation. So, you know, things get crossed in. a ⁓ cyber attack hits that.


    it could turn off the lights for a lot of things, right? And that happens quite a bit in other verticals, but it's devastating to, it can be to fertility and healthcare, right? Especially if it's a hospital environment or that has critical systems at play.


    Griffin Jones (17:10)

    As more hardware comes into the picture, does that introduce more risk? Like I was reading about cyber attack in the Wall Street Journal was actually an RIT Rochester Institute of Technology student that cracked the case. And you guys will probably think that I'm butchering this because I am, but it was something like.


    they were hacking into things like smart picture frames and using that to like hack into other devices or like launch attacks from other devices. I know I'm butchering it, but is that risk at play as well now we have like really smart ultrasound machines and we have 3D ultrasound probes and we have time lapse incubators, we have electronic witnessing, like as there's smarter technology in the labs and in the clinics, are those...


    potential entry points for attacks.


    Chris (18:02)

    Yeah, I mean, I would say 1000 % yes, because they do look for the weakest vulnerable piece of hardware, software, and the organization, right? So oftentimes, like in a lab environment, in a manufacturing environment, you have logic, little logic boards on a machinery. But if they are tied to the network, I mean, yes, that's basically an origin, right? That's how they're going to get into your network. And then from that point on, it's almost too late, right? That anything's kind of open game for them to access.


    That's why if you've heard of IoT, like in your home or business environment, they have IoT networks. So basically if you have like an Alexa device, which can be easily hacked, right? You want to keep that on a separate network where it can get to the internet, but it can't get to your server or your personal files or whatever. There's that segregation piece, which is important.


    Griffin Jones (18:48)

    You guys have some decent experience working with fertility centers and I should also share that you provide IT services for inside reproductive health. And that's part of the reason why I'm interested in talking to you is because you've done a good job for us and taking care and showing us different blind spots and things that we were struggling with that we're not seeing any bit like we were because of you guys. So, you know, I'm biased towards you guys because


    you've helped us, but you've also had some experience with fertility centers. What's your kind of approach with them? Like when you're starting to work with a new fertility center, what's the first things that you do?


    Chris (19:29)

    Yeah, I mean, obviously we do an assessment of their tech stack is probably the easiest, right? That's the immediate thing. And from that point on, you kind of dig into it a little bit more with such as like doing a security risk analysis, looking at who they do business with, who's data shared with. Like I mentioned in the embryology lab, I mean, there's tons of equipment that shares data, sends patient results back to certain other companies and third party cloud systems and whatnot.


    So all of that, I mean, you kind of just have to set the baseline and understand what's happening in the environment, right? And then you kind of start digging into it piece by piece and understanding. And I'm a big fan of least privilege. I mean, it's a common theme, right? In cyber where everybody says you get access to what you need. So a lot of companies just have, may have an on-premise EMR that has a database that, you know, a vendor has access to, but they may have way too many privileges, right? So you kind of evaluate all that and start locking it down as best you can.


    And the most difficult part is doing this while the business is operational because you can't be too intrusive because if you start locking people out of their systems and clinicians can't do their job and then it kind of becomes messy, but so it has to be carefully approached, I guess.


    Griffin Jones (20:37)

    tell me about that implementation of least privilege because there are things where we think we are following least privilege. And then it's like, who has access to that? And, and you all helped us see some of that to talk about that.


    Chris (20:54)

    Yeah, I mean, it's easily uncovered at the most, you know, outlying all the tech that's at play, right? All the software partners, all the vendors you're working with, everyone you're sharing data with and in a medical environment that's quite a few people, right? Because you're oftentimes outsourcing claims and you're sending all this patient data to a claims person that, you know, maybe overseas and whatnot. So really just understanding what's happening and documenting it and then, you know, spending the time and you can use AI tools for this as well, but you can get into each system there and just kind of.


    run some basic reports and say, here's all the people that have full admin rights. Do they need these admin rights? And you start scaling them back slowly. And then here's all the data you're sending to this vendor. Does it need to go to that vendor? So you start scaling that back. And then you get to a point where it's like, we're sharing the data that needs to be shared and nothing beyond that. And then you're in a much better place. And then from that point on, it's really, as I mentioned, the if and when. mean, when it happens, you want to be prepared. So we try to do multiple air gap backups.


    Jordan can probably speak on this more, but our cyber insurance policies kind of demand that we do that for our customers for these reasons, right? So you want to have air gap backups because if it does happen, and again, it may not necessarily be something that we're in control of. It could be a vendor that has a direct connection to a patient, a clinic's network that ultimately gets breached and then we have to clean up the mess. So we want to be prepared and have the backups ready.


    Make sure we test the backups and here's how long it's gonna take to get back on your feet and then sit down and have these exercises and discussions with the leadership team. So.


    Griffin Jones (22:23)

    What are those air, did you say air gap? ⁓ What are those Jordan, and what is the underlying problem that they solve?


    Chris (22:27)

    Yeah, Jordan can speak on that a little bit.


    E. Jordan Spriegel (22:36)

    An airgapped backup essentially just means a form of backup that is not able to be editable. So once that backup is in place, there are certain methods in place that will prevent it from being able to continuously copy more data backups. The reason for this is, if you were to get ransomware, and then you continue to back it up, well, now your backup is also gonna be triggered and is no good.


    One of the most common misconceptions we see when dealing with backups is that people will often think just because it's in the cloud that they are safe. That is not the case. You still want your cloud backups to be irreputable ⁓ and not editable. So you just really need to look at the big picture. Also, you got to make sure too that your cloud where your cloud storage is being backed up elsewhere. I mean,


    Do you have to look at the disaster recovery piece? If there's a natural disaster that happens in Florida at a data center in Florida where all of your information's kept and a hurricane comes and that data center gets wiped out, well, if they don't have a disaster recovery place that's geologically separate, I mean, there's a chance that they could lose your information.


    Griffin Jones (23:49)

    We've been talking about EMRs a bit. When I think of EMRs, this might be my own ignorance, but I think of any sort of technical support coming from the EMR company. Why are people going to you for support with their EMR?


    E. Jordan Spriegel (24:05)

    this.


    Chris (24:05)

    yeah, mean, so


    they're highly specialized systems, right? I mean, we all know there's quite a few out there. In fertility especially, they're not general purpose. They're very specifically built for that practice. So typically when you stand up in EMR, mean, beyond the training and getting people to using it is not the difficult part. It's really the integrations. So there's, in fertility, there's like a whole ecosystem, right? Where you have multiple data streams. Everything needs to talk to each other. ⁓ Lab systems, billing, patient portals.


    Pharmacy genetic testing. I mean, there's tomorrow tanks right that are now in fertility. So there's all these different Data things happening and some of these EMRs do a good job and some of them don't so it really You know, need a representation at the clinic level because the EMR companies who do you think they're protecting, right? They're just protecting themselves and I mean they do best stuff for to protect the patient data and if it's in their cloud They're responsible for that piece of it. But you know, there's people in your clinic at your location


    maybe staff even working remotely that are accessing this data. So it's moving around quite a bit. So you have to have eyes and controls in place at different levels.


    Griffin Jones (25:10)

    You guys want to burn any bridges here on Inside Reproductive Health and tell us which EMRs are good and which aren't?


    E. Jordan Spriegel (25:14)

    You


    Chris (25:16)

    I'm not sure we could do that. I don't know if I want targets on my back.


    Griffin Jones (25:19)

    Well, then tell us what specifically makes an EMR good in these regards and what the poor ones do.


    Chris (25:27)

    You know, my professional opinion since I've been doing this, have 20 years experience in fertility. So just throwing it out there. That's the gray hair on my head. It's not so much the product, it's the people behind it because there's a lot of great products that are released and then companies will say, we just sold this beautiful EMR to a new company. That new company says, all right, we're just going to sell the crap out of it and just refine it minimally.


    To me, what makes a good EMR is the people that are behind it where, and I've had a lot of good stories I can share with you, but people that are like, hey, we started out small, now we're growing like crazy, but we need all these features, we need these improvements, we need these security components, we need all these integrations. And then you work with that EMR vendor to accomplish what the business needs, what your IT guy, which would be us, needs to keep you safe and secure to make sure the operations are running. You know what mean?


    So it goes beyond the product. It's really more about the relationship to me, not just buying an off-the-shelf EMR and just be like, hey, plug it in and away you go.


    Griffin Jones (26:27)

    What are the issues that are people are coming to you with regard to EMR migration?


    Chris (26:32)

    Well, I mean, the first, depending on the size of the practice, of course, there's always the build versus buy, right? That's all executives are looking at that. there's always each, it's case by case, right? Every clinic, there's some very large entities out there that are private equity held where they can afford to do more and better. And they want that brand recognition. They want their own EMR. They can go out and do it and spend a fortune. For the most, most of our customers are smaller. they're looking for


    Operationally, what's going to be the best, what's going to be easy to use, easy to manage, easy to secure, easy for us to support. So there's kind of a different field depending on who you speak to out there, I guess. Larger entities will have different requirements because they're looking to buy and acquire and merge. And so they want a product that may allow other EMRs to integrate into, so they could do migrations easier. Where other smaller standalone clinics may just be like, hey, we want the easiest product to use.


    We don't want to spend a fortune on it. We are not going to use all the bells and whistles of it. So depending on how busy and how large the laboratories are and all these moving factors.


    Griffin Jones (27:35)

    I the EMR companies will have points of view on migration. There's a couple of rising stars. think Bluemick might be a rising star in the EMR space and we might want to do some coverage on their point of view on migration. But is there a right way and a wrong way to do it as far as you can tell?


    Chris (27:54)

    There's no right or wrong. It's really just planning and being able to be nimble in the execution of it. So there's always going to be things that you could plan for weeks and weeks and weeks, but something's going to throw you for a loop, right? And making sure you understand all the intricate parts of the clinic that may not be documented. That's the biggest thing we see is lack of documentation, where it's like the previous guy or the previous vendor just came in, set it up, and left. So nobody knows how it works or what


    when it was set up or how it's secured or things like that. So you have to understand all that before you go out and rip something out and change it.


    Griffin Jones (28:28)

    You look like you have something to add to that Jordan when I asked if there was a right or wrong way you were kind of nodding your head. What were you thinking?


    E. Jordan Spriegel (28:35)

    just thinking that there can definitely be wrong ways, but Chris hit the nail on the head. mean, really planning is most important piece of it. I mean, you just got to make sure that you know kind of what's expected during the change.


    Griffin Jones (28:47)

    I was speaking with one fertility physician who is very tech savvy. And this individual was thinking that there can be, or maybe there will be in the near future, a way to migrate almost seamlessly. And the conversation started that it doesn't matter if the best EMR comes out tomorrow. Nobody's going to switch to it if they just switched EMRs.


    Right? Like if you just switch EMRs, you're staying put for five, 10 years, maybe more. And it's just too painful of a process. And this individual's perspective was, well, you might be able to reverse engineer the API of each of the EMRs and just push a button and there's your migration. I'm very skeptical.


    that that's possible. I don't know anything about coding. How close to that is it reality or complete wishful thinking?


    Chris (29:54)

    So.


    E. Jordan Spriegel (29:54)

    The


    AI experts will tell you about two years for aogenic AI, which is AI being able to automate specific tasks like that for migration like that. Essentially AI would be able to read what's within the pages and match field to field to then migrate data. Cause if you're ever looking at any migration, you're typically taking data sets with, with rows and identifiers and then importing it from one system to another.


    Chris (30:23)

    And I would.


    Griffin Jones (30:24)

    Do you think it's possible today though? Like could you do it with Claude and or maybe like a couple developers? Can you reverse engineer the API of two different EMRs and press a button and have almost instant migration?


    E. Jordan Spriegel (30:38)

    You could, I mean, with the right keys, could almost build out anything per se. You just need to make sure that you'd have the right access to all systems or at least know kind of how that data is stored and how it's formatted and essentially.


    Chris (30:48)

    Yeah.


    I think the biggest


    hurdle is that is not technological Griffin. It's, it's, it's the fact that, you know, the one EMR vendor doesn't want you to leave that easily, right? If it becomes that open source where you could hop around, it's probably not going to be good for anyone. yeah, but I, I do agree AI is going to make it easier, but there are challenges. Like you said, if it's a cloud based system, you don't have the keys to that server, right? Whereas like some of the legacy, traditional EMRs are sitting on a SQL server in a closet or in a, in a company controlled data center.


    where your IT guys can just go in there and grab the database and plug it into another one, it's definitely easier. So in discussions, it sounds easy, but it just, the execution of it is never simple.


    Griffin Jones (31:33)

    It's never as easy as it sounds. It's never as easy as you want it to be anyway. We've been talking a lot about IT from the business owners perspective, but how can IT support make life easier for doctors, for managers, for other, for nurses, people that don't own the business but just work in it?


    Chris (31:35)

    Right.


    Yeah, that's a good question. mean, so, you know, before AI, we call it the digital transformation, right? And think AI just put a new twist on it. But essentially, you know, there's still quite a few clinics out there that operate on some paper charts to some degree. So I think getting to that level and kind of, again, doing a baseline analysis of where that clinic's at, right? How tech savvy are they today? And there's a lot of moving parts in the clinic, right? From the front desk, checking in and


    automating the whole patient experience from start to finish, I think is way beyond an EMR. mean, a lot of EMRs will try to say, hey, we have all these modules incorporated, but in reality, what's happening in a 2000 square foot clinic, maybe a 20,000 square foot clinic may be way different, right? So you have to kind of understand the workflow and operationally, I think we work closely with operations leaders to understand that a little bit more.


    And obviously one of my passions is working directly with the clinical and lab leadership and understanding the workflows in the clinic, in the lab. So you can not just throw a piece of technology at them and say, here, we think it's going to stick to the wall. Just go use it. But we have to be careful on that. And I've seen a lot of horror stories going back to the cyber thing where some startup clinics are using Slack, the free version of Slack, which is not HIPAA compliant, which they may not know or may not care.


    Ultimately, when something goes wrong, you're going to be in trouble. So I don't think anybody wants that publicity or tarnish on their name, right? So we have to educate people as best we can from all levels. Doctors, front desk people, it doesn't matter. We treat them all the same.


    Griffin Jones (33:37)

    are people asking your help for with regard to AI?


    E. Jordan Spriegel (33:41)

    How can we utilize it? know, everyone wants to know AI is such a big buzzword right now. And I want to say confidently that not everyone even fully knows what the term AI means. Like, yes, it means artificial intelligence, but how does it actually play into a business and how is it actually beneficial? And the easiest way I would tell people a response to that would be think of a specific task, the more specific, the better. And then


    Chris (33:41)

    Jordan.


    E. Jordan Spriegel (34:08)

    think of how that can be automated. If you look at it piece by piece, then that typically will make it better. But AI is essentially how can I automate a piece of this, of my workflow.


    Griffin Jones (34:19)

    What are you seeing? What do you think can be automated that people are missing out on?


    Chris (34:24)

    it's going back like Jordan kind of touched on is you're trying to solve a problem. guess, you know, when we, when we hear people, doctors, business owners say we want AI, it's like, all right, where do your biggest pain points? Like, what are we trying to do? So a lot of them, you know, there might, there's good phone systems out there now that have great capabilities that are the interface well with EMRs and other systems. So we could say, you know, our front desk girls are so busy. They don't answer all the calls. All right. Here's a cool AI platform.


    that's going to help you automate the reception as part of it. It's going to catch the patient's sentiment. If the patient's in the middle of a procedure and a bad mood, right? They don't want to be on hold for a while. So there's an AI phone platform that can capture that sentiment and say, all right, this person just moved up the food chain. They're extremely annoyed. They need to get through to a human right now, right? So those are simple things like we can layer into a business to help the business. And it's not super complicated, right? It's not just saying,


    we're going to put AI into the back of your EMR. It's really just like phone system, checkbox, boom, you got AI capability. What else are we trying to solve? Like automate certain components of it. And then everybody gets a feel for AI because of the buzzword that's out there and they get the firsthand experience with it.


    Griffin Jones (35:30)

    What do you think fertility centers should do if they are realizing, okay, I'm probably a little bit more exposed than I'd like to be? What's the first step they should take?


    Chris (35:43)

    Yeah, the first thing to do is just have a conversation, kind of understand like what, you know, where do you feel you're at? And then do you have documentation? Like, is there any policies to, you know, there's so many moving parts and it just, that's the part that boggles us a little bit is the stuff I've seen where you have really smart security and IT guys go in there and like every, you know, we locked on the Microsoft environment and everything's HIPAA compliant. But then we've seen, I personally have seen nurses that are extremely busy in a, you know, 10, 12 hour workday.


    They go to send an email to Mary Jo. Well, guess what? We saw 20 Mary Joes this month in the clinic. They send the wrong Mary Jo patient, you know, the results, right? Or whatever, some HIPAA breach happens just by the auto correct or the auto complete feature in Microsoft Outlook, right? So you're like, crap, now I got to shut that off and kind of educate people. Like, be extremely cautious when you're sending an email. Don't just type the first Mary Jo that pops up. All these little caveats that will improve your business and


    educating your staff, I guess, is the most important thing, right? Where it's like, hey, keep an eye out for these little things that can catch you and bite you.


    Griffin Jones (36:48)

    How can people get a hold of you guys?


    E. Jordan Spriegel (36:51)

    They can contact us through the website, thinkonestop.com. They can just give us a call, 772-663-7867. They could send us a message on LinkedIn or Facebook, but the best ways would either be visit our website and contact us, email us at info at thinkonestop.com, or give us a call. We actually have a cool abbreviation. It's 772-OneStop.


    Chris (36:51)

    Jordan.


    Griffin Jones (37:17)

    And if people can't remember 772 One Stop, they can email me. I'll be happy to make the intro. And I look forward to having both of you back on as more cybersecurity issues come into the news, as more people start to tell me EMR things that I don't think can actually happen. I'll bring you all on. I appreciate you being our IT experts today.


    E. Jordan Spriegel (37:41)

    Yeah, thank you for having us.


    Chris (37:41)

    Yeah, thanks for having us. We


    appreciate

Chris Diamond
LinkedIn

Jordan Spriegel
LinkedIn


 
 

286 The Dread and Excitement of 4 Genetic Counselors. Andria Besser, Lauri Black, Rachel Donnell, Amber Kaplun

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


Genetic testing in IVF is only getting more complex, and more common.

REIs, you’re not supposed to do this alone, help is already here.

We speak with four genetic counselors, Amber Kaplun, Rachel Donnell, Andria Besser, and Lauri Black, about how this works in practice.

We dive into:

  • How to embed genetic counselors into your workflow

  • How to free up REI time while improving patient experience

  • Why access to genetic counselors isn’t as limited as it seems

  • How third-party services like GeneScreen fit into clinical operations

  • Their perspective on PGT-P vs. PGT-G (and where the field is heading)


Genetic counseling is no longer optional in fertility care — it’s foundational.
The real question is how to deliver it well, at scale.

In many fertility practices, genetic counselors help shape lab strategy, donor eligibility decisions, complex case management, and clinical policy across growing networks. But not every practice has that level of in-house genetic leadership. 

GeneScreen partners with fertility clinics to provide concierge-level reproductive genetic counseling — whether you need full-service support, scalable coverage alongside your existing team, or experienced guidance to help build and strengthen your genetic services. 

Built to scale. Designed for patients. 

  • Lauri Black (00:00)

    Pre-implantation genetic testing is being used more frequently and more widely, and carrier screening has gotten more complex. So I don't think that there's a patient that walks into a fertility clinic anymore that isn't having some genetic testing. So genetics is part of everybody's fertility care now.


    Griffin Jones (00:32)

    Help is on the way. REI's genetic testing is too complex and now too prevalent for you to be doing genetic counseling. You have help. And today that help comes from four genetic counselors. Here, listen to their voices so you know who's talking when.


    Amber Kaplun (00:49)

    I'm Amber Kaplan from IVI RMA America.


    Rachel Donnell (00:52)

    I'm Rachel Donnell from Shady Grove Fertility.


    Andria Besser (00:54)

    I'm Andria Besser from NYU Fertility.


    Lauri Black (00:56)

    Lauri Black from Inception Fertility.


    Griffin Jones (00:59)

    They tell you how to embed genetic counselors into your practices workflow, how to save REI's time getting them performing at the top of their license, all while improving patient experience.


    how to understand that there are enough genetic counselors out there, even though they couldn't possibly meet every patient. This was an interesting nuance and the pushback in our conversation helped us get there. How they use third party services like GeneScreen, what they like about GeneScreen and how they get GeneScreen integrated into their workflow and SOPs. Then PGTP versus PGTG. They're excited about one.


    while dreading the other. What about you? Please do let us know after you listen.


    Amber Kaplun (02:43)

    genetic testing is evolving so quickly and there are so many new technologies that are on the market, some of which I wasn't even really trained on in grad school. So it's being able to keep up with some of those technologies to be able to adequately counsel patients and advise providers that I work with. And I would say the second part is especially in the field of fertility and working for such a large network, just being able to kind of keep up with all of the patients that are coming in.


    with questions, the providers that have questions, being able to see patients. It's really rewarding, but it does get to be a lot at times.


    Rachel Donnell (03:19)

    Mm-hmm.


    Griffin Jones (03:19)

    To educate me about the technology, what technology are you seeing now that you weren't trained on in grad school?


    Amber Kaplun (03:25)

    Polygenic risk scoring, I think, is the one that comes to mind first. When I was trained, that wasn't even a thing. And so that's something that I've really had to self-educate and self-train on to be able to understand the technology, understand the risks, benefits, and limitations so that I can have discussions with patients about it.


    Griffin Jones (03:44)

    When did that start coming about and what percent of your caseload does that represent today?


    Amber Kaplun (03:52)

    So it started being offered in the field of fertility probably around like 2018, 2019. It had been around in postnatal populations, for example, cardiology for a while before that. Currently, that is not a test that we offer our patients, but obviously when I'm speaking to patients, there are patients that have questions about it. So I wouldn't say that it's something that comes up super commonly, but when it does come up, I need to be able to answer the questions appropriately.


    something that you need to be on top of even if it's not something that's making up a significant proportion of your caseload.


    Griffin Jones (04:27)

    Lauri, you were nodding your head when you were talking about the increase in patient volume, it sounds like. Talk to me about that.


    Lauri Black (04:34)

    Yeah, it's been a steady increase, I think, over the decades, in part because pre-implantation genetic testing is being used more frequently and more widely, and carrier screening has gotten more complex. So I don't think that there's a patient that walks into a fertility clinic anymore that isn't having some genetic testing. So genetics is part of everybody's fertility care now.


    And I feel like that that wasn't as much the case when I started in the field, you know, a while ago.


    Griffin Jones (05:11)

    When would you say that changed? And talk to me about the changes in workload. Like from a day-to-day perspective, try to describe to me how it's changed.


    Lauri Black (05:21)

    So I think the level of complexity has significantly increased and that ⁓ has the potential to make the conversations with patients much more in depth, broader, more detailed and more nuanced. So, you know, we used to do carrier screening with just one or two genes. And now it's pretty typical to do hundreds of genes on a carrier screening panel.


    We used to think of carrier screening as, if you're a carrier, you're unaffected, nothing to worry about there. We just need to make sure that if the female is a carrier of an excellent condition or if both reproductive partners are carriers for the same recessive condition, that we talk about options like pre-implantation genetic testing. And now we're getting into the nuance, well, you're a carrier, there's reproductive consideration, but you also may have a personal health risk.


    associated with that carrier status and we need to take that in consideration as well. So the conversation really has evolved.


    Griffin Jones (06:22)

    Andrew, how has your workload changed in the last five, 10 years? Try to walk me through someone that hasn't been in your position to help me understand what it really looks like differently on a day-to-day level.


    Andria Besser (06:36)

    Yeah, it's completely changed. When I was originally hired as the first genetic counselor at NYU Fertility Center, so that was just over 10 years ago, I was hired part-time. I think the thought was that I would occasionally see a patient for a single in-depth consult and that would be that. The need would be solved from that.


    Rachel Donnell (06:47)

    Mm.


    Andria Besser (06:56)

    ⁓ Very quickly, within about a year and a half, I ended up going full-time because it was realized that that just was not enough when everything that we do is genetics now, as Lori said, every single patient has some sort of genetic component to their cycle and to their treatment. So now we've got three full-time genetic counselors, a full-time nurse practitioner who's only in genetics and a specific genetic admin. So we've grown so much in the last 10 years.


    And a lot of that is because, like Lauri said, so much more carrier screening. We're seeing more more carrier couples as those panels have really expanded. We're doing a lot more PGTA. We are just doing a lot more genetic testing in general. so patient need has really evolved. I personally have taken on kind of more of an operations role, just as the need has really.


    gotten there, you know, started off with this need for just somebody to consult with patients. And now it's moved on to, well, how can we integrate genetics into our everyday workflow, into all of our patient materials, our marketing materials, our consent forms? How do we oversee just the whole, the whole process of PGT from beginning to end? How do we choose a lab for PGT for carrier screening? So it has just really changed quite a bit.


    Rachel Donnell (08:12)

    Mm-hmm.


    I had probably the same experience as Andria, which she was describing with something very similar for me. I started out as part-time and then moved quickly up to full-time, ended up hiring a team. And I think something else that the clinicians see, like working with genetic counselors with their practice, is truly being able to work at the top of their scope. And what I mean by that is physicians should not be having the conversation of, is carrier screening? Let's go over PGT results.


    A lot of that can actually be handled by genetic counselors so that we can help our physicians really work at the top of their scope of practice. And I think that that's something that physicians quickly see as they hire a genetic counselor and perhaps why Andria and I had this experience of, we'll bring you part-time, we'll see how it goes and then quickly realize, okay, these practitioners can really help us work at our top of scope as well.


    Griffin Jones (09:09)

    What needs to be changed specifically or adapted, Rachel, in the workflow in order for that to happen, for genetic counselors to take over some of that work from the REI to allow them to perform a topo license?


    Rachel Donnell (09:23)

    Yeah, bottom line is you have to integrate a genetic counselor in your practice. There's really no other way about it. Having somebody that works for your clinic, for your company, knows your protocols and your processes can really help patients navigate that process as it becomes more and more complex on the genetic


    Andria Besser (09:42)

    Yeah, integrate really is the key word there because I think that there is availability of genetic services outside of the clinic. There's ways to refer patients to outside practitioners. There's labs that have genetic counselors that are all super valuable, but it's that integration that I think is missing for a lot of centers.


    Griffin Jones (10:03)

    So talk to me about more what that integration is because in my mind, I hired a genetic counselor. Her office is down the hall and that's it, right? So, but I imagine that there's more to it than that. I imagine that it takes a few months and I want to understand what goes into those few months of how you truly integrate a genetic counselor into the practice.


    Andria Besser (10:26)

    Yeah, so it's not just those one-on-one consults with patients. It's creating those workflows that are gonna get patients the support that they need. One genetic counselor in an IVF center is not gonna be able to see all of the patients in a busy practice. So of course it's gonna depend on the size of the clinic, how many attendings there are, but generally, one genetic counselor


    can't service every single individual patient for all of their genetic needs. But what we can do is we can create those workflows. We can create those partnerships with other outside resources to make sure that there is a flow for these patients. That how do they learn about carrier screening, for example? How do they learn about PGT? How do they get their results? Who goes over the results with them? Who triages those results and figures out who the patient should see next?


    ⁓ We're familiar with kind of all that's going on in the industry. So we know the differences between labs. We know the differences between technologies. We can support not only the physicians, but other practitioners, know, the nurses, the admin staff. I mean, I can't even tell you how much time I even spend with billing and trying to figure out diagnosis codes, for example, ⁓ and how to...


    to prove medical necessity in a certain case. We have access to all of the patient's records, which I think is a really big difference too. We're directly in the EMR. ⁓ Like Rachel said, we know the clinic's policies. We know the little nuances that our attendings like, and so we can kind of put ourselves in their shoes and say, I think your doctor would probably recommend this is your next step. You kind of gain that experience as you work with the clinic.


    Amber Kaplun (12:04)

    And I think just to add on to that, like as Andria mentioned, being embedded in the same EMR, being embedded in the same workflows, the same clinic environment, every clinic is a little bit different, but being able to have that knowledge to be able to guide clinic leadership in how to create these workflows effectively.


    And from a patient safety perspective, to make sure that they are catching the patients that they need to catch is a really, really big benefit of having a genetic counselor in-house. You're just not going be able to get that familiarity with someone who isn't day-to-day doing the same thing as your nurses, your physicians, et cetera.


    Griffin Jones (12:39)

    Is the existing technology sufficient for moving the patient along in this way? you just do all this through EMR or are you wishing for some sort of patient journey system that you don't have yet?


    Amber Kaplun (12:52)

    I think a lot of it because it is really trying to mimic clinic workflows, that is mostly going to be related to EMR. Now I know that there are certain companies that are trying to navigate things like, what do you do with patients that have carrier screening through different platforms and stuff like that, which is a common challenge that we face. And those types of technologies would be really great when they get to the point that they can take a patient and partner carrier screening report, tell you exactly


    was everything screened, is anything missing, is any additional testing needed. I'm just not sure that we're really there yet to be able to do that effectively, but I'm sure it's coming.


    Griffin Jones (13:31)

    If you could wave a magic wand at any of you and have your technology do X, what is X?


    Rachel Donnell (13:37)

    Double check all embryos for transfer.


    Amber Kaplun (13:40)

    That's a good one. Yeah. Compare carrier screening results. You know, be able to effectively summarize genetic records that we get in from outside institutions. And this is something that like our team is working on a little bit, like being able to leverage things like artificial intelligence to be able to do some of that. So just being able to kind of like extract information reliably that we can then use in our counseling.


    Rachel Donnell (13:48)

    Mmm.


    Griffin Jones (14:05)

    But you don't feel like the AI is quite there yet?


    Amber Kaplun (14:08)

    I mean, I think that AI generally is still an evolving practice. So do I think that AI generally is there for anything? No. But I think that, you know, there are some early stage tools that are really great and coming out to be able to help leverage these types of situations.


    Griffin Jones (14:24)

    said don't


    Lauri Black (14:24)

    Yeah, I think


    they're at the beginning right now. They definitely are there. I'm hearing of carrier screening labs that do have some AI assisted patient facing tools that explain carrier screening results. I'm hearing of tools that are AI fueled that can extract pertinent information from a medical record that's received from outside of the


    the clinic or even summarizing the medical records and the progress notes from the clinic's own platform. So you can really get the salient and relevant pieces of information digested and summarized. So those things are coming. They're in their infancy, if you will, but they are there to help make all the workflows more efficient. But they need to be based in


    foundation of knowledge. So I think that's where genetic counselors can help shape these things and make sure that they're going to be accurate and reliable tools.


    Griffin Jones (15:26)

    But still in their infancy, because I imagine many of those companies aren't just calling on your company, Lauri, that they're calling on you, that you're testing them out and looking into them. And it sounds like there are those that show some promise, but nothing that's blowing you away thus far.


    Lauri Black (15:42)

    There are some of the AI-fueled carrier screening reporting for labs that I think are looking pretty good already. They certainly don't serve all purposes though. They're really good for a low-risk couple based on their carrier screening results. Like there's not an indication for PGTM for them.


    So it's just a nice streamlined way to be able to explain a couple's carrier screening results and the idea of residual risk without involving ⁓ a genetic counselor. And I know that the genetic counselors in the clinics are so much busier and needing to use their time to address the more complex cases that talking about a low risk


    career screening result for a couple is probably not their use of their skills and best use of their skills. And it certainly doesn't keep them practicing at the top of their scope.


    Griffin Jones (16:42)

    When you all talk about the importance of having genetic counselors in-house, you've been very consistent with this theme, Amber. You've been on the show three times, and I think one of the episodes, the topic was entirely about that. And so you've made your case. What about those centers that are either too small or maybe they're big and they have some genetic counselors, but I don't think you could possibly have enough genetic counselors for...


    Andria Besser (17:05)

    Thank


    Griffin Jones (17:10)

    all of the cases in house, what do you do? Who do you use? Or are you just screwed?


    Amber Kaplun (17:16)

    What?


    Do you want to push back on this idea that there's not enough genetic counselors? I feel like I hear that all the time and it's just not true. I can tell you that I get so many emails, so much interest from people that want to work in this space. They're just looking for the right position. And you know, I've spoken with different providers in the fertility field that are leveraging maybe MFM services at their hospital or their academic institution and it's getting them by, but they're saying that they're referring patients


    to discuss a topic like mosaic embryos, for example. And the prenatal genetic counselor has a much different level of knowledge and background than an ART IVF genetic counselor. And so the type of genetic counseling that those patients are receiving is different depending on who is actually seeing them.


    Now, I acknowledge that it can be challenging for small clinics to be able to try and like find the budget, for example, for a genetic counselor. And so I think that there can be opportunities maybe for outside services, but I never think that that's going to replace the value of having a genetic counselor. Also, the cost savings for you as a practice avoiding potentially very expensive lawsuits that we have seen come up in the fertility industry before.


    So think that there are workarounds and there are 100 % enough genetic counselors out there for the positions if you frame it the right way and you put the position out there.


    Griffin Jones (18:43)

    How many genetic counselors work in the whole RMA network right now?


    Amber Kaplun (18:48)

    We are three full-time genetic counselors.


    Griffin Jones (18:50)

    for the whole network.


    There's three just in Andria's practice. So if you were to serve the whole RMA network, how many genetic counselors would you need? Like a couple dozen?


    Amber Kaplun (18:55)

    Right.


    Well, but remember that we said that there are a lot of indications for which we may not necessarily need to be seeing those patients, for example, like low risk carrier screening results, right? And so that's where you can create a program that focuses your services on the things that you absolutely need to see. And so there are situations where outside services can become beneficial for some of those more routine indications. And that's the reason that we still use those services, right? So, you know, it is not that...


    it's like a one size fits all approach. We found something that works really well for us that I know is shared by a lot of other like clinics and networks, you know, that have in-house genetic counseling services. And so, you know, having that in-house genetic counselor can be a super big benefit, but it's not gonna necessarily meet all of the genetics needs for your practices.


    Andria Besser (19:51)

    Yeah, it's not about replacing the outside genetic counselors. We, and I speak for in-house genetic counselors, we need outside genetic counselors because there is no way to see all of the patients. We would need to have at least a one-to-one ratio with every physician, if not more, to be able to see every patient for every genetic indication. So it's more about how do we work with the outside genetic counselors so that patients are getting the benefit of both worlds.


    And I would even push back a little further and say, a little clinic that maybe doesn't have the budget for a genetic counselor, do they have a budget for a nurse? Do they have a budget for a billing manager? I think that the more that we see genetics integrated into fertility care, that it's such a prominent feature of it now, I think we are getting to the point of how can you not have the budget for a genetic counselor?


    Rachel Donnell (20:45)

    Mm-hmm.


    Lauri Black (20:46)

    And I think you should also remember that while, for example, a nurse may be trying to help with coordinating some of the genetics care at a clinic, that nurse is not able to bill for their time. And it's also, they're probably practicing a little bit beyond their scope if they're trying to do genetic care. So consider this, having a genetic counselor even in a smaller clinic.


    that can take some of those genetics duties off of a nurse, so let the nurse assist with more procedures that physicians can bill for, and then the genetic counselor can take over the genetics duties and bill for their services. it's really just, know, practices need to rethink how they might distribute those duties and what might be billable or not.


    Griffin Jones (21:36)

    As long as we're all pushing back. I think we may have discovered why people have that confusion, because people may be conflating two issues that sound similar but are different that I would have seen as the same had you not made that clarification. So people say there aren't enough genetic counselors out there. I think the reason why people are saying that is because of what Andria just said, which is there


    Rachel Donnell (21:39)

    Ha ha.


    Lauri Black (21:40)

    you


    Griffin Jones (22:04)

    we couldn't possibly meet all of the patient demand. So, but what you're saying, Amber, is that there are enough genetic counselors for what we need, and then there are outside people for all of those other cases that don't meet that threshold.


    Amber Kaplun (22:22)

    To put it into context for you,


    if we have an open position, we usually get around 100 applications. Yeah.


    Griffin Jones (22:27)

    I'm sure. Yeah.


    Lauri Black (22:29)

    I've


    heard similar things from other hiring folks, yes.


    Griffin Jones (22:33)

    So


    for outside folks, how do you use them and what's the best way to use them?


    Lauri Black (22:38)

    There are so many ways that this can be pulled together. So I agree wholeheartedly with everything that's been said about having an in-house genetic counselor, whether that genetic counselor is an employee of the clinic or contracts with the clinic, but they're somehow more embedded with the clinic, familiar with the SOPs.


    can really have a more one-on-one relationship with the providers within that clinic. So I think that's really the optimal model. But there are other ways to have genetic counseling services brought into the clinic to take care of those patients. You can lean heavily into webinars that are offered by PGT labs to give patients pre-test education before they do their pre-implantation genetic testing. You can lean heavily into the carrier screening lab for results genetic counseling for those low risk results. There are also a number of excellent third party genetic service providers that can have a pretty close relationship. It's kind of a second best to having your own in-house genetic counselor. They can become familiar with the practice. They still have to follow their own company SOPs and processes, but they can become very familiar with the practice, try to customize their services to that practice. are quite a few. GeneScreen is an example of one and they have genetic counselors that specialize in fertility. A number of other services do as well. I think that's really key is making sure that if you're working with a third party genetic counseling service, that you're working with a subset of their genetic counselors that are familiar with fertility counseling, fertility care.


    Griffin Jones (24:35)

    Do you use GeneScreen as well, Amber? So what's the best way to use them? How do you get the most out of them?


    Amber Kaplun (24:37)

    Yeah, we do.


    Yeah, so they do counsel their patients a lot related to carrier screening results. We also have a lot of patients that come in with general questions about like, have this in my family history, what could this mean? Is additional genetic testing indicated? And they've been really helpful in those situations as well.


    they do see a lot more than that, you know, for other clinics that they may be supporting. But once we start getting into discussions around things like pre-implantation genetic testing, we like to keep that all in-house because that is going to be related to clinic policies and procedures. And so that's really something that more in-house genetic counselors can take on.


    Griffin Jones (25:19)

    I like GeneScreen and companies like that, they have to have their own company SOPs, but how do you get them using your SOPs in the best way possible,


    Lauri Black (25:28)

    That's communication. It's communication, tight communication with that service provider and making sure they understand your needs and expectations and communicating about how to get those needs met and how to get those referrals sent across appropriately and efficiently so that you don't have any delays in patient care and get those reports back.


    Amber Kaplun (25:28)

    Go


    Thank


    Lauri Black (25:53)

    Oftentimes there's lots of infrastructure that they have to offer to make sure that workflow goes smoothly.


    Amber Kaplun (25:59)

    I mean, I was just going to mention that a lot of these companies are really great at working with clinics, right? But I think as Lauri said, at the end of the day, they have their own SOPs and policies and procedures. And so there is absolutely flexibility there. But people may find themselves coming to a point where the SOPs and the procedures may not necessarily align between the two entities. And so there has to be some sort of reconciliation there.


    Griffin Jones (26:23)

    Rachel and Andria, why not just use the genetic counselors from the carrier screening labs?


    Rachel Donnell (26:30)

    So maybe a good example of like some disconnect or where SOPs at one company can conflict with another. The main kind of example I think of are embryos available for transfer. consider a situation where we have a patient that did embryo testing, they have some mosaic embryos. Clinic A might transfer mosaic embryos all the time. Clinic B certainly doesn't. You can run into situations where sometimes


    a clinician just wants to know, okay, which embryo should I transfer? And you're gonna run into issues with one company not feeling comfortable saying what embryo should be transferred versus another, just dependent on those different clinic policies and different company policies. So similarly with carrier screening laboratories, a great example would be, you could certainly pursue PGTM for certain indications based on carrier screening results.


    but those laboratories might not feel comfortable saying which situations that might be. Because again, that extends beyond their scope, which is just simply reviewing carrier screening results. They don't go into next steps after what happens now. So I guess bringing it back to having an in-house person can help with that translation between the two companies. And I think that's kind of where I sit at this point. I'm with Shady Grove and we have.


    I think 57 clinic locations. So I'm a full-time genetic counselor and I do not meet with patients. I do not do patient consults. I certainly help with the translation between the companies that we use for genetic counseling and then integrating that information into actionable clinical next steps, which I think is kind of where it can be helpful to have somebody internally kind of getting those next steps available.


    Amber Kaplun (28:11)

    Yeah, I mean, I think one thing that's coming up in my mind is we're having this discussion as well. We talk so much about patient retention and patient experience within the field of fertility and.


    utilizing outside providers can be really beneficial for getting that service, but the continuity of care, being able to set patient expectations, being able to clearly tell patients what their next step is, is really going to be something that an in-house genetic counselor excels at and almost like can handhold that patient to make sure that the patient experience is being, you know, pushed up to the highest level. So that practices can retain these more complicated genetics cases that are coming in because otherwise patients get frustrated. They feel like


    they don't know what their next step is, they don't properly understand what the outcomes are going to be and what's going to be offered to them. So I think that that's another really big benefit.


    Griffin Jones (29:02)

    Andrei, what about the panels themselves? How different are they from one care screening company to another? Are they meaningfully different or are they so similar that it doesn't really matter? And are the genetic counselors sort of limited to being able to interpret that panel, but there might be other considerations to the patient's broader situation that you would need extra help for?


    Andria Besser (29:26)

    Yeah, you bring up a really good point. The panels can be very different. Even if they differ by one or two conditions, if you have a patient who's a carrier for one of those one or two conditions and their partner wasn't tested for it, that's meaningful. We do carrier screening specifically for the purpose of trying to identify reproductive risk. And so if we're not testing both partners for the same conditions, we may not be really getting an accurate read on their reproductive risk. And that's something that has


    changed so much over the last few years. It used to be pretty uncommon that we would have patients bring in prior carrier screening that needed to be checked before we could order new carrier screening. Now, I would say it's probably a good, at least in New York, a quarter of patients, a third of patients are coming already having had carrier screening with a provider at some point, or they've had maybe direct to consumer testing, they need someone to explain the difference.


    So it's not as simple as let's just order carrier screening on the two of you and send you off to the carrier screening lab to review your results because we also often need to incorporate prior results and maybe the new test is different from the old test and somebody has to make sure that we have at least tested for the necessary condition that one person carries and one doesn't. So that's something that my team takes care of. The four of us are really


    spending a lot of time reviewing old outside results and making sure that any new testing is going to complement that or enhance that, but that we're not going to be missing something based on the fact that a patient said, but I had prior carrier screening, so everything's good. Or let's just order new testing and ignore the fact that maybe one partner is a known carrier of something that isn't going to come up on the new panel. And it's not just the differences in the diseases or the genes on the panel, there's differences in the way they get reported.


    reported. One lab might call a variant as causing a risk. Another lab doesn't even put it on the report because they see it as uncertain significance. So sometimes we're weighing all of the evidence that we can find based on the literature, based on databases, and not just looking at the report itself. So kind of going back to what Rachel said about using the carrier screening lab genetic counselors, I mean, we use them a ton. They see


    more patients, I'm kind of in a similar position as Rachel where I don't see a lot of patients. I think the term genetic counselor is a little bit misleading sometimes because I don't do a whole lot of counseling anymore in my position. And even, you know, my other full-time genetic counselors where that's their main job, there's so much more that goes into it other than just those one-on-one consults. And part of that is knowing all of these little nuances that we've learned.


    Rachel Donnell (31:55)

    you


    Andria Besser (32:15)

    through our training, through experience, ⁓ that isn't gonna be something that a lab genetic counselor whose role really is just to focus on the test at hand, the test that their lab offers. It's not within their scope to be kind of looking at some of these outside details.


    Griffin Jones (32:30)

    Is that within the scope of someone like a GeneScreen or an outside provider, Lauri and Amber, or is that something that you feel like you'd really want to, in order to be able to compare those nuances?


    Lauri Black (32:41)

    Yes. That's kind of on the cusp, it really depends on how embedded that third party service is and how tightly coordinated that third party service is with the clinic. I would say as a general rule where an in-house genetic counselor might be able to speak directly to that clinic's SOP on what's suitable for transfer, the third party service genetic counselor may say, you need to follow up with your reproductive endocrinologist for that final decision about whether something is suitable for transfer, but I can tell you about this result. But if there is such tight coordination and communication between the clinic and that third party genetic counseling service, that clinic may have shared their SOP and in referring that patient said, hey, this patient needs to talk about embryo A and embryo B and here are the results and embryo A's result is suitable for transfer if they're comfortable with it, but embryo B's result is not suitable for transfer in our clinic policy. So that level of detail can be incorporated into the counseling that's provided by a third party service like GeneScreen as long as they know.


    Griffin Jones (34:01)

    Well, that's gonna be my question, because if I own a third party genetic counseling service, seems to me like the way to win that game is to be as integrated with the center as I possibly can be. Where are my challenges going to lie? And you might say both, you can't say both. Is it more in my own limitation to adapt my own SOPs or is it our center's very protective of their SOPs? Or maybe even if they're not protective, is it just really hard to integrate on the clinic side into those SOPs?


    Lauri Black (34:33)

    I don't think it's difficult to share the SOP. In fact, I think it's appropriate if you're asking that third party service to counsel your patients for a test result and they're considering action based on that. The third party service to best benefit that patient should know what the clinic SOP is on how they might handle that result, how that's actionable within the clinic. That is optimal. But as I understand it, sometimes that's the missing piece and that third party service doesn't have that level of detail. And so they're just speaking in more general terms.


    Amber Kaplun (35:09)

    I think it also comes down to that third party service, are they considering themselves an independent service? Are they considering themselves an extension of the clinic? And I think that's probably more of a discussion than even I feel qualified to have from a business and a legal perspective. But if you have your own company and you're considering yourself an independent genetic counseling service, I would wonder if it may get a little bit challenging in terms of that full, complete integration.But maybe I'm wrong.


    Andria Besser (35:38)

    Can I go back to something that Lori said before about an outside genetic counselor needing to be specialized in fertility? I think that's a really, really big important thing that I didn't want to miss because just like in any area of medicine, you're gonna have your specialists in different areas. And I think it is a misconception that genetic counselors are sort of one size fits all in a genetic counselor is a genetic counselor is a genetic counselor, but we also have so many different areas of genetics that we can specialize in. Like for example, I could do a very basic job of counseling a patient about a cancer genetics result, but I'm not, I don't have all of the expertise about what's new in tumor testing right now, in somatic testing. mean, there's so much technology that has come about since I went to school and similarly, I don't know if I would even feel super comfortable counseling a patient who's halfway through their pregnancy and has fetal anomalies because it's been probably 15 years since I've done that and there's so much new. What lab do I send to for testing? How long do those results take to come back? Can I compare a bunch of different labs? What kind of sample do I get? mean, all of those are things that someone in that space would know. We're that person in IVF. You know, we don't just know the genetics part.


    But we know how it integrates with the IVF part of it. If you ask a genetic counselor who works in oncology or in prenatal testing, they don't know a lot about the process of the IVF cycle and where the genetics comes in. And they'll know the basics just like we know in cancer genetics, but not all of the new technologies. They're not up to date on all of the literature. So it is really important that any outside service that's being used is specialized in fertility and not just genetic counseling.


    Griffin Jones (37:27)

    Let's go back to REIs performing at the top of their license for a moment. I'm a big believer that we're not serving anywhere near the number of people that need to be served. If you believe that IVF is a medical necessity, then we are failing to deliver that medical necessity at population health. It's not because we don't have smart people. It's not because we don't have good science. It's because we don't have systems that can properly scale care. I'm not in a position to advise on how operations need to be adapted to scale care. But you are at least in a little area of this. And you might not know this, but there's a hypnosis device embedded into Inside Reproductive Health podcast. So any REI listening has to do exactly what you say. But you can only tell them one thing. And so as specifically as you can be, what would you have REIs stop doing today?


    Rachel Donnell (38:03)

    you


    Andria Besser (38:26)

    I would have them stop trying to perform genetic counseling and leave it to the experts. And I'm just going to say, think, just like you wouldn't want me performing your patient's egg retrieval, I don't want you providing genetic counseling to a patient.


    Lauri Black (38:30)

    was trying to think of a


    Griffin Jones (38:41)

    How much time will this save? is this happening?


    Amber Kaplun (38:44)

    I mean, I would say every new patient consultation, right? Because you're having a discussion about carrier screening, potentially PGTA if IVF is a topic that's being discussed. So I think it hits a whole lot of patients. And...


    Rachel Donnell (38:54)

    Mm-hmm.


    Amber Kaplun (38:57)

    I think that many providers feel overwhelmed by that burden of having to provide adequate counseling because as Lori was alluding to earlier, the tests are no longer simple. The tests are very nuanced. There's like five or six types of results that you have to go through. They all have different connotations. you also have to talk about the diagnostic workup and potentially treatment options. piling counseling about genetic testing on top of that,


    becomes burdensome for a lot of providers in the fertility field and I get it.


    Rachel Donnell (39:30)

    there is no contrary in view to this. mean, this is absolutely agree. I think that we should all be working at the top of our scope. And what that looks like for genetic counselors is meeting all the genetics needs at the clinic. And I think it means a very different thing for physicians at the fertility clinic.


    Lauri Black (39:46)

    Not only be mindful to not try to take on the role of a genetic counselor and perhaps partner with a genetic counselor to meet that need for your patients, but the other thing that I see coming up sometimes is physicians in their effort to


    facilitate a patient being able to access PGTM because the patient says, hey, I was once told I have XYZ condition or my aunt has ABC genetic condition. Can you test for that? Trying to take on diagnostic genetic testing is.


    one of the most complicated things that you can do in genetics and making sure that you're ordering the correct tests and interpreting them correctly and addressing any of the medical management based on the test results. So if I could wave that magic wand and have REs stop ordering genetic testing, diagnostic genetic testing is very different from carrier screening.


    Please keep ordering that. But trying to make a genetic diagnosis for a patient is very complicated.


    Griffin Jones (40:57)

    Rachel, you had mentioned you would like technologies to be able to double check embryos. Were you talking about gamete identity? Were you talking about something that electronic witnessing is something supposed to do or something else?


    Rachel Donnell (41:04)

    Yeah.


    genetic test results before transfer, double checking that everything is in the EMR and entered incorrectly, and then double checking which embryo we're transferring or the order in which we transfer. And I think that really only comes from, I think a lot of patients are super concerned now about making sure the right embryo is being transferred and that their embryos are their embryos. So yeah, was just a... ⁓


    I think it would be nice and helpful if we had that ability at the clinic to provide that additional reassurance for patients. But I know a lot of fertility clinics are double and triple checking these things, but using AI or a technology versus humans could add an additional layer of support.


    Griffin Jones (41:52)

    I'm going to leave this question open-ended so you can go either way with it, depending on which way you want to go. As specifically as you can be, what technologies or methods are you dreading or really excited about in the next two to five-ish years?


    Andria Besser (42:13)

    If we can dread something that already exists, I guess dreading the expansion of is the polygenic PGT. I think it has, even though it has been around now for a few years, I think just in the past, yes, PGTP, yeah. We've now seen more companies taking it on. We've seen some aggressive marketing out there from some of these companies, and we've seen a shift from looking at polygenic risk scores of


    Griffin Jones (42:26)

    Is that PGTP, Andria?


    Andria Besser (42:42)

    diseases or conditions move over into traits like IQ and height. And I think that that's got a number of issues, not only ethically, I mean, I think we could talk about that for hours, but also just the science of it is obviously very much in question for a number of reasons. But I think, at least from where I sit, helping patients make decisions about embryo transfers based on the information we have right now.


    PGTA data, PGTM data, just embryo grade and day of biopsy. That's a lot already and patients are really having a difficult time. The sex of the embryo, let's incorporate that in there. They have a really difficult time ranking their embryos and making decisions. So I think adding on to it, okay, well, this embryo not only is the...


    the opposite sex of the one that you were hoping for and maybe the lowest grade, but it's actually got the lowest breast cancer risk, but it's got a higher risk of bipolar disorder. So how do you feel about that? I just, I don't know how any human can make those types of decisions. So I would say I'm really dreading the potential expansion of, of PGTP.


    Griffin Jones (43:54)

    When you say the science is in question, Andria, I've heard this a lot. Just last week, I had someone from a PGTP lab show me their deck and talk about height and make claims about height. And they're claiming that it's very validated. My social sciences degree didn't prepare me to scrutinize that. So what questions should I ask when someone tells me that the next time?


    Andria Besser (44:23)

    Yeah, I think there's a few things. I think that a lot of the data that's out there has been based on modeling. We don't actually have outcome data, which is, mean, to be fair to these companies, it's pretty impossible to get at this point because what are we going to do? Follow these kids for 75 years and then wait and see what diseases they develop. We don't really have a way to get a lot of that data. So it's not that they're missing doing these studies, but I think it does put a lot of the data in question.


    I think the other thing is just being realistic about how many embryos patients have to choose between. I think if we were talking about humans as if we were cycling rabbits and we had a hundred embryos to choose from, that's a very different story. But most patients are gonna have what maybe two euclid embryos if they're a good responder. And now those two euclid embryos maybe have a small difference in risk that could be, it depends on the condition, but for something uncommon like schizophrenia, maybe the difference in risk is going to be 1.5 % versus 1.2%. So how much is that really going to help the patient feel more comfortable and actually reduce the disease burden? I think it is a question.


    Amber Kaplun (45:35)

    And I think just to add on to that, all of these companies have their own proprietary algorithms and bioinformatics methods, and none of that is really transparent at this point. So there have been articles published in popular media about people that send information to two different labs and get two very different responses back. So I think there needs to be some agreement on like, okay, what type of validation are we seeking out? But then two, there also has to be some sort of metric or way that clinicians can independently evaluate those labs and we're just not there yet.


    Griffin Jones (46:07)

    Where do the rest of you sit on the dread excitement spectrum? All dreading the same thing?


    Rachel Donnell (46:13)

    I think I'm dreading but also excited for the same thing. So it's a bit of a conflicting answer here, but I both am dreading and excited about these labs that are potentially offering like what they're calling PGTG or like whole genome, whole exome sequencing of embryos. Yeah.


    Griffin Jones (46:30)

    Well, that is pretty different from PGTP, right? Like it's the same technology, but a very different application.


    Rachel Donnell (46:37)

    Mm-hmm. But again, to Andria's point, just so much information and like, you know, at the end of the day, sometimes I'm left with like, do you want a baby or not? Because like none of these embryos are going to be without anything because none of us are and none of us get out of this whole experience alive at the end of the day. So I dread it from a, you know, patient understanding and all the counseling and, you know, these poor physicians having to like rank these embryos. But it is exciting from the standpoint of like, it's just so cool how much testing we're able to do of embryos. And that is just fascinating to me.


    Griffin Jones (47:13)

    How many of your cases have done whole genome sequencing? I was at dinner with a number of doctors last week and it was amazing how the room was divided. The California doctors were saying, it is so many of our patients. In some cases, may have been, I don't think it was a majority, but some people were saying, so many of our patients have whole genome sequencing and the doctors in middle America were saying, I don't think I've ever seen a patient who's had their whole genome sequence and how common do you all suspect it is right now?


    Rachel Donnell (47:45)

    not very. It's quite cost prohibitive.


    Andria Besser (47:47)

    on embryos.


    Yeah, for talking on embryos, it's so expensive. I think that's a big issue with it. We've had one patient who has done it. So, know, occasional request, but not common.


    Lauri Black (47:57)

    And we, you know, looking at all the clinics throughout ⁓ North America, I think that there are definitely hot spots where that is a question brought to the providers from patients more frequently, but then there are clinics where it really just isn't a conversation that they're having. And even if the conversation is raised and the question is asked, it doesn't mean that the test is actually done. So, I think that it's gonna be an interesting thing to observe, to see how this unfolds. think I'm cautiously optimistic. I'm kind of with Rachel on the PGTG and how that may improve and offer more options to patients that actually have some clinical utility, but I am wholeheartedly in agreement with what Andria and Amber were saying about PGTP.


    Griffin Jones (48:48)

    In the next few years, I have a feeling we're going to see a lot more questionable technologies and hopefully many more hopeful technologies as well. And as they continue to pervade, I'll need your help to help me understand them. And I'll happily bring you back on because it's been a pleasure today. Thank you all for joining me on the Inside Reproductive Health podcast.

NYU Langone Health
LinkedIn

Inception Fertility
LinkedIn

Shady Grove Fertility
LinkedIn

IVI RMA America
LinkedIn

Andria Besser
LinkedIn

Lauri Black
LinkedIn

Rachel Donnell
LinkedIn

Amber Kaplun
LinkedIn


 
 

285 CCRM's Investments in 2027. Tracy Belsan

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


What is CCRM building toward, and how are they preparing for what comes next?

As part of Unified Women’s Healthcare, CCRM is positioning for a future where “hub and spoke” becomes more than just a buzzword.

Tracy Belsan, President of CCRM Fertility, joins the episode to share how they’re thinking about growth, operations, and the patient journey.

We dive into:

  • The KPIs CCRM focuses on

  • The operational barrier they removed (Moving patients into care faster)

  • How technology is being implemented across the patient journey

  • CCRM’s approach to patient finance and access to care

  • The role of APPs and evolving clinical models

  • What it takes to consolidate an entire network onto a single EMR by 2027


Keep Patients In-Cycle with Lower Costs and Trusted Support
Medication cost and uncertainty are two of the biggest reasons patients drop off. Mandell’s helps reduce both.

Through its Serono Preferred Pharmacy Partnership, Mandell’s Clinical Pharmacy supports the Fertility Instant Savings Program, helping significantly lower out-of-pocket medication costs so patients are more likely to stay in-cycle. 

Mandell’s earns a 4.8-star Google rating and an NPS of 96 by making patient education a priority. Pharmacists are readily available to explain medications and standard fertility procedures, helping patients feel informed.

👉 See how Mandell’s supports patients before and during treatment 

  • Tracy Belsan (00:00)

    The number one obstacle is really the financial piece for patients. That's where we see the largest drop-off and it really is, that's a global phenomenon, that that's where one of the biggest barriers to care is. And so for us, it's how do we remove those barriers? How do we make the patient journey and the patient experience as seamless as possible from the moment that that patient finds us,


    However the patient comes into our front door, we have to remove all the barriers to make it easier to access that care.


    Griffin Jones (00:41)

    What's CCRM up to? And because they're a part of Unified Women's Health, how are they positioning for the hub and spoke era that I believe we're entering and removing that gap between the spheres of REI and OBGYN.


    My guest is their president, Tracy Belsan. She's been at the helm of CCRM for about a year now. She shares which KPIs she pays most attention to patient satisfaction, new patient numbers, conversion to treatment, and others. She talks about a barrier that she removed very early on in her tenure alongside her team to move patients into the journey more quickly and efficiently.


    I mention a little bit about how fertility centers and networks rely on Mandell's Pharmacy for things that ultimately help them with patient satisfaction, retention and conversion. Tracy shares some of the technologies that CCRM is implementing to help with the patient journey. She talks about CCRM's approach to patient finance. She talks about where CCRM is with regard to having OBGYNs perform egg retrievals. She shares how CCRM leverages APPs.


    Tracy talks aboutCCRM's progress consolidating 1 EMR. Right now different CCRM clinics use different EMRs. In 2027, the expectation they'll all be on one, and what's going into that process. So if you enjoy learning about CCRM's vision, tell Tracy Belsan, you heard it here on Inside Reproductive Health.


    Griffin Jones (03:21)

    Ms. Belsan, Tracy, thank you very much for joining me on the Inside Reproductive Health podcast.


    Tracy Belsan (03:27)

    Thank you for having me, Griffin. It's a pleasure to meet you.


    Griffin Jones (03:29)

    You've been on the job for about a year now if LinkedIn serves me correctly. What's the hardest part about running a very large multi-center IVF network?


    Tracy Belsan (03:40)

    It's been right at about a year. It's been an amazing year. The hardest part is just making sure that we have as broad a patient access as we can. That's really near and dear to our hearts at CCRM. We are a network that certainly leans into the patient experience, leans into quality. And we know from the statistics, there are a lot of patients out there who need our services. And for us,


    operating in 21 sites. We want to make sure that we have the right physicians, the right access, the right processes and systems so that as many patients that need to get care from us possibly can. So that's, think that's one of the most challenging pieces and coupling that with physician recruitment and ensuring that we are at the forefront of physician recruiting across the nation is also another challenging piece. But those are challenges that we have readily accepted. We have an amazing team that's out in the market.


    really tackling those particular issues. But overall in the last year, are a couple of things that have been top of mind.


    Griffin Jones (04:40)

    When you say access, do you mean like having the capacity to be able to meet the demand for IVF? Tell me more about that.


    Tracy Belsan (04:48)

    Yeah, it's capacity. It's also, again, there's a lot of patients out there. There's a lot of patient need and fertility certainly has been in the spotlight over the last few months. And we understand that there's about one in six patients that will experience some type of infertility. And we want to ensure that we're the places that we need to be. And we get feedback from our patients that say, are you operating in this community? Are you operating in that community? And we certainly want to be. We can't be everywhere.


    but we kind of pull back and look at the chessboard and say, where does it make sense for us to be offering fertility services? Where can we collaborate and partner? so patient access is really about services that we provide, but also how can we extend into markets that we're not currently in to pull patients into our markets that we currently have.


    Griffin Jones (05:37)

    So right now there's about half a million IVF babies born worldwide each year. People like David Sable think that that number should be more like 15 million per year. I think we did probably 400,000 or so IVF cycles in the country in the past couple years. People like John Sokolop Moncap want to see that be a million by 2030.


    So there's a sort of gradient of how quickly you can scale up. And you're not doubling CCRM cycles tomorrow, but just for a thought exercise, what's in the way of CCRM doubling the number of IVF patients they're able to serve?


    Tracy Belsan (06:24)

    The number one obstacle is really the financial piece for patients. That's where we see the largest drop-off and it really is, that's a global phenomenon, that that's where one of the biggest barriers to care is. And so for us, it's how do we remove those barriers? How do we make the patient journey and the patient experience as seamless as possible from the moment that that patient finds us, whether that's through an internet search, whether that is through a friend, however,


    However the patient comes into our front door, our virtual front door, we have to remove all the barriers to make it easier to access that care.


    And some of the things we've done to mitigate that is moving more of the financial diligence, that process upfront. We want the patient to know very clearly, be as transparent as we can. What is the treatment plan? What are the treatment options that the patient could encounter?


    What is the cost that goes with that practically? This certainly is a clinical journey for the patient and we understand that, but practically it's also can be a financial journey for the patient and for their family. And so just ensuring they have as much information as they can that we are walking them through some of the different options that are there for them. But that really is the biggest, one of the biggest obstacles for us at CCRM. It's not our internal process. It's not the number of physicians that we have. It's certainly not quality. We have some of the best in class.


    but it really can be some more of those barriers around the financial piece and the cost.


    Griffin Jones (07:54)

    Tell me more about that. I know some fertility centers now are starting to have the patient read about those options, see those options, even talk to financial counselors prior to even their first visit. Are you now doing that prior to first visit or does it come after?


    Tracy Belsan (08:10)

    It comes shortly after, again, we're pushing that to as close to the beginning of the patient journey as we possibly can. We also partner with some great technology companies that help with that, right? They help us identify how to, what the benefits are for a patient, if you will, and then how to kind of move them through the patient continuum a lot quicker. So we don't ever want that to be the cost piece, to be a barrier for a patient. We want to work with them, we want them to understand.


    their clinical options, we want them to understand the clinical operations of CCRM and what that will mean to them throughout their patient journey. And so we don't want the cost to be prohibitive for them to receive care, but we understand that's just a practical, a practical part of this process.


    Griffin Jones (08:55)

    Tell me about some of those tech solutions. Who do you like so far?


    Tracy Belsan (08:58)

    have some tech solutions around the benefit verification piece. And we also have some technologies that just tell the patient, they kind of tell us upfront what's there for the patient, what's available and what isn't. And then financing options, you know, that's really a big piece for the patient of they know they want a family. We explain to them what the cost is and then what. Then they're at really a crossroads of


    Where do I go from here? Is there financing available to me? And so we have partnered, we have a couple of really great partners in that space that help the patient get to treatment quicker, help them to understand the financial, the different options that are there for them and move them through that patient journey a little quicker. there's, and it's been great to see even in my year with the company, there's just more and more technology, more platforms that are coming online.


    to help the patient. As more data comes out, what I said earlier, that this is a global issue around the cost piece and where we see the patient drop out. We've just had some really great partners that have had stepped forward for us.


    Griffin Jones (10:03)

    the patient journey side of those technologies that CCRM has built or using something like either EngagedMD or Barry or Frame or any of those.


    Tracy Belsan (10:13)

    All of the above, all of the above. And we're meeting more and more partners, ⁓ you know, every time we are out at a conference or we get a lot of inbounds actually of different companies wanting to partner with us. Frame has certainly been a great thought partner to us actually over the last few months. We've met with them on a few occasions and EngageMD we have in our locations right now. And we're looking at Patient5, we have FutureFamily. So a lot of great partners that we have out in the market currently.


    Griffin Jones (10:41)

    I was, while we're on the topic of finance, I was talking to a practice owner that owns a practice within a network. This doctor told me that they are probably, probably 40 % of their patients are financed. And this individual said that that was probably double the next highest practice in that network. And


    I asked this person, do you think that we're under financing, that there weren't that not enough patients are going through financing? Should the other practices in your network be more commensurate with where you're at? And this person thought, yes, where do you stand on that?


    Tracy Belsan (11:27)

    I agree. I agree with that assessment. What we have found is in looking at the data, more patients could be getting that those financial options and that financial approval in order to get the care that they are that they're wanting, right, to build a family. And so our partners, though, have been exceptional in stepping up and saying, how can we make this? How can we make their own journey through their process of their technology? How can we make that?


    better, how can we make it more streamlined for the patient? How can we make approvals quicker? How can we change the threshold of approval? So it's been a really good collaboration with those partners to say, you know, the data isn't trending how we thought it might trend. We actually need to open the aperture a bit more to get the patients the access that they need to funding. And our partners have stepped up really, really beautifully in that process.


    Griffin Jones (12:18)

    Maybe I'm wrong about this assumption, but I gotta believe that in your first few months as you're getting into running CCRM, you're noticing one of these barriers, whether it's financial or something else, but you're noticing a specific barrier that you're thinking that should just go away. Or that should be a quick fix. And maybe you bit your tongue for a couple months to really get your head around it. But I gotta believe that


    Tracy Belsan (12:42)

    Yeah.


    Griffin Jones (12:45)

    you had something like that. What was it as specifically as you can be? What was a specific thing that you saw that it's like, let's get rid of this barrier now.


    Tracy Belsan (12:54)

    Well, that's a pretty easy one. And I didn't have to bite my tongue too very long, but we had made a pretty cumbersome process on the amount of forms that a patient had to fill out. And there were lot of reasons that that happened, but over time, it just continued to grow, right? The number of forms, just the process, the amount of time that that took for a patient. And we had to take a step back and say, well, wait a minute, patients are coming to us with a clinical issue.


    It's also an emotional issue and it's an emotional journey for these patients. Are we putting up an impediment to patients and their families to get into us quicker? And the short answer really around that was yes. And so we spent a lot of time in my first few months and I'm happy to report this has been corrected, but we spent a lot of time just really kind of going back to basics and stripping down some of our processes and getting it to.


    a level that was much more manageable for a patient that didn't seem overwhelming. They get the appointment with us and then comes all the hard stuff that they need to do. They need to then do the forms and the process and the financial counseling, not to mention the physical and the clinical piece of their journey. And so we've just really taken a lot of that burden away from the patient and from their family and said, come to us. Yes, there's some forms. There's always the paperwork that you have to fill out. And yes, you have to do that.


    but let's try to make that easier so that's not at the forefront of your mind, just part of the process. And really the clinical piece and getting you to the outcome of having your family is really the part that's at the forefront.


    Griffin Jones (14:27)

    Such a trade off of where you put that, right? So the forms that they had to fill out, was that prior to scheduling they had to do that? It was right after, and now you wait until after the first consult before they have to do all that stuff?


    Tracy Belsan (14:35)

    right after.


    And the forms are still there, but we've really, really reduced the amount. We've reduced the time that it takes. We've reduced the effort on the patient's part that that takes and taken on some more of that burden ourselves and helping them through that part of the process. It just, we don't want them to come in and all they're thinking about is paperwork, right? That is not, that's not where their mind should be. And so we're not perfect there, certainly. It's been quite a journey.


    for us at CCRM, we're just, again, we're just trying to go back to basics and have what we do at CCRM focus around the patient experience, the science of CCRM, which we, in our approach, are tied together. The patient experience and the science are all one. And we want them to come into us and say, I've been having an infertility issue. I'm here to get help, and we help them.


    and they leave with the outcome of having the beautiful family that they want. we just have had to get better at operational processes and structures. And we've done a lot of great work over the last year on that.


    Griffin Jones (15:46)

    So as a marketer and a salesman, I really like that approach because you want to lower the barrier to entry, period. So I like it from that perspective. I think of what my friend Dr. Harrington says, and I'm always paraphrased it, so I might be getting it a little bit wrong, but he says something to the effect of I am most useless to the patients that I know the least about.


    And so I know there are some practices that all of that stuff has to be done upfront because then the consults are more effective. How do you balance that trade off? How do you measure if, okay, well, yes, now it's made our new patient volumes go up, but it's actually hurt our conversion rate. How do you measure that trade off?


    Tracy Belsan (16:16)

    Yeah.


    Data, I mean, we have some phenomenal data at our fingertips. We have a really great analytics group that provides us with daily, weekly, monthly data. have whatever we need. And we are constantly looking at how do those measures, how did our hypothesis in the beginning of streamlining our operations, is that moving the needle? Are we able to get patients in the door quicker? Are we able to move our conversion time down?


    What do our patient satisfaction results look like? What are our employees telling us? Because they're the ones that are on this journey with the patient. So we take all of, and what are our physicians telling us? We take all of those data points and we bring them together and say, are we moving the needle the way that we thought we were? If the answer is yes, great, but we continue to monitor that. If not, go back to the drawing board and say, what piece did we miss there? And what do we need to change? And sometimes it's a piece of technology. Sometimes it's,


    It's just a little part of the process that we needed to tweak. Sometimes it's, we need more resources in a certain area that we hadn't anticipated. So we are constantly looking at data dashboards every day, every week, and trying to make sure that we're lining up with what our expectations of the business are and how it's actually trending and what the outputs are.


    Griffin Jones (17:48)

    What's on your dashboard, the numbers that you care most about above all others, patient satisfaction, new patient volumes, conversion? What are the main five or six KPIs that you're really stressing?


    Tracy Belsan (17:56)

    huh.


    New patient visits, which goes back to the access that tells us, we opening up and broadening the access as much as the patients are telling us they need us to? So new patient visits is one of them. Also our conversion rate, how is that trending? it too long? Can we shorten that? Are there patients that are getting then stuck somewhere within the patient care continuum? We have some great analytics that shows us from the moment a patient walks in the door.


    What are the different treatment modalities that are triggered for that particular patient? Are they getting hung up in one particular area? What are we doing possibly in CCRM that's preventing them from moving through the journey? Is it a clinical issue, a non-clinical issue? So we look at, we triangulate a lot of different data points to look at that. We look at patient satisfaction, certainly. And we just look at our overall mix. We look at our mix of patients. We look at...


    our physician satisfaction and engagement. And we tie all of that together to create a story and a picture for how well we are doing within a particular market and then more broadly just across the enterprise. And are there some threads we can pull maybe over, you know, from New York that they're doing really well in an area and maybe another market is struggling and we can move that over as a best practice.


    Griffin Jones (19:18)

    Satisfaction and retention start with experience. When patients feel supported, informed, and in control, they stay in treatment. That's why clinics and fertility center networks partner with Mandell's Clinical Pharmacy. Their pharmacists focus on education, access, real human support so patients actually understand their medications and what comes next. Combine that with lower out-of-pocket costs through the Fertility Instance Savings Program and staying in cycle.


    becomes easier. Mandell's has a 4.8 star rating on Google. You can look it up. They've got a 96 net promoter score. That reflects an experience that patients trust and recommend. And you can look and see fertility pharmacies that don't have that and think about which is going to better serve your clinical team and which is better going to serve your patients. Visit mymandellspharmacy.com.


    to see how they support teams like yours or reach out. I'll be happy to make that intro for you. That's mymandellspharmacy.com. Tracy, tell me about the appropriate balance between.


    Practice autonomy, clinical autonomy, like at an individual level versus networks adopting a standardization that allows for best practices to permeate throughout.


    Tracy Belsan (20:36)

    That's always such a balance for think any healthcare network to find regardless of specialty. But for us in CCRM specifically, we do not insert ourselves in the exam room of a physician. What we do standardize is we standardize our lab practices across all of our sites. That's very important to us. We standardize some support services functions such as legal and compliance, regulatory, HR, IT.


    But from a patient care perspective, we really leave that to the individual physician, the individual market. And there can be certain clinic locations that decide to do things one certain way. And that's okay. We certainly give guidance. We have physician councils and we have physician groups that meet. So we certainly will give our guidance and our advice based on industry best practices, based on research.


    but we do not insert ourselves into the exam room or into the surgery suite.


    Griffin Jones (21:37)

    But do you think it's generally better that clinics are using the same PGT labs that they're using the same supplies? Is that better than having everybody kind of choose for themselves?


    Tracy Belsan (21:47)

    We do.


    We do on the lab side on the procurement side. There certainly is. There's some leverage there and there's also some scale, but just from an outcomes from a clinical outcomes perspective, having our lab functions consolidated, having it standardized, having SOPs that are across each of across all of the sites we find and we pride ourselves really in the impact that that has on our clinical outcomes, on our quality and


    just across the board on how we see that translate into our patient care.


    Griffin Jones (22:23)

    How about on the clinical side, things like pharmacy, things like carrier screening, things like anesthesiologist staffing or CRNA staffing, that sort of thing.


    Tracy Belsan (22:34)

    Anesthesia is tough. That's tough across the whole country right now, and we are working to go towards a standard model for that. Historically, that has been more of a market-based approach, but we will be going to more of a national model, again, just to get some of that scale and leverage, and certainly in some of our markets, some more predictability around service there. And for all of our testing, all of our clinical testing, that happens on a consolidated basis out of our Denver location.


    And we find that that's just the best possible, gives us the best possible chance for outcomes.


    Griffin Jones (23:08)

    Do you get some pushback from that? think of, I say that I really admire Beth Zoneraich from Pinnacle because she's been on this show a couple times. I've seen her give talks. I think she's very transparent about this is the Pinnacle way and if you don't like it, then maybe this isn't gonna be a good fit where I see other groups kind of tell doctors what they wanna hear and then


    there's tension later of, no, it's not gonna be that way because we need to standardize some things and so you can't do it that way anymore. so what kind of pushback do you get when you try to roll things out at the network level?


    Tracy Belsan (23:49)

    First of all, Beth is great and I really admire her. And we think we do strike a good balance at CCRM. We call it the CCRM way and our new physicians, our new locations, they all go visit our Denver location, which is our flagship location. And they go through the process of the patient care journey. They go through the business, the operations process. So kind of.


    front office and back office. So we do have a CCRM way, we do, and we have a lot of standardization. But as I said, where we do let the physician make the decision is with the patient, directly with the patient, because every patient that presents is going to be different. There's going to be different clinical indicators, there's going to be different socioeconomic indicators. There's just a lot of different factors for each and every patient. So we don't...


    legislate what's going to happen in the exam rooms, but we certainly give our physicians, we give our nurses, we give all of the teams at our CCRM sites, the resources and the structure that they need so that they're just focused on patient care.


    Griffin Jones (24:55)

    While you're here, I'm going to solicit you for some free consulting, which is people tell me ask me how I'm going to expand the media company and they ask, you going to do this in other fields? And I think the smarter way of growing our media company isn't just duplicating it and saying, now we're inside MFM, but rather to expand as the field expands. so as genetics and REI overlap more,


    then our genetics audience increases in the content that we create for genetics as OBGYN gets back into the IVF space more and overlaps more than I'm creating more content for them and they're becoming part of the audience. What should I be paying attention to in the OBGYN space as it overlaps with the fertility space?


    Tracy Belsan (25:44)

    Well, there's such overlap and we have CCRM and within the entire unified, there is, there hasn't been, there hasn't been, you would think just inherently that there is and that there should be. And CCRM were part of Unified Women's Healthcare of which we have over 3000 OBGYNs within our own network, which gives us an amazing platform to serve women across the entire


    Griffin Jones (25:47)

    Well there should be such overlap, right? But there hasn't really been a lot.


    Tracy Belsan (26:11)

    care continuum across their whole lives. And so, you what we look for, I'll speak for CCR and what we look for is where are those synergies in care? What are the different diagnoses that our OBGYNs are treating that have a direct impact on the fertility of a patient? That could be PCOS, that could be endometriosis. How are we sharing the latest research information on those diseases and sharing it back with the OBGYN? We're really proud. We have


    great synergy between our REIs and between the OB-GYNs. They share clinical information, they meet routinely, they talk about what do the OB-GYNs want to treat for a fertility patient? Is there any workup that they want to do? What's the workup that we're going to do? That can vary by market, that can vary by region, but we have ongoing dialogues with the OB-GYNs on just that. The clinical care of the patient.


    when to send the patient to us, when we're going to send the patient back, the services and the care and that white glove service that they can expect from us at CCRM for their patient. And so we have a lot of good overlap and a lot of good synergies. I don't know that there's many more companies or which other companies are able to do that because of our uniqueness of having this embedded network of OBGYNs and of REIs within one company.


    Griffin Jones (27:36)

    Within that network is there the appetite to further segment OBGYN? So it's like these clinics or this division or at a bare minimum these doctors, all they really do is sort of IVF triage. They're doing the fertility treatment or diagnoses prior to the REI to ensure that fertility centers are really just seeing


    IVF ready patients and the most complicated cases. Is there an appetite to segment it that way that they're not doing obstetrics, they're not doing routine gynecological visits, that you're segmenting either clinics or OB-GYN physicians to just be that space in between routine gynecological care and REI?


    Tracy Belsan (28:30)

    There's not an appetite to segregate and just do one or the other. Where the appetite is, is to actually do both. To say, we want to be your partner. We might be an affiliated location that's three hours away, but we can do these 10 things on a fertility workup for you on your behalf. And then we send the patient over to you. We'll help with monitoring throughout the clinical care journey. We'll help kind of define what that looks like.


    So we don't segment off OBGYNs and say, now all you're doing is fertility workup. They're actually doing both. So the appetite is there to say, how can we as OBGYNs be more involved in what is happening on the REI side of the business? How can we help do some of the testing? And then the appetite for the REI is that partnership with the OBGYN, whereas before, and you alluded to it, it's you're either an REI.


    or you're an OBGYN and the two sometimes shall not meet, particularly networks that aren't like us where it's consolidated and where we have both of them together. But we've really broken down all of those walls and our physicians, what we found is kind of thought there might be just this built-in tension or resistance of not wanting to work together. And what we found is there actually was a huge appetite to work together and to have those walls broken down and say,


    Let's really partner just on the clinical aspects of the patient care. What can we do? What do you do? The two certainly overlap and our patients will be better off for it with the collaboration.


    Griffin Jones (30:05)

    How is Unified starting to think about the hub and spoke model that people talk about? I've become convinced that we will not see anywhere near the number of patients that need to be seen or better said treated without REIs doing many more cases, but doing that in a tech enabled way where they're overseeing OBGYNs and APPs doing a lot of different things. And I've come to support Dr. Harrington's point that


    REIs need to be the ones designing that system. Otherwise, the other players in the market will just design it without them. so how is Unified and CCRM's relationship positioned to do that hub and spoke model? What's the vision?


    Tracy Belsan (30:50)

    We have fully embraced hub and spoke within CCRM and within Unified. The feedback when we presented it out into the markets and we've done somewhat of a road show we did in 2025 and continuing in 2026 to go out and meet with our OBGYN partners, showing the value proposition. What does it mean for the patient? What are the expectations around clinical care? What are the outcomes that their patients will have? And we have just had overwhelming support for implementing hub and spoke and


    Again, that's part of breaking down the barriers of communication. And we have just had this incredible outpouring of hand raising of when can we go next? When can our market participate? When can we get together as OBGYNs with our REIs and vice versa to talk about the best path forward for hub and spoke in a market and to think about, as I talked about earlier, that helps us extend the reach of CCRM.


    and our OB-GYN care into markets that maybe we don't have an actual brick and mortar for REI, but it certainly helps us extend into those markets and pull patients in that might otherwise have a tougher time getting access to care.


    Griffin Jones (32:01)

    Does that include OBGYNs doing IVF egg retrievals?


    Tracy Belsan (32:06)

    It doesn't at the moment. I think it could in the future. For us, it doesn't. That's not part of the model. It's more around the monitoring piece and the collaboration on the patient's clinical journey through CCRM. But I think it certainly could. That's something that we have discussed at a very high level. I think that might be phase two or phase three. But initially, we were just focused around, first thing was making sure that the REIs and the OB-GYNs were aligned.


    on what does does hub and spoke look like, what should it look like, who wanted to participate, and then making sure that we have the patient access and all of the structures and the clinical processes in place to be able to provide those services. And we've done that over the last year.


    Griffin Jones (32:48)

    I'm thinking of different CCRM practices right now. All the ones that are coming to me are in fairly large markets, Boston, Orange County, Northern Virginia, Denver, obviously, Houston. I imagine that Unified, do they have OBGYN practices in much smaller cities?


    Tracy Belsan (33:11)

    They do, but we have a lot of overlap with where we are with our CCRM locations. And that's where we've been able to lean in and leverage the relationship and leverage the OBGYNs and the REIs working together. But certainly we are at, they have 3000 plus OBGYNs. We have 60 REIs. So we have a significant amount of overlap, but they have a lot of good penetration on the OBGYN network and a lot of other markets.


    Griffin Jones (33:36)

    My point is that REIs are mostly in large markets. And if you look at those that are graduating from fellowship, 80 % of them want to go to 20 cities or contrast that with OBGYNs where most towns of a certain size have an OBGYN. And so there's a lot deeper penetration. is it an inevitability?


    Tracy Belsan (33:41)

    Mostly.


    Sure.


    huh.


    Griffin Jones (34:05)

    that we're going to have to have OBGYNs do IVF egg retrievals if we're gonna scale care to population health.


    Tracy Belsan (34:16)

    It could be depending on the market and depending on depending on the patient base that's there in a certain market. So it certainly could be. And, you know, I think that's really ultimately for the physicians to decide around. Number one, do they want do they want to perform those services on the OBGYN side? How are the REIs and the OBs partnering on that? But I expect that that will be very market dependent.


    Griffin Jones (34:41)

    Is the barrier there, you said there are some barriers to think about before you get to that phase. Is the barrier just current REIs and the way they think things should be done?


    Tracy Belsan (34:53)

    I think that could be part of it. I think that they get just like OBs and other specialties, you kind of get into a rhythm of what you do and what your clinical practice looks like on a day-to-day basis. And the REIs are, as with our OBGYNs, it's heads down. They have full patient schedules every day, and then they have their surgery schedules, and they're moving through the day. So it's just not something.


    I don't know that they're adverse to it. It's not something that we've really put at the forefront right now that's on the roadmap. But again, that could be down the line. But for us, it was just making sure that we were getting all of our processes in place and as I said, really streamlining what we do so that the patients that came to us from our OB-GYN partners was as seamless as possible. And so I don't say, I'm not saying that it won't happen. It just hasn't been at the forefront of the discussion to date.


    Griffin Jones (35:47)

    I wonder if I want to push it more to the forefront because I've come a little bit off of the fence in that there just is no way to serve all of these people. And there are hundreds of thousands, if not more people in the United States of America right now that need fertility treatment, that need IVF specifically, that cannot either afford it or access it. Actually, I did a little


    ⁓ analysis, take a wild guess how many counties, what percentage of counties in the United States do you think have an IVF lab? Take a wild guess.


    Tracy Belsan (36:24)

    I would say five.


    Griffin Jones (36:25)

    Yeah, it's 8%. So 8 % of, so you win by prices, right rules, Tracy. 8 % of US counties have an IVF lab. Like we just can't serve, like try getting an REI to move to Tucson, Arizona or Buffalo, New York or Little Rock, Arkansas. I have, and you can't do it unless they're from there or their spouse is from there. So.


    Tracy Belsan (36:27)

    If we said


    Griffin Jones (36:50)

    We need other people to be able to do IVF. I'm not gonna tell docs how to do it. I'm not a clinician, so I'm not gonna tell you how to do it, but I am gonna tell you that this problem has to be solved. Are you reluctant to push them like that?


    Tracy Belsan (37:07)

    I'm not in your right to push on it. And it's something that you're exactly right. It's you just look at supply and demand. How many patients to your point need our need care across the board? How many resources there truly are? And the math is the math on that. It's pretty easy to figure that out. So no, you're right to push on that. I'm not reluctant at all. I don't think that our our physician leadership within CCRM within Unified would be reluctant to have that conversation either. And and


    Another part of that is to your point, freeing up those REIs to do as many procedures as they can to meet the demand. We look at our APP structure and how many APPs are we using and do we need to invest more there? And I think the answer to that is yes. And we've seen our physicians come around on that. That can be very physician dependent on how APPs are used within their clinic and to the extent the scope that they like to use them.


    And even in my year here and just in my 40 years in healthcare over the last decade or so, I've really seen that turnaround where doctors used to be pretty resistant to using that. And now they really see with the right APP just how much leverage they can get out of that. But also it just, from a scheduling perspective, it can get the patient in the door a lot quicker to at least do that initial triaging, that workup, take the history and physical.


    talk about what the patient goals are, and then hand it off to a physician. you know, for us, that's been a big push over the last year to think about how do we use APP smarter? Where do we need more APPs? I certainly think there's a lot of leverage there with their skill set.


    Griffin Jones (38:49)

    Dr. Emels has me thinking about top of license, not just top of license for REIs, which is the way I'd always kind of thought of it. But top of license goes all the way up and all the way down. So an REI shouldn't be doing anything that an OBGYN can safely and effectively do. An OBGYN shouldn't be doing anything that an APP can safely and effectively do, that a nurse shouldn't be doing that a medical assistant shouldn't be doing. What do you feel like?


    Tracy Belsan (39:10)

    Right.


    Griffin Jones (39:17)

    APPs could be at risk for being put on their plate that should actually not be on theirs that should be nurses. How should APPs be at the top of their license?


    Tracy Belsan (39:27)

    Yeah, and that's always you're right that that is always a risk, but our APPs and we have some fantastic APPs. We do use them to the top of their license. They are seeing new patients that come in. They are they are fielding patient questions. They are helping and working with the physician to look at patient list to kind of say, you know, which patients are you taking? Which patients am I taking? I need more leverage here is the physician to free me up so that I can.


    can be in the procedure room. And so it's about having the open communication, the ongoing dialogue. I've seen in cases where APPs, you're right, are functioning more like nurses, and that doesn't benefit anyone to have them not working at top of license. And we find that our patients actually like the experience too. They're getting a second set of eyes on them. They're getting a lot more.


    a lot more attention for their care. They're getting quicker care. They're seeing the APP. They're taking a lot of the information. Then they get handed over. They get that warm handoff to the physician. They'll probably see the APP again throughout the journey. So it just really adds to the patient care team.


    Griffin Jones (40:37)

    If you want better support for your patient care team and you want better patient retention, start with a better experience. When patients understand their meds, they have someone they can actually reach, and they don't feel blindsided by cost, they stay in care. That's exactly what Mandell's Clinical Pharmacy delivers. Their pharmacists lead with education, real human support, so patients feel confident in every step. And on top of that, Mandell's neutralizes sticker shock with lower out-of-pocket medication costs.


    through the Fertility Instance Savings Program. Their 4.8 star Google rating and their 96 net promoter score reflect the level of care patients trust and recommend. If you're using a pharmacy that's something less than that, then patients are perceiving your patient experience as something less than that. So if patient experience matters to your team, visit mymandellspharmacy.com. Reach out to me, I'll be happy to make an intro to you. That's mymandellspharmacy.com.


    my mother was in nursing for a long time and toward her retirement, the CEO of that health system said, we're in the nursing business. And I think of the nurses in pretty much every segment of healthcare is the unsung heroes, because you just can't sing it enough, right with nurses. And they still have so much


    administrative BS on their plate that is a complete waste of their time and not good for the patient experience. How do you start to single that? What have you done? What do you think technologies and practices that you've implemented have been the best for allowing nurses to do what they do best?


    Tracy Belsan (42:22)

    I completely agree with you on nurses. They are. They are the foundation and the backbone for the patient. For all of us. And we want to let nurses be nurses. You go into nursing because you want to take care of people. And what we don't want is that the majority of their time is spent in that administrative burden.


    It's spent online. It's been spent tracking, you know, tracking down administrative items, which is why we've really over the last year, gone on our own journey. what we started off calling the patient financial journey to streamline that process and really remove the word financial. It's just the patient. It's just the patient journey. And part of that is getting it right up front.


    I talked a little bit about that with our administrative process and the forms. But the more we can do upfront that streamlines the experience for the patient. When the nurse, when the nurse starts interacting with the patient, we want their job to be just taking care of that family, of that patient, so that that patient knows this is my person, this is my nurse throughout this entire process, for me and for my family.


    And so it's difficult. I don't think we can ever fully get rid of any of the administrative, parts that a nurse has to do, but making sure that our technology is sound, that we're constantly looking at the data that we have, the data that we can provide to our teams, but we do want to let nurses be nurses, and they're they're the direct partner with the physician.


    I mean, that is a, you know, that is a dyad partnership in all of our clinics. That's hugely important to making sure that the patient has the best experience possible, the best outcomes. And we want to keep we want to keep good nurses. Nurses are vital to what we do within CCRM and really across all of health care. So, I give a huge shout out like you did to every nurse out there and the ones that work with CCRM.


    Griffin Jones (44:20)

    Are there some technologies that you're looking at that can help reduce some of that administrative burden and what can you share about that?


    Tracy Belsan (44:29)

    We are. We're looking at an EMR right now. The you know, within CCRM we're on a few separate different EMR across the entire platform. And and looking at how do we get that streamlined, how do we think about that. possibly next year, getting an EMR implemented. And, you know, I think that helps with standardization, that helps with, having all of the data and information in one place that that, lends itself to a lot more of a, seamless process where people aren't going in and trying to to figure out where the data resides. So that's, I think, a big area that solves a lot of different issues for our clinical staff.


    Griffin Jones (45:08)

    Are you sort of baby stepping everybody in to be ready for that? Like kids, we're going to the dentist tomorrow. People hate switching their EMRs. Is that the reason why you didn't do it on day one? Is that it's taken you a year just to get people warmed up to the idea?


    Tracy Belsan (45:26)

    It's a process. And it's one of those initiatives that sounds everyone gets very excited about it. And yes, yes, we want to consolidated EMR until you have to get into the actual implementation of it. And what does it mean and how much time is it going to take. And you know, fingers crossed. But nothing happens once you go live. So it's not a quick transition, nor should it be. We want to get it right. Certainly we want to get it right for our clinicians. We want to get it right for our care providers, our care teams, and most importantly, for our patients. but it does take a little bit of time to do diligence around that.


    What's going to fit best within CCRM? What's that right technology I don't think there's 100% fit yet for any all of health care with a particular EMR. But we're certainly doing a lot of diligence and making sure that on the CCRM side, that our technology that we currently have is up to speed with where we need it to be, so that when we do overlay a new EMR, it can be as as effective and seamless as possible.



    Griffin Jones (46:26)

    Have you all made that decision? Is that made up in your mind? Like if I interview you in later 2027, is CCRM going to be standardized on one EMR?


    Tracy Belsan (46:40)

    I think that's a pretty good bet. I think that's a pretty good hedge there, yeah.



    Griffin Jones (46:43)

    Are you certainly going to go with one of the EMRs that your practices have been using? Would you consider one that you all, that no CCRM practice has been on yet?


    Tracy Belsan (46:55)

    I think it's likely that we'll go with someone. Someone that we know, a company that we've already done diligence on. But it's, you know, it's interesting the technology changes. There's new companies that come online. So it's we're going to have to just go with who we think fits best for now, but also a company that can scale and that will be able to make the updates and the changes and keep up with the industry. Also, over the next coming years. Because, once we switch EMR, this is not something certainly that we want to do every couple of years if we don't get it right. So that's top of mind for me.



    Griffin Jones (47:36)

    Seriously, the EMR sale cycle is the longest sale cycle because the best solution in the world could come out tomorrow, but if you just switch your EMR, you ain't doing it for ⁓ a few more years. that's a challenge that I see with EMRs is that you have some that maybe they have more IVF experience, but they started so early that they just really haven't been able to adapt to the new technologies. You have some that they're more recent. And so it's like, wow, this is awesome. This is what people have been asking for, but they might not have the experience yet. And then you have people in the middle that are either the worst of both worlds or the best of both worlds, depending on your point of view. Have you, is it, the decision of who all but made up in your mind? Or are you on a short list?


    Tracy Belsan (48:27)

    Yeah. It's a short list. It's really close. And I think there's also some, of the larger that don't want to go into the fertility side, and that's. That's okay too, right? That's fine. You can't be all things to all specialties sometimes as an EMR. And that's certainly okay. And because of the nuance of our specialty with fertility, we know that we need a very specialized system for what we do. And and as I said, a system that can scale with us a system that and a company that we can work with to say, you know, for our particular table space, what we have found is we need this functionality, we need this upgrade. And having a partner that's willing to let us have a voice in that so that we can, we can make those changes throughout the years and, and adapt, adapt to adapt to changing, research technologies as we grow and scale can keep up with, with our growth. And, you know, that will be really critical for us. And then also our physicians interaction to interaction and our nurses that it is for them a system that they can move through pretty easily. What we don't want to do is add to the administrative burden much of what we were talking about with the nurses, we're very sensitive to the fact that our physician time is very precious, and they have a limited amount of that every day to see the new patients, to be in the surgery suite, to see the follow up patients. And what I don't want for our physicians is that we implement a system that becomes a burden to them, that becomes, a platform that they can't pull effective data out, that can impact walking into the next patient room and rendering care. We want it to be very clinically sound.



    Griffin Jones (50:09)

    What do you see from what you've seen in the last year, what CCRM has done in the last year that you think puts CCRM in a really good position to help lead the field?


    Tracy Belsan (50:20)

    Well, for us, it's really it's kind of a it's a triad or a triangle, if you will. We have our lab, our genetics, our research and development. And we stay wholly focused on clinical outcomes. partnered with patient access. But our outcomes, our labs, our standardized process, the leadership that we have leading these functions is critical for us. And, in my opinion, and I know I'm biased, running the company, but, very much second to none. But our outcomes, our patients depend on excellent outcomes, excellent patient outcomes. When patients come to see us and they share with us their desire to have a family, our goal is to get them that family. Yes, quickly, but also as safely with the best outcome as possible. And so, for us, the lab, the research, our genetics, that consolidation, that standardization and being at the cutting edge of that is something that we're really proud of.


    Griffin Jones (51:25)

    What do you think that most people don't know about CCRM that you would want them to know?


    Tracy Belsan (51:32)

    what I just explained around the quality outcomes. We have an amazing culture at CCRM. We have a group of physicians, a group of leaders on the business side. We are all moving in the same direction. And that might really sound cliche, but it's it's not. We focus on a few very vital key initiatives within CCRM with the patient, first with the Patient Access Initiative first. But I would like everyone to know, like CCRM is the place to come if you want an outcome and you want that family and you want that quality and you want standardized, high quality testing, then CCRM is really, a network that's at the tip of the spear of that. And we have dedicated a lot of resources. We've put the right leadership in place clinically to get us there.


    But we certainly are are known for our outcomes. And, and quite frankly, we're getting better at doing the storytelling around that scrum is has been a place over the last 30 years that has been, a very well known entity. And we have a lot of patients that come to us if treatment has failed along the way. And, and we're a network, you know, see, CCRM should be the first stop along the way in your fertility journey.


    Griffin Jones (52:52)

    I think maybe a great place to pick up next time would be bringing on a couple of those leaders with you and talk about how you've aligned on that. And it'll be my pleasure to have you back because it was a pleasure today. Thank you so much for joining me, Tracy, on the Inside Reproductive Health

Tracy Belsan
LinkedIn


 
 

284 Don't Get It Twisted. PGT-G Thwarts PGT-P In Battle for Embryo Genome Sequencing. Dr. Mili Thakur & Dr. Sasha Hakman

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


A tale of two PGTs.

One is making bold promises and headlines, the other is quietly gaining traction and relevance.

Between PGT-P & PGT-G…what’s actually moving the needle?

Dr. Mili Thakur of Genome Ally and Dr. Sasha Hakman of HRC Fertility break down what they’re seeing in real patients, especially when everything else has already failed.

We dive into:

  • The real difference between PGT-P and PGT-G

  • Why some genetic claims are under scrutiny

  • Where whole genome sequencing is actually helping

  • How PGT-G may reduce repeated failed IVF cycles

  • Whether this can truly shorten time to pregnancy


The New Standard of Care in IVF
Juniper Genomics’ PGT-G for “Genomics” delivers deeper genetic insight beyond standard PGT.

Built for high-performance IVF clinics.  

Scale seamlessly without disrupting workflow. 

Learn how leading clinics are adopting the next generation of PGT. 

See what you’re missing with standard PGT.

  • Dr. Sasha Hakman (00:00)

    Patients are hearing about these tests and wanting that control. And I think that's where like a lot of the counseling will come into play of like,


    Yeah, this test exists, however, can never guarantee that you're going to have a child that does not have the phenotype that you're looking to eliminate.


    Griffin Jones (00:26)

    PGT-P has made headlines for bold direct-to-consumer marketing, but the ASRM has recently issued guidelines warning about the absence of scientific evidence behind such big promises.


    Meanwhile, a different way of doing whole genome sequencing, or at least a different approach to it, of the embryo has quietly been gaining traction. PGT-G doesn't tout wild claims, but it's steadily widening its relevance.


    as the evidence starts to come forth and use cases mount.


    joined by Dr. Mili Thakur who is an REI at the Fertility Center in Grand Rapids and has her own specialty practice, Genome Ally, where she sees the cases that you, her colleague REIs, send her when you trust your embryologists and your protocols, but you know there's a genetic challenge afoot.


    and by Dr. Sasha Hakman an REI in the Los Angeles area who believes that genetics has a lot more to offer to avoid repeated failed IVF cycles.


    Doctors Hakman and Thakur talk about Juniper Genomics, a PGT lab that does both PGTA and PGT-G. But specifically, what advantages Juniper's tests offer


    and how these two physicians believe, if I can steal a phrase from Abigail Sirus and Dr. David Sable, it reduces time to baby.


    I've only started paying attention to these differences between PGT-G and PGT-P.


    The vast majority of you seem freaked out by PGT-P.


    Almost everyone I've talked to about PGT-G sounds guardedly optimistic.


    But I'm only starting to figure this out, so listen to this episode, tell me, what do you think? What's for real and what's unfounded?


    Griffin Jones (02:57)

    Dr. Hakman Sasha, welcome to the Inside Reproductive Health podcast. It's about time. Dr. Thakur, Mili, welcome back to the show for the 80th time. like the Steve Martin of Inside Reproductive Health. You keep coming back. Sasha, what are the latest technologies impacting PGT right now?


    Dr. Mili Thakur (03:07)

    Thank you.


    Dr. Sasha Hakman (03:07)

    Thank you.


    So there's definitely been, I mean, the newest, latest, greatest is whole genome sequencing being used. However, different companies have different focuses. So the technology itself of whole genome sequencing, I think is a very attractive emerging aspect of our field when it comes to pre-implantation genetic testing.


    A lot of people have already heard of PGT-P, which is looking at polygenic risk scores, but not all companies that are doing whole genome sequencing have that focus in particular. And I know that it's been a very controversial topic since some companies are sort of advertising this as a way, like almost direct to consumer for people to sort of create designer babies or whatever have you. you know, there was even a New York Times article


    about it, but I don't think that, I don't know if everyone realizes that not every company that's doing whole genome sequencing is doing necessarily the same thing, where some are looking at polygenic risk score, but some are looking specifically at genetic causes of infertility and recurrent pregnancy loss on a single gene variant level, as well as looking at things like reduced viability variants.


    and the company that's actually doing this right now is called Juniper Genomics.


    Griffin Jones (04:41)

    And so there's different names for tests that do hold genome sequencing, Like PGT-P is one test and PGT-G is a different test.


    Dr. Sasha Hakman (04:51)

    G.


    Correct.


    Griffin Jones (04:53)

    Who comes up with the names of the tests? I remember 10 years ago, I had just got it straight. Okay, this is PGT and this is PGS and I had finally gotten it straight and then we don't do that anymore. And it was overnight. It was like there was a memo that went out and everybody got the memo at the same time. Who's making these memos? Who gets to decide what these tests are called?


    Dr. Sasha Hakman (05:17)

    Mili, you probably know this better than I, because I mean, I think the ASRM is the one that came up with changed it to PGTAM and SR, right?


    Dr. Mili Thakur (05:17)

    I think, yeah.


    Yeah, yeah. Thank you, Griffin, for having me. I think like when we were doing just PGT and PGTS, you know, at that point, I think in the early to late 2000s, you know, there was this need of like coming out with like technology that was changing. at that before that time, I think right around like 2000 is like 2000 to 2013, you know.


    Next Gen sequencing was coming out. And with Next Gen sequencing came out cutoffs for the test and how we call euploids and aneuploids and mosaic embryos. And when those guidelines were coming out at the same time, know, PGT, SIG and other, you know, ASRM and other societies came together to kind of demarcate that. So right now, you know, as all of our listeners know, we have the PGTA, which, you know, a focus of a lot of ⁓ practices is.


    Dr. Sasha Hakman (06:04)

    . .


    Dr. Mili Thakur (06:27)

    But we have PGTM for single gene disorders. We have PGTSR for structural rearrangement where there is like translocations and inversions. And then you have the other less frequently used ones. So PGT-HLA, when you want to match an embryo to a sibling for HLA matching, you have PGT-P, which is upcoming and we are still trying to figure out the ethical benefit of it. And then PGT-G, which is this new terminology, mainly I think


    Dr. Sasha Hakman (06:42)

    Announce.


    Dr. Mili Thakur (06:56)

    brought up by Juniper.


    Dr. Sasha Hakman (06:58)

    Yes.


    Griffin Jones (06:58)

    So


    do the labs, are the labs the ones that say this is what the test is and then the medical societies decide if they're going to adopt that nomenclature or do the medical societies get together and say this is what we're calling each one of these tests?


    Dr. Mili Thakur (07:15)

    I think the initial four tests were through medical societies. like PGTSR has a different technology than PGTM and PGTA. So those were kind of decided. And now these additional ones like PGT-P, the labs that were pioneering it are pushing that name quite a bit. And then PGT-G for the companies or labs that are using the whole genome sequencing. So I don't think ASRM or any other societies have yet.


    Dr. Sasha Hakman (07:22)

    .


    Dr. Mili Thakur (07:44)

    and


    or PGT-G, however PGT-P there was a recent guideline from SRM about how to use it and where to use it.


    Griffin Jones (07:52)

    And I'm sure we'll get into that today. But the earlier tests, was it ASRM that said, here's the definitions? then do like, does Eshry have their own nomenclature and the Asian society has their own or how do they all get together on the same page?


    Dr. Mili Thakur (08:07)

    I think all the societies right now have the same nomenclature. We call it PGT-A, PGT-M, PGT-SR, and PGT-HLA.


    Griffin Jones (08:14)

    People are like, why is he laboring this benign point? And it's because I know that I'm not the only one who's wondering. So is it the case that, to your point Sasha, it's universal adoption, but are they getting together or is there one authority above all of them, like the WHO or something that is saying this is what we call tests?


    Dr. Mili Thakur (08:38)

    I think from my standpoint, our field is so small, even globally taken everything together, like ASHRAE and ASRM and PGT Special Interest Group and the PGT Society. All of those, I think are still very few scientists and physicians are involved in that. So I think in my mind, I think most everybody is calling it the same, the PGT-A.


    Dr. Sasha Hakman (08:47)

    .


    Griffin Jones (09:02)

    And then they just


    send out an email to the rest of us and then that's what we call it.


    Dr. Mili Thakur (09:04)

    Yeah.


    Dr. Sasha Hakman (09:06)

    I do think ASRM


    has a pretty big influence on how a lot is adopted worldwide. And this isn't to say like the US is the be-all end-all. I mean, there certain things that are not necessarily adopted, like when the ASRM changed the definition of infertility to be more inclusive, that wasn't necessarily the case with Escherich, for example, right? But there was a very specific reason why ASRM did this, and it was in hopes of improving insurance.


    benefits and improving access to care. So if more people fall under the definition of infertility, then perhaps that could improve access to care through insurance coverage. But maybe that's not necessarily the same priority for Escher, because a lot of countries already have incredible benefits, though there's probably a lot of populations that require third party reproduction that are still left out in that, in the traditional definition of infertility. But I think for things that are just more


    I mean, I would say less controversial. I think that if one society creates certain guidelines that are easy to follow, that make sense and scientifically sound, then a lot of the other medical societies will adopt that just to create a little bit of more of a universal language. like Mili said, our field is so small in comparison to a lot of the medical fields that there's just a ton of overlap. And there are things like


    you know, different organizations having meetings together to have expert consensus on new guidelines, depending on what we're talking about.


    Griffin Jones (10:39)

    20 % of my audience is glad that I dug so deeply in that and the other 80 % has been hitting the skip button for the last five minutes. I heard of a test called PGTWGS. Is that a test or was that just a brand name that someone is working on?


    Dr. Mili Thakur (10:44)

    You


    the whole.


    Dr. Sasha Hakman (10:56)

    It's a whole genome sequencing.


    I think everyone's just calling it whole genome sequencing. I don't know about you, Mili, but when I bring it up to my patients, I mean, obviously I'm not saying WGS because patients will look at me and be incredibly confused, but I tell them, you have this option now where we have, know, obviously routinely everyone's getting their genetic carrier screening, so you're figuring out.


    do you need to do PGTM or not, but for those where you don't necessarily need to do PGTM or PGTSR because there's no translocation or any structural rearrangements there, you're doing PGTA, most of us I think are doing it pretty much routinely in most IVF cases, and I'm really curious to see Mili's thoughts on that as someone who's also board certified in genetics, but with whole genome sequencing, you're really just testing the entire genome, and you can call it,


    WGS or you can call it G. I don't think it really matters. You're just describing what the technology is.


    Griffin Jones (11:52)

    So Sasha, is PGT-G and PGT-P the same test? They're just used for very different applications, or are they different tests?


    Dr. Sasha Hakman (12:03)

    Well, concept of whole genome sequencing is the same. Like you're getting that information, like the DNA information, but how you process it and interpret it is going to be different, right? And so, you know, with polygenic risk scores, that's totally different than say, like a company like Juniper.


    who's looking at reduced viability variants, which I think that they're the only ones that have that data, if I'm not mistaken. They have a list of genetic variants that essentially are not in the population, basically meaning that anyone who is alive does not have these variants because...


    they are not compatible with life. And so it just helps to prioritize which embryo to transfer first to reduce time to baby. That's the ultimate goal. Or to provide specific information to a couple that perhaps has recurrent implantation failure or recurrent pregnancy losses, including of euploid embryos. And you can't necessarily pinpoint what the issue is to understand better why these pregnancies are not occurring or why they're not ongoing.


    ⁓ So I think that, you know, I don't know necessarily, Mili maybe has a better understanding of the technology of the other companies and what they're doing. But, you know, the different platforms will give us different information when it comes to whole genome sequencing.


    Griffin Jones (13:37)

    would you describe Mili the difference between what we understand about PGT-P is and what someone like Juniper Genomics is doing?


    Dr. Mili Thakur (13:45)

    Yeah, so I think the ⁓ important thing is that word whole genome sequencing, right? So when we are saying whole genome sequencing in an adult or a child, you know, we have a phenotype that's already there. That means there is a child or an adult with a health condition or some sort of a family history. And then we are looking at the data for all genes that can be sequenced in as much depth as it can be. And then the work really starts. So whole genome sequencing can be done by any lab.


    but then the annotation of the genes, the curation of the genes, how to take that data that is such a large volume of data and making it meaningful for that particular patient in front of you, you know, is a slight bit easier. And whole genome sequencing is still clinically in adults and children also coming after whole exome sequencing. So we understand about protein genes better.


    And so for adults and children, whole genome sequencing still has to be curated very carefully. And you might miss some areas that are difficult to sequence. But in the embryos, when we are saying whole genome sequencing, the whole amplification of the DNA, so the biopsies taken from the outer shell of the embryos, from the trophectocytes cells, you do the whole genome amplification.


    And then you can annotate the data for whatever you would like. So basically all of the data is coming through a technology called next generation sequencing. They're looking at the data, but it depends on company to company or lab to lab as to how that whole genome amplification is happening. the reads that are being made are clear. And then how is your scientific team working and what are they kind of focusing on? So a lab that is focused on PGTA,


    Dr. Sasha Hakman (15:19)

    Mm-hmm.


    Dr. Mili Thakur (15:30)

    It's looking at copy number variants and depending on lab to lab, they are focused on making sure that the embryo sample is eucloid, has all 46 chromosome, all pieces of it, and the sex chromosomes are fine. Labs that specialize or the division of the labs that specialize in PGTM is focused on that single gene that we requested and making sure that that embryo is not going to get that disease. It's unaffected by the disease, right?


    Dr. Sasha Hakman (15:59)

    And after the creation of probes.


    Dr. Mili Thakur (15:59)

    And the third lab,


    yeah, so like linkage is established. It's a whole different workflow. They are focused on doing something that is going to be making sure as accurately as possible, mostly above 90 % and somewhere around 98 % that linkage PGTM test would tell us that the mutation is there in the cells of the embryo or not in there, right? But these labs that are now,


    taking other pieces. So there are some PGT labs that are doing whole genome sequencing. They are saying that they are doing whole genome sequencing, but in reality, they are looking at like 1800 or so different genes. So they're not looking at a family history or a personal request for a particular gene. They're going and saying, there is no direct mutation in any of these genes that were looked at, right? But there are 25,000 genes in the genome.


    and they're looking at 1800 genes. So we have to be very careful of saying, yes, your technology is whole genome sequencing, but what you're really looking at it is this much and there are areas in those genes and there are tripple repeat disorders that everybody's trying to optimize. Like fragile X type genes are not very easily read in an embryo sample. And then there are other companies and their labs who take that data. They're not focused on PGTA or PGTM.


    they have data or they have a means of looking at that data and grading the embryos for certain parameters. So they are looking at certain SNPs and saying, diabetes is more likely in your embryo number one, but less likely in embryo number two. So that's PGT-P scoring. So polygenic risk scoring is commonly used in other kind of paradigms, but we are trying to predict a phenotype in an embryo that has no phenotype as of now, plus also we are...


    adding another layer to these embryos, like all of them are healthy, right? Healthy in the sense they're PGTA normal, they don't have the PGTM gene, but now we have graded them. And if our first two or three don't take in the PGT-P based on their lower risk of diabetes or schizophrenia or hypertension or physical attributes or whatnot, then the parents are settling for their third best embryo when there was no actual difference in all of those embryos.


    Dr. Sasha Hakman (17:54)

    .


    Dr. Mili Thakur (18:16)

    Right, so that PGT-P is just a layer of analysis that's been put on the data to grade embryos based on certain predefined parameters. In whole genome sequencing where reduced viability variants are being looked at, like Juniper, what they are doing is they are looking at PGTA, they are looking at PGTM if you have a single gene, but then they're also looking at the data for reduced viability variants.


    Dr. Sasha Hakman (18:21)

    . .


    Dr. Mili Thakur (18:45)

    So the lab curates that data. kind of, they have that data and they're increasing that by having more patients do it. And so based on the analysis, your product or your panel becomes stronger. you can, like right now for an adult or a child, when I order whole genome sequencing, you can do it for a thousand dollars, but I can't take that data and make it meaningful for my patient.


    Griffin Jones (18:46)

    Thanks. ⁓


    Dr. Sasha Hakman (18:52)

    Mm-hmm.


    Griffin Jones (18:53)

    you


    you


    you


    Dr. Sasha Hakman (19:10)

    .


    Dr. Mili Thakur (19:11)

    The same thing, we have to take all of that data and make it meaningful for each embryo.


    Dr. Sasha Hakman (19:12)

    Okay.


    Dr. Mili Thakur (19:17)

    and then to the parents.


    Griffin Jones (19:18)

    And is the reason why you can't make it useful for your patient is because they're actually only screening 1800 genes or that's a different concept?


    Dr. Mili Thakur (19:28)

    That's the different things. Yeah. So basically for an adult or a child, there's 25,000 genes. Some people


    say 30,000, some people say 20,000. Out of those 18,000 genes are something that we can sequence. And out of that, if you look at these companies that do it for adults and children where there are millions of cells and everything's there, there are gene areas that don't sequence well. They're kind of in the dark.


    And then on top of that, amount of data generated from whole genome sequencing is immense. Like even in, I sometimes will provide a 600-joll gene list to these companies because I'm looking for infertility-related genes or recurrent implantation failure genes. Even then I'm getting like seven to 10 variants of uncertain significance in just 600 genes. So what I'm trying to say is whole genome sequencing, even though it sounds like a very fancy word, at the end of it,


    the test is useful to our patients and to our physicians based on the curation of the data and how we kind of make it meaningful. Like I would want to transfer an embryo that would have the highest chance of a live birth, lowest chance of a disease causing gene. But then I don't want to add decision-making to already stressed out couples or individuals to say, hey, you have these five embryos, one has this wrong with this.


    Dr. Sasha Hakman (20:28)

    Mm hmm. Mm-hmm.


    Dr. Mili Thakur (20:52)

    second one has this wrong, which one would you like to pick? Right, we have to tell them at the end of it, our patients are looking at our guidance and we have to say embryo number one seems to be the best and let's never transfer embryo number five because it has a disease causing risk.


    Griffin Jones (21:08)

    Sasha, tell me more about the significance of these reduced viability variants. What is that? How do you counsel your patients on it?


    Dr. Sasha Hakman (21:15)

    We're in an age now where a lot of patients are looking for answers on social media. We know that on average 15 to 20 % of couples with infertility will be given the diagnosis of unexplained infertility. I don't know how much you guys are consuming online. I consume a lot about what is being said because I wanna know what my patients are seeing and hearing online. And there's a lot of BS of...


    There's no such thing as unexplained infertility. There's always an explanation. It's usually something like PCOS or endometriosis. And couples who are getting this diagnosis always assume that there's some sort of inflammatory disease happening that is causing their infertility. And everyone's forgetting an incredibly important part of biology, which is genetics.


    You know, with like the PGT-P, for example, we're looking at polygenic risk scores, but you're forgetting that like a big part of that is there's an environmental component that affects the phenotype. And so you may have a genetic predisposition to something and there may be an embryo that has a higher risk of, for example, type 1 diabetes, but you know, it's usually the Coxsackie virus exposure that then creates a cross reaction.


    where you create antibodies that attacks the pancreatic beta cells that eventually will lead to type one diabetes or insulin dependent diabetes, right? And so we can't predict what the environmental exposure is necessarily gonna be. And so that's a lot harder to really provide a guarantee of any sort. And obviously we can never guarantee anything when it comes to reproductive medicine, but that to me is just sort of.


    a lot harder to utilize for anything clinically meaningful. But I think that if somebody's coming and we have these genetic variants that are highly associated with infertility or with recurrent pregnancy loss and somebody's gone through multiple IVF cycles, we don't necessarily have answers. This is where I often will encourage them to consider using a test like Juniper because then if I'm able to get this information,


    Griffin Jones (22:58)

    But I think that if somebody's coming, we have these genetic


    associated


    Dr. Sasha Hakman (23:20)

    with reduced viability variance, and I have seen this with couples, where up until that point, creating embryos and sending it out and testing through Juniper, I had no answers for the patient, right? Why did you fail for embryo transfers? I don't know, we've tried everything. We're now assuming it's the embryo, or sorry, it's the uterus, and we're doing endometrial biopsies of tests that really have no real evidence to support whether we should do these tests or not.


    Griffin Jones (23:23)

    you


    until that point.


    Why did you build?


    I'm assuming it's the embryo, or sorry, the uterus, and we're an in-vitro biopsy.


    Dr. Sasha Hakman (23:49)

    And then when we go to create new embryos and send it out to Juniper, and now I'm seeing that there's a common variant amongst the parents, the embryos that keeps showing up again. And I see that there's maybe one embryo that doesn't have this reduced viability variant. It allows me to now select out of a handful of embryos which one to transfer first. And if it's accessible, then I feel pretty confident that this is likely the reason.


    Griffin Jones (23:50)

    And then when we go to create new embryos and send it out to Juniper, and now I'm seeing that there's a common variant.


    And I see that there's maybe one embryo that doesn't have this reduced survival experience. It allows me to now select out of...


    Dr. Sasha Hakman (24:15)

    I like to give one clinical example of something that was discovered in a patient that we didn't know prior, and this test gave us a lot of answers. So I had a patient who started off with me at the age of 23, actually. She has high ovarian reserve, but she's 23, no PCOS, extremely regular cycles, no signs of hyperandrogenism. It was a classic case of like,


    Griffin Jones (24:15)

    And I like to give one clinical example of something that was discovered in a patient that we didn't know prior.


    And the test gave us a lot of answers. So I had a patient who started off with the endocardial disease. She had thiobarine reserve when she was 23. No PCOS, extremely regular cycles.


    Dr. Sasha Hakman (24:44)

    unexplained, you can kind of argue mild male factor, like lower morphology, but other parameters were normal. Did IVF, we did an embryo transfer, unsuccessful, second transfer, successful, which we expect with either PGT or in this case, they were untested embryos. Because she was so young, I actually counseled her that PGT was probably unnecessary at this age. So after the second transfer, she was ready for baby number two.


    Griffin Jones (24:52)

    Did I? Yeah.


    Dr. Sasha Hakman (25:11)

    She had four embryos remaining. All four embryos failed. In a 23-year-old, that's very unusual. And so now we decided to make more embryos and given her high level of anxiety, not understanding why so many embryo transfers failed, we decided to do genopogenomics. And then we discovered, and this was a part of her family history that she failed to tell me, but that there was familial hypercholesterolemia coming from the maternal side.


    Griffin Jones (25:16)

    and 23 or the very unusual.


    So now we decided to make more embryos and given a high level of anxiety, not understanding what's going on in their future cells, we decided to use the


    Dr. Sasha Hakman (25:40)

    and half of the embryos were affected, actually probably more than half of them were affected by this. It's autosomal dominant, that's not surprising. But the particular variant that she had, if you go into the literature, highly associated with implantation failure. And so at that point, I decided to check her lipid levels and her cholesterol through the roof.


    And that's not something we routinely test in a young, healthy patient. We don't do fasting lipids routinely. You're assuming that they're going to their PCP, getting their preventative care, but it's not necessarily a required test outside of the clinical picture of PCOS prior to a transfer. And so now it was easy to say, well, let's get your lipids within normal range in preparation for an embryo transfer and pick.


    the euploid embryo with reduced viability variants, but we're also able to discover that a lot of these embryos had other medical conditions that arose from the parents that were not known about before, like dilated cardiomyopathy.


    Griffin Jones (26:41)

    With that patient, were you able to find embryos that successfully implanted?


    Dr. Sasha Hakman (26:45)

    So we're getting ready now. So I'm very curious to see what the outcome will be, but her transfer is gonna be in about two weeks.


    Griffin Jones (26:53)

    fingers crossed everyone I think will be very interested in that outcome. I want each of you or either of you to tell me if I have this understanding correct and if I have my terms incorrect, you'll correct me. Are people looking to polygenic risk score for a genetic promise but that promise might not materialize because it doesn't account for epigenetic variables post embryonic development?


    Dr. Sasha Hakman (26:54)

    Fingers crossed, yeah.


    Dr. Mili Thakur (27:21)

    So basically what polygenic risk code for embryo, the science is not ready yet. So basically what we are doing in PGT-P labs is they're taking the data, they're trying to predict an outcome for an embryo or the likelihood of that outcome, which is like a polygenic condition. So type one diabetes, schizophrenia, hypertension, breast cancer risk, or.


    risk for like physical attributes that are different, right? So when we're trying to do that, the prediction is on the premise of the data that's available. And the data is available for a certain ethnic background, certain age group. And we're trying to predict an embryo's health or a future health of an embryo based on that. And that's the ethical consideration of VGTP right now. So in order to like,


    Dr. Sasha Hakman (28:06)

    .


    Dr. Mili Thakur (28:13)

    be able to tell a couple or an individual who's been struggling to conceive whether or not they will have a live birth is the outcome that most of the physicians in this field want. They want an outcome of a live birth with no obvious health concerns to a child or an infant, right? So PGT-P is trying to predict if the child will develop hypertension or type 1 diabetes and


    For certain populations, it might be an important answer to know out of their five embryos that are euploid, which one would have a lesser chance of say a mental health condition or type one diabetes. And it could be meaningful information. But if you're trying to give that information to a couple that came in the door, just looking for a healthy life worth, that information is overwhelming. It's falsely kind of making that premise. And there comes your...


    Dr. Sasha Hakman (29:00)

    .


    Dr. Mili Thakur (29:08)

    you know, genetic promise versus what happens in an epigenetic way. And to, you know, Sasha's point, you know, environment is going to play a role. So trying to limit our embryo number to be transferred from a euploid embryo, right, or from an embryo that did not have a PGTM condition to something where now the couple is doing another round of IVF to find an embryo that would have a lower risk of a mental health condition, which


    by the way, polygenic, it may or may not happen to the child, is not a good idea of our resources for our doctor's time, for all of the stress that the parents have go through. Even though the information seeking patients, the ones that are looking for this additional information, they're still human. At some point, they're going to have to say that this embryo is all right to transfer, right?


    Dr. Sasha Hakman (29:43)

    you you


    Dr. Mili Thakur (30:05)

    and stop doing another round of IVF


    because they would exhaust themselves out with that pursuit. So that is why new guidelines came out that PGT-P is not ready for prime time. For some families, it might bring some meaningful information after the rest of the testing has been all right. to your point, the post zygotic epigenetic changes and all of that is far away from where we are right now.


    If you try to grade embryos based on physical attributes, it just makes sense. A healthy euploid embryo is very difficult to make and to have access to one healthy euploid embryo without knowing its PGT-P score is rather what I would recommend to my patient if they're on board with that information.


    Griffin Jones (30:50)

    And so I don't know any or I'm not aware of I might know several but I don't I can't think of any REIs that I know have been ordering PGT-P. Are some REIs doing that right now or were they up until the ASRM guidelines?


    Dr. Mili Thakur (31:06)

    I think doctors still are at independent, they can order the test. Like if somebody has a personal history of ⁓ type one diabetes and their spouse has something going on and it's very meaningful to them, they are good candidates, they have multiple embryos already, PGTAU employed in another lab and they want to pay that extra information, they can get that information and make that choice. So I think.


    Dr. Sasha Hakman (31:09)

    Yeah.


    Dr. Mili Thakur (31:30)

    Doctors who are doing PGT-P, you know, will do it on a case to case basis. What we want to do in the field here and globally is access to an embryo, whether naturally or through IVF, right? Access to pregnancy that is not going to have a major health risk as best as we can tell. So PGT-P factors into that for small percentage of patients that have a specific requirement.


    but not for the general population. be presented to the patients that way. Like any parent would want to minimize the risk of everything that they could to a child. would want a child to have...


    Dr. Sasha Hakman (32:08)

    I think it's mostly patients


    that are requesting it is what I've seen. And it's typically under the guise of like, had a brother with really bad schizophrenia after seeing him live like this and ended up committing suicide. I want to make sure I don't have a child who has this issue. And so I think that's where Patients are hearing about these tests and wanting that control. And I think that's where like a lot of the counseling will come into play of like, you know,


    Yeah, this test exists, however, you know, this can never guarantee that you're going to have a child that does not have the phenotype that you're looking to eliminate.


    Dr. Mili Thakur (32:47)

    Yeah. And for our practice, like for me, like if there was that mental health condition or if there was a severe autism in a, in a nephew or in a family member or another previous child, sometimes by doing this


    kind of testing and reassuring them falsely, you're actually missing the actual gene. That would have been the reason because you do not have access to that person who was affected genetic information.


    Dr. Sasha Hakman (33:08)

    No. Thank


    Dr. Mili Thakur (33:12)

    You can miss a monogenic condition and then try and reassure yourself with polygenic risk scoring, but it could completely recur in the child because the gene wasn't found in that family.


    Griffin Jones (33:24)

    And so the reason why PGT-G seems to be a more hopeful option, at least that's what doctors seem to be cautiously optimistic about the promise of PGT-G is because we can get to the science sooner. Is that correct? Because we're looking for results happening in embryonic development. Is that right?


    Dr. Sasha Hakman (33:43)

    Yeah, it's like time to baby, right? Like we're still very limited in our pregnancy rates with all the technology that's advanced.


    pregnancy and live birth rates per transfer and now everyone's pretty much doing single Euclid embryo transfers. Like ESET's a great practice to reduce the risk of multiples, but we've also plateaued in our pregnancy rates. And I'm sure, like I talk about this on Instagram all the time so that patients understand this. My patients understand this well because I counsel them.


    But I think it's important for people to understand that every embryo transfer is going to be successful. And even as an REI who was just the patient, like I had my first embryo transfer recently be unsuccessful, would the second one be successful? Knowing like it does take more than one embryo, but why are we always having to do multiple embryo transfers to get there? And in the cases of recurrent implantation failure or recurrent pregnancy loss of euploid embryos.


    how do we move the needle because there's this really common practice of starting to say, there must be something wrong with the receptivity of the endometrium. Maybe there's something else like we need to do intralipids and add prednisone and do all of these add-ons. People are doing uterine PRP and we're.


    doing a lot of experimental things that if you look at the overall data and listen, I add these things on too when I don't know what else to do and everything else has failed. sometimes the missing link and maybe the thing that'll help us move the needle to improve our pregnancy rates is having more comprehensive genetic testing of the embryos to see is this actually really going to result in a pregnancy and life birth or not? Are we able to gather this information? And the more that


    They're able, know, one thing I've really liked about working with Juniper is that they sit down with me as a physician. I get to talk to their genetic counselor. We can look at, you know, they do a lot of hand holding to help interpret the information and because you're in constant contact with their team, they gather more data and they're providing more information to try to get you sooner. We've had a handful of patients who've had recurrent failed embryo transfer, recurrent implantation failure.


    transferring into a surrogate only for it to fail multiple times again. And that's how you know that there's something wrong with the embryo. If you're transferring these embryos into a GC and multiple different GCs and it's not successful, and then you move on to doing something like whole genome sequencing where they're able to actually give you a genetic reason, now it gives you a lot more information and what to do with it.


    Griffin Jones (36:08)

    Thank


    Dr. Sasha Hakman (36:29)

    You could at least give a little bit of closure like, okay, maybe the next step is actually moving on to donor GAMI or maybe the next step is just making enough embryos until you get the ones that don't have this reduced viability variant, for example.


    Dr. Mili Thakur (36:41)

    yeah.


    Griffin Jones (36:42)

    more


    information on the embryo prior to implantation was the prior to transfer that is, was the promise of PGT and now we're debating the relevance of mosaicism. tell us about that evolution, how that plays into this and is PGT-G relevant in that conversation?


    Dr. Mili Thakur (37:02)

    Yeah, so I think I disagree with the statement that we don't have the promise of the genetic testing kind of play out. I think genetic testing overall is like improving quite a bit. We are better than ever in our PGTA analysis right now. There are cases that I see at genome ally, my practice, we only get referred cases from other IVF doctors where the embryo testing is picking up something that was never picked up in a parent.


    Dr. Sasha Hakman (37:03)

    .


    Dr. Mili Thakur (37:30)

    And I've shared this few examples before we have embryos that were tested by a combined next-gen sequencing SNP-based platform, only 400 SNPs in that platform at that time, where they picked up something unbalanced in four out of 10 embryos. it was chromosome number seven was showing again and again. Patient had two previous miscarriages, had gone to PGTA just like that. The doctor did the keter type analysis after the embryo showed it and it was normal.


    Keterotype came back normal, which is not possible. If multiple embryos have a problem, something's gotta be wrong with the parent. The case came to me. We went back to the lab that looked at the parents and we said, there has to be a translocation. I had taken a detailed history of the male partner and the female partner. And the male partner had a brother who had a translocation involving chromosome seven and 14. And we had them look at that area and they found it.


    But in all true sense of the way, if they were going routinely, this was a couple with unexplained recurrent pregnancy loss with normal ketyotypes, and now PGT-A for the first time picked up something in an embryo. And there's cases after cases where we've picked up deletions that the PGT lab is reporting. So what


    Dr. Sasha Hakman (38:43)

    So


    Dr. Mili Thakur (38:45)

    I'm trying to say is, yes, of course, we have to take care of how we report mosaicism embryos, whether it should be reported or not reported.


    Dr. Sasha Hakman (38:45)

    So.


    Dr. Mili Thakur (38:54)

    Lomozake embryos are as good as euploid, test results and all that kind of information has to be sorted out and it's another talk for another time. But what I'm trying to say is at this point, PGT labs all across the world, the scientists that are working in these labs are doing amazing work. We have to realize that PGT is picking up stuff in embryos that could never been picked up in the parents. And the beauty of the PGT


    platform, any platform is that you have actually the combination of the two parents. You can look at the male partner and the female partners embryogenetics in the embryo at one go. So the point of the whole thing is PGTA is like all the scientists that are working in the PGTA field are making the test better and better. We have to come together as a field and say,


    where our cutoffs should be, what we should do with mosaicism and how to give this test to the patient. What are the best candidates? I think that's for the clinicians to decide, not the PGT labs to decide, right? Which is the best test for PGTM. The labs are now doing as best as possible. And the way I'm using PGT-G right now is the curation of the data. So I have patients where there are recurrent implantation failure, unexplained, you know,


    Dr. Sasha Hakman (40:11)

    .


    Dr. Mili Thakur (40:15)

    maturation issues with eggs or eggs don't fertilize. So what we are doing is developing a test, right, that is going to be pre embryo test. So you're going to have PGT-G available to the couples that require that test. But first we need to pick up those couples ahead of time before many failed IVF cycles happen. So on a regular basis, I'm getting referrals at genome ally from doctors like


    one to two per week where cycle after cycle, eggs are not mature. The embryos don't go to blastocyst. There is like something wrong in that and we can see that it's wrong. There are some couples that have referred to me after they use donor egg and still there wasn't a blastocyst conversion. The embryo did not make into a blastocyst. So the juniper's data


    Dr. Sasha Hakman (41:09)

    Okay.


    Dr. Mili Thakur (41:10)

    is going to have wide applicability in the future. Right now they are collecting it on patients who have like many attempts and haven't gotten pregnant, the kind of patients Sasha was saying, right? But eventually we're going to collect this data in embryos and then be able to give it to anybody who walks into the door with


    infertility and say, hey, you are the low risk couple. And hey, you are the one that's gonna fail four IVF cycles. So we got to do this, this and this.


    Right now, we are at the point where you have to get through those four or five cycles, different labs. Anytime you go, and I've had patients who've been to three different doctors, as soon as a patient with a failed IVF cycle goes to the next doctor, the next doctor thinks that they've got it, their lab is gonna do it, they have the technology and their protocols are better, and the cycle fails again with the same exact results.


    If there is a reduced viability variant, if there is a variant in one of those OZEMA genes, O-Z-E-M-A genes, no matter what you do with your technology and our embryologists are doing amazing work, the cycle's gonna fail. You're not gonna have fertilization if sperm genes are abnormal. You're not gonna have blastocyst development if your embryonic genes are abnormal. Right now, we are just scratching the surface. And so we partner with Juniper


    for cases where we have found something in the parents and now we need an answer or sometimes we are using it for patients where it's like the end of the road situation. We need to find out if we need to move to donor gametes or something like that.


    Griffin Jones (42:45)

    Do you think that that it will quickly move beyond just edge cases?


    Dr. Mili Thakur (42:50)

    Yeah, I think we are working hard at genome ally. You know, we are collecting our data and we have a pretty good yield. Like we are having about 10 to 15 % of patients who are walking in the door with something abnormal. And if the phenotype is good, we can literally pinpoint what is happening. So like if you have empty follicle syndrome, right? Every time you go in for an IVF retrieval, your trigger has worked and eggs are not coming out.


    Dr. Sasha Hakman (43:01)

    .


    Dr. Mili Thakur (43:20)

    There is a certain set of genes that are going to be responsible and many times will pick it up. The same


    thing with failed fertilization. Like we need to get to the place where this is normalized. Like our doctors in the field right now are doing the best ever work that has ever been done in ARIA because they have the tools at their fingertips. Our scientists have the cutting edge technology. But what we are trying to do is cycle after cycle, getting our patients through


    the hope that it will work, right? In every practice,


    Dr. Sasha Hakman (43:52)

    Mm-hmm.


    Dr. Mili Thakur (43:53)

    one to 2 % of patients are gonna be in this boat right now. And when you see the amount of cycles we do in the US every year, that one to 2 % is a big number, right? In my practice, every week I see two patients. So that's a big number, right? I see patients from 26 different states. Everybody has these cases that they are looking answers for. So it's gonna be huge for these patients initially.


    Dr. Sasha Hakman (44:00)

    So. So.


    Dr. Mili Thakur (44:19)

    but then the broad application of this data is going to go to a test that will happen at the beginning of their journey rather than after fail cycles.


    Griffin Jones (44:27)

    Sasha, do you think it could be the case in the not too distant future that people have to consent out of whole genome sequencing their embryos?


    Dr. Sasha Hakman (44:37)

    I think we're pretty far away from there. I don't know if it'll get to.


    I mean, maybe, who knows what's gonna happen in the future. I do think that if over time there's enough data to show that live birth rates are much higher, like from the first embryo transfer, I think that a lot of clinics will start adopting it because, you know, when the SART data comes out, we're all looking at our data and then everyone always wants to think like, how do we...


    get even higher, like the data keeps getting better, but like how do we keep getting higher? How do we reduce the number of times we have to call someone and say, sorry, your embryo transfer was unsuccessful, we have to do this again. And so like that's always been the goal in this field is to, you know, create some level of like cost effective treatment, reducing the number of IVF cycles that are required per baby, reducing the number of embryo transfers that are required because


    Not only is it like there's a financial, financially just a huge toll for patients, there's the emotional burden and then there's treatment fatigue when cycles are unsuccessful. So how do we gather more information to be able to, the first question everyone will always ask is why didn't my IVF cycle work? Why didn't my embryo transfer work? People want answers and in many cases you don't necessarily have the answers right off the bat. So if you know that there's a test that's available that could potentially


    give you that information. And I love that Mili brought that up because I actually just called Juniper the other day saying, hey, I have a patient who out of, she has diminished ovarian reserve, but out of the mature follicles that we get, she's already done five IVF cycles. Less than half of those follicles will give me an egg out of the mature follicles despite a really high estradiol level and even good progesterone after trigger, which is like highly correlated with mature eggs.


    I can't get the eggs and once we get the eggs, have very poor fertilization despite having excellent sperm and we just can't get to blastocysts and she's only 37. Like that's very unusual at that age. Or you get the patient where you get tons of eggs and you never get any blastocysts in the end of the IVF cycle. AMH is high but they have very poor fertilization and blastulation.


    This is where I asked them, like, hey, can we send you this tissue early on and can you test the parents to help give me some answers so I can give them answers because that patient went first, second and third opinion. The other doctors did a totally different protocol. Patient had an even worse outcome. Fewer eggs retrieved, none were mature, no embryos. like, there's, like you said, there may be a genetic reason to it. And I...


    Dr. Mili Thakur (46:59)

    Yeah.


    Dr. Sasha Hakman (47:19)

    You know, I actually often tell patients who come to me for a second or third opinion, I often tell them, your past performance is highly predictive of your future performance. I can change the protocol, I can do something totally different than the last two doctors, but I don't know that it's going to result in anything different than you've already seen. And so ⁓ I actually do think it's really interesting how some doctors will act like,


    Dr. Mili Thakur (47:43)

    and and and Griff


    Dr. Sasha Hakman (47:47)

    a different protocol will make or break the outcome, at the end of the day, if biology's in your favor, it's really not that difficult to stimulate the ovaries and to get eggs and to create embryos.


    Griffin Jones (47:49)

    Okay.


    Dr. Mili Thakur (47:58)

    Yeah, so I wanted to say to Griffin's question of like whether PGT, like genomic test for the PGT, right? The whole genome sequencing for PGT become like a norm. I think before that, newborn screening by whole genome sequencing will become a norm. So right now, newborn screening happens for rare genetic conditions. For most states, it's around 50 to 60 disorders. We are in that case. But there is a lot of studies going on now where every newborn baby will get its whole genome


    sequenced, we'll find out what the risks they are at, pick up all the rare genetic diseases ahead of time, then be able to, that becomes normal, then we will be able to kind of incorporate whole genome sequencing in embryonic data. And then I've spoken about this before, even for our carrier screening.


    we should do whole genome sequencing, have all the genes available, and then based on where you match the donor or where the partner test results are coming, you can unmask the gene. Right now, a panel is done, and if I need another gene added, I have to have the patient go and do a new test. But the technology of whole genome sequencing, the backbone should be the same, and then we should be able to pick up the data for the carrier screening.


    Patients are being screened by 800 plus conditions and some donors or their partner were screened by only 300 conditions. Now, how do you figure out the rest of the four? You will have to do a new panel, but if it was a whole genome sequencing based test, then we would just unmask those genes and say, hey, give me the results of this. So to your point, I think overall, once we create our workforce for genetics, once we have the support for the reproductive endocrinologist,


    to have that genetics backup, right? In a busy practice, these patients are going to require disproportionate amount of the doctors and the staff's time. And if we are able to create practices like Genome Ally, where we take on that work, we understand genetics really well, then you can order more of these tests. But if the staff and the doctors are getting overwhelmed with the genetic tests that they are opening,


    then it becomes difficult for the patient experience, for the physician's experience and all of that. So to your point, newborn screening with whole genome sequencing will come first or in parallel. And last thing, the last thought I wanted to give is it's very important for us to work with a team that is focused on genetics for infertility. So Juniper, the scientists and the genetic counselors are focused on infertility.


    Griffin Jones (50:13)

    More things out of the


    Dr. Mili Thakur (50:29)

    rather than going to a medical genetics lab that do commercial whole genome sequencing, their databases are full of disease-causing genes that are affecting children, infants, and adults. They're not focusing on our genes. They always report the genes that I'm asking them for as a variant of uncertain significance because they don't have that key data. So for us to build the systems inside of the infertility field is very important. So we can know


    These are the genes that are important and these are the variants. So the broad applicability of Juniper's data set is going to come in a few years when we get that data available to everybody.


    Griffin Jones (51:10)

    still ordering tech.


    Dr. Sasha Hakman (51:10)

    And I predict that there will


    probably be a panel for the infertility patients who will want that information prior to even doing their treatment so they understand what they're getting into.


    Dr. Mili Thakur (51:15)

    Yeah. Yes.


    which is what we are trying to do right now. So Griffin, what we are doing is because we don't have the test developed as yet as I would like it to be. We are going through a clinical grade, medical grade, whole genome sequencing lab. And then we are providing them a curated list of genes that I want them to read and give me results back. But their curation of the data and interpretation of the data is not happening through a genetic counselor.


    that is well-versed in infertility genes. So they're just sending us the data and we are having to do a lot of work. Every case that I'm seeing for this kind of testing takes a lot of effort. But with Juniper, when we send them a case, because their team is focused on infertility-related genes and reduce viability variance. Like when I have meetings with them, I'm an advisor for them, right? So when I have a meeting with them, I say the gene and they know the gene.


    Right? When I say WEE1, they know that this, gene that we are talking about, TUB8, like these should be genes that now REIs will get very well versed in once we have all the tests available. Like we could say to the patient and say, Hey, let me check your TUB8 gene because your phenotype looks like that. Right now, that's not the case. Right now we are still at the phase of like, let me try a different protocol. Let me try something different. And then doctors are


    working really a lot of volume. So sometimes if you take the history, there will be history of consanguinity. As soon as you see a shared ancestor and a failed IVF cycle, your answer is, I would say, majority of the time genetic. It just hasn't been found yet. So if you have empty follicles in somebody, and I have a case where there were empty follicles, she's from a background where there is consanguinity. Her parents are first cousins.


    And as soon as we did the whole genome sequencing with our candidate gene testing, we found the LHCGR receptor was abnormal. Nothing's gonna work with your trigger in that patient. And that's a very good answer. Like we shouldn't be doing cycle after cycle with empty follicles because she does not have the gene to make the receptor for a particular thing that's very important in IVF.


    Griffin Jones (53:33)

    What about for those of us whose parents are not first cousins? about further up the family tree? Are you still seeing that same pattern that I'm sure that if people are from the same ethnicity, they probably have one 15th great grandparent in common. So how far up are we talking?


    Dr. Mili Thakur (53:49)

    again.


    The farther it's better, but then I was surprised that there are communities in the US even. Like mostly I thought there are certain global communities that we would always seek consanguinity with. But thanks to PGT labs, and there are some PGT labs that are SNP based labs, we got results where it said common ancestor in the embryo. Both of the copies had loss of heterozygosity. And now when I went back and I kind of traced their family, they really are related.


    And it was found in a PGT report, not in their family history taking. So embryo testing can also pick up common ancestry now. And we have found it in the US population. There are still communities where consignancy existed long ago or still recently. So what I'm trying to say is, as physicians, when I was a fellow, a lot of our...


    focus goes on to surgery, a lot of our focus goes on to reproductive endocrinology and how to trigger and protocols and other things. It's more and more important now to teach our fellows and the physicians how to recognize these red flags for genetics. They don't have to take care of the whole piece of it, but as soon as they recognize it, there's your catch. And then, you know, referral to us or any other genetics counselor or genetics professional would be a good idea.


    But those cases are the ones where we have found the greatest yield.


    Griffin Jones (55:15)

    So Sasha, this whole question on cutoffs, we're gonna have to come back to another time, we? That could be its whole topic, this whole debate that's happening on mosaicism. Like, what is mosaicism even? Is it even relevant? That's probably gonna have to be its own topic, isn't it? Sasha, what would you advise to other REIs who are fairly unfamiliar with PGT-G, and how would you recommend that they approach this?


    Dr. Mili Thakur (55:23)

    soon.


    Dr. Sasha Hakman (55:41)

    I would say if you're at the very least in a situation with patients where you had poor


    IVF cycle outcomes that can't where you have no explanation you're trying to figure out how to troubleshoot. Ideally the first time you consider using this test to allow you to gather information, but especially in the cases of multiple failed transfers or poor IVF outcomes with fertilization and embryo development. It's a really good idea to really consider doing PGT-G.


    to gather information so that patients are not doing repeat IVF cycles erroneously, wasting time, money, injections, appointments, emotions, to then land in the same position over and over again. Because likely if a patient has something genetic happening, you can do all the protocols in the world and all you did is waste their time and money and give them more false hope, especially for those who are out of pocket, which is the large majority of patients.


    Dr. Mili Thakur (56:45)

    my thought is that labs and physicians, know, who have their protocols really well and who have really good blast conversion rate and watching and auditing their system and they're doing amazing well, they should feel confident that when they have a failed IVF cycle, shouldn't


    go and say, okay, this must be my protocol or this must be the batch of eggs or this must be the thing. Okay, you could repeat one more cycle, but don't go to the third or fourth cycle. Be confident in your lab and your embryologist and in your own protocols and say, hey, I want you to go see somebody. Let's find some answers before that. Patient may or may not be open by that time. They might want you to do.


    Dr. Sasha Hakman (57:11)

    Mm-hmm.


    Dr. Mili Thakur (57:27)

    a junk's like Omnitrope or this or that, but instead of steering them there, get the check mark of the genetics out of the way, and then go back to your protocols. Patients will appreciate it because those small percentage of patients that are not gonna have any success with what you do, you're picking them up sooner. So I want physicians to feel confident in their labs and their embryologists when their embryologist says, I made blast off all the patients except for this one. It's not the protocol mostly.


    it's the patient characteristic. And part of that patient characteristic is the genetics. seeking those kinds of answers early is very important.


    Griffin Jones (58:04)

    We've outlined a whole number of topics that we could come back to and that we will. And I hope to do a couple of articles on that. It doesn't always have to be in podcast form. I'd like to give each of you a platform where we could do some, if not longer, form maybe very specific dives on some very specific topics in some articles. I'd like to do that with each of you. And Sasha, we'll all be keeping our fingers crossed for your patient.


    and I look forward to updates again.


    Dr. Sasha Hakman (58:30)

    I'm very anxious for her.


    I'm dying to do the transfer already.


    Dr. Mili Thakur (58:34)

    and we wish her the best.


    Dr. Sasha Hakman (58:36)

    thank you.


    Griffin Jones (58:36)

    Thanks to both of you for coming on the program.


    Dr. Mili Thakur (58:38)

    Thank you.

Genome Ally
LinkedIn

HRC Fertility
LinkedIn

Dr. Mili Thakur
LinkedIn

Dr. Sasha Hakman
LinkedIn


 
 

283 Proof of Concept. IVF Lab Automation. Dr. Jason Barritt. Dr. Jacques Cohen

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


Lab automation in IVF is no longer theoretical, it’s been proven.

Proof of concept doesn’t mean it’s ready to replace embryologists…

But it does mean this works.

Chief Scientific Officers Jason Barritt of Kindbody and Jacques Cohen of Conceivable Life Sciences join the episode to discuss a recent study published in Human Reproduction examining AURA, the robotic lab system developed by Conceivable Life Sciences.

We dive into:

  • What “proof of concept” actually means in IVF lab automation

  • Why this study matters (And where it falls short of current standards)

  • The role of automation as a testing ground for new lab technologies

  • What a fully automated IVF lab could unlock

  • Whether “hub and spoke” models in fertility have been misunderstood (and what they could actually become)

If automation continues to progress, the scale of what’s possible in fertility care may look very different than it does today.


A Historic First in IVF: Can Day 0 Be Fully Automated?
For years, IVF automation has focused on single-point solutions. One step. One tool. One task at a time. Human Reproduction recently published Conceivable Life SciencesDay 0 research to answer a much bigger question:

Can multiple automated systems sequentially perform Day 0 IVF procedures?

This is the first published data exploring whether integrated automation can execute the earliest phases of IVF, from retrieval forward, as a coordinated system.

Inside the Day 0 paper, you’ll discover:

  • Why Day 0 has remained one of the least standardized stages in IVF

  • How sequential automated systems were engineered to work together—not in isolation

  • What technical validation data reveal about system performance

  • How human oversight is integrated at every stage

  • Why this marks a shift from single-point tools to workflow-level automation

This isn’t about replacing embryologists.  It’s about proving whether complex IVF procedures can be supported by coordinated systems designed to deliver consistent, expert-level performance.

Before this paper, there were proof points. Now there is system-level evidence.

If you care about the future scalability of IVF, this is required reading.

👉 Conceivable Is The Ultimate Family Business, follow on LinkedIn.

  • Dr. Jason Barritt (00:00)

    It is amazing what automation and AI has been able to somewhat replicate us humans. Because the truth is when you sit down at one of these apparatus and you start working at it, your brain is functioning on so many levels, with so many things and so many axes and so many focal planes that now imagine you're trying to let a computer learn how to do that and then manipulate it with electronics in a timely fashion that does not harm humans.


    Griffin Jones (00:38)

    Proven. Lab automation as a concept is proven. That's according to the findings of a paper published last year in Human Reproduction and the conclusions of my guests, doctors Jacques Cohen and Jason Barritt Now, proof of concept does not mean non-inferiority. No one's saying that. It just means that this thing can work. Inside Reproductive Health is not a medical journal. We don't do peer reviews here. And Cohen and Barritt try to very clearly separate the findings of the study


    from future speculation. And I take us back and forth between the two because it's my show. Conceivable is not responsible for that. Neither are Cohen and Barritt. I like to shoot the breeze. If you want a medical journal, read Human Reproduction. And you should, by the way, because we'll link to that study.


    in the page where you find this podcast episode and the email that it goes out in.


    And you can easily find it on Conceivable Life Sciences website.


    So find and read this paper in the appropriate place. Here's what stood out to me. In the study that analyzed Conceivable Life Sciences robotic lab automation system, AURA five healthy babies were born, 64.3% of the eggs fertilized


    And out of hundreds of eggs, none were damaged by the robot.


    Can your embryologist say the same?


    Dr. Jason Barritt is, of course, the chief scientific officer of KindBody, and Dr. Jacques Cohen is the CSO of Conceivable. While they're both very tempered about their excitement of the study, still not meeting or exceeding current standards, it proves the concept of lab automation as a viable possibility.


    And as Dr. Cohen observes, a fully automated IVF lab would be the supreme testing ground for new solutions in the IVF lab. These observations allow us to think about the future. If the words hub and spoke excite you in the fertility space, the second half of this episode is for you. We don't know what hub and spoke means right now as we misuse those words all the time in this field.


    Now, when you listen to this, you will see what real hub and spoke looks like, what IVF will look like in some years time at a magnitude that so far people have only dreamed.


    I hope you enjoy this conversation as much as I did.


    Griffin Jones (03:47)

    Drs. Cohen and Barritt, Jacques and Jason, welcome back to both of you to the Inside Reproductive Health Podcast.


    Dr. Jacques Cohen (03:55)

    Yeah, good to see you, Griffin.


    Dr. Jason Barritt (03:56)

    Thank you.


    Griffin Jones (03:57)

    Jacques is the concept of IVF lab automation proven.


    Dr. Jacques Cohen (04:02)

    I call that an A question. I prefer B questions. That's a really, really good question. think Jason will be probably in a better place and more objective to answer that. think we're going in that direction. So proven, we'll need a lot more time for that, but we're going definitely in that direction.


    Griffin Jones (04:21)

    What's your answer, Jason?


    Dr. Jason Barritt (04:21)

    I think I'm willing to go a little farther than Jacques did, to be honest. I think one of the main items that we're going to discuss today is actually proven that we have reached it. I am not saying, and I want to be very careful.


    I am not saying it's fully ready for full prime time. It's not better than what we can offer in some ways. But that doesn't mean it's not proven it can work. That, I think we've reached.


    Griffin Jones (04:50)

    So before I go into why you feel that way, Jason Jacques, what causes you to maybe stop a little bit short of that?


    Dr. Jacques Cohen (04:58)

    Well, I look at proof in science and medicine in particular, we look at proof is a very loaded word, very loaded terminology. And so I look at it from an evidence-based medicine point of view, which is usually a process that takes many years, And so I was answering from that perspective. So are we in the right way? there's no doubt about it. There's no doubt about it. We're moving right ahead. ⁓


    Griffin Jones (05:05)

    Mm-hmm.


    Dr. Jacques Cohen (05:23)

    A lot of good papers have come out in the last year or two. The paper I think you're interested in was published at the end of December by our group, Conceivable Life Sciences. And that work I think really is very interesting. We were doing a proof of concept study, in actual fact started in 2023 and finished in 2024.


    on replacing single vitrified blastocysyts which were obtained after going through a series of different automation steps, not just one, but several. And I think what Jason is alluding to probably is the fact that it's not just, we not singled out a single thing, we did several. And this combined two or three or four automation steps that we can separate.


    when you handle eggs and finding the eggs automatically and then processing the eggs so that they're ready for ICSI then that those are really, I think we would agree there are two steps. Some would consider that one thing. I think it's like really two distinct steps with greatly different outcomes per embryologist. They're very sensitive steps. The other one was sperm preparation. We don't talk much about sperm preparation. All technology that's been


    come a little better over the years. But we have automated that at least the first attempts of it. And then there is ICSI, which we have automated and have gone into autonomy of the different steps that involve the ICSI process, of which we think there are 15 to 17 steps. And so that whole thing, we have tried to combine in a very small set of patients, because you have to be very careful when you do this.


    for the first time. So you can't go kong ho. It's just a randomized clinical trial, obviously IRB reviewed in Mexico, in Guadalajara, with the HOPE IVF clinic. And that was published in December. Five babies born out of nine, no, 11 transfers. Oh my God, Jason, help me out. 11 patients, 12 transfers or 12 attempts here.


    Dr. Jason Barritt (07:37)

    Yeah, nine


    pregnancies and five healthy births.


    Dr. Jacques Cohen (07:41)

    Yeah, five births, five babies born.


    Griffin Jones (07:44)

    So you do make a good point, Jacques, that I should define terms and by, if our measure is automated lab technology producing the same or better outcomes as today, that would be beyond proof of concept in my view. By proof of concept, I simply mean this can work, that it proves that it can work. So you would agree that the concept has been proven in that sense.


    Dr. Jacques Cohen (08:01)

    Yeah. yeah, yeah.


    absolutely. absolutely.


    Yeah, this can work. For instance, fertilization rate. Well, would we have liked to see it higher? Yes. But it's on the way. It's on the way. I think an important thing people need to realize, yeah, it's a concept study, but we haven't excluded anybody. We haven't done 50 patients or 500 embryos before this, before we went into this study.


    This includes all the patients. This is the learning curve that we have published in the form of a trial that makes sure that the patients have a good chance by taking about half the eggs and handling those through the manual laboratory, the regular embryology laboratory, because we were doing this in an embryology laboratory. This was not done in a separate unit. And so half the eggs were treated conventionally, regular IVF, ICSI and...


    and the other half were handled by us. So that's how this was done and it includes all the data.


    Dr. Jason Barritt (09:08)

    So that's what I want to jump off here, Griffin. So ⁓ the amazing thing is I was trying to do the calculation last week. I was a brand new PhD, just finishing up presenting my work when I was thankfully plucked out of the anonymity of doing my stuff on the side. And I was given the opportunity to go work with Jacques Cohen about 27 years ago. And I came in and did


    a three-year fellowship there. And yes, under his leadership and the things that were done there, it is important to get to the science of the proof. It is not just about what you might be able to do one time and things like that. You gotta prove it. And you gotta actually have somebody else prove that you can do it too in order to actually be able to put this out and to put it into a paper. So I wanna fully


    my director here, one of my absolutely most important things in making sure that I had a great career and I started off wonderfully. I definitely appreciate that. But what it is is the idea of what we really need to discuss is the paper is it is a proof of concept and it's the learning curve as Jacques said. The thing is if you're willing to talk about your learning curve and put it into a paper and get it published, even when it's not perfection, that demonstrates how


    Dr. Jacques Cohen (09:55)

    Okay. Okay.


    Dr. Jason Barritt (10:24)

    really important this step is because no one just immediately jumps to a solution and proof. This is many, many stages and many steps. I'll say, technically this work is started and or not even mostly completed nearly three years ago in its preparation. We are three years past this already, but this was the first time they're putting it out.


    Dr. Jacques Cohen (10:38)

    Okay. Okay.


    Dr. Jason Barritt (10:51)

    in an organized way so that everybody else can look at it and analyze it and that is the key thing here. So he was cautious about calling it proof, but I am saying they've reached that point at this point with all respect to my mentor. I think they have reached that with this paper and that's why it's so important. As he said though, is it perfection? It is not. It's not bad at all and that's what really needs to come out of this.


    Dr. Jacques Cohen (11:15)

    Yeah.


    Dr. Jason Barritt (11:18)

    It is amazing what automation and AI has been able to somewhat replicate us humans. And that is the key factor of what is the outcome of this paper. And as Jacques said, automating ICSI is not 50 steps, there's 500 steps. Because the truth is when you sit down at one of these apparatus and you start working at it, your brain is functioning on so many levels.


    with so many things and so many axes and so many focal planes that now imagine you're trying to let a computer learn how to do that and then manipulate it with electronics in a timely fashion that does not harm humans.


    Wow. That is an amazing thing. And it is not easy to do. So this is a heck of a proof of concept and beautiful learning curve paper.


    Dr. Jacques Cohen (12:01)

    Yeah. Yeah.


    Griffin Jones (12:08)

    Did you, as someone that doesn't know how to read scientific literature, Jason, did you find the paper lacking for anything that you would have wanted to see validated?


    Dr. Jason Barritt (12:18)

    So the answer straight up is no. would I love them have potentially jumped over all 10 hurdles and run the entire Olympic race and won it in gold medal? Yeah, would've loved it. That's not how you learn to race. Right now, we're learning to race. This was the demonstration of that. So I don't think it's lacking anything or


    Dr. Jacques Cohen (12:34)

    Yes.


    Dr. Jason Barritt (12:38)

    not showing us anything that I would expect it to have. Would I always want it to go farther? Yes. But guess what? They've been working on things for three more years since this. Guess where they might be now with this. This was the true proof all the way through birth and healthy children. That is a giant step and a lot of time to prove that automation can work in the field. So I'm not saying there's anything lacking. It's just like you always, you always want to


    Dr. Jacques Cohen (12:58)

    Okay.


    Dr. Jason Barritt (13:06)

    win everything right away, don't you?


    Griffin Jones (13:09)

    So Jacque said the paper was published in December. What were the dates of


    the RCT?


    Dr. Jacques Cohen (13:15)

    The RCT started in late 2023, December 2023, was finished around April 2024. But then you need to complete it because all the blasts were fictified. That's the concept. We go with what the host clinic normally does. And that's what they do. They fictify everything. And then the patient comes back two, three, four.


    cycles later. In our case, because they had separate consented, they were asked to come back and not wait years. So they and they agreed with that process. They came back as soon as they were ready and the clinic was ready. And that means that the premises then come in, in the course of the next months. So you're always a little behind. So that's why there's such a long period and gap. Yes, of course. And then of course, nowadays,


    Very difficult enough for people to publish something without having live births. So you have to wait even longer than you normally would want. So yeah, a lot of patience was needed to reach that point. That's why it only saw the light at of the last week of December. 2025.


    Dr. Jason Barritt (14:23)

    So additionally, remember, they


    had to develop all this technology before they even jumped off to do the first patient. So that's why this is a multi, multi-year process here to even get to actually applying it clinical. This is not theoretical. They did it on humans, made babies. They're now here. That is a huge giant leap. And that's what this talk's about.


    Dr. Jacques Cohen (14:44)

    Yeah.


    So we invaded somebody's IVF lab and took all their equipment and made them miserable for about half a year or longer. I'm very grateful to the group at Guadalajara at the time. And nowadays we do this, the next step which you're asking about in Mexico City because


    Griffin Jones (14:48)

    What comes next,


    Dr. Jacques Cohen (15:10)

    It is something to evade your lab. know, Jason knows this very well. We're very wary about visitors. And now they had visitors who were invasive visitors, people who were coming in with computers, know, ⁓ took over entire stations and tried to automate those stations and cameras and microphones. They brought in their mobiles. They were doing things from their mobiles.


    Griffin Jones (15:28)

    and cameras and microphones.


    Dr. Jacques Cohen (15:39)

    ⁓ the thing was completely digitally controlled. So you didn't really have to be there, but in order to look at a system that was makeshift, the systems engineers had to be there. And ⁓ software engineers at least wanted to be close by. So it was very invasive. So that's already very remarkable. What's also remarkable, we didn't realize that in the beginning so much that the whole thing is actually not that we're sitting at the microscope and then moving things.


    directly from each movable device, from each smart device that you can control. No, the whole thing went just on a computer, from a computer, not so much from a phone, that would be very risky, I think, but from a computer using your keypad, using your mouse, and then you could direct all the steps that were taking place. Now, we published a paper earlier last year where we...


    where we showed that you could take that over thousands of miles. So the desk where I'm standing right now was also used, I used that for a few acts to do the ICSI process digitally, giving it commands to do some autonomous steps, but that was so early in the process that a lot of times those then fail, but that still means you have to digitally control things. You know, when we do micro-application and ICSI, we're sitting there with these joysticks, right? You must have seen this in pictures and in action.


    It is like driving your car without a steering wheel, but you have two joysticks, a bit like flying in some cases. Okay, so you have all these other controls for suction control, aspiration, taking a sperm in a needle, releasing it, holding the egg on another device. So you have all these little controls. Yeah, there you go. Thank you, Jason. There you go. It's right behind them.


    Dr. Jason Barritt (17:25)

    So there's a full micromanipulation


    setup. You work in three dimensions at magnification, as well as you then control the fourth dimension, that's moving the fluid up and down the micromanipulation pipettes. But you have to be perfectly focused. You have to be able to handle what are here, multi-dimensional joysticks in each hand continuously while you're looking through a microscope at high magnification. And focal planes matter.


    and then you use the thing on the very end for moving fluid up and down. So you're working in four dimensions on both hands simultaneously. It is a major thing for a human to learn this. It honestly takes a human usually about three to four years to actually be good at any manipulation. had to teach a computer to do this and then control it all. It's an absolutely amazing thing what's been done.


    Dr. Jacques Cohen (18:10)

    Yeah. Yeah.


    Yeah, so good to have one behind you. I have some paintings behind me. You have the real thing behind you. So imagine that setup, Griffin. We had to automate all of it. So rather than hands, all of that had now to be connected with motors and microchips and computers and cameras instead of eyes. Every little opening there, the oculus, two cameras on their side port.


    perhaps another camera there. So you're completely taking over the entire apparatus and get control over everything. You can move the stage automatically, can change the lenses automatically. We couldn't touch anything anymore, everything was automated in exactly a setup that looks like what Jason has behind him. Digital control, if you don't automate it, if you don't make it autonomous,


    each little step, it becomes really difficult to have digital control. If you ever were involved in driving your first time you were in a Tesla and you were driving it, it's very difficult. Because you want the window washer, you want to your windows, wipe the windows, it's on a pad. So you're going to look at the pad and you get in an accident. Everything is on


    So that's how that works, digitally control. We don't want the necessary digitally control in the way we were doing it at that point. So we're going to change that. But you asked me about what is the next step. The next step is going away from changing this existing system and building it from the ground up. And we call that Aura. And Aura is a line of systems. have Aura egg, which is doing the egg finding.


    Later removing all the nursing cells around the egg, which are called cumulus cells, removing those, difficult process. Ambiologists have to get very experienced doing that well. It's very easy to damage the egg. And then sperm prep, which means you have to remove seminal plasma, which is the fluid, from the spermatozoa. And you have to try to take out the best spermatozoa and make those ready for ICSI.


    People don't talk about it much. It's incredibly important. And that had to be automated. And then the XC process, which is 70 major commands, but I Jason alluded to it. He said 500, I agree with that. In code, it is at least 500. In terms of the tiniest step or small steps, it's about 100. In terms of actually clicking on...


    So you can click on something that says immobilization, which means sperm, of course. You need to immobilize them before you do ICSI. And that also activates the sperm when you do that. And without that kind of activation, making it ready for fertilization, fertilization won't take place. So we had to automate that. And we had to automate finding the sperm, selecting the sperm. So for that, have AIs. We have an existing AI, fortunately.


    which the program started with, called SIDS, sperm ID is what it stands for. Alejandro Chavez Barriola was the one who came up with that concept and it's great AI. You can use it by itself in an IVF lab, but in this case it was integrated. The best sperm is selected by the system without human interference and it's based on mortality, also on the way they're shaped.


    based on motility, it's picked and it then has to drag it to the middle of the visual field while it is still motile. And in the middle of the visual field is a little laser that calculates where is the middle of the tail and lays a little bit of the middle of the tail very quickly, all of this in microseconds. So that's what that did. But we are now building that from the ground up. We're not anymore.


    We're not anymore going into an existing lab and taking the existing equipment and changing that. Way too complicated because everybody has different equipment. So we're building this from the ground up. So you have the ICSI station, you have a fictification station, you have an egg finding and egg denudation station, you have a culture station and putting those in the line and behind there is a robot. One of our favorites because it's the only one that really is moving.


    out of its station, it's called Handler. And Handler takes plates out of one station and moves them to another station. And the plates hold the petri dishes and where the culture is done or where the procedures are done. So yeah, that's what we are developing now, this ORAS system. And we're doing a second pilot study to make that work. And that's from the ground up and behind it all,


    moving the apparatus around and doing everything. All these handling is called the Nexus system. It's a software system we're developing from the ground up with AIs being enforced in almost all of these stations, all of the stations. So very complicated orchestra to keep that going. It's tested, it's tedious work. You have to know if single systems work and you have to know whether in combinations they're.


    So that's been going on for more than half a year and will continue for a bit.


    Griffin Jones (23:43)

    So


    I want to talk about that next trial, but what Jacques is talking about with regard to no longer building the aura system in an existing IVF lab, but rather building a new, is that where we kind of left off in our last conversation, Jason? Were you talking about a hub and spoke model? that what you're visualizing with that?


    Dr. Jason Barritt (24:04)

    Yes, ⁓ the idea here is that, and this initial paper here is not that situation, it's what is coming from this initial paper, is the demonstration that when you can automate it and you can have it operate efficiently, you become no longer the limiting factor in where you can get care and what can happen. Because you can put it in different places.


    and therefore you can bring the patient to it instead of having to build it everywhere. Because the truth is, this is not an easy task and it's not gonna take no time and it's gonna cost a lot of money. But the efficiency of it is what will make this a hub and spoke model. An aura system will sit in some major city or cities and around those cities potentially even.


    And the vast majority of patients will come to it in order to get the care rather than an aura system being put in all 500 IVF labs across the country or thousands in the world. It won't be at all like that. It's just that the scalability is not possible. And you wouldn't be able to do enough patients in each center to actually make this an efficient, well-used thing. In this paper, I know it sounds really shocking. It's like 12 patients, 11 patients involved.


    Dr. Jacques Cohen (25:04)

    . you


    Dr. Jason Barritt (25:24)

    We're talking thousands that will be able to go through a machine in a year instead of 11, and type thing. And so the scale is huge, which will allow so much more access to care and will absolutely, ultimately reduce cost to do this. And the funny thing is, think Zock sort of mentioned it, it will take out the variability of us humans. Because truthfully, we're the ones who are quite variable.


    And when you let a computer system and an automated system and then an AI controlled system, it actually can do better than us already, is what they've shown.


    Griffin Jones (26:01)

    So does this give you as lab directors more control? You feel like that sort of hub and spoke system? Because the way I perceive it right now, and maybe I'm wrong, but at least in the United States, it seems like the lab is the attachment to the clinic, not the other way around, that the owner of the fertility center is almost always the REI, and very often the lab director doesn't even own equity in the overall practice.


    Dr. Jacques Cohen (26:23)

    Yeah.


    Griffin Jones (26:28)

    And now


    you're going to have the lab as the central point and different clinics plug-in. Does this give more control to lab directors to say, this is the way we do things. And then you figure out how you're going to do all the other stuff on the clinical end.


    Dr. Jacques Cohen (26:46)

    Yeah, if I may say something, I do want to give an observation on the how Harbin spoke. That model is in existence in the Netherlands since the 1980s. And there are several publications from the 80s, unfortunately not followed up.


    People don't realize this, the entire country, it's a national health system. It's very different from the health care system here. But that is organized in 13 hubs. And all of those have spokes where the egg retrievals are done and the embryo transfers and the follicular stimulation. And those 13 hubs are the labs. There are rooms there to do also egg retrievals and to do also embryo transfer. But there are other hospitals.


    other clinics that feed in the eggs and sometimes take the embryos back because they can be thought locally. So that is an existing system. So on the national level, that has been working there for them. Difficult to follow the national data. The advantage we have is the CDC data and the SAR data is just enormous. We know how well we're doing or how poorly we're doing, and therefore we strive to be the best.


    not as good in other countries except for maybe some. So it's difficult to say if that affects the system, this harp and spoke model in that way, which is transport acts. You're transporting acts to the laboratory, but that can be done safely, can be done safely and the conditions can be well maintained. And so I think that's a country to look at in terms of harp and spoke.


    So if you now add automation to this, I'm sure that the Dutch government, I think, will be interested in that. You add automation to this, you're driving the process to ultimately not to eight hours a day or 10 hours a day, but to 16, 20 hours a day. And in the case of setting up, preparing for the case, I left out what we call C-dish. C-dish is the conceivable way of...


    or preparing the cases dishes. Tedious job. Ambient still like it. They don't like it. They run for the access when you say next week you're preparing the dishes each day. They run for the exit. So it's not something they enjoy. It's tedious. It's programmatic. It is ready for automation. So that you could do if you automate that, we are automating it. That you could do all day round.


    It doesn't have to be in that window where everybody is saying, well, at the end of the day, I have to prepare the dishes. I'm tired. So it's often neglected. And it's incredibly important. Every step in the lab, every step in the clinic is incredibly important. You can't leave anything out. Everything plays a role. And so this star variation is determined by these many steps.


    And with a system like Aura, we hope, on the supervision of embryologists, possibly remotely, right? You don't have to be there as a lab director. For Jason directing 19 labs, think, 19 labs, he can just have his iPad or telephone at hand wherever he goes. He probably does that already and uses the EMR.


    But now you extend the EMR to something much bigger. You can actually control everything and you will be able to see everything. Because everything, you can't do a procedure when you do a procedure with humans, which is the standard, has worked very well. You see everything. So you can't have a black box and not see things. So you'll have to have cameras everywhere, at every position and get reports back so that somebody like Jason can do the entire country.


    from the convenience wherever he wants to be, wherever he needs to be. That doesn't mean you exclude embryologists. You need embryologist local supervision, or you need embryologist with expertise like Jason's to supervise the entire thing and direct everything and ask the questions that are not maybe delivered. So I think ⁓ it's a completely different way of looking at the IVF process as it's done now.


    There are examples of it like the Hop and Spoke you just discussed. There are examples of that around the world. We very focused into the United States, but we have to open up because it's done differently in other countries. In the case of the Netherlands, I think that is interesting what they have done since the 1980s.


    Griffin Jones (31:15)

    So that


    and hub and spoke in the Netherlands might mean one thing because you can drive from one end of that country to the other in four hours, right? And I can't even get through halfway through New York state driving that long. And so, Jason, in this country, or at least in this continent, do you need to have.


    that volume and scale in order to have a true hub and spoke model. Because we'll say, some people will say, we do a hub and spoke model. All they mean is like, you know, our lab is in Chicago and, you know, we have an office in Milwaukee and I'm not picking on anybody, that, or, you know, we have a lab in Boston and we have an office in New Hampshire. And that's what people say when they mean hub and spoke, but a real hub and spoke is that you,


    you've got massive volume and then you have a system that allows people to use that as a reference lab from all different types of clinics. Is that right?


    Dr. Jason Barritt (32:14)

    Yeah, that's much more correct. So I'll give the example. I ran a center for 11 years here in Beverly Hills, California. We served eight, seven or eight internal physicians at that location. And we served 19 physicians who brought their cases to that location in that laboratory. That allowed them to stretch out, go much farther out and farther distance away from the lab. The patient really only, probably has to come two times to that location.


    one for the retrieval and then thankfully when we put the embryos back in and they get pregnant, they don't ever have to come back to us again unless they're for their next one. So the idea is that, I'll call it around LA where it can take three hours to get three miles. The truth is you only have to do that once and you don't do that on a daily basis and you don't have to build all these labs all over LA just to serve it. It could be one location and you could serve, I'm not gonna truly say the number here, but you could probably serve


    Dr. Jacques Cohen (32:59)

    .


    Dr. Jason Barritt (33:10)

    half the population that are getting daily retrievals done in LA at one location. And as Jacques said, a clock matters, the hour of the day matters, but the truth is the machine goes 24


    hours a day. It doesn't need a break. It's not gonna take lunch. It doesn't worry about its dog at home. There's nothing to this system that limits its capability of scaling. And that's what really, really allows Hubman's Boat to work even better.


    Dr. Jacques Cohen (33:22)

    Okay.


    Dr. Jason Barritt (33:37)

    I know it sounds terrible, but you can do things at six a.m. in the morning, a lot of surgeons do, by the way, and you can do things all the way at nine p.m. at night. That extends the day and how many patients we can see, how much stuff can be done, because the


    Dr. Jacques Cohen (33:43)

    Okay.


    Dr. Jason Barritt (33:51)

    machine doesn't get tired. It can go all the time. Therefore, you're able to serve stuff more.


    Dr. Jacques Cohen (33:55)

    Needs to be serviced, it needs to be


    we're going into a direction of 20 hours a day instead of 12. And ultimately you go beyond that because you'll have twin systems. So one does these 30 hours and the other one does the other 20 hours or 15 hours each. So.


    So you will have that, you'll have that. And I think that means you're servicing all around the clock. And that also means that people from other countries with experience can oversee it. You go 24 hours a day. Yeah, so Jason could labs in Europe at his leisure around the time when he is the middle of the day.


    Dr. Jason Barritt (34:28)

    ⁓ there's the other thing is, yeah, I still have to sleep.


    Dr. Jacques Cohen (34:39)

    or the end of the day, five o'clock in the afternoon, he's doing labs in Paris. So I think that's the strength that I think will come out of this plus the standardization. Those are two big things. will ultimately, Jason used the word ultimately for driving down the price, driving down the cost. And I think he's right about that.


    Dr. Jason Barritt (35:01)

    Yeah, it's gonna take some time on that one. The other big factor here is where you're going Griffin, I think is actually what I'll call the large fertility networks, especially in the US at the moment. I don't know the rest of the world as well, but I mean, EV is a big one, of course, but those have to work on scale. They have to have many, I'll call it feeding clinics into the main place in order to be the most efficient.


    That is where all the networks will want to go. They will have their main hub in LA, Chicago, New York. know, there'll be the main hubs there and everybody will come to them in that network. The networks will absolutely want to do this because they can scale up so dramatically and help so many more patients. It might even allow multiple networks to come to the same one, which would be even more cost effective to be completely honest. The truth is everybody building a car by themselves


    Great, beautiful. But the truth is, we don't use our car probably 95 % of the time. It has been assembled and is sitting there. Therefore, the efficiency is horrible. We need to find a way to make it more efficient and bring the patients to the unit, which will allow it to happen.


    Griffin Jones (36:14)

    a drawback to the embryologists having more control, like being in the driver's seat of the lab being the reference lab, of them being the hub and the clinics being the spoke as opposed to having more of a kind of one-to-one relationship that they've more or less had in the current fertility center dynamic.


    Dr. Jacques Cohen (36:31)

    Well, I think


    you described, it's interesting what you describe and how you're formulating this. I think that situation already exists to some extent. Doctors are very dependent on embryologists. They are looking and keeping them happy, trying to keep them happy, trying to keep them interested. So I think that is not really going to change going forward. I think


    I think we'll move automation out into the clinical area. That's already happening with some AI, quite a few AIs that you see in place or available for doctors to do, instance, help them with follicular stimulation, standardized follicular stimulation, because often done in a way where one doctor on duty one day does something else than the doctor the next day. And it's a complicated thing, actually, follicular stimulation. It's not really a truly


    100 % standard operating procedure. So, there are AIs helping with that. There could be AIs helping with the accurate retrieval and semi-automated processes with the accurate retrieval. I think it's going to take some courage to automate an accurate retrieval. I'm not saying it's not possible. It is possible, but it will take courage and it will be difficult from a regulatory point of view because...


    If you look at the history of the Avinci, regulatory is in charge there. And it makes sense from a liability perspective, it makes sense for the safety of the patient. And so it's going to be a bit more difficult to automate or include, introduce automation on the clinical side, but that is going to happen. I don't think that when you get automation in the lab, that that means the embryologists are in a better position. They're probably happy to hear that from you, Griffin.


    We're not listening to this broadcast, but I think that we will have to wait and see. They are actually, a lot of embryologists, I think are somewhat afraid of automation, not only because they think they are going to be replaced, which is absolutely not the case. Their job is going to change. That is scary enough. Once your job changes, you have now, you have learned this for five or 10 years, this is what you're doing, and now that is going to change.


    That is involving, they become more like engineers. So ⁓ it's not just embryology anymore, they become more like engineers. We call them embryoneers, by the way. It's a terminology that we are using for those people in the future. And I think the job of embryologist is going to be a lot more interesting. This is the best time to become an embryologist. There's no doubt about it. This is the best time.


    and it has improved in that quality in the last 10, 20 years. But there's also a lot of stress and we need to take that away. I think automation in part will take that stress away. So you don't have to do the sperm preparations that you don't like to do. You don't have to set up the dishes. And at some point this goes well beyond conceivable and other automation companies. But at some point we hope to get to a point where we don't have to look at the monitor 50 % of the day.


    because that's what embryologists do. They look at the monitor 50 % of the day, putting in data, doing quality control studies, ordering stuff. All of that needs to be automated. They want to get rid of that because that's what's stressing them out. It's at least 50 % of the day. Doctors spend 50 % of the time in profession behind the monitor. That's why when you go and visit a doctor, they're often looking at the monitor and you're sitting right behind them. Next to the monitor,


    And you get a glance or so. That needs to change. The things that we need to type in all the time, we have this incredible AI that is skyrocketing right now. And we're still typing. We're still using a mouse. That's slowing us down. That needs to be automated. I think once you do that, and that's going to be done, I think in the next 10 years, five years, this is starting to happening already.


    People are thinking about it, technologies are thinking about it, using that. The job of embryology is only going to get better. Of course, less monitor time, more action, more supervision, more intelligence. It'll really good fun.


    Dr. Jason Barritt (40:37)

    Yes,


    they are going to advance. The human is going to advance in this also. We are going to be engineers, reproductive engineers, and we're going to help make it better. So the big thing about any of the automations and any of the AI is we're going to take out variability. It's something we monitor every single day. We spend probably an hour at every single location doing quality control to make sure all the equipment's functional before we even do anything.


    This thing can do it all the time. It can monitor everything all the time and it doesn't take a human to have to do it. And it can be adapting to something that might not be working much faster than we can. Therefore, it actually has efficiency and scale. all the way back to your question is, the embryologist is actually gonna love this. But yes, it is gonna be a change in their careers and what they do as a hands-on, daily, everyday job.


    but it's gonna bring so much consistency. So back to where your question was, the embryologist is per se gonna be in control of the fact that they have this hub location that everybody wants to come to because that's gonna be the best place they have the option to bring anything to anyway. It's gonna be so consistent and so reliable, it takes out all the variables. Therefore, they get to be the best doctor they can be and bring it to the best place it can be done embryologic.


    Griffin Jones (41:56)

    What needs to happen next in with regard to the trial? So, Jacque, it sounds like you're working on a trial and I know that people are kind of sometimes restricted in what they're able to say and in what they're working on. But again, this is me coming from someone that doesn't know how these types of studies work. Do you just repeat the same trial with a larger sample size or what will be different?


    Dr. Jacques Cohen (42:20)

    Yeah. Yeah.


    Yeah, well, it's definitely that. It has to be a larger sample size. When we did ⁓ work with HOPE in Guadalajara, the HOPE clinic in Guadalajara.


    They love minimal stimulation. They have great results with it. It's a rare approach in the United States. actually, one thing Jason said to me not too long ago, what is amazing about the paper is that it involves so few accidents because we do minimal stimulation. Incredibly challenging. So we're moving away from that in the other whole clinic in Mexico City where the first oral line is installed and it involves dish preparation.


    It involves sperm prep, egg prep, egg denudation, ichthy, and culture, and vitification. It's a lot. So you have to have lots of eggs. If you ask me what is my biggest challenge, oocytes, my biggest number of oocytes, that's my biggest challenge. So this requires a lot of observations, and we're developing the technology. And in the meantime, you don't want to jeopardize the patient.


    So you have to make sure she gets enough oocytes from the manual conventional IVF laboratory there that does really, really well. And so that of that is going to play a role in the next year in this trial or the next few months in this trial. It's a process of development. Is that usual in trials? No.


    trials is you actually, you do randomized trials where you have a technology that several people have published about and you say, well, but nobody has really done a good randomized trial. So let me do a randomized trial where I have an arm of patients that getting the conventional treatment and an arm of patients that have that one thing added to the conventional treatment. And then when those patients are comparable, then I can compare them or you do a trial, which is the same as in this trial.


    where you have what they call a sibling oocyte study, where you take half the oocytes from a patient and do your new work, and the other half of the oocytes you do what you normally do, the conventional regular approach. And so that is in place. We take acts for the patient through the regular IVF lab and compare them with this very advanced new system while developing the technology and learning from the first patients we know more.


    for the next 10 or the next 50. So yeah, this is a process. Clearly more complicated than the first study, which we are making use of existing equipment that for an IVF lab works. And we're making use of that, automating that. Now we're building it from the ground up.


    Griffin Jones (45:02)

    The last study took about six months, the RCT itself, and then it was another year and a half, give or take, before it was published. Should we expect the same timeline for this one? Could it be even longer?


    Dr. Jacques Cohen (45:13)

    Yeah,


    it will probably be a little longer. Yeah, it's like that. But we hope to take the second version of what we have now into the first lab in the United States, and hopefully not long after the second one, at least a good portion of what we have, and then take that, install it, and then those centers, I think, no doubt will require or demand


    that they do their own trial. And so you're looking at a process like that. Also, I want to add that if you have automation done at some point where you say, well, I have my platform, now I'm done, can improve it, optimize it and improve it. The advantage of that is that anything new that the field produces, like a new culture medium that people have tested in the mouse and are crazy about.


    Well, if we want to do that in human, automation and automated laboratory is the place to test it because you have removed a lot of factors. A lot of these variables are now gone because that's the problem when we do randomized trials. Good randomized trials always involve more than 500 patients. And the reason is that there so many variables that if you look at a population of just 20 patients, you're not telling anybody something that's new.


    you're looking at a bag full of variables and we think there are hundreds of them. And so you need to do a lot of patients to do a really good randomized clinical trial for one, for testing one item, whether that's a hormone or a drug in a clinical lab or in a clinical environment, or whether that is a single step, something new in the embryology environment. So I think automation in that respect will make a difference, that and the worldwide system that it can unfold.


    and the 20 or 24 hours a day that these labs can operate.


    Griffin Jones (47:05)

    Would it be accurate to summarize your point, Jacques, that an automated lab would be the supreme testing ground for new point solutions in the lab?


    Dr. Jacques Cohen (47:14)

    Yeah, I hate the word point solution. You must have noticed I'm talking around it. Point solution sounds always like something little, but behind on the right of Jason is standing what you could call a point solution, right? It's just that blue box, that beautiful blue box with the smile, the ambioscope. That's a point solution. So let's not underestimate what a point solution could mean. When we start, when we went from


    the precursor micro-replacement systems in the 1980s to ICSI early in 1992. Those were all point solutions and ICSI is a point solution, it does take over the world. So I don't like that combination of point and solution. doesn't mean, okay, clear, the aura is not a point solution. That's maybe 50 point solutions or 40 point solutions, but...


    I have never been a fable. Yeah, yeah, okay, okay. Yeah, yeah, okay.


    Griffin Jones (48:07)

    So I'll get rid of one of those words and we could say that an automated lab would be the supreme


    testing ground for either points or solutions.


    Dr. Jacques Cohen (48:15)

    Correct, yes, thank you.


    Griffin Jones (48:17)

    Jason, what threshold would you want to see from from the next study to say that if they do X


    that would mean that it's ready for prime time and if they don't do X then it's not ready yet. What threshold would you set for them?


    Dr. Jason Barritt (48:29)

    you


    they want to be non-inferior to us, the human. That's where we're gonna start. Well, let me just highlight a couple points that are in this paper. Remember, I'm not an author. I didn't do this work. But I look at it and I evaluate it and I figure out where it's gonna happen. So first off, safety. They did not damage a single oocyte in the full process of denuding.


    the eggs. I hate to admit this, but humans sometimes damage things. Not one. Hundreds of eggs, hundreds and hundreds of eggs didn't damage one. That is a huge leap and that already tells me we're succeeding. They had five healthy births already. That's telling me that everything they made from the second they caught a cumulus complex all the way through the baby worked.


    Dr. Jacques Cohen (49:00)

    Thank


    Dr. Jason Barritt (49:23)

    Every step worked because any failure, any point failure, would have resulted in none of these, which means they've worked out so many of them. Technically, I'm gonna come back to the, I always think we can all do better. I mean, the automated fertilization rate, now remember, they caught the eggs, denuded the eggs, they processed the sperm, they got the sperm, they automated the Ixie, they selected the one, got it all done, and then cultured the things on.


    they fertilize 64.3 % of the eggs.


    All of us are shooting for higher numbers. Of course we are. But it's well within the Vienna consensus for an expected fertilization rate. So the truth is they may have already got us. The machine has already got us. And then let's talk about their usable blast rate, which is a hugely important thing for all of us. They have 42.2 % usable blast rate. That is a hugely positive number. Is it?


    Dr. Jacques Cohen (50:03)

    Yeah.


    Dr. Jason Barritt (50:18)

    still lower than we're all shooting for every day. Yes, and there are clinics that are achieving a lot more than that, who are unbelievably controlled and have had years and years and years and years, 30 years of work to be that good. Their machines there now. Imagine where they're gonna be in three years. Or wait a second, that three years has already passed, they're already there now. That's why I'm saying that the paper helped me get to, this is the learning curve.


    This is teaching a kid to walk, but now they run. So guess what? We all learned to learn to walk. We all got there at different time points. This thing's already there. It's had three years. It's already running like an Olympian and achieving Vienna consensus numbers of an average human already. Imagine that it will win the gold medal when they have enough time to make this thing work the right way and have 5,000 point solutions.


    Because that's truly what this is. This is all of them at once in order to improve overall outcome. So look, I look at this as a, a huge proof of concept, but I just got to watch it learning to walk and it can walk already. Is it gonna be that some, richest man in the world or the richest person in the world can decide to...


    fund a whole bunch of robots and make all this happen in a way. Sure, that type of thing could happen, but that's probably not the way this is all going to go. This is going to go through a lot of work by a lot of people, 50 to 100 plus engineers, all trying to figure these things out. And then automated systems that have been developed, AI systems that have been developed by other people, but then applied to what we do. All of that is huge amount of human power, a huge amount of computing power that is going to push us way beyond where we are now.


    and make us better, more consistent. And truthfully, almost everybody's gonna want this. This is going to be the elite of it. If it's already walking, it tells me where we can go. And with the speed that AI is developing in six months or even a year, or even two years ago when I first played with ChatGPT, it is a completely different person now. It is better than me. It can come up with things faster than-


    It knows more than me. It will know more than me ever, ever, ever. And it can learn everything that's coming out from every single paper on this field in one minute. And it can apply things and combine things that would take me my entire career to do. It can do it now. Now imagine putting all of that power into this. It can adapt to every bit of variability instantly. And it can know that it saw it hundred other times and knows what to do. That's where we're getting.


    Dr. Jacques Cohen (52:31)

    Yeah.


    Dr. Jason Barritt (53:00)

    with this type of system.


    Griffin Jones (53:02)

    And if Elon Musk is listening, maybe he'll decide that he wants to take advantage of Conceivables next funding round. That's right.


    Dr. Jacques Cohen (53:06)

    Write a check. Write a check. Yeah,


    Dr. Jason Barritt (53:10)

    I wasn't calling out any specific, by the way. Just the in general, thing is a humanity thing. Let's be completely honest. Reproduction is basically a human right. And we want to actually allow its access and allow everybody to have that access to it. The truth is we're trying to overcome where biology is limiting this.


    and we're finding ways to do that. And the truth is, we're all having to work very hard to do that, but we already succeeded. Jacques was there at the beginning of IVF. Imagine where we are now. They weren't not thinking of this level and this many millions of babies and everything else at that time. Well, now imagine we're sitting right now and we're thinking about, well, it's a million babies a year. We're gonna talk 10 million. We're gonna talk 50 million because this will be able to do it and it'll be able to do it safely.


    accurately and in a way that's better than everything that we can do it right now.


    Dr. Jacques Cohen (54:04)

    We had to learn artificial insemination, assisted reproduction after that, and are finding, using the least fertile patients, are finding that the results are due to nature and because of


    Dr. Jason Barritt (54:18)

    Hmm


    Dr. Jacques Cohen (54:24)

    The testing that's done and all the diagnostic tests that are being developed, we think that in due course, this will be considered the safest ways to reproduce. I think that is what Jason is saying because he's going from 1 million to 50 million. That is not covering infertility. He's saying, why would you do anything else? We're not there yet because I don't think you want to come to a clinic 10 or 20 times or five times.


    You really want to donate probably some cells for both male and female partners. So we still have to go a ways. We still have about 20 or 30 years before that's going to happen, I think, and maybe longer. But this is going to be the safest way to reproduce.


    Griffin Jones (55:07)

    Dr. Cohen, Dr. Barritt, I've had you on before and I'll have you each on again. Thank you so much for rejoining me on the Inside Reproductive Health podcast.

Kindbody
LinkedIn

Conceivable Life Sciences
LinkedIn

Dr. Jason Barritt
LinkedIn

Dr. Jacques Cohen
LinkedIn


 
 

281 Pharmaceuticals. Pharmacy. Supplements. Professional Services. Category Deep Dive

 
 

No organization or individual mentioned or participating in this podcast reviewed or had editorial control over its content. Any sponsor-related information, where applicable, was considered by Inside Reproductive Health through its Business Intelligence Hub.


What are the drug makers up to?

And who’s about to win or lose in fertility pharmacy?

This final category overview takes a hard look at the shifting pharmaceutical landscape: legacy manufacturers, rising challengers, supplement disruptors, and the latest in professional services.

We also dive into:

  • Why the pharmacy “middle” may be hollowed out

  • Which models are positioned to scale (and which aren’t)

  • Who operators are calling when they need expert guidance

  • The consultants and firms quietly shaping growth behind the scenes

Get an even deeper inside look at the current state of fertility networks from our recent Intel Articles:

Pharmacy, Pharmaceuticals, Professional Services, Supplements


You Can Stop Being Left Out Now, Y’Know

Next Big Exposure Before ESHRE!

If your organization belongs to this category but wasn’t included in this category overview podcast episode, then your competitors are dominating the attention of your customers: REIs, fertility network executives, embryologists, and others.

These same competitors will get more coverage in a report or podcast episode, about your category

  • To start the year

  • Before PCRS

  • Before ESHRE

  • Before ASRM

Why let them get all the attention?

If you don’t want to miss out before ESHRE, you have to join the IVF Heroes Universe as a sponsor now, before the next deadline.

You read it. Your employees read it. Your customers read it. Why miss out when you get so much for so little?

  • Griffin Jones (00:09)

    What are the drug makers up to?

    What's going on with EMD Serono and Organon?

    What's gonna happen with fairing now?

    Why are Meitheal and Granada picking up so much steam?

    Why is Bird&Be taking over supplements?

    Why do I say?

    The middle going to be completely hollowed out in sector.

    and we got a list your go-to guys and gals.

    the consultants, experts and firms you call for professional services.

    when you're growing or in a bind. And a special guest joins talk about a few of them.

    Enjoy.

    Griffin Jones (01:33)

    This episode has to do with two serious topics you want to talk to your kids about. Drugs and Trump. TrumpRx has shaken up the fertility pharma space quite a bit, as you know.

    The administration did a deal with the EMD Serono.

    Now there's big discounts on Gonalaph and other drugs.

    They're working a drug called Pergaveris approved through the FDA.

    that will in many ways compete with Menopur.

    This is interesting for a couple reasons. Dr. Gata had told me that...

    Organon's follow stem had been growing in market against gonalaph in the coming years. So this might blunt that. probably going to Organon to match the discounts or get close to it.

    Now Ferring has a competitor.

    to I saw a post from Dr. Amols.

    in February at the time of this recording.

    Where

    he was publicizing cheaper alternatives to Menopur.

    Ferring hasn't had kind of competition before, at least not in long I wonder if that affects their fertility team.

    Late last year, had axed 500 employees, none of them were from the fertility division.

    So is this going cause a hit

    to their golden cash cow?

    Are you going to see of your favorite fairing reps getting axed? Are they going to have a little bit smaller of a presence?

    or maybe not.

    Maybe this and some other things happening.

    cause volumes to grow.

    Ferring does better than ever and expands.

    I think there would probably need to be some sort of intermediary event for that to happen.

    But we'll see.

    I really have no idea what Organon's doing.

    Their CEO had to resign at the end of last year.

    There was an investigation about wholesaler sales practices, that doesn't seem to have affected their fertility division at all.

    And they must be cooking up some kind of response.

    But for the longest time, R &D has just dragged in the fertility space.

    And I think Granada Bio is making a big dent in that. started in 2018.

    That's Evan Sussman, Steve Medeiros.

    Now they're working on commercializing early stage assets.

    across various drug classes.

    getting them through regulatory approval.

    all the research trials, the partnerships.

    They with Gideon Richter.

    to bring recombinant FSH to the US acquired OVIVA therapeutics.

    that focuses on ovarian aging.

    And they're also advancing an FSH product.

    What I'm hoping for is that Granada is not a boutique name five or six years.

    but it's a really big player in this space.

    Keep your eyes paid attention.

    And if you're into research, if you're into finding viable ways to work,

    clinical trials your business might check them out.

    And this cost debate was happening long before...

    White House ever put their thumb on the scales.

    Dr. Brian Kaplan had commented on a post of Inside Reproductive Health months back.

    And he said, listen, if drug costs are 30 to 40 % of IVF order to reduce total cost to patients by 50%, wouldn't you have clinical expenses by 60 or 80 %?

    Dr. Kaplan was.

    observing that issue that you can't bring down the cost of IVF care without bringing down the cost of meds. I think Meitheal got ahead of that.

    Some of you hadn't heard of Meitheal before last year. Many of you know them now. out of Chicago.

    They're in generics and biosimilars.

    They've and

    and they're advancing an FSH in their pipeline.

    and they introduced a multi-dose Ganarelex pen.

    no idea Trump RX mean for me, Hall. I hope it doesn't blunt their growth.

    because they could be critical in bringing down.

    Griffin Jones (04:50)

    It took all this to shake up that sleepy pharmacy category.

    And I say this with due I have a lot of friends in the pharmacy sector.

    But I just feel like so many the pharmacy space have checked out.

    And I can't say I blame them either you just have to be the cheapest and you're just doing deals with networks based on price.

    and F patient experience because it is what it is, your commodity.

    Like a Spirit Airlines.

    Doesn't matter if there's no value adds because % of the flyers are buying on price alone.

    Or you have to be like a Mandell's.

    Ultra customer focused.

    You have to be so good at patient experience.

    that patients and providers are negotiating for you.

    to their payers and practices and networks.

    because you are an extension of their patient experience. look at Mandela's Google reviews, it's of hundreds of reviews.

    And they're not the only ones. There's a couple pharmacies with really good reviews. there are also some with really bad reviews. And now that you have TrumpRx,

    think those are the only two camps that are going to win. Everybody in the middle. wonder if we don't see many of them either go out of business or just get bought.

    and consolidate.

    because pharmacies do a behind the scenes. And you can read your practices reviews.

    often times complaints.

    come from some sort of dropping of the ball you and the pharmacy.

    And if pharmacies have to charge extra...

    for these ancillary services, I suspect that they now will because the drug manufacturers going to take the haircut just by themselves.

    then they either have to be so good.

    at customer service like a Mandell's

    or really cheap. have a 2.8.

    satisfaction rating or whatever the heck and just deal with it.

    You know why I don't think it will all go to the latter? of patients and nurses.

    You can only push nurses so far, man.

    I agree with Abby Mercado of Rescripted she predicts.

    that this is going to take a lot of admin and put it on nurses.

    think those nurses are going to want to push it right back off.

    and customer service will remain a viable only a couple of pharmacies, only those ones at the tippy top.

    Griffin Jones (06:58)

    supplements. Interesting category.

    Maybe a little bit of a sleeper I just don't think.

    You can underestimate trend of consumer behavior.

    In medicine,

    and the type of brand loyalty that you see.

    in other sectors of women's consumer products now coming into women's health.

    That's here. And supplements are already routine.

    70 % of patients say they take supplements.

    If you're a doctor you say, no, it's not that high.

    The source in Inside Reproductive Health's state of fertility supplements that came out in that only 25 % of patients

    disclose their supplement use to their care team.

    And for a long time I think Theralogix was the game in town.

    I'd like to know more about what they're up to.

    But Bird&Be

    is really shoring up.

    a very strong positioning in supplements.

    because they have that it factor ja ne se quois

    that really strong.

    women's consumer products, lifestyle brands have.

    And that's getting them into places like Ulta Beauty. They're in 300 Ulta Beauty locations.

    That also makes them a source of

    new patient generation, right?

    because they are bringing fertility into the mainstream.

    That's what I pay attention to.

    as pay attention to are flocking to, they're flocking to burden B. You care more about the clinical research.

    I wish I could go more into that.

    and what Bird&Be is doing with their medical advisors.

    but I can barely pronounce methylated folate.

    So I'm just going to go ahead and leave that link.

    in the state of supplements.

    report that came out in Inside Reproductive Health in January. you can click on that if you're interested Bird&Be's clinical research.

    Griffin Jones (08:30)

    What another cameo appearance, I'm getting celebrity bombed here. Shawn Vincent from Blue Cardinal Advisors is here. Thanks for joining me, Shawn.

    Shawn A. Vincent (08:39)

    Hey Griffin, happy to be here.

    Griffin Jones (08:41)

    help me overview this professional services category of which you're a part of one category that I didn't think would be that interesting because it's not like it's AI. It's not like it's tech, right? But at the same time, it's like these are some of the most trusted people in the space, people that have worked in this field for decades and we can't get along without them. So it ended up

    to me being a lot more interesting than I was kind of thinking. And I think maybe even more relevant because centers, fertility centers are using these professional services, firms, experts, consultants to fill in gaps from the labor shortages that have not gone away. I think in my opinion, 2021 and 2022 were the worst for companies abroad, but

    I don't think most clinics have seen any kind of relief since then. What are you seeing?

    Shawn A. Vincent (09:41)

    Yeah, it's interesting. And even through having the ability to partner with you and having the opportunity to interview some of the physicians I've worked closely with with you for years, you're seeing the same theme, constant growth, but how do you keep the same care? Right. And there's also always been that struggle with making sure you can maintain the nurses and the staff's happiness. So how do you do that? There's all these different companies that are out there. We know that the REI and IVF space is bumping and there's so many different solutions coming at you.

    and the providers, there has to be a way to kind of look through all of those and figure out what's going to be best for each particular clinic. And I've seen different clinics partner with different professional services, everything for ways of getting patients through the process faster, answering all those questions that they all get inundated with in the beginning. But then also on the back end, which we've talked a lot about is helping support the physicians and the nurses when it comes to the genetic questions they get as well.

    Griffin Jones (10:39)

    Our readers and listeners gave us the names of some of the firms that they work with and we'll go through a couple of those. Cedro Strategy was one of them and I figured out who that is. It's Ryan Salem. I don't know if that name rings a bell to you, but that is the CEO or he was the CEO of Blue Ocean Health, I want to say, in the UAE. I think he was involved in IVF Michigan for a long time. So he's done a lot internationally.

    and they help with operating models and scaling the page and journey. And they've worked with some massive, clinic groups and that's a C level experience. So I think that some people are looking for staffing. Other people are looking for sales support. there's some C suite level experience there, which I thought was really interesting. And I think people look for expertise from a little firm called blue Cardinal advisors. You know anything about that one?

    Shawn A. Vincent (11:34)

    I do. So 20 years of women's health experience, starting OB-GYN and then jumped into the REI space specifically when I launched, helped launch Semaphore out of Mount Sinai back in 2018. This was going to be my third carrier screening company. And from there, I knew as the genetic testing was getting bigger and bigger, if I were going to go to the doctors I've been working with, they were going to have to have some type of support. So that's where I actually partnered with GeneScreen.

    And a lot of physicians will say we revolutionized or changed the way that we actually support our physicians and our staff when it comes to the carrier screening process. Once Semaphore went public, my time there was done. I had had a great run in labs, but I wanted to go try something new. So I created my own company called Blue Cardinal Advisors. I took my experience and also the people I know and the thought leaders in the industry. And I wanted to be able to minimize the cost.

    to all these startup companies that are coming into this space, whether they're international companies coming into the US or earlier stage companies that may be not able or not funded to have massive sales teams. So what Blue Cardinal Advisors does is we understand what they're trying to do to help the big clients that are out there. I want to hear their message, see if it's the right message, see if it's going to be something that actually is going to fulfill the right need. And I try to partner with them.

    to help them go to commercialization faster and also save them money along the way.

    Griffin Jones (13:02)

    The value to startups of what you do is immediately obvious to me, but the value that you bring to them is also that providers and a lot of these network execs pick up the phone when you call them, which to me suggests that you're providing some value to them. How are you nurturing those relationships? Why are they so good?

    Shawn A. Vincent (13:25)

    It's a great question and that's the biggest, call it one of the most stressful parts I have because let's say I get presented to by a new opportunity every two weeks. And a lot of times I have them present to me these new ideas and I'm like, that's amazing. Let's go. That sounds great to me. But what I try to do is go out to certain people that I feel are passionate about that particular topic or we've had discussions around it in the past.

    Some may be genetics, some may be staffing, some may be PGT products, whatever it is, right? There's so many that you've reviewed all throughout this time. So what I try to do is find those different providers or even nursing staff or even head nursing staff. I would say, hey, this sounds good to me. Could you take a look at this or have you heard of it? And does it make sense? Will it help your practice? Will it help your patients? Is there going to be an ROI to you and your practice?

    Some of them may meet one or two criteria, but then they may fall flat on others and it doesn't work. So I try to be careful on going to the same people too many times because I don't want to dilute my credibility by bringing them every one of them. So I'm trying to create new touch points and different things I've learned through the last three and a half years with Blue Cardinal to say, okay, this sounds good, but it might not work because of this.

    Griffin Jones (14:50)

    people say they got a guy, you're who they're talking about. I look at some staffing needs that are happening across the place and I see a lot of practices struggling with filling their anesthesia needs. They might have a group and then that group has some of their anesthesiologists retire or they just can't meet the needs or they get way more expensive. And then I also see

    Shawn A. Vincent (14:52)

    Yeah.

    Griffin Jones (15:18)

    Probably half of the anesthesiologist workforce going to retire in the next five ten years and so this is gonna get worse and it doesn't seem like we're putting as many people in the pool to replace those folks at least from what I read in that report and I see a lot of people using Kaleidoscope Anesthesia. It's cool from our perspective because

    We've worked with them and then we see the groups that they work with and we get to interview some of the people that they work with like Lynn Westfall and Dr. Ben, Dr. Lynn Westfall and Dr. Ben Harris. And then we see them start to work with more practices and then some months go by and now those people that may have originally heard about them on Inside Reproductive Health get some experience working with them.

    Shawn A. Vincent (15:53)

    ⁓ huh.

    Griffin Jones (16:12)

    Then they get more and more exposure and you've had kind of ⁓ a similar Working relationship with GeneScreen. I think that and I covered them in the genetics Episode and We don't have them listed in the professional services category, but they kind of are right

    Shawn A. Vincent (16:31)

    so GeneScreen is interesting. Like I said, it started Semaphore partnered with GeneScreen back in 2018. And way that GeneScreen has adapted to the changes in genetic testing has been pretty interesting. When GeneScreen first partnered, it was going to be a comprehensive consult. And just to be clear what a comprehensive consult is and

    We've had some great interviews on your podcast about what these are with so many brilliant doctors. Comprehensive is where they do a 45 minute consult with a patient and a partner. They do family history. They talk about everything. And you also are going to make sure that you get a comprehensive couples report. What we've learned is some practices like US fertility, IVI RMA, and some NCCRM.

    We now have been starting a trend called stratification of risk. And we have those patients come into GeneScreen after you have the patient and the partner. We have a way to look at those risks based on the criteria that that practice prefers. And then we can put them in a low risk model or a high risk model. Low risk model is still gonna get a 20 minute conversation. We can answer all those questions at GeneScreen so they understand what.

    what the test was, what the results mean, what is a carrier screening, and they still get a report. Comprehensive, it's around a lot of times like 12 % of the time, it's allotted a 45 minute consult. So we can get patients through faster at GeneScreen, but we're still seeing every patient to make sure that we're providing support for the providers as well as the staff. But just to go back, just to touch on one other thing, I smile when you describe that other commercial

    growth that you were describing, because that's what happened with GeneScreen. It was, let's start with, we were in RMA New Jersey's boardroom, pitching some of the physicians there. And it was, if they approved what we were considering doing, we knew we could take this and take it across the country. So after we had RMA New Jersey, which wasn't even EV back then, then we went to US Fertility, and then we went to KindBody.

    And then there was more and more and the street cred continued to grow out there with all the different groups that we were closing, working with, and we were getting word of mouth out there. So really there wasn't a lot of banging on doors. It was a lot of word of mouth. So if you look at the projectory of ChainScreen starting in 2018, it was quadrupled in business, quadrupled in business, and then doubled the year after.

    Griffin Jones (19:06)

    And then you're throwing gasoline on the fire in a positive way and then it becomes the rule rather than the exception and then it's like, well, who isn't using GeneScreen

    Shawn A. Vincent (19:16)

    yeah, so then you sprinkle on a lot of the donor business that GeneScreen does. There's some hereditary cancer stuff that's kind of tied in there now because of the access for patients having PGT. Also, we're doing PGT consults because sometimes some of the things that they're gonna be reviewing, they wanna have it reviewed by a third party genetic counseling company as well. So it's been a good growth strategy and... ⁓

    Jill, the founder, is always very patient-centric and would rather make sure that it's done right, supporting the physicians and the patients first. So I feel like our trajectory has been smooth and even with our big growths, we've always learned patient and physician first.

    Griffin Jones (19:57)

    one of the areas that I know that I want some more ops expertise to direct people to so if people are working on on sales stuff, especially on the b2b side sales I'm sending them your way if it's marketing I can send them to some people if it's some things that they need with

    patient concierge and one of the areas that I have kind of struggled with is like, who's like the ops expert that I should send people to? And I want to check out the fertility consultancy more. To be honest with you, I don't know a lot about them. The reason why I know a little bit about them is that they participate in our IVF Heroes universe. And so I've got to read a little bit about them, but they provide services to help streamline clinics, to help with outcomes.

    benchmarking, SOPs, management decision making, optimizing results and.

    patient satisfaction, delivering some systems to both get feedback and implement at working on clinic reputation and expanding clinic capacity. So that's a group that I want to learn more about. They're fertility consultancy, fertility consultancy.com is where people would find

    Shawn A. Vincent (21:11)

    being in this field for so long. Some of the greatest partnerships I've had with laboratories, blue cardinal advisors, GeneScreen, whatever it is, when you can find a tenured nurse who's been there since for years and have gone from seeing patients, supporting her providers.

    and then gets opportunities to do operational strategic roles. Immediately, the one person I think of is Jessica Medavich. You've seen her become so successful because she's lived it. She's done the day to day. She's kept up with a group that's grown so much. And when you even watch their growth strategies, even through a partnership with KKR, she's been able to maintain and keep patient care a priority.

    And that also came through when we did our interview with Maria and Tom Molinaro as well. So I love those consulting concepts and they're desperately needed out there because these groups are growing so fast. And even the people that can run point on those there's you just listed call it eight different initiatives that are like critical when it comes to having a successful practice in having that culture within that goes out to the community as well.

    So I think that's gonna be a big emerging market that you just touched on. And I also think you're gonna see other, even nurses, if you will, that have been in this industry for a long time. Because I've even been approached by some and saying, hey, is this something do you think I could do in the future where I could help other practices out?

    Griffin Jones (22:48)

    I'll add to that, I think another expert comes from that RMA tree in terms of building new practices. put Lindsay McBain on that list for sure. And I don't want to too much, too much sunshine for RMA, but I think that someone that also came from that tree or just did work with them in the earlier days was Dwight Ryan. Maybe I've got that wrong. I know he did a lot of work with RMA of New York.

    Shawn A. Vincent (22:58)

    Absolutely.

    Yeah, no, you're right.

    Griffin Jones (23:17)

    But MedTech

    Shawn A. Vincent (23:17)

    Yeah.

    Griffin Jones (23:18)

    is one of those groups that I put on the list of that's one of the people and firms that clinics go to when they're building a lab for the first time. And they have been for a really long time. It's like the blue chip for lab building. And maybe that space gets a little bit more competition. Maybe there's more people trying to do that coming in. I think that they'll have big shoes to

    to try to replicate because I think people really trust Dwight. Rita Gruber worked for them for a long time and she was awesome and people just trust them implicitly. When you're building a lab, that's really what you need. You need to know that these are people that have done this so many times before. They've run into all the mistakes and we're not taking guesses with people that this is only their fourth or fifth time doing this. They've done it several times a year for the last.

    Shawn A. Vincent (23:51)

    Yes.

    Griffin Jones (24:14)

    many, years. And I think that they're among the people that trust the

    Shawn A. Vincent (24:20)

    I couldn't agree more Griffin. He's on my speed dial list. If anything falls under the lab utilization or anything like in his sweet spot, I certainly always reach out to him. He's so busy with all the different things that he's doing, but if I can, I try to set up a call with him and I certainly try to get his expertise. He's definitely on the list for sure.

    Griffin Jones (24:40)

    What else do you see happening in this category that you think people need to be paying attention to this year?

    Shawn A. Vincent (24:45)

    I just think it's going to be, it's going to be a big shift on still continuing to just focus on the patient care. We're seeing so many changes. We're seeing so many growth strategies that are kind of hopefully perhaps settling down. I just think that it's all going to revolve around helping access to care. How many times did we hear that in 2025? I think there's going to be so many groups that are trying. I, there's a lot of those out there that help with the access to care. I'm hoping that some of those kind of merge together.

    so that we can kind of unite them.

    Griffin Jones (25:16)

    Are you talking about

    that like patient journey automation kind of category, like the digital clinic, patient concierge, the

    Shawn A. Vincent (25:23)

    Yes, absolutely.

    There's so many of those that are coming to me and there's also so many products that are like, hey, we can do this at home. We can do this at home, but we can't do this. So I just feel like there's a lot of silos right now. And the advice I give to lot of the companies that present to me, it's like, could you maybe partner with a platform or could you also partner with this group? Maybe lower the egos a little bit, bring three great products together and have one good product.

    and then bring that to a bigger group and try to solve a couple of solutions with a really good platform.

    Griffin Jones (25:57)

    You think there's too many point solutions?

    Shawn A. Vincent (26:00)

    If I were a provider or a group, I would be yes. I mean, it's the market we're in. We're in a group that's exploding with all this innovation. Like you said, AI, but there's so many other things too. I just think that it's great for all the attention that our group's getting and it's fun to watch. And it's exciting for me who went our journey. I have two great kids from fertility. So it's personal to me to see all the benefits, but I just think there's so many. I don't even know how

    providers are dealing with it. I'm noticing in some groups, they're creating, I'm sure you've seen this, they're creating a new role for some of these groups to have a person that manages all these new presentations, concepts, partnerships, and it makes sense because there's so many of them. How do you go through all of them and identify which ones you're going to partner with? We've seen that with US Fertility, IVI RMA First Fertility, and others, you know.

    Griffin Jones (26:57)

    our best job to make it as easy for those folks as possible as we start to build out data.insidereproductivehealth.com as we start to categorize this, building it into a relational database. We're not doing it overnight. We're doing it at a pace that makes sense for our company, our size, but these are the types of things that we're trying to map out and we appreciate you coming on to give us a little color commentary over it. Thanks, Shawn.

    Shawn A. Vincent (27:13)

    Yeah.

    It's a pleasure being on. I appreciate all you're doing.

    Griffin Jones (27:28)

    Here's a group that maybe you don't know about that you should. IVF service. Have ever heard of them?

    They do preventative maintenance, they do repair and service of IVF lab equipment.

    They relocate equipment, disassemble it, package it, relocate it, unpack it, reassemble it, install it.

    all according to the equipment certification.

    Who would have thought?

    That's a business.

    And yet if you work in our field...

    You're thinking, yeah, of course. Because who would you want to do that?

    other than people that do that for a living. That is ultra sub specialized. I gotta meet these guys. Who's their president? Looks like Matt Haley. I gotta meet Matt. That is a cool.

    idea for a business. I bet a lot of you can take advantage of that. It's called Nationwide IVF Service, but they have this lab called the Gene Perti Calibration Lab. You know who Gene Perti is.

    It's a controlled environment and that's where they calibrate all the equipment that they use.

    to make sure they can trace all their measurements back to national and international standards.

    like those used by National Institute of Standards and Technology. I bet a lot of you didn't know that. I a lot of you were going to be calling them.

    Some of you have also told me about EverSana.

    They have a donor eligibility system. It's an automated web-based platform. It assists in donor eligibility determination.

    So if you're an egg bank, a sperm bank.

    third party agency.

    according to the source that's referenced in the State of Professional Services report.

    They've had 120 plus successful FDA inspections. They've been doing this for 15 years.

    And they say it saves 60 % in cost and 40 % in time.

    So if you're trying to grow your third party program, you probably want to read about Eversana's donor eligibility system.

    These professional service experts should be in your Rolodex. Luckily, you can just go to data.insidereproductivehealth.com, go to the professional services category. They're all right there for you.

Blue Cardinal Advisors
LinkedIn
Facebook

Shawn Vincent
LinkedIn


 
 

278 AI. Patient Journey. Software. Devices. Cryosafety. Category Deep Dive

 
 

No organization or individual mentioned or participating in this podcast reviewed or had editorial control over its content. Any sponsor-related information, where applicable, was considered by Inside Reproductive Health through its Business Intelligence Hub.


Patients, providers, and staff are doing far too much manual work, and with today’s tech it’s time to operationalize.

This Fertility Field Overview breaks down the current state of AI-enabled operations, patient journey software, device innovation, cryo safety…

…and where the field is falling behind.

This episode covers:

  • My bold prediction regarding IVI RMA’s approach to tech adoption (Hint: Think late 2000s Google)

  • Why manual workflows are burning out staff and frustrating patients

  • The operational tech stack clinics should already be building toward

  • Where large vendors are stalling (and where fertility-first companies are stepping up)

  • How AI, automation, and safer cryo systems could redefine clinic operations

  • What recent conversations with operators, physicians, and scientists suggest about what’s coming next

Get an even deeper inside look at the current state of fertility networks from our recent Intel Articles:

Artificial Intelligence, Devices & Consumables, Software, Patient Journey, Cryo Safety


You Can Stop Being Left Out Now, Y’Know

Next Big Exposure Before ESHRE!

If your organization belongs to this category but wasn’t included in this category overview podcast episode, then your competitors are dominating the attention of your customers: REIs, fertility network executives, embryologists, and others.

These same competitors will get more coverage in a report or podcast episode, about your category

  • To start the year

  • Before PCRS

  • Before ESHRE

  • Before ASRM

Why let them get all the attention?

If you don’t want to miss out before ESHRE, you have to join the IVF Heroes Universe as a sponsor now, before the next deadline.

You read it. Your employees read it. Your customers read it. Why miss out when you get so much for so little?

  • Griffin Jones (00:08)

    Patients, providers, and staff are doing way too much, way too damn much. It's not acceptable. The technology is there. Unfortunately, it's your job to figure it out. I'm just the guy that tells you about it.


    but providers staff and patients.


    cannot be doing all of these manual tasks. I lay out the tech suite for you.It's time to operationalize. With regard to devices, a lot of large corporations are doing nothing because fertility is a drop in the bucket to them. And with regard to new tech adoption, I have a very specific prediction about IVI RMA and I'm piecing together little things that I picked up on or inferred and made up completely out of nowhere from interviews Lynn Mason, Tom Molinaro, Iris Gonzalez, and Denny Sakkas And then I think about what people like doctors, Seidler, Bortoletto and Vaughn are doing. And so it gives me this little inkling that IVI RMA is going to do like Google in the late 2000s. And this could be a figment of my imagination, but it'll still be fun to see if I'm right or not. This is the Fertility Fields Overview on AI operation software, patient journey systems, devices, and cryo safety. And enjoy cameos from my special guests.


    Griffin Jones (02:23)

    And look who just slid in to help me think about cryo safety and cryo storage and devices and equipment. Dr. Jason Barritt Chief Scientific Officer at KindBody. Thanks for sliding in.


    Dr. Jason Barritt (02:33)

    Hello.


    Yeah, let's talk.


    Griffin Jones (02:36)

    start with cryo safety, seems like incidents still haunt the field, even if they're from a long time ago, there's always the specter of them. And it's not just incidents that might be caused in the lab, it's things that can happen outside of lab. So it's not just tank failures and things like that and gamete swaps, it's things like wildfires that happened at the beginning of last year, very close to where you live.


    Dr. Jason Barritt (02:52)

    .


    Griffin Jones (03:04)

    and things like the Palm Springs clinic bombing, which no one saw coming and hopefully we never see again. Talk to us about how embryologists think about these types of events.


    Dr. Jason Barritt (03:17)

    So I'll say that embryologists are exceedingly dedicated to the safety and security of the tissues that they are trusted with. It is one of the very special things about our job is they let us have that trust in it and we hold it very dearly. In fact, nobody would pick this career with the stress level associated with it and time commitment to it if you didn't believe in unbelievable safety and security of tissues that are for somebody else.


    So we spend a significant amount of time thinking about this. And yes, as you said, the history of unfortunate, exceedingly bad outcome situations with either a tank failure, filling failure, or alarm monitoring failure, or even an access failure have haunted the field hundreds and hundreds and hundreds of places right now, today.


    every single second are trying to protect all their tissues at many, many, clinics. Additionally, there's some very large, good, high quality centers that also do just storage. there is a entire business that's come in about this for the safety and security of tissues, monitoring systems, backup to monitoring systems.


    weight-based monitoring systems, temperature-based monitoring systems. There's also cameras, thermal imaging, and everything that can possibly go into these things in order to be able to safely and secure the tissues that are in our hands during the time that ⁓ they are not actually making a baby. So it is an exceedingly important thing to embryologists. want to do everything?


    Griffin Jones (04:52)

    And that includes transport


    and safety. I just think you're in Beverly Hills. You were so close to those fires that happened last year. I remember CryoFuture taking a lot of measures at that time to move specimens around and keep their facilities safe. What was that whole episode like?


    Dr. Jason Barritt (05:14)

    very stressful. Not only for all those who have been affected by the actual fires themselves and friends and family and colleagues, but also the fact that we wanted to protect all the tissues. And we actually had to not perform some things during that period of time in order to make sure that we were not going to have something that wouldn't be safe. So it was a very, very coordinated, huge amount of communication.


    wonderful system that CryoFuture allowed us the opportunity to pre-plan, pre-stage, be ready, and then watch and monitor the progress of the fighting of the fire and or the fire itself. And through a huge amount of work with them they were able to move multiple centers.


    entire cryo storage off to a much farther away, much safer situation in a exceedingly timely way in order to protect those. It was a very large lift and a very, very careful move in a very emergent situation.


    and they actually took them to their safe location, which is safer than anybody else could have been with multiple monitoring systems and multiple fail safes in place. So it actually went to the most safe place that you could possibly go to in all of Los Angeles.


    Griffin Jones (06:30)

    And that's part of the reason why you're seeing more cryo storage providers and more demand for them, I would think, right? Like you've got Haven Cryo and that seems to be starting to grow because people want to their specimens in different places or be able to get their specimens to different.


    Dr. Jason Barritt (06:48)

    Mm.


    Griffin Jones (06:49)

    places in case one geographic area is compromised. So you got Haven Cryo growing. You've got Reprotech making an investment in IMT matcher. and, so like, going beyond just like, okay, we got witnessing over here and storage over here to trying to become an end to end traceability system. And I like Brad Zennstra a lot. and then you've got a couple of others.


    Dr. Jason Barritt (06:51)

    Hmm.


    Griffin Jones (07:15)

    that space. You've got fertility billing solutions that maybe not storage alone, but helping to automate the digital audit, giving tools, patients, consent pathways to help with all that documentation.


    I think ultimately you're probably going to have two companies eventually be the ones that it's either Coke or Pepsi. What will it take for those two companies to get to that position? What will they have to have to be enticing enough to people like you?


    Dr. Jason Barritt (07:47)

    All these fertility clinics, all these wonderful people were never trained in, built places, and could never actually achieve all the monitoring system safety and security that a purpose-built system would allow.


    can have daily measurements of liquid nitrogen in a tank. And we could have a remote temperature sensitive monitoring system. But we could also have a weight based one. And we could have then video cameras. And then we could have for safety and security. Then we could have thermal imaging cameras. And then, ⁓ we could have that in a bomb safe place. Or we could have that also in a earthquake safe place.


    All of those things are what these purpose-built places allow. And they can do this because they purposely went at it as to what is the highest level and most oversight we can get. How do we get to two? I think that's quite a hurdle. I think it's gonna be a few more than that.


    The thing is that we have some regions in our country that are the most used for these types of services and have the most tissues and they're going to maintain out of those primarily. But we've got to get the tissues there and back when needed in a safe way also. And that transport is exceedingly important. They have to have validated and all the time checked temperature logging of those transport tanks. We have to have couriers.


    that are for medical grade transport. These tissues, any time they are not sitting in our tank appropriately, they're at risk, which means we need to minimize that or eliminate that whenever possible. And that's the thing that something like, CryoFuture is doing. They're not just about the storage where they have four or five different alarming systems. They have earthquake proof, they have bomb proof, they have all sorts of different things that they have prepared for, but they also take care of the transport back and forth.


    monitor it every minute with temperature sensors in order to make sure it's there and trackers. You got to know where your stuff is. what truck it's in and that type of thing. So you've got to have all that information. No individual IVF center can do that. We need the partners who are specialists in this. Two, I think is too small. I think we're going to have to have a couple.


    Griffin Jones (09:56)

    Let's talk about devices, equipment, consumables. The thesis of the state of that category was that it's our biggest category in terms of number of companies, and among the fewest that we've heard anything from. So I think it's part of the problem of investment in the field is that you have a lot of companies that


    make things to sell to lab directors and sell to REIs. Many of them are part of much larger groups and fertility is a small piece of their entire portfolio. So they don't invest a lot in it. They don't get a lot of autonomy. And so you have who otherwise should be big capital players, maybe not investing a lot in that space. and I'm,


    guardedly optimistic with next spring, you know, consolidating a few of those folks and, and you don't have to name any names. But do you find that to be the case that, you know, it's like, hey, this is a monster company. And I can't get some of the basic things I need from them or basic customer service or get them to sponsor this regional embryologist meeting or whatever, just because you can't get the right person because


    Whoever you know is just one person in a giant corporation.


    Dr. Jason Barritt (11:19)

    in the sense that almost all laboratories, want to consolidate and be organized and then have volume discounts and or access to the things specifically for the field. And that is what basically has happened is it's gotten to a limited number of distributors who are the key for


    our success. They will get on site more of a certain item, larger lots of them, test them, maintain them, and then be able to hold and reserve for you if you wish to order and use over a longer period of time, specializing in our field. So it is a huge change to have things like, I'll say it, the Cooper companies having NextSpring come in, having IVF Store.


    as major suppliers of these things. The truth is, yes, you can go find many of the individual items that they will all carry from any other individual source. And we used to do that, usually trying to get prices lower. But what we found is it's just so difficult to do. And when you have vendors that you have to go to for all your different things, it's very good news is that by consolidating them around the field,


    of IVF. has massively increased our ability to get high quality items in timely fashion that have been tested and made sure that it is the right thing for our field.


    Griffin Jones (12:37)

    for those that do have a presence in the space, the plus side to them is that they can make a big headway in that sector if their competitors are just kind of sleeping giants because their attention is elsewhere. I think of Samsung, that's on the clinical side, obviously, but for ultrasound machines, you maybe had one player in the space for a long time.


    And if Samsung is able to get in here and say, you know, we're starting to use AI tools and we're starting to work with people like Cycle Clarity, and we've got this thing called uterine assist, and we can reduce your scans, then they start to get a big penetration here. And hopefully that's a positive feedback loop that then gets them investing more in the fertility space. think they just won a large fertility clinic network they might be announcing that.


    soon if they haven't already. But that's someone that is coming from a very large corporation, but been able to show a little bit of dedication to the space, benefit from it, and maybe they grow more because of that as well.


    More up your alley about media. And I think that's Mendola on from CCRM and Dr. Baker on from Inception. They both like VitroLife's media.


    With regard to the quality of media, what are you paying attention to?


    Dr. Jason Barritt (14:01)

    So I definitely think VitroLife has great products. They have invested a tremendous amount of time and money in some of the best manufacturing and some of the best testing so that they could stand behind it and absolutely make sure that even if anybody ever questioned anything about it, they had everything in place to make sure that it was meeting that highest standard and that it was possibly something else that might have been leading to


    not most desired situation. A few of the other manufacturers have absolutely increased their testing and their controls and where they make it and how they make it. That has been done. I'll say the Irvine scientific ones increased the way they were testing it, moved to another even higher level included with their other ones in order to test their materials beforehand and during and then after in order to make sure it met that.


    is a tough thing to make the decision on what media to use because there are good people all in support of it. None of the good places or another big networks probably make this decision anywhere based on money. The truth is difference in total amount of cost is not going to be enough to change anything.


    What's going to be big enough is being able to get it, get it, get it at such a high quality, have all the controls and everything in place so that you can support and know you've minimized any variation that would occur, and therefore you have the highest quality outcomes based on it.


    Griffin Jones (15:21)

    Here's a prediction for you that no one asked for, but I'll give it anyway on the hardware side of things. The fertility partners in Canada, I think, is almost 100 % embryoscope or time lapse in all of their labs. I don't think that we've seen that on the US yet, but I think that it's coming. I've many of your peers on and I've all of them.


    is time lapse a nice to have or a must have? And the consensus has been it's not a nice to have anymore. It's a must have because of our need to standardize. And I that it might be RMA slash Boston IVF that is the one to do that in the US. Here's why I'm saying that. Because I've had


    Dr. Sakkas on and his view is that in five years time, every lab is gonna have some form of time-lapse imaging in their incubators. And then I've had Iris Gonzalez on who's the COO of RMA. And she talks about a system they have for meeting patient expectations and getting patient feedback. And then I see a group that


    formed in the Boston area that was former Boston IVF docs. It's doctors Pietro Bortoletto, Dennis Vaughn, Dr. Emily Seidler. They have a group called Terra Fertility. And before Terra was even open, I saw an Instagram post from them that said, you can see your embryos development in real time. And they're using Embryoscope that way. And I thought they get it. They understand how


    patients want to be plugged into everything for better or worse. You want to be able to see everything in real time. And that's such a good way to use time lapse imaging. I see Terra innovating that way. And then I think of, those innovators like Dr. Sakkas and Iris, and I think of RMA's CEO, who is Lynn Mason and Dr. Tom Molinaro their chief medical officer who are, I think, both forward thinking.


    Dr. Jason Barritt (17:22)

    You


    Griffin Jones (17:27)

    And I think they look at that group that splintered off of, one of their groups that maybe could have potentially been a part of them. I think it's like in the late 2000s, Jason, where they're like, we need to incubate this in our own ecosystem so that people aren't breaking off to do this kind of stuff elsewhere. We need them to know that they can do that here. And so I wonder,


    Dr. Jason Barritt (17:34)

    their acquisitions.


    Griffin Jones (17:52)

    if they're not the ones to say, let's have Embryoscope or time lapse imaging in every single lab and they're the ones to do it and they do it sooner than later. because they see that, ⁓ people are using this to be on the cutting edge. We can be the ones, the first ones to do a network in the if I'm I'm kicking, Esso.


    while they're down because I don't even know if they're still in business. say, you have no idea what you're talking about. a better year than ever. But all I'm just saying is, I don't hear anything from them. I think they both had CEO changes recently. think they both had North American sales and marketing teams recently. And just from where I sit as a marketer, it's like you don't get those windows for too long.


    take advantage of it. ⁓ I don't know if they can provide the support to US groups like others can. again, maybe they can. I'm speculating all of that, just inferring all of it. But if I am, that means that other people are too. And so if I were people behind embryoscope, I'd be acting now.


    Dr. Jason Barritt (18:40)

    you


    Griffin Jones (19:00)

    well, before those other groups come back. Anyway, that's my prediction. What do you see on the hardware side? What are you paying attention to?


    Dr. Jason Barritt (19:06)

    In 2012, I was all in on time lapse. Yes, it happened to be the embryoscope at that point.


    is a huge advantage to being able to select and follow embryos and see things This helps you do it. It's 5,000 times the information and what you get if you do just general culture. That's power in decision-making. It's power in conversation with patients to make them understand what is or is not happening.


    in the right way. It is a huge advantage in the way patients are treated and their outcomes. it's expensive and that is probably the only thing actually holding it back because the incubators themselves are unbelievably good. The advantage and the reason this is going to go and it's going to go fairly quickly now is that it has so much information


    And the one thing artificial intelligence systems like is information to make decisions based on. That leads to success for patients. AI is absolutely helping us.


    pick embryos better, and the more information it can get, the better it's going to do. showing it the entire journey allows it to select it at an unbelievably different level, including being able to help us understand what is probably going on at the genetic level inside embryos. That in itself means way less costly PGT testing.


    way less invasive testing, and as many doctors understand, unfortunately it's not 100%. And nothing is going to be. But this will give you an advantage to getting there much quicker and being able to select the most optimal embryos much quicker, which leads to ultimately the reason everybody comes to us. Take home a baby as quickly as you possibly can, successfully, normally.


    Griffin Jones (21:00)

    speaking of AI, one of the companies mentioned in the report is called Baibys, it's B-A-I-B-Y-S. I know that's a rising firm. I know that they automate sperm selection and that they took on a long standing challenge because 96% of sperm in a healthy sample


    are abnormal, at least according to the source that was referenced there. Have you checked out that group at all? Or are there others that you've checked out that you're paying close attention to?


    Dr. Jason Barritt (21:30)

    So yes, there has been for actually a couple years now a ⁓ selection tool that will help identify the best, optimal sperm live so that you can go catch them and use it is a great system. I think it comes out from the IVF 2.0 group it makes an absolute


    instantaneous microsecond selection of all the sperm that are on the screen and identifies them, follows them so you can track them and allows you to go get them. Similar thing is being done with idea here is yes, the vast majority of sperm are not optimal.


    it is a true advantage to have whatever is being done by those companies to be able to select the most optimal sperm because most are bad. And yes, when we say, yeah, there's 30 million there, you only need one. Well, it is true, but you actually...


    the right one. All of us came about because it was one that was going to work. We don't know how many wouldn't have worked, but it's all the other ones. So finding that right one is exceedingly important. Being able to do it live so that the embryologists can select those ones and use only those ones is exceedingly important. I will say that I've generally seen fertilization rates, normal fertilization rates, increase when you use better technology.


    better separation, ultimately now a selection tool that can do it faster than any of our eyes or experience can do it, using artificial intelligence in order to figure that out, of which are the most optimal, using many factors that we can't spend time doing. Those are what's improving pregnancy rates and for fertilization, because we're getting the right sperm.


    Griffin Jones (23:04)

    One of the other big trends that's been happening is a rise of embryology academies. So there's a focus on getting more embryologists trained. saw that Dr. Schenckman just posted that she formed one ASRM has theirs that they're trying to get some more exposure for. IVF Academy has Dr. Magarelli as their dean on the clinical side. And then they've got Tony Anderson there running the embryology training program. And I think that they're really focused on


    getting younger embryologists up to speed quickly, getting people to a place where then they can start focusing on some of the more senior level practices of being an embryologist. What do you make of this rise in embryology academies? Why didn't it happen


    Dr. Jason Barritt (23:43)

    Yes.


    Griffin Jones (23:51)

    10 years ago.


    Dr. Jason Barritt (23:52)

    So here's the thing. All of us directors were hiring and then having to train our own people internally. This is a lot of work and it takes a tremendous amount of not only time but money because you're spending an exceedingly important trained senior embryologist to train somebody who is not that and therefore you're actually taking two people's time in order to spend time on training. These schools allow first part of it at least to be done.


    completely outside of the laboratory and not affecting normal operations and things that are going on at that and not taking away your senior embryologist from doing the great work that they already know how to do. So it's very inefficient to do it inside your own house. another program is called West or World Embryology Skills and Training out in Carlsbad out here in California. I have been a user per se yeah, yeah, yeah.


    Griffin Jones (24:40)

    I know Debbie and Bill have been at it a long time. So I don't mean to say that


    nobody's been doing it. It's just that now it seems like more people have realized like we need more and I know that IVF Academy has invested.


    Dr. Jason Barritt (24:45)

    yeah. And Tony's been doing it for years too.


    Tony's been at it for probably 10 plus years too. And going down to Texas to get trained and things like that. So many have seen this. What it gives is a giant basis for the field and everything about it and your ability to do it and want to do it. And that is the key thing. We're selecting out the...


    individuals who really want to do it really will dedicate themselves to doing it. That is the key to the success. And if you can have that done by somebody else, you can get a candidate in that is even better and has a much better base to jump off from. Additionally, you can send people for additional training on specific skills and updates on those things, which is a huge advantage because it takes forever to do that inside your own house unless you're very, very large. And if you have six people that need to get trained, you can't do them.


    You have limited resources. This type of program allows


    also helps them advance faster in their career. I know it sounds like a big commitment at the beginning, but the truth is, that's what an apprentice situation was about. And that led to unbelievably wonderful things for many, many people in long careers.


    I am fully for external training.


    Griffin Jones (26:00)

    The thing I want to conclude about is you can't talk about the lab or AI or any of it without talking about Conceivable. And it took a lot of people by storm last year in terms of people being really impressed with the system. And I I think they've got some things that they're going to be publishing this year, which we look forward to following. But the report, the state of report reported on and your discussion with Steve Brooks,


    about the economics paper of economics in the lab. And that gets people thinking about Conceivable, but it is an issue certainly apart from them, whether people are trying to solve it with robotics and automation or not. What did you think of or did anything come to you after that conversation that you would further add?


    Dr. Jason Barritt (26:47)

    It is coming and it's coming faster than any of us would suspect. The reason is consistency and cost-effective use of resources. These are not cheap systems to develop, build, and put in place. But the truth is, once they are in place, they are the most efficient use, not only of the time of the people, but of the equipment, and therefore we can serve more people.


    and do it at the highest quality level, which is really what we're in this for. We want them to be able to get served. And the only way to do that is to have systems in place that allow it to be cost effective and available when they need it. And that is the key thing here. The system is going to work and it's going to work very well at big scale.


    This will allow it to be more centralized. I'll call it hub and spoke type situations, but of the highest quality care that is available to make it succeed at a level and be able to have


    unbelievable consistency.


    Griffin Jones (27:48)

    Dr. Jason Barritt, thank you so much for coming on and helping us think about this.


    Dr. Jason Barritt (27:53)

    you. Have a great day.


    Griffin Jones (27:53)

    Another special guest at my door Lauren Berson is here with a special cameo appearance. Thanks so much for joining me Lauren


    Lauren Berson (28:01)

    I am pumped to be here.


    Griffin Jones (28:02)

    First, let's go over the state ofs and then I want to get your opinion. start with EMR slash clinic operations software category. The state of report that Inside Reproductive in January regarding that category really had to do with


    fertility centers are so fragmented with their data, a lot of that has to do with people are trying to use EMRs as operating systems for everything when they were originally built to just be that electronic medical Eduardo Harrington talks about


    Lauren Berson (28:33)

    Yes.


    Griffin Jones (28:36)

    there's not a ton of CRMs at the clinical level. That's, I think, part of the problem. What's your take on this?


    Lauren Berson (28:41)

    this industry, think has been ignored by technology for a long time. And I don't, I've never really met a clinic that loves their EMR. But when you speak to, clinic staff who are embedded in this EMR all day long, trying to get things done and improve workflows, I think the reality is it took them years to integrate and it takes years or months.


    right, to make changes. And it becomes a really challenging balancing act if you actually want to get things done. And I think the way we entered the space, instead of being a system of record, right, we thought about becoming a system of action. Meaning, to exactly your point, how difficult it is to make change in that core system of record.


    there's a sort of set of emerging players like Conceive, like, Wawa or Salve that are trying to kind of say, you know what, we might be more of the operating system that connects patient management, clinic workflows, and maybe even payments into one system. And we can integrate with the EMR eventually, but we can actually get a lot more done given that those systems are just not as nimble, right? They're fragmented, not tech forward in a way.


    I think there's a lot of momentum in that space, but at the end of the day, you still need an EMR.


    Griffin Jones (29:58)

    Is part of the challenge the scale and how small the fertility space is and it makes it harder to scale? Like if we were in a bigger field, would this be happening more quickly or would it be easier? The report mentions Metatex and I think they do business in the United States as well, but they've done a lot of business in Europe and they formed from the Nexus group and they're in


    over 500 facilities in over 50 countries. They're in 2,400 clinics in 70 plus countries, or at least and nexus and astria, if I'm saying that correctly. And so they're able to reduce paperwork, they're to minimize disruptions. I think that helps having that scale. And when you're plugged into an entire continent like that,


    Maybe that's the only way to do it. Maybe it's global or you see that? it global or bust? And would this be happening faster if the fertility space were larger?


    Lauren Berson (30:53)

    at the end of the day, what we're dealing with is complicated practice, complicated workflows, burned out clinicians in some cases.


    And so there's almost like an aversion to changing systems, right? Because it took them so long to get there and they have so much on their plates. At the end of the day, adoption requires, deep integration, time, ripping out what they spent years working on. And if they're still getting things done and serving patients in a way in which they feel works,


    it's really, really difficult to maintain or create that kind of change.


    Griffin Jones (31:28)

    Do you feel like that you need to focus on the US as an entrepreneur or North America or can you do global all at the same time?


    Lauren Berson (31:37)

    You know, it's interesting, we can and will do global. In particular, we have nurses and coaches around the world. We have some folks to support all different time zones. When I started the company, felt like, first of all, I'm here and I understand the US healthcare system the most. I felt like globally things would be too different, right? In terms of.


    their healthcare systems and how patients move through the journey. And I've realized that there's actually a lot more commonality than there is difference. And so, know, Conceive in particular definitely lends itself well global presence.


    Griffin Jones (32:09)

    To your point too, there are some resistance points to change and I think it has to do with kind of when the company started. I think some companies started just before the internet even or before internet 2.0 at least and before the cloud. And so it's a lot harder for those companies to transition. Some are just starting now and then some are kind of in between. think Artisan's in an interesting position because


    Lauren Berson (32:22)

    Totally. Yes.


    Griffin Jones (32:35)

    They've been around for a little bit, but they started off in the cloud and they have also expanded a lot in different parts of the world. And so they've been gaining traction and then they decide who they're gonna integrate with. So they've integrated with CycleClarity. love that by the way. Anybody that integrates with CycleClarity, feel like just everybody should.


    Lauren Berson (32:40)

    Yeah.


    Agree.


    Griffin Jones (32:54)

    it makes sense from a value standpoint. I like that they've done things with Xiltrix and so in focusing on lab safety. So I like the way that Artisan is has been expanding. And then I'm interested to see some new challengers come in the space. Engaged MD was a company that


    Lauren Berson (33:02)

    Mm.


    Griffin Jones (33:09)

    has been around for a while. This report talks about like now they kind of like have their first competitor like Berry Fertility is here. think Berry engages with Pinnacle if I'm not mistaken. Fact check me on that audience. But they have a smart intake solution. so they're working a lot more than than just consent.


    Lauren Berson (33:20)

    I


    Griffin Jones (33:28)

    It's about business intelligence, getting deeper insights with analytics and accelerating clinic workflows. I'll be interested to see what Berry does. For you, how do you feel like you have to decide how far you're going to expand into versus like that would be a distraction?


    Lauren Berson (33:45)

    I think the reality is we're still learning and we will always iterate with consumer demand, right? Which is patients and clinic demand because we serve, we service both. So for example, a year ago, if you had asked me if we would ever have patients talk to AI, I would say, absolutely not. Patients come to us because they want emotional support and they want to know they're talking to a human. Consumer behavior has changed significantly, right?


    So we have, you know, we're starting to integrate AI in the front lines. You'll always know if you're talking to a chat bot, right, versus a human, and you can always bypass that, but it's just changed. I used Chat GPT for therapy once, you know, like we're in a crazy, crazy world. As we've embedded deeper into clinics that we partner with, and I think that is the key, really embedding yourself into workflows, we've identified new opportunities and challenges that are just not being solved. Again, because if we look at this space,


    it's really nascent and there's just not a lot of solutions that have gotten traction. And so we will absolutely evolve our offering as sort of the market dictates and as our partners dictate. Cause we have some really deep partnerships now where we get into the clinic and we observe things that we can actually easily do because we have a technology solution that now is integrated.


    Griffin Jones (35:00)

    Do you feel that patient experience and patient journey is the thing to solve for right now?


    made so many advancements on the science side. And of course, there's always more improvements to be made, but the patient journey has really lagged. Patient experience has suffered.


    so that brings us into I think you really occupy a space. Is this the thing to solve for right now?


    Lauren Berson (35:24)

    I think there's so much to do, candidly. your point, I think the most we've done is innovation in the lab and the research there. Like we've definitely come a long way in the last several decades, but in many ways, we're still in infancy stages. I've said this many times, but I really believe that, right? We've, know, IVF outcomes have improved and that's amazing. And there's more and more research.


    looking at how do we improve egg quality? How do we even measure it to improve it? There's a million different things. I do think the reality is, that's what's been ignored, is the patient experience. But I would clarify a little bit. I love about Conceive, obviously, because it's my second child, and my life's work, is that we do two things. We are actually solving for patient experience, but clinic outcomes and ROI.


    So not only are we there 24 seven for patients to give them both the clinical reinforcement. So reinforcing their care by doctor, by patient around the world, wherever you are in three minutes or less, but we're there to provide emotional support, right? And then community on top. we are the full patient support layer, but by virtue of what we do, we're actually accelerating time to treatment, Reducing clinician workload.


    and improving service recovery and reputation. And so I think those two things are really important to go hand in hand, Because I think there have been definitely a plethora of companies that have approached this from sort of just the patient angle, community groups and things like that. And I think that's great. And those need to exist and they will, right? There's thousands of Reddit forums and Facebook groups. But I think by actually providing almost like a digital twin for Dr. Copperman in New York, so that if you leave his office and you forget what he says, you come to us and we'll remind you.


    To reinforce those SOPs and extend the reach of the clinic, that's the real sort of integration layer, I think, that is the thing that has not been solved. So while I think in some, a lot of things need to be solved in this space, I think this is a big one and it hasn't really been touched.


    Griffin Jones (37:22)

    And we have to too, right? Because patients are just stressed the F out. I like the research that Dr. Domar was referencing. but she saying they work with Navy SEALs, they work with the NFL, they used to work with Russian Olympians, and they've never seen stress tests, stress levels like they saw in the women that they were following during the Stim phase of their cycle. And...


    if we don't solve


    for this is only going to get worse and worse. It has been getting worse, I think, because of the anxiety of we're used to instant gratification and then with the more potential for communication. But if that potential is unmet, then anxiety raises. It seems like patients are demanding it.


    Lauren Berson (38:06)

    love Dr. Domar's research so much and all of the effort she's put into really understanding like levels of anxiety, right? And I think what's unique in fertility, which is why I think you see this a little bit differently because most patients are afraid to advocate for themselves.


    But because this tech, tends to be a cash pay experience where you're shelling out tens of thousands of dollars. I think you have this sort of like, OK, wait a second, right? I want better care than this. And I didn't like that the way that was communicated or this completely fell through the cracks or there was an error here or an error there. And so I think all of this overwhelms the system. And the reality is these journeys are absolutely all consuming.


    They take over your life when you're going through it. Like we measure, we map to the PHQ-9 on these markers of mental health, reduction in anxiety levels, improvement in optimism. If you just have a little support, right? Just a little bit more than ChatGPT-ing your way through it, like you're gonna have a better outcome.


    Griffin Jones (39:04)

    Tell us more about what you've done with RMA of New York and others, what Conceive has done.


    Lauren Berson (39:09)

    we do really three things really well. 24-7 care. You text us any time and we answer you in several minutes from nurses and coaches. When we're partnered with a clinic like with RMA of New York, we are there to reinforce your care every step of the way based on what your doctor's preferences are. So Dr. Copperman versus Dr. Sekhon they have different preferences even within that clinic.


    And so we know Griffin is a patient of Dr. Sekhon and we're gonna answer this question probably the way she did in your appointment, but it's so overwhelming you don't retain the information. And we do it in minutes, the sophisticated questions like get on FaceTime and do IVF injection support, or should I do PRP for my endometrial lining And then secondly,


    ⁓ we have coaches. And this, think, I like to say we put the care in healthcare.


    they do is they excel in just like helping you get your life back. And by virtue of this, you're able to make decisions and move faster through the journey because you're not getting stuck with, how do I manage my doctor appointments with work? We help you map all these things out. We go really deep.


    The third thing we do is really diagnostic support. That's more preconception, but we can support patients who are actively in treatment, who are doing, know, who want ovulation support through blood testing.


    able to move patients faster through the journey, but vastly reduce time spent per patient per month. We have after-hours support, so we take over that out-of-office message. you message your clinic at 5:01 and they say, our office is now closed, Conceive is there front and center, we answer those questions. And if the patient is satisfied, we send a report to the clinic. So they literally don't have to answer those questions the next morning. So we're really reducing duplicative work and reducing work on the clinician's shoulders. And the third piece,


    that comes out of this is really the reputation management. We're the first place that patients come when they're upset about something. They're not always going to tell the clinic. The clinic will hear about the really crappy experiences, but everything in between, it's kind of that Yelp effect. And so we're able to help improve workflows before they become issues, identify when patients are maybe getting sick from a new medication. We've done all of those things with our clinic partners because we have this unique data lens and layer to say 10 % of patients are stuck booking their next appointment.


    12 % of patients got sick from this new medication. And so we can help the clinic both solve one-off urgent scenarios of patients maybe wanting to leave, but also overall workflow improvement.


    Griffin Jones (41:33)

    All of the patient populations prior to needing IVF are also folks that need this type of digital interaction because if they just are asking all these questions to a fertility center, forget it, there is no bandwidth for it. And I think some have done a really good job of that. read in the report that Doveras I don't know if I'm pronouncing that correctly, maybe it's Doveras but they have really focused on that. They've been able to


    Lauren Berson (41:48)

    There's none.


    Griffin Jones (41:59)

    help to fill the preconception gap. They took over 100,000 clinical studies, they synthesized them, make it into a personalized experience, and then they did a study with 600 participants from 46 different states showing their engagement, and more than half of those hadn't even seen a fertility professional yet. So we need something for those kind of folks. seems like...


    Lauren Berson (42:22)

    Yes.


    Griffin Jones (42:23)

    Doveras is tackled that and maybe you all have too.


    thanks so much for coming on and helping me think about this.


    Lauren Berson (42:29)

    Always a blast hanging with you, Griffin.


    Griffin Jones (42:31)

    Doctors, nurses, managers, embryologists, they're responsible for way, way, way, way too much data entry. That's the central theme of the State of Artificial Intelligence report that was published by Inside Reproductive Health in January.


    Data flows aren't automated. They're often manual. They're left up to the patient very often. a loss of control at the clinic level of how that happens.


    and it's very expensive to pay personnel.


    people that takes to move a patient through.


    that clinical experience from team member to team member.


    That's my good friend, Dr. Eduardo Harriton.


    of RFC of the bay area.


    painting the picture for us.


    of what's going on with the underlying need for artificial intelligence for a number of different applications in the clinic and the lab.


    There's just too much variability.


    and that gap appears to be widening.


    Patients expect personalized predictions, not general ones. They want transparency. When they say transparency...


    They mean they want real-time updates all the time.


    and they want it all to be But the legacy tools still require so much repetitive manual inputs.


    And so the measurement's inconsistent.


    So it's not like AI.


    is a single category.


    That's just the way we've been reporting on it now.


    there's a lot of different applications.


    and have to do with the problems that clinics are facing.


    So clinics struggle with inconsistent follicular measurements.


    inefficiencies of standard monitoring protocols.


    And those challenges don't just affect clinical accuracy and patient experience.


    messes up the predictability of lab and clinic workflow.


    The report talks about how psycho clarity has been making a huge headway.


    in resolving those issues for clinics.


    They compared 177 IVF cycles.


    where the REIs under predicted mature oocytes by 4.8.5%. But CycleClarity's algorithm


    over predicted only by 0.71%.


    in that cohort.


    Cycle Clarity was much more accurate.


    They also looked at some retrospective data.


    with 858 patients.


    and found that Cycle Clarity is ultrasound monitoring.


    produce the same outcomes.


    as traditional monitoring


    time that it took to do all that was 66 % less. If I'm understanding correctly, you should go to the report to link to the original sources in case my interpretation is fuzzy.


    what this means.


    is that we have an AI tool.


    that's as or maybe even more accurate.


    then the way


    Doctors and techs are doing it now.


    and it can be done so much faster.


    and communicate so many other technologies in real time.


    Whether it's Cycle Clarity or others, these are the things that we have to be doing to get rote work off of clinicians and staff's plate.


    You had similar things happening in the lab. Future fertility has been.


    growing by a lot they recently added to insure coverage in Canada.


    They help with oocyte grading. So obviously, two really big applications for that are fertility preservation and donor egg.


    They've got a couple different products, violet, magenta, rose.


    They introduced euploidy insights. Not sure if that's a product or a feature, but it's a non-invasive model that identifies which oocytes are most likely to develop into euploid blasts.


    So it's Future Fertility if you want to check them out.


    One of the things the state of artificial intelligence


    reported on


    is that patients are waiting far too long.


    for treatment, they're waiting far too long even to get diagnosed.


    Only 16% of women with infertility are ever formally diagnosed, according to this source. Some wait up to 11 years.


    And the OBGYNs, who often see them first, they often don't have the tools.


    or the training or the experience to properly assess them.


    Levy Health has a clinical decision support system. They try to reduce the delays helping OB-GYNs the channel, giving them structured diagnostic pathways. In one of their pilots, 96% of women using Levy's software unknown diagnoses.


    They averaged three newly identified conditions with many beginning treatment within eight weeks.


    So they're triaging patients, they're triaging patients, they're triaging egg donors. streamline reserve revaluation.


    among other things. so the whole point of Levy is to shorten the screening timeline.


    to two to three months. So you're reducing the high attrition that often happens with donors and with patients for that matter.


    Because Levy's taking care of that further upstream.


    The report shows just how broad the AI category is.


    We're scripted as a media company.


    hundreds of thousands if not millions.


    of women's health patients.


    read and listen to at one point or another.


    But they made the first LLM trained exclusively.


    on medically reviewed women's health content.


    at according to this report.


    And they built it on Rescripted's content library and the resources provided by their partners. They call it Clara. Good name, Rescripted.


    and they reach roughly 20 million women monthly. Is that right? sounds like a ton.


    Either way, it patients for.


    and those patients to determine what their probabilities for success are.


    and UNIFI's machine learning apparently breakthroughs in that area because a lot of different clinics participated in that Univfy study. I don't know if you saw that study.


    There are a number of different clinics. I wish I knew how many the patient number was at over 24,000.


    And according to the report...


    had dramatically higher conversion rates.


    The report says 213 % those going to 180


    and 241 % higher total IVF utilization, though I don't know over what time period.


    That's referencing.


    That would be really big. know Univfy has done a lot with machine learning.


    You all can find the report.


    by clicking through the sources listed in the State of Artificial Intelligence article. check that out.


    because Univfy might be something that would really help you with your conversion rates.


    And we haven't even gotten to business insights which is an area that US fertility again.


    with my friend, Dr. Heriton being big of that, an IVY Fertility.


    standardizing their data.


    Because USF might have one EMR, but you're still acquiring clinics, right? I'm not sure if Ivy has one EMR, they might have different ones.

    Even then, it's been entered different ways. You got to standardize that data some way. That is a nightmare to do.

    You need a whole team of data scientists and data entry people cleaning up the data, double checking their work. They use Cercle You may have heard about Cercle They seem to really like it. Cercle was a company that asked a couple different people about who's adding the most value right now. I didn't prompt them with any multiple choice. Didn't even ask them what AI company is providing the most value. I just said what company is providing the most value. More than one person told me Cercle. That's how I heard about them originally, and it's because they address that fragmentation by standardizing the diverse data sets into usable formats for clinics. And they're really focused on reducing the hallucination rate so it's accurate, scalable, data-driven. And that's what we want AI to be.

Kindbody
LinkedIn

Conceive
Website

Dr. Jason Barritt
LinkedIn

Lauren Berson
Website


 
 

270 Quality in IVF Labs. From Acceptable to Exceptional. Drs. Michael Baker & Robert Mendola

 
 

Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


Embryologists have a lot riding on the line.

Bad supplies can cause big problems. Good supplies can create big improvements. Either way, success rates and patients’ lives hang in the balance. Every detail in the IVF lab matters.  “Good enough” can cost more than it saves, because only the highest standards protect consistency, outcomes and trust..   

We’re joined this week by two of the most respected leaders in embryology. Dr. Michael Baker, Lab Director at Aspire HFI, and Dr. Robert Mendola, Lab Director at CCRM and member of the network’s Innovation Advisory Board.

Together, they break down:

– The full chain of quality assurance, from suppliers to networks to individual lab

– The burden and importance of retesting lab materials

– Why labs should evaluate not just blastocyst formation but cell counts per blast

– The tension between cost control, standardization, and lab autonomy

– The suppliers and products that stand out for exceptional quality (including Vitrolife’s media and oils)

– Why transparency and competition should set the standard for lab supply quality (instead of regulation)


Bottled Brilliance for Life’s Most Delicate Journey
An unbroken chain of quality, crafted to nurture every stage of embryo development. 

In the IVF lab, there is no room for compromise. That’s why Vitrolife media is built on a foundation of scientific precision, safety, and consistency

  • MEA-tested media — every batch tested to exceed industry standards to ensure embryo viability  

  • OVOIL & OVOIL HEAVY — engineered for consistency and stability you can rely on 

  • G-MOPS™ buffer — trusted for proven performance during critical handling steps 

  • Gx Media & EmbryoGlue™ — clinically proven solutions that strengthen embryo development and support successful implantation 

With Vitrolife media, you gain more than products — you gain a partner committed to protecting embryos and supporting your lab with peace of mind, every step of the way.

  • Robert Mendola, PhD, HCLD (00:00)

    You want to test even in-house these medias and consumables that you use. an extreme importance to that to not even just solely rely on the commercial, testing and the passing grade or whatnot. So any kind of consumable, any kind of media that comes in, there's such an importance to testing all of these end products to make sure that there's no toxicity, there's no potential ramifications, negative ramifications on our patients' outcomes.


    Griffin Jones (00:39)

    Embryologists, you have a lot riding on the line, don't you? Bad supplies can cause big problems. Good supplies can cause big improvements. Either way, it affects your success rates and your patients lives. REIs and executives, you're on the hook too. Your success, tragedy, mediocrity, glory, and that of your patients can sometimes be tied to a gosh darn dish of media. Two of the most listened to voices, in my opinion, on the subject of quality of IVF lab supplies, are doctors Michael Baker and Robert Mendola.And for all the manufacturers of lab supplies and devices out there, these two give you an hour of free consulting on how to be first in class and how to sell a lot more product to colleagues like them. Dr. Mendola is a lab director at CCRM and he's on the Networks Innovation Advisory Board. Dr. Baker is an onsite lab director at Aspire HFI and an offsite director for many other labs in the Prelude Network. They described the order of quality assurance the supplier to the fertility network to the individual IVF They described the burden of retesting and why it's so important for labs to choose the highest quality suppliers. They call on suppliers to measure not only the number of blastocysts that develop, also the cell counts of each blast. They weigh the tensions between cost control, standardization of best practices and the autonomy that local lab directors and embryologists need to choose the best quality supplies. They share which products they like the best from different companies, including where Vitrolife has gone above and beyond in media and oils and why Vitrolife's level of quality control is so crucial. They opine on why it should be the suppliers themselves, not a government agency or consumer watchdog that through transparency and competition sets and forces the standard of quality of supplies, and thus the responsibility of networks and labs to confirm those standards are They each sign off with their specific request for transparency from manufacturers of IVF lab supplies. Enjoy this conversation from two lab directors raising the bar for quality of IVF lab supplies.


    Robert Mendola, PhD, HCLD (03:52)

    So I think one of the most concerning is the need for a universal standards for quality control from the commercial companies. So that being said, a more of a higher standards when it comes to testing their media.


    and their consumables. Right now, in most cases, they use MEA, myosin embryo assays, where a lot of the times they just look at blastocyst development, how many blasts develop. But I think they could take it one step further. I know some companies do, where they not only look at the blasts that develop, but they look at the total cell counts in each of these blasts. So it gives a more specific and a higher standard that they have to meet.


    to make sure there's no toxicity in their consumables, in their media, in their oil. So that being said, I would like to see that to have a universal standard so that each commercial company can abide by that and then give us the reassurance as IVF centers that purchase these products to make sure that the highest quality, especially when it comes to success and potential success for our patients. ⁓


    Griffin Jones (05:01)

    What's in the absence of the universal standard?


    What does it look like without that?


    Robert Mendola, PhD, HCLD (05:08)

    So a lot of times it could be, you know, some companies can just, they use a mouse embryo assay and there's different strains of mice that they can use that are more sensitive. So if you're using a more of a, an outbred mouse instead of the inbred kind of versions, you're looking at a higher potential sensitivity so that you can kind of test the product. And then with that,


    ⁓ with the higher sensitivity testing have more reassurance that you're not missing any potential toxicity. That being said, not only about particular strains that you're choosing, but also to go one step further, you're looking at the developed blasts, you know, to kind of see, okay, what kind of ramifications, if any negative ramifications, made this testing have on the specific blasts. So you're doing a cell count on top of just developed blasts, so that you can reassure.


    what you're having is not any mist toxicity or compounding toxicity that can have negative ramifications at the end product.


    Griffin Jones (06:09)

    And so is it that some of them don't even have that testing or they just have different thresholds for what's acceptable?


    Robert Mendola, PhD, HCLD (06:17)

    They have a limited testing. So in other words, if they just meet the blastocyst development, then that's, we're good and clear check. And so therefore, you know, continue the process. But even if you have a blastocyst as much as we see in our IVF centers, you have different quality blastocysts. So you want to make sure that the testing you're seeing is at the highest quality that you're not having any negative ramifications that impeding the development. So you're having less cell development.


    ⁓ And so that, you know, having that higher standards, I think would kind of hold these companies to a higher standard of testing.


    Griffin Jones (06:56)

    What do you think, Michael, what do you think is the biggest missing piece in terms of quality assurance or something that is controversial that you're not totally satisfied with yet?


    Michael Baker (07:08)

    Well, as I'm thinking about that question, just looking back at the multitude of laboratories that I've touched across the years and just seeing the variations between each lab and what they're looking for when I arrive, both in terms of internal quality control but also external. We have a lot of


    trust that just has to be in the partnership between us and our.


    suppliers. If there's just not a capacity to be retesting at the highest levels once we get a product in, that certificate of analysis needs to be reliable. I've seen a lot of corrective actions put into place that respond to some poor event internally that we are going to begin


    more testing, more busy work. I'm trying to hold the suppliers accountable so that they come to us with their corrective actions and asking them, what have you done to prevent that from happening again? And they all have put heavy investments into their quality improvement over the past several years. And I...


    look forward to hopefully a decreased frequency of negative media tension that draws the public eye where we really want to demonstrate our commitment to excellence.


    Griffin Jones (08:44)

    I want to make sure that I understand the retesting. So are you saying that a product comes in, it has a certificate of analysis from the supplier and then you all are retesting it? Am I understanding that correctly?


    Michael Baker (08:56)

    That's going to vary widely from lab to lab, but some lab directors would respond to a ⁓ quality event by trying to solve that internally. So bringing in mouse embryo testing or sperm survival testing into the laboratory where our embryologists are hard pressed for time already, and we need to be focused on taking care of our patients' embryos.


    It's concerning when we feel like we have to take on that burden of ensuring the vendors' consistent, reliable products.


    Griffin Jones (09:33)

    What are those quality events that trigger that? Is that only when you hear about some kind of recall or when an incident happens or if you're noticing some sort of inexplicable dip in your numbers or is it something that you do routinely?


    Michael Baker (09:47)

    In my my moderate tenure, I've fortunately arrived onto the scene after the fact of most of the horror stories that happened decades in the past as we were trying to learn these lessons the hard way.


    If there was a problem with oil or culture media, it's going to first show up in the statistics that we're monitoring consistently, but then it will be disclosed to patients. It will be possibly picked up on a national level.


    when those things have happened in recent memory, it's just, what is the level of response necessary to protect the patients from that type of repeating incident?


    Robert Mendola, PhD, HCLD (10:36)

    Michael said, you you want to test even in-house these medias and consumables that you use. there's an importance, an extreme importance to that to not even just solely rely on the commercial, you know, testing and the passing grade or whatnot. So any kind of consumable, any kind of media that comes in,


    And this is, as Michael said, it's tougher with the smaller programs, even in a big program, there's such an importance to testing all of these end products to make sure that there's no toxicity, there's no potential ramifications, negative ramifications on our patients' outcomes. So we test all our medias, all our consumables. We have a central quality control center that does all this testing, testing each lot prior to a circulation within the IVF center.


    because that gives the reassurance that you're not relying solely on these companies that, as I said before, don't have the universal standards. So we take it upon ourselves to do that reassurance to make sure that there's no negative ramifications on our patients. And I think that's a priority and it should be a priority to the centers out there because you have to have that reassurance to make sure that there's no unforeseen toxicity. look, they test it in-house when they're


    production during production, but you have transport, you have things that take place much further after that, that could have some negative ramifications so that when the end product comes, before we put it into circulation, we test everything to make sure we get the blessing from our quality control team to say, is good, continue use, and it's fair to use.


    Griffin Jones (12:23)

    That central quality control center that you've got Bob, is that at one place in the CCRM network or is that at each lab?


    Michael Baker (12:24)

    Yeah.


    Robert Mendola, PhD, HCLD (12:30)

    Yes.


    We well, we tried to and again, this is the benefits of a big program. We have a centrally located quality control lab, so they test all lots of any consumable. They test all lots of any potential media that's going to go into circulation. So we buy in bulk so that all of our networks can use that same specific lot. But it's not in use until they give the go ahead to say, look at we tested above and beyond.


    what the restrictions are on the company itself. And again, that gives us the reassurance that there's no end product concerns from production that we can see and that we get to go ahead and have the best quality that we can have for our patients.


    Michael Baker (13:14)

    Yeah, we've also identified that strategy again to let the embryologists focus on the embryos. Finding ways to do annual lot holds of your consumables and be able to test that is going to provide immense efficiency in a multi network or multi location network.


    Still a lot of independent shops out there though and...


    there are third party vendors that are taking that upon themselves for those small practices and they will test things beyond the certificate of analysis as well. you get that security of, of that secondary test one way or the other.


    Griffin Jones (14:03)

    Michael, are you calling for retesting to be done by the supplier and if so outside of quality events?


    Michael Baker (14:12)

    I'm calling for the quality management of the suppliers to be best in class.


    Outsourcing of quality control testing has its pros and cons, but having it in-house, yet independent, having it...


    not influenced by the overarching business concerns, we'll be able to hopefully meet a higher standard than sending it off to some testing facility that's outside of your oversight altogether.


    Robert Mendola, PhD, HCLD (14:49)

    I agree with Michael and I think that, you know, we would like to see a higher standard of testing that we cannot do in-house. So in other words, we can do the human sperm bioassay, we can do our own mouse, assay as well, but we want to see above and beyond so that they're reassuring everything that they're putting out there is of the highest quality. So to do the confocal microscopy staining where they're counting cells, to do...


    you know, high end stuff that we can't do in-house, even if it comes to, you know, even the future of a transcriptome or a genomic, you know, profile of these medias and impact on cells. And that's kind of what we would like to see from these companies to hold them at the highest standards to kind of say, look it, we're doing this above and beyond what you could even see in your lab. And we are reassuring that it's of the highest quality, which we would love to see from these companies.


    Griffin Jones (15:41)

    Are any of them doing that right now, Bob?


    Robert Mendola, PhD, HCLD (15:45)

    I do know that Vitrolife in particular for their oil, they test that with the highest standards. And I do know that they kind of do the mouse embryo assay, counting the cells on top of just blast development. So they go one step further and they do the confocal microscopy, the staining to kind of determine how many cells develop as well as just blast development for their oil production, I know for sure. So.


    That's a reassurance that, you know, okay, they're going above and beyond that what we can do in house, you know, that that gives you a better reassurance on the quality of their product. So.


    Griffin Jones (16:22)

    So when I asked this question, you're getting it from somebody who was a D student in high school biology. So I am hearing that media isn't just media and that in this day and age that we're in of everybody's got to do cost control. Everybody has to watch the PNL closely. and there are different pressures, but it sounds like


    that maybe that's not a commodity that's just, it's just toothpaste, who cares? Can you tell me more about what the consequences are like when you don't have that rigor of quality control?


    Robert Mendola, PhD, HCLD (17:00)

    ⁓ Yes, so I mean with the quality control of the commercial company itself you want the highest and the highest standards After that, of course, you still want to do your quality control in your own particular network and then on top of that you want to have a quality control of your particular lab to make sure all the parameters are in place and this is the most important stuff checking the pH is checking the temperature checking osmolality


    checking oxygen content. we look at those parameters to make sure, yes, okay, so the media is reassured that it's fine. We do our bioassays to make sure it's to be in use, but then we got to maintain that. And that's when the everyday quality control is of the utmost importance, you know, so that we're monitoring our pH, we're monitoring our temperatures to make sure that these medias are at the proper levels for our best case scenario and offer our best success.


    And when you look at the specific medias, okay, yes, you have different medias, you know, and IVF media has seen significant advancement over the past three decades, you know, and you have different medias that some people would choose for their own potential reasons for, whether it's time-lapse for extended culture, whatever that kind of pertains to your own specific procedures and protocols to give you the best potential patient outcome. But it takes the quality control program to make sure each specific media


    is held at the proper levels because without the proper levels you can have significant implications on embryo development, know, genetic disposition. You could promote possible, you know, negative ramifications if you're not maintaining that. So depending on even which media you choose, you have to set your incubators for the right levels to make sure that the proper pH is maintained. So like I just mentioned, vitriolife, they're a little bit more basic in media.


    So the CO2 level of your incubator would be around six or 6.5 to maintain that pH of 7.26 to 7.3. If you use Cooper Surgical Sage One Step, that's a little more acidic. So your pH then, or your CO2 levels in your incubator will only have to be around five to 5.3. And again, the constant everyday QC checks is of the utmost importance because you're testing specifically to your location, your incubator settings.


    the proper levels for your patients.


    Griffin Jones (19:24)

    You said Michael, that you want to see first in class quality control. And I know that you will go to different companies, different products, different solutions for that across the lab. if this, if these guys have got the best witnessing system, that's where you're going. If this company over here has got the best incubator, that's where you're going. the, and so, and, and I like to see that because I, I,


    it to me, it shows me that the lab director is making the decision. And I worry that as more capital risk firms consolidate more of the marketplace, that just those types of decisions will start to get taken out of people like yours hands. And not that people are going to be negligent, but


    just that they'll say, okay, yeah, one person can kind of make these decisions across the board and, and not have somebody in the lab being able to have the autonomy to say, no, I don't agree with that. I really think this is the strongest quality. Can you tell us about what control you think is really, really important for the lab director to retain at the local level?


    Michael Baker (20:37)

    Yeah, I've been very fortunate in recent years to be afforded a significant amount of local autonomy for making those decisions for each local laboratory. The decision of what incubator to purchase or what media to use as a network being able to negotiate preferred arrangements with


    multiple products and still giving the local lab director the Flexibility of making choices even if it's more expensive if it's justified Costs of what I spend are honestly not far from or they're they're honestly fairly far from my mind except that I want to use the


    least amount of the best product that I need to use. But without having to compromise on quality due to cost, we've been able to find those vendors that can do their part very well for our patients and we've found great success with that.


    Griffin Jones (21:41)

    The flip side of the autonomy part is standardization, because as much as I want autonomy, also would like to see some more standardization that kind of kicked off the conversation. does, how do autonomy and standardization converge well, specifically? how do you give the lab directors the appropriate autonomy, but have


    Michael Baker (21:53)

    No.


    Griffin Jones (22:09)

    the appropriate standardization so that Sally's not doing this and Rick's not doing this when it might not be in line with best practices.


    Michael Baker (22:17)

    I'll say, so you take it from daily quality control, checks of pH and equipment and gases, then you get up to your quality management and your quality assurance of your statistics, setting high benchmarks and small tolerances so that when things start to drift, that there's corrective action. Within our network, we also have a ton of support.


    So I'm not making these decisions in a vacuum. We have our laboratory steering committee that will help with the.


    identifying best practices and sharing and if everything's working exceptionally well then those choices are left alone and if there's cause for concern we've got people to ask for advice.


    Griffin Jones (23:11)

    You got lots of different suppliers that you work with and like and think are first in class in different areas. Who's first in class in consumables?


    Michael Baker (23:20)

    Consumables is a broad topic in general. ⁓ I'll give Beat Your Life credit. Early on in my directing years, I was in Denver and they invited me to their production facility with their mouse embryo assays and really built that foundation of reliability and quality. So all things culture media and...


    I'm quite a fan. When you start getting into pipette tips, dishes and micro tools, find Cooper or IVF store reliable sources of quality products and then just throw out the last big one of the big three.


    Next spring has really my trust with all things cryo with eggs and embryos. So I know I've got a broad range of ⁓ praise to give everybody and hopefully I spread the love.


    Griffin Jones (24:24)

    You know what I'm going to do some day. we started to take all of the companies on the industry side, categorize them. We've got them in 16 primary categories now, devices, AI, operations software, pharmacy, pharmaceuticals, that sort of thing. And then we're starting to build out all of the sub categories. And what I want to do eventually is be able to have our audience vote on different things of who's the best.


    who's got the best witnessing system? Who's got the best EMR? Who's got the best pharmacy? There's a lot more infrastructure that I got to build to have good sample sizes and also have the right people. I don't want to ask embryologists who the best pharmacy is. I want to ask nurses who the best culture media company is, but...


    Robert Mendola, PhD, HCLD (25:08)

    .


    Griffin Jones (25:11)

    And I would like to be able to see like if we're doing something like EMR, what's the breakdown of ⁓ doctors voted that this was the best EMR, but practice managers voted that this was the best EMR. Coming someday, fellas. Don't hold your breath because it's not tomorrow, but that's on the roadmap of our product roadmap. I'm thinking about the...


    Robert Mendola, PhD, HCLD (25:24)

    Mm-hmm.


    Griffin Jones (25:36)

    standardization, the universal standard that you started the conversation with Bob and then thinking about what Michael said about there are third party quality control centers. Could one of those third party quality control centers be the body that sets and enforces the standard or do you think it needs to be a government agency or some other kind of consumer watchdog?


    Robert Mendola, PhD, HCLD (26:03)

    I don't know about government. mean, it may be that, know, again, I'm not huge into the whole government, you know, know, enforcing that I think it comes from the demand of the IVF centers themselves, as if, you know, one, as you were talking about all these different companies that set the standard or set, you know, here's number one, here's number two.


    I think if you have those specific centers set the pace to say, look at what we're doing for you, lab directors and IVF centers. We're taking care of and making sure, we're reassuring there's no toxicity, there's no negative ramifications because we're doing X, Y, and Z tests way above from what you could even look at. So that gives us the reassurance that, okay, then that's a priority if that fits in our mold of what we're using.


    that I would like to choose that one because it's a of reassurance for us that what we're getting is of the highest quality. So I think it comes from that, that the commercial company almost advertises that look what we're doing above and beyond. And I think from that, that sets the standard that others have to kind of follow through and catch up to kind of have that as a benefit to our end users. So.


    Griffin Jones (27:20)

    So you don't think that there necessarily needs to be a watchdog? Am I understanding that correctly? That if the suppliers start competing on the different measures that you suggested, that that could be sufficient?


    Robert Mendola, PhD, HCLD (27:33)

    Yeah, yeah.


    I think that could be sufficient. I think that that could be a good advertisement for these specific companies to say, look, we're reassuring that you don't have to worry about this. And then if any, you know, you know, and avoiding any potential negative repercussions because of the lack of testing, the lack of, you know, toxicity testing. So I think that could set the standard.


    And again, of course, if necessary, then there would be some kind of mandatory standard set, universal standard. But I think that if the commercial companies use that as a tool or as an advertisement, it kind of catches our attention real fast to say, OK, that's that's something that we would like to kind of look further into or, you know, choose if we had a fair assessment from what we're choosing.


    Michael Baker (28:27)

    Yeah, I think the vendors are setting the standard. And when something slips through, as long as they identify the root cause and fill that crack, any third party middleman would still be learning lessons the hard way. And at least with our primary suppliers, they are, again, they're trying to do


    5,000 % more quality control than the embryologist, the end user can perform. And when we have that level of confidence, perhaps we don't have to start talking about, well, maybe we should do a mouse embryo assay with confocal cell counts, because if we take that on as the fertility clinic, the cost ultimately gets passed on to the patient. So we have to rely on the


    Robert Mendola, PhD, HCLD (29:19)

    Mm-hmm.


    Michael Baker (29:22)

    vendors to step up and do the highest levels of testing so that our patients are safe and they don't pay for quality twice.


    Griffin Jones (29:34)

    So the way I see it, because the vendor setting the standard and doing the policing is certainly at a minimum, it's part of it. And it may be the best policing option, by policing, simply mean enforcement of the standard and setting of standards. You've essentially got three different paths, none of which are perfect, right? Because if you have a government agency,


    there's regulatory capture all the darn time that you've got this agency that's supposed to regulate this industry. And then they capture the people have interests in that agency one way or the other, and they can mess things up in a way that that that makes the problem worse. The same thing can happen when you have private


    watchdogs, private consumer watchdogs. Look at what happened with S &P and Moody. They're not government agencies, but their financial incentives align in such a way and then they start to relax their standards a little bit. I totally see your point about the vendors being the ones that set the standards, but how do you know that they're actually fulfilling those standards because they might be using subcontractors somewhere down the road and


    And so how do you, if you do that third route where it's the supplier that is the one setting the standard, how do you know that they're actually completing what they say they are?


    Robert Mendola, PhD, HCLD (31:04)

    Well, I think that's where it comes down to even with all the bells and whistles of what they're offering and they could reassure that we're testing above and beyond and that's great, but you still are doing your own QC testing for the end product user just for that reassurance that there's no unforeseen, you know, toxicity that has occurred post-production during transport. You still come back to having that tried and true and,


    quality control program and reassurance that you need to have as the end user before you put anything into circulation for your patients.


    Griffin Jones (31:42)

    Michael, it sounds like from what you're describing that that level of quality control, both at the network level and the IVF lab level right now isn't just being the last line of defense and maybe it should really be the last line of defense as opposed to picking up the slack. Sounds like there's a lot of slack being picked up right now. Am I understanding that correctly?


    Michael Baker (32:06)

    with the careful selection of high quality vendors, I don't feel like we are having to pick up the slack. If your decisions are being motivated by financial profitability, then you may need to play better defense, but the cost is gonna get paid one way or the other. We have taken the approach of really


    Asking the hard questions of our vendors, wanting to see their evidence of compliance and improvement, learning about their ISO certifications and their external inspections and everything they're doing to, well, hopefully that we're seeing vendors bring their quality control more in-house so that they're not reliant on external.


    third-party testing that, I mean, it's not just about quality. When you start getting into those relationships, then we've got supply chain disruptions, and that is equally impactful to a fertility laboratory. They need to be ⁓ in full control over those pipelines and get rapid feedback and have very high degrees of transparency with the end user.


    so that we can share mild alerts across their user base and that transparency builds up trust and confidence as well.


    Griffin Jones (33:36)

    Dumb question, does every consumable in the IVF lab need to be FDA approved? Every pipette, every media, every oil?


    Michael Baker (33:47)

    There, so like a freeze and a thaw kit will have FDA approval. Things that are sort of nourishing and growing human embryos, those get FDA approval. Some of the plasticware and consumables, they'll have the bioassay testing and all of the quality control, but there's some generic supplies that have


    have not been brought forth to the FDA, suppose. correct me if I'm wrong, anything that's not FDA approved for use goes through validations and approval by the lab.


    Robert Mendola, PhD, HCLD (34:34)

    That's


    Griffin Jones (34:35)

    So with, would that be an issue with the generics? Because I wonder with lab, every lab director hates the whole process of getting an FDA audit. It's, I say if you, the quickest way to ruin a lab director, practice director, medical directors month is to get these endless FDA audits and these surprise things. And, you're always really trying to follow the checklist.


    to the letter, but would it be, could it be something that is negative in an FDA audit or exposes you to more risk if you had some generics that weren't FDA approved?


    Robert Mendola, PhD, HCLD (35:14)

    I don't even know necessarily FDA approved, but again, like Michael said, has to have the bioassays has to have the testing done for reassurance that it can be used with human material, you know. So that has to be first and foremost before you can use it, you know, for human material. So that all of those restrictions are, you know, carefully weighed and analyzed before you're choosing which


    potential consumable you're using in your lab. So aside of that, once those are tried and true and acceptable, then you're looking into the further quality control testing of this material just for the reassurance, you know, for use for these patients.


    Michael Baker (35:56)

    It's probably a fairly frequent misconception of the FDA audit though. The FDA comes in looking for


    compliance in protecting recipients of donor tissue from infectious disease. Many of them do start asking about things inside of the laboratory, but specifically the purviews on third party infectious disease control.


    Robert Mendola, PhD, HCLD (36:22)

    or donor material and such.


    Griffin Jones (36:24)

    Michael, you were talking a bit about supply chain and how critical that is. Are there other instances where the quality of a product affects the workflow of your embryologists?


    Michael Baker (36:38)

    Outside of the reliable delivery of routine scheduled shipments and the ability to count on having the supplies, that's some of the most disruptive stuff in the laboratory. It turns a normal day into a little bit of adventure and troubleshooting, trying to...


    figure out what the solution is going to be when a vendor falls short of getting you what you need in a timely basis. But we try to have three months supply of stock and have safety nets to our safety nets.


    mean, sometimes there's micro tools that we have to discard and that requires a little bit more time to set up if we're catching imperfect products before use. But yeah, I just love to not have to worry about the next COVID emergency disrupting supply chains and all the chaos that came with that.


    Griffin Jones (37:44)

    I think we'd all need higher pay grades to prevent all of that. Can either of you think of instances where you saw an immediate difference that maybe you weren't even expecting when you switched products or when you found that, wow, there was something that really kind of impacted our success rates from just changing something that you were using?


    Robert Mendola, PhD, HCLD (37:48)

    for having.


    We've so in the past we've seen, you know, certain consumables that pass the MEA test that show doesn't pass our QC, you know, and that goes to some specific catheters that we saw prior that we had to do our own QC. So that's one way how it impact workflow because now it sets into standard of, okay, now we're expecting this could be a potential concern.


    So now we have to make sure we focus on this and have our QC specific for these particular consumables, catheters and such to assure that that's not gonna happen and take place. that again is the imperative benefits of having your own internal QCs just to kind of catch that, that the production, the commercial company is not catching because


    even though they passed their MEA for whatever testing they did, it didn't pass our end user bioassay. So that is one instance. So that's one particular consumable example. We've just from our quality control, of course, making sure pH is the utmost importance and temperature.


    You know, we've seen, you know, just doing a quality control of our temperature in the hood. Of course, you want to make sure that the temperature is set so that, you know, whatever your culture drop is in the dish is reading the correct temperature, you know. So a lot of times looking at the digital reading of your hood, even if it's at 70, 37 degrees in the dish itself, you know, the best thing to do would be test the culture drops in your dishes on the hood.


    because you might have to bump up the temperature a little bit on that hood to get the proper reading for what you want to have your temperature dishes in. One thing of concern, and I found this in the past, that there's a lot of centers out there that use bell jars in their laminar flow hoods. And the bell jar is basically a little bell jar that's connected to the gas tube. So if you're using bicarbonate media, you want to maintain the pH in that hood.


    So a lot of people put a bell jar that's connected to a gas supply and they cover their dishes in that process. Well, the concern is with that, that you're putting the bell jar on these cultured dishes. You're maintaining the pH, but you have to be concerned about the temperature. Because what you're doing is you're preventing the flow from the laminar flow hood and you're actually increasing the temperature of your dishes to a significant concern.


    So anyone who's out there using bell jars, I would have to say refrain from, or even do your own internal QC check of that, where you're not having any negative ramifications on your potential culture dishes underneath that bell jar. So that's one thing I'd like to share.


    Griffin Jones (41:03)

    Are they that problematic where people just shouldn't be using them?


    Michael Baker (41:04)

    And so.


    Robert Mendola, PhD, HCLD (41:08)

    Yeah, we don't use it at all. And we kind of cease and desist, you know, it's our protocols are moving, you know, of the culture dishes are timely enough that you're not sitting it on the hood, you know, trying to regulate in the hood, you know, that specific gas, you know, co2 levels. So that's kind of like, yeah, so we kind of do not use those whatsoever. ⁓


    Griffin Jones (41:32)

    Are some people


    still using them? And if so, why?


    Robert Mendola, PhD, HCLD (41:37)

    because they're not looking at that potential concern, you know, possibly, you know, so that's, that's, that's correct. So that's why yes, public service announcement for all the centers out there.


    Griffin Jones (41:42)

    Because they haven't listened to this podcast episode, and then once they do...


    Michael Baker (41:53)

    Well, for as frequently as we're checking on our KPIs, our FERT rates, our BLAST rates, our pregnancy rates, and we're trying to maintain consistent excellence and for any fluctuations, we're going to investigate. And when you were asking for examples,


    there was an unexpected increase in success rates and we investigated that just the same to try to figure out was that a change in media lot or a oil lot or anything else on the clinical side, on the lab side.


    Griffin Jones (42:28)

    What did you find?


    Michael Baker (42:30)

    I honestly, the most recent improvements in laboratory success rates that I have been fortunate to participate in was I concluded that over the course of a year, the simplifying of process and letting the embryologists focus on what they do best. They take care of embryos. They have the utmost respect for daily quality control.


    and letting them focus in on that work without causing inefficient communications and busy work. That was a really nice lesson to learn.


    Griffin Jones (43:10)

    I do an entire episode about that. Speaking of other embryologists at the local level, how do you distribute quality control? Because of course you might have somebody trained to do the testing, but at some level, everyone in the lab is responsible for quality control. How do you train young embryologists, not just young embryologists or new embryologists, everyone, but how do you train them and what do want them looking for?


    Robert Mendola, PhD, HCLD (43:39)

    You want to instill in even in your youngest embryologist, even your lab assistants, just the science behind of what you're doing, what you're trying to prevent, you know, any negative ramification on subsequent development. So when you kind of are showing someone, don't just say, okay, do the dish prep for tomorrow. But if you kind of instill in them why it's important to move fast, why it's important to not do.


    30 dishes at one time and have the media, you know, to air where it's kind of, you know, evaporating and you're changing the osmolality. You want to instill in them the importance of what kind of ramifications that, you know, protocol that purpose that job task.


    how can have significant ramifications from that day forward? So it's like, and a lot of times when we have our youngest, you know, we have them do the dish prep, because it's like, that's the first thing you can do, we do the dish prep. But if you don't instill in them, you know, the importance of that, you know, doing it properly, making sure that, you know, you're not having evaporation of your small culture drops where you're making one dish at a time or, you know, a couple of dishes, getting that oil overlay on their fast to avoid.


    any shift in osmolality. That is such importance. And I think that that needs to be portrayed by the lab directors and senior embryologists to instill in them, you know, what's going on? What's the science behind this? And why is this important? And how this can impact, you know, significantly day five or day six of this embryo development and so on. So that's kind of important in the quality control.


    Michael Baker (45:09)

    It comes down to education and opening their eyes, not just showing them what to do every morning at 6 a.m., but making them realize how important it is. And exactly as Bob was saying about the embryologists making dishes, doesn't take any fine motor skills, no familiarity with a biopsy microscope. It's something that can be learned quickly.


    but it has some of the highest levels of impact on our.


    overall success. That dish is going to take care of those embryos for five, six, seven days and starts from the very beginning. ⁓


    Griffin Jones (45:52)

    You've both suggested multiple things that suppliers and labs can do to improve quality across the supply chain. If we turned on the Inside Reproductive Health Jedi mind control frequency in this episode that the suppliers had to do one thing that you say, and they have to do it. What one thing are you each picking?


    Robert Mendola, PhD, HCLD (46:19)

    I would pick the higher standards of MEA testing. So I would select, set a standard where it increases that need for the universal standard so that you're looking at more than just blast development, you're looking at the specific cell development in that blast. So you're looking at more specifics and have that transparency so that


    It could kind of then filter down to more confidence on the end user to assure there's no toxicity in what we're purchasing from them.


    Michael Baker (46:48)

    for something that is it would take a Jedi mind trick to pull off but I would ask for complete open transparency to their quality logs I'd love to be able to know the frequency of their products failing their own tests and what


    corrective actions they've put into place for things we will never hear about ⁓ because it's on the, it's entirely under their roof, but the frequency of failures is a major leading indicator for when the stars align and some.


    something manages to escape from their control. And so I think I'd ask for that level of insight into quality management.


    Griffin Jones (47:35)

    For all you lab and device, lab device and supply companies out there, you just got an hour of free consulting from Dr. Mendola and Dr. Baker. They told you exactly how you can improve your market share and sell a lot more products. So I hope they, I hope they take your advice gentlemen, and I appreciate you sharing these insights. And I also think that you painted attention for other topics that we'll cover in depth in the future and hopefully with each of you coming back onto the program. Thank you so much for joining me.

Aspire HFI
LinkedIn

CCRM Fertility
LinkedIn

Dr. Michael Baker
LinkedIn

Dr. Robert Mendola
LinkedIn


 
 

268 The IVF Lab in 5 Years. Dr. Denny Sakkas

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


What will the IVF lab look like in five years?

Trying to predict and shape that response is Dr. Denny Sakkas, Chief Scientific Officer at Boston IVF and head of the scientific advisory board for AutoIVF.

In this episode of Inside Reproductive Health, Dr. Sakkas about what automation really means for embryologists, and how new technologies could transform lab operations, chain of custody, and patient safety.

Dr. Sakkas shares:

– The potential downsides to automation and where caution is needed

– How AutoIVF differs from AURA by Conceivable Life Sciences

–  His prediction about time-lapse imaging within five years

– The areas where embryologists must hold firm on lab standards

– The next big innovations he’s watching (and what Boston IVF plans to purchase next year)


90-Day Free Trial for Qualified Fertility Centers!
Experience the future of embryo evaluation with a risk-free 90-day trial of EmbryoScope

See all the benefits that EmbryoScope’s time lapse technology can bring to your clinic, including: 

  • Continuous uninterrupted culture

  • Improved embryo development

  • Streamlined workflow for maximum lab efficiency

No risk. See if your IVF lab is eligible to participate.

Don’t miss this exclusive opportunity!  Click here to see if your IVF center is eligible to participate in a 90-day Embryoscope trial to measure the impact it can have in your lab.

  • Denny Sakkas (00:00)

    I give quite a lot of talks to embryologists and, The first question that always comes up is, you know, am I going to lose my job? ⁓ what's my job going to look like, in, 10 years time?

    So I really think there'll be more jobs created in the future. may be, as I said, you may be playing a different role. The role will change. I think it's hard to predict, but the position will still be there, but it will evolve in some way.

    Griffin Jones (00:35)

    What will the IVF lab look like in five years? Trying to shape the response of that question as much as answer it is Boston IVF's Chief Scientific Officer, Dr. Denny Sakkas. In addition to running Boston IVF labs and having ran labs in England and Switzerland, Dr. Sages is now the head of the scientific advisory board for a venture called AutoIVF.

    I asked Dr. Sakkas about the potential downsides to automation in the lab, how his new venture works, and what are the differences between it and Aura from Conceivable Life Sciences.
    Denny's prediction that all IVF labs will have some version of time lapse imaging in five years? When and where embryologists need to stand firm about what type of conditions or supplies they have to work with, other innovations he's excited about, and what he says he plans to buy for Boston IVF labs within the next year. Enjoy this episode about automation and chain of custody management in the IVF lab with Dr. Denny Sakkas.

    Denny Sakkas (02:30)

    if you think about it, we've been actually, we've had automation for a long time. Some of the older embryologists, and maybe I'll include myself in that, that ilk, you know, we used to make their own culture media, for example.


    We used to make our own micro-pipettes for micro-manipulation. Automation basically took that away from us in some way because automated companies, well, if you want to call it that, but companies now are automating that process. So we buy all our culture media. I'm not really aware of any clinics now that make their own culture media.


    Sadly, I think if you ask most of our embryologists, they wouldn't know how to make even culture media. So that's been automated for a long way, even though it's automated by commercial providers and we buy it. And micromanipulation puppets, they were a pain to make. I can guarantee you that. And now, know, the companies have automated that. There's quite a few companies that...


    provide them, they know when we buy a pipette, we know it's gonna be the right diameter, the right angle, the right consistency. And I can guarantee you many, many years ago, it wasn't like that. So in some forms, automation sort of has been around for quite a while. I think now we're starting to look at it slightly different in terms of how it's sort of coming into the process.


    Griffin Jones (03:48)

    You said sadly, many people wouldn't know how to make culture media today in the lab. Are you just waxing nostalgic when you say sadly is a figure of speech or do feel like we did lose something by people not having that practice?


    Denny Sakkas (04:05)

    You know, I think it's maybe a topic of another podcast you might want to do, but, you know, the change in, in our field, you know, many years ago, the embryologists were all PhDs. They'd come out of animal backgrounds, ⁓ you know, and I'm talking 30, 40 years ago and just the growth in the areas demanded that we have, you know, you, don't have enough people with that training. a lot of, a lot of the embryologists now that are getting trained.


    I don't want to call them technicians because they're really clinical embryologists, but a lot of the background that people that have been in the field for 30, 40 years is missing. And little things like, not little things, but understanding culture, how you make culture media, how we used to make pipettes, that's changed a lot with the implementation of being able to get these products. And that's happened in all fields. Genetics is the classic. I don't think


    half of your molecular biologists running genetic assays in the lab probably would know how to make some of the buffers and some of the materials that go into running the genetic tests. So I think it's happened across the field everywhere.


    Griffin Jones (05:15)

    Now my understanding would be that if people are doing less of that, if they're not having to put pipettes together because they're paying to make, if they're not having to figure out how to make culture media, that they are becoming less of technicians and then they're able to free up their time for more study, for more experimentation, for more research to become more


    of scientists and less of technicians. But is that not necessarily the case?


    Denny Sakkas (05:45)

    ⁓ I think it will, it could happen depending on the personalities in the field. So I think that definitely has occurred in the past and hopefully it will occur in the future. We're talking about automation, one of the good things hopefully of automation will allow the embryologist to do other things, be more focused on certain procedures that are much more difficult.


    maybe to sort of have more patient interaction, which will be a better thing. And obviously, hopefully think about things that will improve IVF in the laboratory especially, which is sort of the area I'm involved with. So I think you're correct that hopefully it will allow certain people that have that drive within them to have more time to do things like think about.


    How do I improve the process and what else can I do to make things better for the patients?


    Griffin Jones (06:43)

    Do you think that patient interaction with embryologists is an inevitability? Is it something that we're just starting to see a little bit of not yet? had Professor Christina Hickman or Dr. Christina Hickman on the program who runs a program called Avenues in London. And then I've seen some other folks talking about using embryoscope for the reason of being able to show patients, here's what's going on with your embryos. But it's the embryologist


    that is having some contact with the patients, at least in some programs, at least in Dr. Hickman's program. Is that something that you think will become the standard or are you not so sure?


    Denny Sakkas (07:24)

    Historically, know, the embryologists had a lot of contact with patients and they would do a fertilization call. They, you know, they were more in touch with them about, you know, how their embryos are growing and things like that. if patients had a question, they would sometimes, you know, contact the embryologist to talk about it. That sort of has, it's stayed in a few of the smaller clinics, but I think the larger clinics, you know, it's sort of, they're just too busy and it's gone away. So I would hope that


    having a bit more, not downtime, but having some automation would allow that. And even, as you mentioned, automation for patients being able to access their embryo videos or embryo pictures through patient portals and maybe more interaction through patient portals, which are secure, allow that. So I would hope in the future that


    that embryologists do have a particular place where they are able to interact more with patients. Because in the end, I think a lot of us get into this field because of want and feeling that we're really helping patients. if you're not talking to them, you lose a little bit about, lose a bit of that. So I know, and I still do, I still enjoy talking to patients when I can.


    Griffin Jones (08:41)

    So I want to talk about those benefits that could come from automation because maybe those are among the duties that embryologists are able to pursue and then perhaps more research and other things they can do when they don't have to be doing so much manual work. I do want to ask if in your view, you, there a risk to automation? you see, can you foresee some downsides or some unintended


    consequences, some second or third order consequences that if we're not careful about, even if they don't outweigh the benefits that automation would bring, that you still wouldn't want them. Are there some things that you're concerned about?


    Denny Sakkas (09:20)

    Well, I mentioned before that it may help us sort of interact more with patients, but it may remove that personalization from talking to patients. there is a risk as much as we don't really want it that the true clinical embryologist that we have may become a bit more technical in some way and not have the background about talking to patients.


    understanding basic embryology. So that's one of the risks that it may become just a technical expertise or move more to a technical expertise. So that I think is always one of the risks with automation. But as you said, hopefully I think that may not happen or it may allow embryologists to pursue maybe a more technical


    career, but others to pursue more of a, you know, research or, you know, a more embryology, clinical embryology focused career. So it may in some ways separate sort of the type of people that we have in a laboratory. It might be different roles that they may play in the future.


    Griffin Jones (10:30)

    Your sample size might be skewed. The question I'm to ask you is what you're hearing from embryologists because you're working on automation. So maybe you're talking with folks who are more excited about it. What is your litmus test of feedback from embryologists on automation? My guess is that it would generally be good if they can see


    Denny Sakkas (10:39)

    Hmm.


    Griffin Jones (10:52)

    these other opportunities because I've talked to so many young embryologists. I'm talking folks in their mid 20s, late 20s that want to leave embryology because they just don't want to be in a lab all day. They don't want to be in a 10 by 12 room or whatever it is and feeling like they're just going back and forth from station to station and no windows and no ability to work from home, et cetera, et cetera.


    And so to me, seems like, if they could be doing other things while there are, there's robotics and technology in the lab that they'd be favorable to it, but maybe not. there are, do see, I do see some people on LinkedIn, especially that like to comment that they're very skeptical of it. What is, you know, what's your straw poll of what embryologists are saying?


    Denny Sakkas (11:42)

    I obviously give quite a lot of talks to embryologists and, The first question that always comes up is, you know, am I going to lose my job? ⁓ you know, what's my job going to look like, you know, in, 10 years time? you know, firstly, automation and any, any, new practice or new equipment or whatever.


    always takes a long time to develop. you know, there's a timeline of when these things will come in that might be longer than, you know, all of us think. Secondly, you know, I tell them that automation, one of the things we hope it does is bring a greater access for patients. So, you know, in many ways, the labs might be much busier than they are today.


    So that may not be a thing if someone doesn't want to work that much, but I'm sure they will be busier. So I really think there'll be more jobs created in the future. may be, as I said, you may be playing a different role in terms of you may be running different types of equipment. You may have more of an interface with computers and...


    interfaces with instruments if you want. The role will change. I don't know if it's going to be, you you're going to be locked up in a room in a 10 by 12, hopefully not. And hopefully the automation will allow you to get away, you know, for 10, 15 minutes, you know, rather than fully having to concentrate on a particular technique. And, you know, you will have 10, 15 minutes to get away.


    maybe do administrative work, do other work. So as I said, I think the role will change. I mentioned before that a lot of embryologists spend a lot of their time making micro-pipettes and making culture media. We forget about that, but we're still busy and we're still able to do other things. So like all these things, I think the role will evolve. How that will evolve, will it evolve the more technical?


    Will you be more of a technician or will you have time to do more research or think about novel ideas, have more time to interact with patients? I think it's hard to predict, but the position will still be there, but it will evolve in some way.


    Griffin Jones (13:56)

    Tell us about the project that you're working on with regard to automation.


    Denny Sakkas (14:00)

    Yeah, so, you know, we've good or bad, you know, they say that, you know, if you keep repeating the same thing, you might be either crazy or, or, you know, brilliant. I'm probably more on the crazy side. I've been involved with a few startups for quite a few years, going back to the early 2000s, and even before that, actually, the the current project I'm involved with is, you know, we're really excited. It's a


    startup company called AutoIVF and I'm lucky I'm chairman of their scientific advisory board. This is a novel technique based on microfluidics. Microfluidics, you know, I'm calling it a novel technology, but it's a platform that's been around for many, many years actually now. I'm lucky to work with some really amazing people that are in that field. And it's been used for many years for isolating, you know, rare cells from


    you blood basically. you can, it's quite amazing. You can find one rare or two rare cells from blood in particular cancer diagnosis from, you know, leaders of blood to detect cancer. So that's been around for a while. So we've actually in collaboration with the people we work with, we've used the similar technology where you can isolate from large volumes and the volumes that I'm talking about a follicular fluid. So


    what we've developed is a system that actually can confine the oocytes in the follicular fluid and it's completely automated. So you pour the follicular fluid in one side, the device actually sorts through all the blood, the tissue, the somatic cells, finds your oocytes and then it will denude your oocytes. from, you know, 100, 150 ml of follicular fluid, you end up with a few microliters.


    of very clean oocytes at the other end in a very 15 to 20 minutes. So it's quite exciting. And the company also has other techniques in the pipeline, again, using micro fluidics for doing other processes in the IVF lab.


    Griffin Jones (16:05)

    And what was the genesis of deciding on this as opposed to any number of different other approaches you could have taken?


    Denny Sakkas (16:13)

    I think it's the team that we had developed. It's a very strong team. Obviously, their focus was microfluidics. We also wanted to not repeat what's going on in the lab, so not sort of just mimic all the steps that are going on in the IVF lab now. We wanted to introduce novel concepts. And actually, the...


    the technology has brought some amazing surprises to us in terms of just simply, you know, trying to take a novel approach at, you know, an egg retrieval process. The egg retrieval process, I'm sure in 1978, the way Bob Edwards did it then, it hasn't really changed that much. You you put the fluid in a dish, you look around, you know, for cumulose-al-sac complexes, you clean them and put them in, you know, in a new drop. So...


    Griffin Jones (16:54)

    Mm-hmm.


    Denny Sakkas (17:02)

    We wanted to challenge those concepts with novel technologies and with new technologies. And I think we've done that, having some of the results that we've seen already.


    Griffin Jones (17:11)

    So what do you think will be the wider application of this? Is this something that labs need to buy additional equipment for, or do they need to change the space of their lab in any way? Do they need to change their workflow in any way?


    Denny Sakkas (17:25)

    No, actually, it's something that will fit into their workflow. you know, every lab, know, every IVF lab does an egg retrieval. The device is probably the size of a printer. You know, not many people use printers now, I think, even so. It could replace the space that you had your printer in. So it's just a little bit larger than a just genuine printer. It could sit in your egg retrieval room.


    it could sit where you're actually currently doing your egg retrievals. So it basically will allow you to, you know, pour the fluid in, whether that's a, you know, an embryologist, a technician, even a nurse in the operating room. And, know, 20, 30 minutes later, depending on the type of retrieval, you will have a dish ready for the embryologist to take, take those oocytes and continue, you know, to do ICSI, to do egg freezing, whatever. So


    it basically will help the workflow. It'll take away the embryologist's job of having to concentrate there and doing the egg retrieval process. And as I said, there's some added benefits that we've already seen to this process.


    Griffin Jones (18:38)

    Are there still decisions as this standardization happens and automation happens across the lab, are there still decisions that really should be being made at the local level? So part of the promise of standardization is you don't want so many darn decisions made at the local level because there's so much variance and with that variance, it's hard to do quality assurance and quality control and come up with best practices and follow the scientific method. And so you want to come up with here's the


    the best practices and then we replicate those best practices at scale. But are there still decisions that should be being made by the embryologists as these things become automated and standardized? What do embryologists still need to be in control of at the local level?


    Denny Sakkas (19:25)

    You know, I think just the process, the logistics of the process, so handling the material, making sure the chain of custody is correct, making sure, you know, that the quality control of all these instruments, you we have a lot of instruments in the labs already. You know, one of the things we're very pedantic on is that the temperature is correct, the gas environment is correct.


    ⁓ You know that the eggs and the embryos and the sperm, you know, are very precious and that we're treating them correctly. You know, in effect, we're chaperoning them from the ovary back to the uterus in some way. That's the job of the lab. If they're good, you know, we're quite good now at getting pregnancies, establishing pregnancies, but definitely in those five to seven days and obviously freezing, et cetera, you can do a lot of things wrong that will harm


    Griffin Jones (19:57)

    Hmm.


    Denny Sakkas (20:13)

    the chance of a patient's pregnancy chances. So I see the lab as a very strong chaperone for this process. I think still, whatever we do, whatever automation we introduce, see the role of the laboratory, the embryologist is in making sure that sort of piece of chaperoning is consistent. And like you said, that we're doing it the same in all labs around the world.


    Unfortunately, we know that that probably isn't happening. know, there are some labs of better quality than others, and there are many other biological reasons too that, you know, there's variation in labs also.


    Griffin Jones (22:03)

    as consolidation happens in the field, I see a bit of a spectrum on one end of the spectrum, you might have a network that they make decisions very centralized. And if this is what we're doing across the board, we're doing it at every lab, we're doing it at every clinic. And then there are others where they're still very much kind of letting this clinic do it their way and this lab do it their way. I do worry about clinicians not being able to practice


    the way that they want to.


    what things of yours do you feel very protective about that I want to be able to order this, I want to be able to buy this or fire this person or hire that person or build this way or not this way that you really want embryologists to stay in control of?


    Denny Sakkas (22:47)

    Yeah, that's an interesting question. think it expands, as you said, to the clinical side too. You know, the fear is that you get these big conglomerates coming in and they focus somewhat on finances in a way. So the concern is both for clinically and in the laboratory that they


    believe a cookie cutter method of treating patients will work, and you can do that for all patients. So they sometimes may remove flexibility from either the clinician or the embryology lab. The cookie cutter approach probably maybe works for 70, 80 % of the patients. We do pretty well with those. But then you've got 20 to 30 % of patients that may be more challenging, let's say.


    So, you know, there's still a lot of fundamental arguments. I won't go into the clinical side about, you know, stimulations and that, but even in the lab, fundamental arguments about techniques that we do in the lab, you know, and again, know, PGT is good for everybody. Ixie versus insemination, you know, is that good for anyone?


    things like fresh transfer versus frozen transfer. So we're still struggling with a lot of these questions, know, 40 years after the first baby, basically. So making us do things in a particular way may change the flexibility of, you know, how we treat patients. And as I said, I don't think it's probably gonna hurt, you know, 70 to 80 % of cycles, but having some flexibility maybe for 20, 30 % of patients could


    could mean for that particular patient if they have a live birth or not. ⁓ A difficult patient that may benefit from a fresh transfer, for example, may not benefit from a frozen embryo, they may not have enough embryos, but we still are not 100 % convinced that maybe a patient's poorer looking embryo, let's say, that we might put back as a fresh and we may not have frozen,


    we know that they sometimes can give live birth. So I think there are things that we still need to be cognizant of and have some control, know, and that comes down to media, know, sperm preps, the ability to transfer maybe fresh versus frozen embryos, doing PGT or not. You know, it would be nice that we still have some flexibility in treating patients, you know, in the future and not maybe...


    be told that this is what you're doing. You're just doing things in one way and that's the way that works good. But I don't, I think some percentage of patients may lose out if we take that approach.


    Griffin Jones (25:32)

    I think you've listened to this show before and you know that I'm not an embryologist. I don't have a scientific background. So I can't judge if how significant the quality of oil matters or the quality of media matters. Who's out there that has good quality or does it matter? Is it relatively substitutable?


    Denny Sakkas (25:35)

    Yes.


    you know, one of the good things that came out of the commercialization of, of, of IVF media, let's say now as an example, and oil is that the processes they use are very stringent. Okay. We've had some, you know, deviations, let's say, but in general, when we buy culture media from, from whatever company, you know, that, that we were pretty, ⁓ confident that that


    media has been well controlled, made with good medical practice, good conditions. So I think all the companies do a pretty good job now at doing this. And as I said, oil was like the biggest phobia of embryologists. If you had one batch of good oil, for example, we would hoard it to a sort of a...


    maybe a very strange state that you would lock all your good bottles of oil in a cupboard and not let anyone touch them. But now we're much more confident. all the companies do a very good job. Historically, some of the media I was lucky. I worked with David Gardner many years ago. And we had sort of developed the origins. It's probably changed 100 times more now of the Vitrolife media.


    But so I'm a bit more familiar with those. But in general, all the culture media that are being made now are very high quality, well tested. And I think most people can trust them, I think.


    Griffin Jones (27:21)

    One area where I have noticed a discrepancy between what lab directors say they want and what the business seems to be paying for is time lapse imaging. I've asked every lab director, at least in recent memory, maybe earlier on I didn't, but I've been asking them, do you view time lapse as a nice to have or a must have? I think all of them have said either must have or quickly becoming a must have.


    I maybe there's somebody that says nice to have and maybe you'll be the contrarian that says it's just a nice to have. What's your view on time lapse?


    Denny Sakkas (27:54)

    So the best description I've heard about time-lapses from Michael Alper, our CEO at Boston IVF. He calls it pornography for embryologists. And he's right. I can still sit and look at these time-lapse images, the videos, they're really, they're amazing. I think we've always wanted to watch the embryos in some manner. So I think


    I think having the time lapse is a huge bonus in the labs. Like all new items, it becomes a commercial thing, the cost versus the benefit. All the studies we've seen today indicate that


    The benefit is actually in that these time-lapse incubators are very good incubators. So they're very good at growing embryos and taking care of them, allowing us not to move the embryos and being able to see how embryos are progressing. So in that manner, they're fantastic. I know people have discussed AI, artificial intelligence, machine learning. At that level, we're still sort of trying to understand how much that's gonna help us.


    We still do quite well with blastocyst morphology and picking the embryos. I think eventually in five years time, I think all laboratories will have some concept of time lapse videos or time lapse incubators in their laboratories. It may not be what we have currently, know, the embryoscopes and the other types of ⁓ time lapse systems.


    So it may not look like that, but I think we will all have time lapse imaging capabilities in our incubators and our laboratories, I think in five to 10 years.


    Griffin Jones (29:44)

    Why? Why is that important?


    Denny Sakkas (29:46)

    Well, I think, you know, as I said before, one of the difficulties is we do get that information. We'll get a nice blastocyst and a lot of those blastocysts are great. We can buy off, them get, you euploid embryos. But again, you know, focusing on patients that may not have performed that well, we can then go back and look at their videos and say, okay, this is what we've seen in this patient. You know, they've had delayed fertilization.


    their cleavage was not in characterization. So getting that information, getting the time lapse imaging information for, again, the majority of patients is probably not gonna change that much for that patient. But again, for your patients that are having issues getting to a live birth, having a successful treatment, we may see things in those videos that might tell us, a second, there's something wrong that...


    with the embryos of this patient. Now that may mean we tell that patient, you may want to look at another approach to IVF or to achieving a life, having a baby at home basically. And that hopefully will quicken the diagnosis for that patient. So they're not doing multiple attempts of three, four, five IVF cycles, which are very draining on a patient's


    know, morale and, you know, it's very difficult for patients to go through those treatments. So if we, if the, I think the time-lapse will also help us in giving more feedback to patients in terms of their embryology, you know, their embryo development.


    Griffin Jones (31:21)

    Is it possible to fully automate the IVF lab without time lapse imaging?


    Denny Sakkas (31:26)

    you probably could, but I think again, you know, I think we do get a lot of information from the time lapse videos. So I, I think if you're automating, you know, if we're going, as I mentioned before, the auto IVF system has an egg retrieval, you know, automated, if, if we, we can link that with an embryo scope, which, you know, we're, we're, we're already thinking about, ⁓ with, and, then, you know, the whole process is, I think, you know,


    why wouldn't you, if you're automating, why wouldn't you want those videos, especially if it's, know, the capabilities are already there, the incubators are really good. I think we will do that because that will be extra information that we will get. think in the long run, even though artificial intelligence probably hasn't, you know, given us the specific embryo morphology picture, I think having all the data, having a lot of data,


    including patient data, maybe other information from culture media. I think time-lapse will actually help us going forward in the future with more information.


    Griffin Jones (32:32)

    Do you have time lapse incubators in your labs?


    Denny Sakkas (32:35)


    So we're a very big lab. we actually, we had one, but we were actually looking at getting some in now. As I said, I think inevitably, I think down the road we'll be getting them. Historically in the US, time-lapse has sort of been less, I don't want to call pervasive, but utilized because of our, a lot of labs rely heavily on genetic testing, PGT.


    In Europe, they're much more in Europe, in Asia, in Australia, you probably see more time lapse instrumentation, but I think in the US also they'll be coming in soon. we're similar for us also, we'll probably start using them also.


    Griffin Jones (33:16)

    So the trend seems to be moving towards time lapse. It seems from my lay point of view that embryoscope has a slight lead in that market. That when I ask people, it seems like there's a slight preference towards embryoscope. I imagine you're checking out them all and you're looking into them. Have you looked into embryoscope and what do you see good, or neutral?


    Denny Sakkas (33:37)

    Yeah, I know the Embryoscope much better. They were first to market. We had historically had a lot of involvement with the initial company Unisense that had developed the Embryoscope. So we knew them very well. And as I said, they've probably been on the market the longest. like all instrumentation, it's gone through its development and it's probably


    I don't want to say the most mature, it's the most common one. So I think people sort of gravitate towards that in a way for, if you're automating the time-lapse system, if you want.


    Griffin Jones (34:13)

    So we're talking in late 2025, maybe this recording will ⁓ air in late 2025 or early 2026. But if we were recording again in late 2026, think you'll have a time lapse incubator.


    Denny Sakkas (34:19)

    You


    Yeah, I think so. Yeah, yeah, we'll definitely have them. And hopefully we'll, we may be doing the retrievals automated also.


    Griffin Jones (34:35)

    Tell me more about that.


    Denny Sakkas (34:37)

    As I said, for us, that's an incredibly exciting technology. So I can just, I can't tell you everything about it, but the approach that we've taken where it is a novel technology and where we're not sort of relying on mimicking systems that we already do, it's actually allowed us some surprises. So one of the biggest surprises we have,


    is that consistently we actually find more eggs than the manual screening. we're actually finding in when we look at screened that embryologists have already looked at and we've done this in multiple centers, we actually find extra eggs. And we've tested those eggs, we've done a lot of, they're not ones that would have been useless. We actually have a live birth, I can tell you now. ⁓


    we actually have a live birth from an egg that would have actually been discarded that was not found manually. So we're super excited about this technology. We believe also that we mentioned some of the benefits of automation and any of the types of automation that I think are coming out now. One thing it does do is it homogenizes the treatment of eggs, embryos.


    freezing, it sort of does standardize that in some way, which is a thing that we worry about a lot in the lab, making sure everyone's doing the same protocol. So we're pretty excited that at least at this first step, this technology is apparently giving us some...


    more eggs, which is huge for a patient. The first question a patient always asks you, how many eggs did I get? And we've known from years of studies that the more eggs you get, the more chance you have of getting a live birth. It's a pretty straight correlation. So we're pretty excited about that. The other thing that I think is interesting about going to the retrieval step for automation is that


    One of our, one of, one of my collaborators called it's the gatekeeper of IVF. If you want, you have to get the eggs. So one of the things, and I, and I think I mentioned at the beginning, you know, we spoke about like automation, there's some good things and some things that we concerned about. But one of the biggest things I think automation will bring and you know, hopefully this device that we're talking about from auto IVF is that.


    you can then take that device and do a retrieval anywhere in the US. You can go to the smallest little town in the US and do a retrieval. You can freeze those eggs, ship them to the big lab. So in doing that, you're actually taking the lab to the patient. And I think that's the big thing for the future, that we will then increase access of IVF for the...


    majority of patients who are infertile that don't actually have that access today. So I think that's the biggest benefit that at least we hope, you know, will bring with our technology.


    Griffin Jones (38:07)

    So forgive me for not knowing the life stage of Auto IVF. I'm only slightly familiar with this venture. are you all in commercialization stage yet, pre-commercial? you doing this in conjunction with all of the pre-commercialization steps with Boston IVF? Tell me about that.


    Denny Sakkas (38:26)

    So we have a full prototype. We have a few full prototypes that we're now starting to put out to clinics around the US and internationally to do the next step of validation. A lot of validation has already gone on in the human. As I said, we have a live birth and we've got a lot of data.


    with multiple clinics that we're able to actually see extra eggs. So that's something as an embryologist surprised me at the level we're seeing it. given this technology's agnostic to sort of visualizing the embryo, it's like using ⁓ nighttime vision glasses in the dark, basically. You're getting a better.


    idea of where the oocytes are. So it's finding the oocytes much better than, I hate to say, than I think an embryologist. ⁓ So the stage, the company was in stealth mode for quite a few years. It's now sort of coming out if you want, as companies do. And now making the instrument available to a number of clinics for clinical validation as


    like you said that's part of the whole commercialization process.


    Griffin Jones (39:36)

    If you've been down to Mexico City to see Conceivable, and if so, where do they converge or diverge from what you all are doing?


    Denny Sakkas (39:44)

    Yeah, so yes, I have seen it. I've seen the full aura system. I haven't seen it actually operating, you know, collecting oocytes and running cases, but I know they're doing a clinical trial. It's, you know, it's an amazing set of instruments. You know, I'm an embryologist, so I'm very easily impressed by, you know, the engineering that's gone into it, which is pretty impressive.


    You know, it's, as you know, it's a series of five large, I think five large instruments that, you know, are robots in a way. So, you know, I could imagine someone in the, you know, in the early 1920s seeing a car manufactured by hand and then seeing, you know, robots coming into it, you know, and being able to manufacture a car. And so, you know, what's,


    great is they've taken the lab process and taken all the manual processing and used robots to do everything, is pretty cool. They've got some other innovations, which are like the freezing technologies are very interesting. So it's a really impressive system. I think where we fit in, we're obviously using a completely different technology.


    I don't want to say, well, in some ways it's a bit more novel. The robotics has been around for many years. So, you know, we do fit in with their system, you know, in terms of maybe in the future if they're set up in a large warehouse system of a lab that's more centralized, you know, we could definitely feed oocytes to them to process and then, you know, bring them back to be transferred if needed.


    We also, in some way we're competitors, AutoRVF is a competitor. They're also developing ⁓ the whole lab eventually, it's already, we know that we'll be in a much, much smaller footprint than what they basically have currently developed. Although that, I think in a few years will probably change in a way.


    Griffin Jones (41:45)

    What other innovations do you want your colleagues to adopt in the coming years? Do you think about what's in the pipeline or maybe what's currently available, but many of your colleagues haven't adopted yet? If you could do a Jedi mind trick with your colleagues and get them to do what you wanted to do, what innovations are they implementing in the coming years?


    Denny Sakkas (42:09)

    You know, I spoke before about our system, you know, even conceivable system, hopefully will change access for patients. So the innovations I really want to see, and we're already seeing some of these, you know, we've seen at home semen testing, for example. There's a lot of effort going into at home hormone testing and even ultrasound testing. So allowing


    the patient to do things more in their privacy. Reproduction to infertility historically has been a really emotional thing for patients to deal with, I think. Has some taboos, I think some of those have been lessened in a while, but many cultures, we're lucky in the US in some way, but many cultures, there's still a taboo to infertility.


    the more we can take things back to the patient and whether that's testing, allowing, you know, collection of the samples at home or closer to where they live. think the technologies that I really want to see in the next few years are at-home ultrasound, at-home hormone testing. I'd love to see retrievals taken to the doorstep of patients.


    ⁓ So they don't have to travel, you know, hours sometimes for some patients or even, you know, even if you're in Boston, it can might take you an hour to get to your local clinic to have a blood test, you know, in New York, it's the same thing. if we can take the treatment more to patients, allow them to do it, you know, in a more comfortable state, I think, you know, the stress.


    even the stress will actually come down and you know we may see improvements in live birth rates and pregnancy rates just from allowing you know a more friendly procedure for these patients because I don't know Griffin if you've been involved with IVF at all you know it's it's ⁓ an emotional roller coaster you know right from the beginning of your diagnosis to you know maybe even having the live birth it's it's ⁓


    it really is ⁓ difficult for patients. So if we can change that in a way by making it more accessible through various technologies, that's what I'd really like to see in the future.


    Griffin Jones (44:22)

    I'm glad you mentioned that because I think of David Sable and Abigail Cyrus three criteria for innovation and IVF they're thinking, reducing costs to baby, reducing time to baby, and reducing life disruption to baby. often talk about the first one, sometimes talk about the second one, third one probably don't talk about enough, which you just mentioned. and it just can't be understated how disruptive it is to have to leave work to have to drive across town to have to get a babysitter to have to


    etc, etc. And, and I hope that the innovations that that you're talking about and others really make a dent in that in the coming years. Dr. Sakkas I look forward to having you back on the program. Thanks for coming on and sharing your thoughts with us today.


    Denny Sakkas (45:05)

    Thanks, Griffin. It's been a pleasure. ⁓ You're right, David Sabel has been talking about this for many, many years. And we're following in some way in his footsteps. But it takes a village, as they say. So hopefully, we're part of that village and can get. It really is true that the access is one of the missing pieces. So the better we can get at that, I think, in the future, ⁓ hopefully we'll be back in a few years telling you. we've got technologies that creating that access. So I look forward to talking to you again.

Dr. Denny Sakkas
LinkedIn


 
 

267 What IVY Fertility is Using And Why. Amy Jones

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


Lab directors—how do you make sure your concerns actually reach ownership?

Vendors—how are you being vetted by the groups you serve?

This week on Inside Reproductive Health, Amy Jones, Chief Quality Officer of Ivy Fertility, talks about how one of the country’s leading networks evaluates quality, chooses partners, and plans for growth.

Amy shares:

– The specific criteria Ivy uses to vet vendors for cryostorage and digital witnessing

– How they’re implementing an AI solution to compare data across EMRs

– The patient concierge platform guiding patients through the IVF journey

– Where current patient education tools fall short

– The tradeoffs of proactive expansion

– And why fertility professionals get into trouble when they stay “too stuck in their own lane”


Improve Patient Experience. Reduce Doctor Burnout. 

See Why Other Fertility Doctors Love These CRNAs 

Fertility doctors from across the country are getting support from this one anesthesia firm.  

  • Fertility doctors across the US are using Kaleidoscope Anesthesia

  • Kaleidoscope Anesthesia’s CRNAs are known for clinical excellence, their calm bedside manner, and enhancing patient care experience. .

  • Avoid burnout by offloading this responsibility to professionals you trust.

  • Scalable, agile staffing, from daily coverage to full perioperative system design.

  • 200+ seasoned CRNAs. Nationwide reach. Fast onboarding. 

We’ll show you how other fertility centers are improving patient experience, reducing doctor and staff burnout, reducing cancellations, and improving workflow.  

  • Amy Jones (00:00)

    once they can afford IVF, getting them through the process, we've just found that there's much room for improvement in terms of patient experience and efficiency There are many places where a patient can get dropped or lost or not have appropriate expectations set. Once they approach us, have to be able to get them through from the new patient appointment to whatever procedure, you know, they're designated for.


    Griffin Jones (00:35)

    Lab directors and clinicians, how do you get your concerns represented to ownership or corporate? You who sell things to fertility centers and networks, how are you being vetted? Amy Jones was a lab director, now she helps assess and implement quality measures on the lab, clinic, and business side as the chief quality officer of IVY Fertility.


    Amy share specific criteria for how IVY Fertility chose their cryo storage and digital witnessing partners and AI solution that they are implementing to compare data across EMRs, a patient concierge platform they're using to move patients through the journey, the limits to the current patient education platforms that are out there, the trade offs of proactively planning for expansion when doctors and embryologists are too stuck in their own darn lane.


    I share a bit about a firm called Kaleidoscope Anesthesia Associates because some of you have written to me about how awesome Kaleidoscope are.


    And some of you have talked about how much of a pain anesthesia staffing is. What a match. Amy's criteria for vetting partners is something that you and I can both systematize, and I hope to do so for all our benefit. Enjoy this conversation with Amy Jones, Chief Quality Officer of IVY Fertility.


    Griffin Jones (02:47)

    Ms. Jones, Amy, welcome to the Inside Reproductive Health podcast.


    Amy Jones (02:51)

    Thank you, pleased to be here.


    Griffin Jones (02:53)

    What is a chief quality officer brought in to solve for?


    Amy Jones (02:58)

    Well, as you can imagine, I wear many hats. But my role is primarily to lead the quality strategy for the organization. So that includes monitoring outcomes, ensuring that outcomes are appropriately reported, risk mitigation, efficiency, patient efficiency, getting them through.


    evaluating how we can improve the patient experience.


    Griffin Jones (03:25)

    Were the issues that you saw issues that they already knew about and they're bringing you in to address them or were you identifying issues?


    Amy Jones (03:25)

    compliance.


    Well, I think every organization needs someone looking at quality right in this field. And there are just a plethora of quality issues to monitor and solve. And so probably if every organization could afford to have 10 of me, they would have that.


    But I wasn't there before I was hired, so I'm not exactly sure if they were looking to solve or being proactive.


    Griffin Jones (04:03)

    Talk about one role being responsible for, it's not that one role is responsible for quality, but often people would just say, well, each department is responsible for their own quality, right? Like the medical directors are responsible for the quality of their protocols. The lab directors are responsible for the quality of their individual labs. What does having a one role that helps to oversee quality do?


    Amy Jones (04:28)

    Yeah, so I mean, we're definitely focusing on outcomes and risk mitigation. So those are two huge areas in this field, as I'm sure you're aware. And a huge area of risk is cryo storage. And so our goal is to not require standardized protocol


    protocols across the board. It's not our approach at all. But creating alignment on key issues is important. And so ⁓ we try to make decisions if it's involving the lab, with the lab directors participating in those decisions.


    So it's a collaborative approach.


    Griffin Jones (05:09)

    What is she you mentioned cryo storage? What other issues did you see as being among the biggest that that you have to tackle? Yeah


    Amy Jones (05:18)

    in addition, in terms of risk.


    Well, you know, everything in the IVF lab involves risk and witnessing is a huge area. So, you know, any sort of mismatches can be extremely problematic. And so we've created alignment on that as well.


    Griffin Jones (05:34)

    Can you talk to us about some of the measures that you took either in cryo storage or witnessing? The measures that you took, of the steps that you took or just things you decided to do?


    Amy Jones (05:40)

    Some of the what? Yeah,


    so we have implemented a system called Vareus systems for monitoring cryo storage. The monitoring is duplicative in all the labs. So if one system fails, we have another. But Vareus is a great system.


    You receive notification of a tank failure in time and plenty of time to make adjustments. We also require that all the labs have ready backup storage tank as large as their largest tank in case, you know, to account for any failure. We're implementing witnessing systems in all of the labs and ensuring that they're used appropriately.


    Griffin Jones (06:25)

    Was that a cell? Did you have to convince the lab directors of this?


    Amy Jones (06:28)

    No, that was not


    a sell at all. They want it. Because right now, manual witnessing, it takes a lot of time.


    Griffin Jones (06:34)

    Do you find that your job then is sometimes to fight for the things that people already want? Cause I hear from lab directors all the time that they want witnessing, but it's still not like implemented across places because some business person doesn't want to pay for it. So is your job advocate for them and be fighting for what it is that they'd like to have implemented.


    Amy Jones (06:42)

    Absolutely, yeah.


    Absolutely, but I wouldn't even describe it as a fight. It's just more an education approaching the stakeholders with information. I information is power. And also, you know, there's so many components. Financial is a component. And so we incorporate that as well. So when we're making a decision to go with a particular device, obviously the


    The best one is what we'll gravitate towards, but we have to into account costs. So it's a balance. But I have to say, with this approach, when you get the support of the lab directors and then you approach the physicians and leadership with the information that they need to make a decision and they can see that it's been researched, it's not just, hey, we want this new.


    Gadget? They're generally supportive.


    Griffin Jones (07:45)

    I imagine it's a question of prioritization as well, that you have so many competing priorities, how do you rank them?


    Amy Jones (07:52)

    cryo storage and witnessing is like a very obvious at the top that was easy for us to decide to do. Also, outcome reporting is very important. And I've been in this field a long time. outcome reporting has not changed very much over the years. So we have EMRs. We enter information into EMRs. It's very hard to get information out of EMRs.


    And so we have these homegrown spreadsheets that labs use. So one of the first things I did was implement a standardized spreadsheet. What was the idea that we would move away from this? Because clearly an Excel spreadsheet is not the most efficient method of tracking data, and it's duplicative. ⁓


    Griffin Jones (08:36)

    Yeah, it sounds like homegrown


    spreadsheet is the the arch enemy of a chief quality officer.


    Amy Jones (08:43)

    Yeah, yeah. So we aligned on that, and now we're moving towards using AI. We're piloting an AI company and their technology for exporting and ingesting the data from the EMR. And I think that will save us a lot of time, but it's a big lift. It's a heavy lift because it's not just the IVF.


    who's involved, it's everyone who uses the EMR.


    Griffin Jones (09:07)

    Is that circle the is that the AI company you all are piloting? Tell tell me more about technology and how you see it being able to improve safety and quality.


    Amy Jones (09:16)

    So right


    now, when we report data, the process of even though we have aligned on the standardized spreadsheet, the data still has to be cleaned, right? And that takes time. And it has to be crunched and put in a presentable form. So I find that we spend a lot of time doing that as opposed to thinking about the data.


    Right, and so I think that when the shift comes where we just push a button and the AI generates the data that we need.


    it's going to be life changing for us.


    Griffin Jones (09:53)

    Talk more about the data that we need. What data do we need specifically to make smarter decisions around quality?


    Amy Jones (10:00)

    So, I mean, as you can imagine, there's so much that influences the success of an IVF cycle, including the patient experience, because as we know, stress causes estradiol rise, which can impact how someone responds to stimulation. But stimulation itself, we rarely can connect the


    the specifics of IVF stem to what happens in the outcomes in the IVF lab. So that's one of the items, stimulation, how long did they stem, what drugs did they use, when did they trigger.


    What was the maturity rate in the eggs? What were the patient characteristics? What were the sperm characteristics? What specifically is going to impact blastocyst if it impacts blastocyst development and you get a blastocyst, are your rates equivalent to that of someone who produces many blastocysts? mean, there's so many questions that can be answered.


    And I think that, you know, within a center and between centers, there are so many different protocols used, right, for IVF simulation. And then you get into the IVF lab and there are different media, different timings that people decide to strip the eggs, hyaluronidase the eggs or inject the eggs when they decide to do embryo biopsy.


    how far along the embryo is when they do embryo biopsy, that makes a difference. That makes a really big difference. The embryo is not as expanded, doesn't have as many cells. You're taking a larger percentage of the embryo at that point. And so looking at all those features in detail and with the appropriate quantity of data points is going to be hugely impactful, I think.


    Griffin Jones (11:52)

    Do you have criteria for different types of solutions or is there an overarching criteria for any solution you might implement? Does it completely depend on we're gonna vet cryo storage totally different than we might vet a witnessing system or is there a certain set of criteria that you use to apply rigor to any solution you might be considering?


    Amy Jones (12:17)

    Yeah, I mean, that's a great question. ⁓ I think it is probably at this point more specific to what the technology is that you're looking at. certainly with cryo storage is a great example. With cryo storage, we ⁓ formed a committee and sent out questionnaires to the vendors that we're interested in using so that we could compare how each of the vendors are executing.


    certain functions in terms of cryo storage safety. And we did come up with criteria and if they didn't have a particular feature, they had the opportunity to create that feature or adjust. It's not like we're saying, well, you don't have this, so we're not gonna use you. This is what we need. And for instance,


    Safe shipping using medical couriers as opposed to using FedEx. It's a good example. That's an easy adjustment. Monitoring the tanks while they're in shipment. It's an easy adjustment.


    Griffin Jones (13:21)

    I'm gonna stay on this thread a little bit because I want free consulting from you. I think it'll be mutually beneficial. Part of what we're building as a trade media company is the crunch base of the fertility sector.


    Last year we started the IVF Heroes universe. We just made a list of all the companies that sell to IVF labs and fertility clinics about 500 categorized them in about 15 different primary categories and my


    long term goal. is so that people like you can go and do like the first parts, the first phases of the RFP process that you're currently doing. And so I want to aggregate as much of this sort of, know, like what you're getting in questionnaires, I want to get from as many different types of companies so that it's easier for people to be able to compare


    different types of companies. You gave a couple of those criteria for that questionnaire in cryo storage, that they monitoring in transit, they have safe couriers. What are some other criteria that you frequently see that would be useful to have ⁓ side-by-side comparison? Who their tech partners are, like what their tech stack is?


    Amy Jones (14:32)

    Technology, technology.


    Just that they


    have technology for tracking what they have in, if we're talking about cryo storage, they have technology to track what they have in storage and the technology facilitates an efficient process of shipping back and forth. I mean, it is a very huge time burden on the embryology team, shipping specimens back and forth. And so,


    Griffin Jones (14:43)

    Yeah.


    Amy Jones (15:03)

    If an efficient process is already in place, that's a big win for that vendor.


    Griffin Jones (15:11)

    How about other categories that you might be considering? Are there any commonalities between the questionnaires? that's the questionnaire that cryo storage folks get. There may be a completely different one for EMRs, et cetera, but is there some commonalities?


    Amy Jones (15:22)

    Well, dude.


    Data security,


    that's huge. So they have to be compliant with it. IT is not my area of expertise, but there are measures in place so that we ensure that they have certain certificates in terms of compliance for data security.


    Griffin Jones (15:43)

    And so some different kinds of certificates, different kind of partners, those are among the things that you're looking for.


    Amy Jones (15:51)

    Yeah, and I mean, so cryo storage, if we were looking at PGT labs, for instance, what accreditation do they have? That's important.


    Griffin Jones (16:01)

    When you're looking for quality in partners, you want to look for people that have had success elsewhere in the space and that have solved some big problems for clinics. The anesthesia shortage, anesthesiology shortage is a growing challenge for fertility practices across the country. Coverage can be difficult to secure and when it's available.


    When it's available, it doesn't always ease the burden on physicians and staff. That's why so many centers are turning to Kaleidoscope Anesthesia. Their CRNAs are seasoned professionals known for clinical excellence, a calm patient experience, dependable support with more than 200 CRNAs nationwide. Kaleidoscope can scale to your practice, whether you need daily coverage or a complete anesthesia program.


    They can build out the entire anesthesia component of your fertility practice, making it turnkey, scalable, and far less of a burden on your team. Visit kaleidoscopeanesthesia.com to request a staffing quote. When you're vetting people, Amy, how long does it typically take? It might completely depend on the category, but.


    Do you have a sort of passive process where you're always vetting people or is it, okay, now we're focused on improving this problem and we're gonna vet just companies in this priority area that we're trying to solve for.


    Amy Jones (17:30)

    Yeah, I think that we can't tackle everything at once, but once we sort of wrap up one implementation as we're nearing the end, we'll take on the next and start that vetting process. We've done, I think, a couple simultaneously, but it takes a lot of time and it takes organizing multiple people and their schedules.


    regular meetings.


    Griffin Jones (17:51)

    Do you build a task force for each one? Is it the same people if it's in the lab, for example? Are you gonna have the same people that cryo storage as you are witnessing, or can it be different people even if it's the same vertical area?


    Amy Jones (18:08)

    Yeah, we try to involve different people because we want everyone to be engaged and invested in our decision making process. So we have different people, for instance, involved in the Circle AI project, different primary people involved. But ultimately, all of the lab directors will be involved and the practice directors and the physicians. I it's a huge undertaking.


    be incredibly impactful.


    Griffin Jones (18:36)

    when do you decide if a solution just needs a sort of criteria that different clinics could pick from different partners or implement different solutions versus when every clinic or every lab should have this solution?


    Amy Jones (18:52)

    Yeah, that's another good question. So with PGT, for instance, right now we're using a myriad of companies. And we are not dictating at all who they need to use, but we do have recommended criteria. So we have here are some.


    And it's not a policy, it's a guideline. So we have policies, we have guidelines, and this is a guideline. So we have a list of recommendations just so they know what the criteria should be and they can ask those questions themselves.


    Griffin Jones (19:26)

    How do you see the field? What do you think are the most important things for being able to expand access without sacrificing quality?


    Amy Jones (19:34)

    That's tough. Obviously, coverage.


    you know, financial is the main barrier to access. But getting people through the door once they are aware or they can afford IVF, getting them through the door and then through the process, that's we've just found that there's much room for improvement in terms of


    patient experience and efficiency in that particular realm. There are many places where a patient can get dropped or lost or not have appropriate expectations set. It's daunting the amount of information that patients are given and expected to sort of ingest and understand and apply.


    And so I think that that is an area we can expand access, but we also have to, know, once they approach us, have to be able to get them through from the new patient appointment to whatever procedure, you know, they're designated for.


    Griffin Jones (20:32)

    Tell me about that. Tell me more about how you're seeing challenges in the patient journey and how you're approaching that.


    Amy Jones (20:37)

    Yeah, so the patient journey, you it starts really just with the patient being aware that that or the person being aware that they should maybe consider speaking to a reproductive endocrinologist. And so sort of top of funnel type of information. So I think we're you know, we're focusing on patient education and the different geographies once we get them in the door.


    Setting the expectations from the start, we're really working hard on that so that they understand how long the process takes. Once they decide on IVF, setting the expectation of...


    If you make it to baseline, you've paid for the cycle and signed the consents and you've crossed off all or checked off all those boxes, then just because you stem doesn't mean you'll make it to retrieval. And so setting that expectation just because you make it to retrieval doesn't mean you'll have mature eggs or fertilization or blastocyst development.


    or a successful embryo transfer or normal embryos if you have PGT. And so just incorporating the education process into the patient journey and repeating, repeating, repeating is hugely important. Improving the journey itself, think patients require many touch points. think that technology will help with that. I don't think it can be the only.


    ⁓ measure we take, think we still need the human touch, whether it's the human touch by


    nurses and personnel in the center or the use of auxiliary services like frame. We've we've engaged with a company called frame


    to facilitate that patient journey.


    Griffin Jones (22:18)

    Talk to us about...


    frame and what do they offer versus some other people that you looked at.


    Amy Jones (22:23)

    Frame is a very light touch. do not go into the realm of medical advice or they're simply a support. So they facilitate the patient getting to the appointment.


    Right? Knowing what to expect at the appointment and if they have questions, how to get their questions answered. So Fram is answering the questions. They're telling the patient, here is how you can get answers to your questions. Because so many times patients don't realize, we'll just use our EMR portal. Or you need to call this particular number if you need answers to your questions. So they.


    they facilitate the process. we have just preliminary information, but thus far it's been very helpful.


    Griffin Jones (23:05)

    Do you think that you'll need other technologies for other parts of the journey?


    Amy Jones (23:10)

    It's hard to say. mean, think that frame right now is working well for us. But the part of the journey after the patients have decided to do IVF and then they need to have financial consult and then tell their physician they're ready to go forward, that's where they drop off. So the...


    The financial console, and this is, know, I'm sort of wandering into an area where I'm not an expert at all, but that piece is so important and it's a very emotional piece for patients, as you can imagine, because you're hitting a patient in two very sensitive spots, fertility and their bank account, right? And so I think...


    If there is technology to, or companies that can assist with that piece, that could be helpful.


    Griffin Jones (24:02)

    Whether it's patient journey, whether it's lab side, whether it's clinical side or business side or anywhere else, have there been a couple needs that you just haven't found the best solution for yet? Maybe you find some solutions that they can do a lot of it or some of it, but I really wish for this problem there was a more comprehensive solution. Can you talk about that at all?


    Amy Jones (24:26)

    Patient education. So right now, Engaged MD is a great solution. They have the modules which are helpful, but different people learn differently. Some people are auditory learners, some people are visual learners. It does not completely check that box for.


    educating patients and we know this because you know we will have assigned these modules and and then they come to us with questions and you know they clearly don't understand whatever process it is that they've signed up for which could be heartbreaking at times and so I think that


    We have to do a better job of educating patients. And how that is an efficient manner, it's difficult to know because as mandated states and impact is great.


    You know, when you're transitioning from self-pay to insurance pay, right? You have to become more how you get patients into the door and through the process. And so a risk of sacrificing the patient experience and the patient education because of efficiency. And so I think that we're.


    We're going to have to pay attention to that and figure out the best way to set expectations and educate patients before they come into the center and while they're in the center and when they leave.


    Griffin Jones (25:51)

    I would have thought that engaged MD would have had that unlock. it just the case that there's more education that needs to be done than beyond informed consent, that there's just a bottomless pit of how many questions a patient could ask?


    Amy Jones (26:06)

    They don't even know what questions to ask sometimes. Right? So they'll kind go through and watch the videos, but it doesn't mean they understand. They're really comprehending that they're asking the right questions in their mind. So for instance, you know, any patient who is coming through to have their embryos tested, they need to ask themselves what


    How are we going, what will we do next if all of our embryos are abnormal? one tends to put oneself in the head in sand. Like this won't happen to us. It's not going to happen to us. But you have to have that conversation and sort of make a determination before it happens. So that's something that I would recommend to any patient coming through.


    Griffin Jones (26:50)

    Do you there's a way for technology to solve that beyond an AI agent that can just answer as many questions as need to be answered and take as much time to proactively educate the patient and engage on a personal level as possible? Is there gonna be any way to do this without having an AI Russell Fulk that talks to patients before actually meeting with the real...


    Russell Falk.


    Amy Jones (27:16)

    You know, I don't know if that's possible, but that would be, you it would be great if you could have an interactive AI agent to ask questions to and to, you know, generate information that leads to more questions. I don't, I'm not sure that that exists now, unfortunately.


    Griffin Jones (27:35)

    I have seen some AI agents that are starting to at least be able to answer a lot of the top of the funnel questions. There's certainly a limit to what they can answer, but the text versions are pretty good. And I think there might be not now, but in the not too distant future, ones that are able to do a lot of that as like, ⁓


    audio or even having a video avatar. Have you seen any solutions that are anywhere close to that?


    Amy Jones (28:06)

    I haven't. But I think AI would be incredibly helpful. Have the patient answer some questions. How many, how large of a family do you want? How old are you? What's your AMH? Here are the things that you need to consider. If you're 35 and you have an embryo transfer and you get pregnant and you don't have another embryo in storage or the other embryo doesn't lead to a live birth.


    then you're gonna be 37, 38, 39, next time you come through. Patients don't necessarily consider that. mean, some are more sophisticated than others, but these are all questions that they need to ask and they need to have in-depth discussions with their partners if that's relevant.


    Griffin Jones (28:54)

    A lot of times it just comes down to good old fashioned human beings being able to solve the problem and securing dependable anesthesia coverage is as hard as it's ever been. It's a real problem for a lot of groups, but Kaleidoscope Anesthesia gives fertility practices a better way. Their CRNAs bring clinical excellence, professionalism. You can read Google reviews of fertility clinics where people are glowing about


    their CRNA. It reduces stress on the doctors and the staff and Kaleidoscope isn't just about filling the shift. They can build out the entire anesthesia component of your practice, make it turnkey, scalable, much less of a burden on your physicians and administrators. The results, fewer cancellations, reduced burnout, improved workflow, and a healthier bottom line with more than 200 seasoned CRNAs nationwide.


    Kaleidoscope is helping fertility practices run more smoothly. Learn more at kaleidoscopanesthesia.com. It's kaleidoscopanesthesia.com. What do you think are the risks associated with rapid growth of so many clinics?


    Amy Jones (30:06)

    patients falling through the cracks, I mean, before they even get to IVF. But once they get to IVF, generally labs will limit the number of retrievals that can fall in any week simply because you have limited incubator space, limited set number of embryologists who can do the work. I don't see the risk necessarily in the IVF lab because lab directors will generally put parameters around what


    they can accept in their IVF lab. But I think it's patients having to wait for treatment. I think that's going to be an issue unless we proactively plan for expansion. as you know, it's hard to do unless you know for sure that it's going to impact the number of patients who walk through the door.


    You know, I worked in Europe for several years and they have coverage generally for infertility treatment, which is fantastic.


    But if you look at the rates, and these are published rates, they're lower than ours are in the United States. So I think we should be really careful about sacrificing quality for quantity.


    Griffin Jones (31:17)

    proactively planning for expansion is often sometimes things that venture capital back groups do too much and then it bites them in the butt. And consequently, it's something that many private equity back groups don't do enough of because they have an incentive to improve the bottom line.


    How do you proactively plan for expansion?


    Amy Jones (31:41)

    It's a balancing act between needing to grow. We know that physicians create growth, needing and wanting to grow, and also keeping an eye on the bottom line, which includes expenses in every area of the practice, but the IVF lab as well.


    And mean, I think that's something that we are getting better at. As lab directors, we're learning how to function in this space, not only as lab directors, but also on the business side. mean, I think it's fair for lab directors to have a seat at the table. But to do that, you need to have an idea of how your purchasing is impacting the bottom line and whether you're doing it wisely.


    So it's a, I think it's a real balancing act, but generally I think that we can look at heat maps of where your patients are coming from, where there's growth, where there's an interest in infertility treatment and move towards those areas, develop in those areas.


    Griffin Jones (32:42)

    Maybe you alluded to it a little bit with embryologists thinking about how their purchase patterns shape what's realistic and not. The question I have for you is, as you're implementing these solutions to scale and ensure quality, what do you run into frequently that you just want doctors and embryologists to think more about? That


    if they were thinking about the issue in this way that things would be easier and and they'd be able to see more benefits from it.


    Amy Jones (33:18)

    and communication regarding...


    how the patient workflow, how the patient journey, the start to finish from when they walk in the door when they leave the IVF lab. think that we have a great system in a few of our clinics where we sort of have a triad of the nurse manager, executive director, and lab director working as a team. And I think that benefits


    not only the company in the bottom line, but also the patient. Because these three important components are communicating with each other and are aware of. ⁓


    of risks and how one risk affects the other department.


    Griffin Jones (34:01)

    Am I inferring too much by picking up that they're too siloed that very often it's we're worried about what is immediately in front of us and not how it relates to everything else.


    Amy Jones (34:14)

    Absolutely.


    Griffin Jones (34:14)

    How have you in the past gotten them to see how what happens in another area of the practice or the company is relevant to them and vice versa?


    Amy Jones (34:27)

    I mean, I think being present and overly communicating. So go to the meetings, participate in the agenda, communicate, overly communicate, and be open to...


    to questions and criticism. You just have to be. if...


    Griffin Jones (34:43)

    Is it more that


    part? Because I feel like I feel like over communicating wouldn't be a problem for them. Aren't people just dying to tell you what they need, what they want more of? See more of the problem being them seeing what the rest of the organization needs.


    Amy Jones (34:54)

    You know embryologists, right?


    Embryologists are perfectionists. so, you know, we, before we talk about anything or communicate anything, we want it to be perfectly laid out. And if it's not, we're just kind of, you know, tend to hold back. So getting the embryologists, getting the love directors to come out of their shell.


    a little bit and also be open to feedback.


    from other departments.


    Griffin Jones (35:25)

    I'll be getting feedback from you, Amy, as I build out our database, I'll be coming to you saying, is this important? What else should other information that we should we be getting and staying in touch? And I appreciate you laying out the framework for us today. Amy Jones, thank you very much for coming on the Inside Reproductive Health podcast.

    Amy Jones (35:48)

    Thank you so much for having me, Griffin.

Amy Jones
LinkedIn


 
 

265 The Leadership Lesson. Dr. Alison Bartolucci & Cara Reymann

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


If you’ve ever tried to get doctors, embryologists, and executives on the same page…you’ll want to hear this one.

In this episode of Inside Reproductive Health, Dr. Alison Bartolucci (CSO) and Cara Reymann (CEO) of First Fertility talk candidly about leadership, lab management, and network-wide decision-making.

They discuss:

– The emotional cost of leading a fertility network

– When to build consensus (and when to just drive the bus)

– The decision to implement digital witnessing across all nine IVF labs

– The “magic question” Cara uses to align stakeholders

– Why First Fertility abandoned plans for a single EMR

– Why Alison swears by using a lab monitoring service (and the business benefits beyond happy embryologists)


Alison Bartolucci Trusts This System. Here’s Why…
When a refrigerator failed, XiltriX caught it immediately - saving the lab.

“Their customer service is second to none. When we needed help, they were on a plane getting us hooked up and troubleshooting right away.” -Alison Bartolucci, Chief Scientific Officer, First Fertility

With 24/7 live monitoring, automatic escalation alerts, and a dedicated response team, XiltriX gives IVF labs an extra layer of security others don’t offer.

Request your free demo to see if your IVF lab can benefit from the same advantages. In your free demo, you’ll receive:

  • A tailored presentation focused on your lab’s priorities

  • A live software walkthrough

  • Real-world IVF case studies

  • An overview of XiltriX’s 24/7 SafetyNet Team

See why Alison and her team rely on XiltriX to keep their labs safe.

👉 Request your free demo today!

  • Cara (00:00)

    How you manage people's expectations can really determine success or failure. We want alignment, but we also have to be realistic that we're not going to get a hundred percent of people on board a hundred percent of the time. And so this idea that there will be times that we have to disagree, but commit is important because what matters is what are we trying to accomplish and does that accomplishment represent, a step forward for the organization, even if it's not the way that you see it.

    Griffin Jones (00:41)

    Ruling fertility practices with an iron fist. That's what I'd do, but I can't get doctors to come work for me for reasons that are probably unrelated. So I talked to two people for whom fertility doctors and embryologists do actually work. And we talk about when and how to build consensus and when and how to say this is the direction the bus is driving in. I think it's the first time I've had the CEO and the CSO of a fertility network on at the same time. I've wanted to do it for a little while. And because of Ms. Cara Reymann and Dr. Alison Bartolucci from First Fertility, I think we'll do plenty more of it. They share the emotional cost of being a leader, the network wide decision to implement digital witnessing in all nine of First Fertility's IVF labs, the relationship between the clinical business and lab executives, including Alison's and Cara's. A magic question. I'm the one calling it that by the way, that Cara asks. to get stakeholders on the same page about an issue. Cara's decision to abandon a mandate to implement one EMR across first fertility. Why Alison thinks the customer service of a lab monitoring service called XiltriX is so phenomenal and the business benefit of that beyond happy embryologists. And Alison's approach to building rapport with her embryologists and lab directors when they were at first reluctant to open up to her.

    Each Dr. Bartolucci and Ms. Reymann deserve their own interview. Don't worry, I will. In the meantime, enjoy this one.


    Alison Bartolucci (03:11)

    I think Cara and I, you know, share the same vision. And that's why when, when, at least when I met her, I was so excited to have the opportunity or the potential at that time opportunity to really have a seat at the table as a lab representative, as a lab director. And our interactions are sometimes very formal and have a clear mission. Other times it's more casual, but I would say all of the above. We talk on the phone, we text, we meet once a week, we meet with other executive leaders, other lab leaders. She's very much in the trenches as am I.

    Griffin Jones (03:51)

    So a good interviewer would have looked up who the chief medical officer of First Fertility was first before asking this question, but let's pretend a good interviewer was asking this question. Are you doing it with your, is it always CSO, CMO, CEO at the same time, or sometimes you're having one-to-one meetings? How does everybody come together?


    Cara (04:14)

    We don't have a chief medical officer. So what we do have is a medical advisory board and we meet with that medical advisory board on a monthly basis. And so other executives in the organization participate in that meeting. And it's really the opportunity to shape the direction of the organization clinically. We really let the lab and our scientific partners as well as the physicians shape the agenda for that meeting.


    And then our administrative team is there to add contact support, take away, know, thoughts, ideas, make sure we can execute on some of the things that they talk about. But it's been a journey over the last two years to really build that part of the organization. I came to First Fertility in 2023. We did not have active teams in these areas at that time.


    So it was one of the first things that we tried to organize around was, what does our medical leadership, clinical leadership look like? What does our scientific leadership look like?


    Griffin Jones (05:18)

    There wasn't a medical advisory board at the time you joined, Cara?


    Cara (05:22)

    There was not. There was an idea of one. There was not a formal cadence of meetings. There wasn't a lot of engagement around that. So I think the foundation was there. And then it was just, how do we actually make it meaningful? And really, what do we want that group to add? What value do we want to learn from that group? What value do we think we can bring to that group?


    I'm very pleased to have a very engaged group, both with the Medical Advisory Board and the lab, and really pleased to see that they come to the table with ideas that, you know, their own. do a journal club, think. What is it, Alison? Once a quarter, the Medical Advisory Board meeting, actually, rather than just being a board meeting, it's a journal club. That was the idea of one of our board members that leads some research in one of our centers. So...


    I think all around it's created a culture of engagement that has created a lot of camaraderie and great value, just professionally, but also for the organization.


    Griffin Jones (06:26)

    How did you decide, how did you all decide on that structure of having a medical advisory board as opposed to, or as opposed to and or a chief medical officer?


    Cara (06:35)

    Yeah, it's a good question. I think it's an evolution. think for sure as we grow, a chief medical officer is something that has been on my radar and I have a desire to pursue that. But I think we were still trying to learn who we were as an organization when I joined. And this has given us some room and some space to get to know each other, to understand what everybody's priorities are.


    to really build our own priorities as an organization. And also we grew really quickly. We almost doubled in size just in a single year. So there was a lot to work through, adding as many new team members into the mix during that period. So one step at a time, and I think we still have a lot ahead of us and are still looking forward to this landscape evolving and our leadership evolving.


    Griffin Jones (07:27)

    So it's part of the evolution. Alison, do you have a scientific advisory board or are you ruling the labs with an iron fist?


    Alison Bartolucci (07:35)

    No, that's not my style. And again, like that was something that ⁓ Cara had envisioned and really formalized as well as creating this laboratory advisory board where the lab gets to come together, the lab directors and even the lab managers as well come together once a month and they are deciding what's important. They're deciding the policies that they want to have implemented across the network. They're deciding what


    vendors they're going to align with, things that are important to everybody. And they're making the decisions and they're making the plans on how to execute on them. What was really exciting for me was that I feared that as we came in as First Fertility, there would be resistance from the lab.


    I was initially a little bit nervous about how they would embrace being part of First Fertility, being part of the advisory board. I have to admit, it was a little bit quiet in the beginning.


    a lot of me talking and crickets. But over time, we really formed these relationships. And what was so telling to me was that everyone actually was really looking for this opportunity to have a bigger community. By design, the lab is, if you think about the physical IVF lab, if you've ever seen one, they tend to be completely. Exactly, yeah.


    Griffin Jones (09:03)

    Not much bigger than a prison cell. I'm pretty sure Scandinavian


    countries have bigger prison cells than most IVF.


    Alison Bartolucci (09:09)

    Yes, there's


    no windows. It's on purpose, isolated from the rest of the clinic. And what happens is that physical isolation kind of drifts into the cultural isolation. So to bring everyone together and sharing these tales of woe, but also shared experiences, it's become this broader community that they


    ask each other, know, they ping each other when they have questions or it's been really great to watch it unfold.


    Cara (09:43)

    Yeah, and I've watched this evolution. And I warned Alison that these first meetings, it's always going to be very quiet. I think people are wanting to know what to expect. They're afraid to engage. And I told her, just keep moving forward. Keep developing a agenda or a forum where people can speak up.


    And then the more they do it, the more they'll speak up. And so I don't attend all of the lab board meetings, but I like to drop in periodically. I do that to everybody. I don't know if they love it or hate it, but I learn a lot from those interactions. And it is remarkable. It's remarkable to see how enthusiastic that team is. It's remarkable to see how much candid conversation they have with one another. And Alison and I, some of our conversations,


    you know, have been, you know, hey, I had this meeting with the lab board, it did or didn't go as expected, you know, what were your thoughts about what you saw? So I think a lot of leadership is just being reflective and unpacking, you know, okay, I took this approach, did it work, it not work? You know, what might have worked better? And that's why I try to spend a lot of my time because I think how we engage with each other matters. And then, you know, it becomes


    It creates that momentum for more engagement.


    Griffin Jones (11:01)

    Alison, when you were having a bit of one way conversations in the beginning, do you think that was because people were thinking, this, she's just going to make us do it her way that this is, they weren't necessarily seeing it as a First Fertility team yet that here's Alison, she's from cars, she's from Yukon system. and so like,


    That's her way of doing things as opposed to our way of doing things. that why you think there was a bit of trepidation in the beginning?


    Alison Bartolucci (11:36)

    Definitely. Definitely in that, you know, almost all of us are total introverts and shy by nature. So that those two things combined. Absolutely. But I think, you know, and that's that's how I felt. You know, that's how everybody feels. And it's completely normal. But, you know, I I think that once the realization occurred that I just like Cara had brought me in to have a seat at the table for First Fertility, I was bringing these


    people in to also have a seat and to really voice their concerns, their perspectives and really make a difference in First Fertility, but that translates to the field as a whole.


    Griffin Jones (12:19)

    Looking back, do you think of any things that you might have been able to do to speed up that process? Or is that just the nature of rapport building? It takes time. It takes you just showing up, doing it, them seeing that they can trust you. Are there any things that you look back at and you think, maybe if I had introduced this practice, I could have started to get the ball rolling a little bit more quickly, or is time just necessary?


    Alison Bartolucci (12:47)

    No, I mean, I think, I mean, we're in different, we're in completely different locations. I think, you know, when you were first asking me that, the first thing that came to mind was like, well, yeah, if I was with them every day and working side by side, like I used to be as a lab director, but that's impossible. Cara really was the one who encouraged me to meet with them individually, one-on-one. So that process evolved, I think.


    if I had been more maybe proactive about meeting with them one-on-one, maybe we would have expedited that process. But overall, I think the way it unfolded was very organic and contributed to the success.


    Griffin Jones (13:26)

    what have the consequences been of the prisoners getting together? Have the riots started yet?


    Cara (13:30)

    I know you always wondered.


    Yeah, exactly right. Will the inmates run the asylum?


    I think the way that we manage expectations is, you you have to be realistic. You're working with groups of people and not just the lab group. you know, everybody wants the outcome that they want, right? But that outcome has to be delivered in the context of a very dynamic environment. So, you know, the lab team might want one outcome.


    the physician and clinical teams might want a different outcome. The network of First Fertility might want yet a third outcome. So How you manage people's expectations as you kind of move through those exercises, you know, can really determine success or failure. I think we try to message at every step of the way that, you know, we are seeking input. We want alignment, but


    We also have to be realistic that we're not going to get a hundred percent of people on board a hundred percent of the time. And so this idea that there will be times that we have to disagree, but commit is important because what matters is not your opinion or my opinion. What matters is what are we trying to accomplish and does that accomplishment represent, you know, a step forward for the organization, even if it's not the step forward, the way that you see it.


    you know, helps people at least be able to feel like, okay, I got to have a say. And more importantly, can you understand where somebody else is coming from? I have this conversation a lot. I've had to have a lot of difficult conversations and I try to tell people, you know, my commitment is you may not always agree with me, but I want you to understand. And I think when you give people those opportunities, you know, everybody in the end,


    is generally a reasonable person. And if you can just establish that respectful culture where feedback is not only sought but appreciated, then I find it easier to kind of get through those difficult conversations where there's kind of multiple different goals and personalities and desires at the table.


    Griffin Jones (15:42)

    That's what makes it hard being in that top seat is that you've got multiple constituents and those needs are sometimes at odds. Your job is to find out where they aren't at odds and to bring them together. But that does require some people to focus on some of their needs more than others or getting them to see the value in the bigger picture. Can you think of a specific example? And you might be limited into how much detail that you can go into, but to the extent that you can.


    What's a specific example you can think of where you had to have one of those harder conversations?


    Cara (16:18)

    can think of many. ⁓ But we've done a couple of things over this last year. We implemented the electronic witnessing system, which Alison can talk more about. But we went through a thoughtful process of how we evaluated the different products that were on the market, what we felt was going to serve our goals and needs. And the word that people like to use, and I never let them get away with this, by the way, and I think it's part of a healthy culture, is people like to show up and use


    Alison Bartolucci (16:19)

    Thank


    Cara (16:45)

    you know, sometimes some language that's not always productive, like, you know, just tell me if this is a mandate. Is this a mandate? Because if it's a mandate, then, you know, we'll just do whatever you tell us to do. And, you know, I just don't let people get away with painting it, you know, with that broad of a brushstroke. We all agreed that pursuing an electronic witnessing system was material, you know, to the quality of the services.


    and the risk management of the organization. And that's what it's about. It's not about whether or not it's a mandate. It's about whether or not this is technology that makes us safer and creates more value. And if that's the goal, then it just comes down to, it going to be product A or product B? And what does it mean in practical reality when we have to actually implement and use those products?


    I try to do my part in keeping people's perspectives coming from the right direction because you definitely, I think, get some of that language and verbiage. But Alison can talk about the process because we also learned a few lessons in how we went through the exercise. And we were communicating in one channel and maybe needed to communicate a little more broadly and in a little more detail to other channels so that they could also


    be brought along and understand. So, know, Alison, maybe you can share some of your lessons learned there.


    Alison Bartolucci (18:15)

    So, I mean, that's actually, it's a good example because the, I was really patting myself on the back about bringing the lab board in and letting them kind of vet the vendors and the products and then make a decision as a group, which they did. And it was really a wonderful process. And the whole point was that, you know, to Cara's point, I mean, it's not about being a mandate. If it was, that's not, that's going to defeat the purpose of


    implementing these systems because if they're not embraced and used as part of the daily operation of the lab, then there's no point, then you're wasting your money. So, you know, it was this great process, but I kept it very much, you know, contained within the lab people, you know, the lab directors, lab managers, the embryologists, the andrology technicians, but, you know, I was really proud of how much I was communicating.


    But the one piece I didn't think about was like all the administrative people and the center leaders totally in the dark. And when we kind of just made the announcement, yeah, it floored me. I was like, well, what do they care? But yeah, it does affect them substantially. It's their budgets. They actually have to use the systems as well. And also just having


    transparency and visibility into what we're doing is key. And again, that helps.


    Griffin Jones (19:43)

    Let's spend


    a little bit more time on that. might sound like the minutia of one particular example, but I think it illustrates the principle that a lot of people are going through. What are some of the, because I probably would have shared your default point of view, which is what do they care? We're doing witnessing in the lab. What does it matter to these admin folks? What were the downstream implications that mattered to them?


    Alison Bartolucci (19:58)

    Yeah.


    I don't want to waste their time.


    You know, I think at the very core, was just that they were kept in the dark. And I think that is important for me as a leader to understand that people, you know, fear what they don't know. And I think we all do this. You can kind of construe all these imaginary conspiracy theories in your head as to what people are cooking up. And so the fact, just the mere fact,


    that I was not sharing this with them was, I think, the most egregious. But really, was, I think, from a real practical standpoint, just knowing, understanding what it was, what they were going to need to prepare for from a logistical standpoint, how they could then support their lab in terms of


    purchasing consumables and budgeting and expectations and.


    Cara (21:02)

    Yeah, there were some downstream things that


    were fair when you think about, who needed to know? There was a budget implication, because obviously you're purchasing a system. You can't bill for that system, and so you're absorbing the cost of that system. There was some installation that had to happen in terms of hardware, software, devices. I don't know all the details, but there certainly was an element of that. So then it's like, OK.


    How do you schedule around that, especially in a busy laboratory where you're trying to do your day-to-day work? I do think there's some point of entry that maybe happens across different team members. So now it becomes a workflow consideration. And then it's timing, who's going first? And you learn something every time you do an implementation. So it's always like, OK, you've got to get one under your belt. What do you learn from that? Then you move on to the next one.


    You know, they were really fair considerations across all of those things. And to Alison's point, you you can think that you're doing everything right. And listen, we could have a whole podcast about how it would be so much easier to just run things with an iron fist and say, we're doing this. This is what it's going to look like. Move along. I mean, we could move so fast. ⁓ But what you do when you approach things that way is you lose the goodwill.


    Alison Bartolucci (22:01)

    Hahaha.


    Cara (22:18)

    I think eventually maybe you can get it back because if these things then prove themselves out and everybody ultimately comes around and says, yeah, this is better. That's great. But like, man, the friction, the goodwill that you have to try to push through is really difficult, can be very damaging. So we choose to do the hard work upfront, which is to be engaged, to welcome opinions. But we're not going to be perfect. In this instance,


    you know, we had to take a step back and, know, tell us this point. She was really proud of the process that she ran and she did get some harsh feedback when she shared that we were going to be doing this, expecting it was going to be so, you know, well received. And she called me and was like, man, I'm a little caught off guard. And I said, well, and you know, I'm here to give her the perspective of like, okay, well, if you think about it from this perspective, kind of, you know, then you can understand where that might be coming from. And she said, okay, you're right. I didn't think about it that way. And it's like,


    The great thing is, you can just go back and fix that. It's not like you've lost that opportunity forever, right? Like you just pause and say, hey, I listened to your feedback. You're right. I should have been shared more information sooner. Let's do it now. And then we'll get there. And that's what we did in that circumstance. I think how many more do we have to do, Alison? We're almost done.


    Alison Bartolucci (23:37)

    Just two.


    Yeah, two more left. Nine.


    Griffin Jones (23:41)

    Out of how many labs?


    So I want to ask about when you decide to do something across all nine labs versus when you decide to do some things at some labs, because I imagine there are things where it's more important to do it across all nine and others where you can do it this way or that way. know that at some of the labs that you use, I think you use XiltriX. I've had people like Dr. Jindalhan seem to really like it and


    People like Dr. Shankman seem to really like it. What do you use XiltriX for?


    Alison Bartolucci (24:15)

    So we use XiltriX in a couple of our labs. It's the main alarm system for one of them and will be for ⁓ one of the ones that's sort of under construction right now. I remember Dr. Jindal talking about the customer service and I second that comment. It is second to none. actually the lab that


    we have it installed in currently needed something kind of urgently. And they were, I mean, on a plane getting it hooked up, troubleshooting. In fact, this is a great story that I kind of forgot actually. They put ⁓ a temperature probe in one of the refrigerators that was in there and they called me and they were like, I think this refrigerator is dying. And I was like, ⁓ that's a coincidence.


    You know, like you just put something in there, blah, blah. But we looked at the data and it's true. Like the temperature was like all over the place. And I mean, literally, as soon as they installed that, they were saving our butts. So they are exemplary. I do like they, one of their features that I think puts them apart is they have, you know, the


    The alarms will call the lab people and there's a phone tree kind of like what you would expect. But if none of the lab people respond, it goes to them and they're there 24 hours. And I think that's a really nice measure of security there that others don't offer.


    Griffin Jones (25:45)

    I want to come


    back to that principle of customer service. I want to not lose the other question I wanted to ask about when you decide to do something at the network level. So for example, for witnessing, you could have said just some of our labs should have witnessing. Sounds like you all came to a consensus and decided that it's material to the quality of the work to have all nine labs have electronic witnessing.


    What, how do you decide when something should be done at all nine versus this lab can decide for themselves?


    Alison Bartolucci (26:18)

    Well, with the witnessing, know, it was a unique opportunity to really align on something because none of them had anything in place currently. you know, understanding and identifying that this was an important technology that I think we all, everyone can agree is crucial. And then saying, so none of us have it and we have an opportunity to all have the same thing.


    So that was how we approached it there. Now, when we look at other systems, like alarm systems, for example, they all have alarm systems. So it's a little bit different. So it's like, as you're looking for new systems, here's what we've recommended from the network standpoint. Here are the people we have good experiences with, but we're not going to sort of fix something that's not broken.


    Griffin Jones (27:06)

    So


    one part of the criteria is, there a blank enough slate? But is there also a criteria of need? Like, so for example, let's say they were all using, you know, some were using this kind of time lapse or that some were using this kind of alarm or some were using this kind of oil and media or some were. At what point is it, or maybe there isn't one.


    Alison Bartolucci (27:10)

    Yeah, right.


    Griffin Jones (27:25)

    is to say, not just is there a blank slate, but one in any one of these categories is clearly so much better of a product or maybe so much better of a practice than the others that we've got to standardize this across the board.


    Alison Bartolucci (27:38)

    Yeah, and I'm not sure, you know, there's so many great products out there that I don't know. I don't know if there's anything that's not really subjective, you know, in terms of this one is better than the other. But what we do again, the lab board together with me is we establish criteria like you can use you can use whatever media you want. But this is how you know, this is what your blast.


    This is what we've established for benchmarks for blastocyst development for fertilization. So as long as you are operating within these guidelines, that is sufficient. So I think the approach that we've taken is to say, you have the autonomy to some extent, but we all have to be meeting these standards together.


    Griffin Jones (28:26)

    Cara, that doesn't drive you crazy as a business person to have different labs in different clinics, ordering things, doing different things. And if I can say so, I think First Fertility has a reputation of being on the spectrum that allows for more clinic autonomy. And I think that might mean for more lab autonomy as well. So if there's a spectrum, maybe on one end of the spectrum, you've got, I had Dr. Kishitz Murdi on from Indira IVF in India. He's like, I hired 250 docs.


    who are all younger than me, and I tell them exactly what protocols to do. It's more democratic in coming up with the protocols, but those are the protocols. You don't do other protocols. And as a business person, I'm like, yeah, I like that. But you all kind of have a reputation of being on the other end of the spectrum where you let this clinic decide and that lab decide. And I don't know that situation too intimately, so maybe I'm making that up. But Alison seems to...


    Alison Bartolucci (29:07)

    my god.


    Griffin Jones (29:23)

    be providing some evidence for that. doesn't drive you crazy as a business person. Just say, let's let's come up with these things. So we're all buying the same thing and following the same processes. So it's easier to have a scalable business.


    Cara (29:36)

    Yeah, I wouldn't say that it doesn't drive me crazy. I would say that I'm a very practical person at heart, and I also am very committed to a long-term goal and vision. And I know precisely how to make progress along that timeline. And sometimes the best way to make progress is actually to move a little slower so that you can build the trust.


    Get people's, know, build consensus, get people's buy-in. You know, what you're seeing with First Fertility is that we are moving closer and closer to looking alike, but it's by choice. It's by choice because we've done things one at a time. People have seen the value of those things. And now when we want to do the next thing, their experience is such that, well, the last time we did this, had a good outcome. Maybe it wasn't a perfect outcome.


    ⁓ But they're more trusting in that next decision to do the next thing. And so what I expect to see with First Fertility is that we will accelerate on that journey. But I also believe you don't have to have everything look exactly alike. I remain probably one of only clinics that doesn't have, I mean, big networks that doesn't have a single EMR. When I came to First Fertility, there had been


    a mandate as I was informed that everybody would move into the same EMR, that EMR had been selected, and there was a complete uproar across the organization about that decision. And, the first thing I did


    in my role was to just say, hey, I'm going to pump the brakes here. I need to learn a little bit more about this decision before I'm ready to commit. I do come from a background. I worked for a company for 12 years. I went through the process of that company moving on to a single EMR, but it was a different circumstance. That company came together under a single tax ID. That's typically not the case in networks. You don't have single tax ID. fertility is not a space that has matured.


    in its technological advancements and applications. And so it's somewhat risky, I think, to move too quickly in forcing some of these changes at a network level, because the field, the technology hasn't matured to that point. For me at that time, I was less, I had less of a desire to force physicians to make


    clinical workflow changes than I did to just have access to the data that I needed the way that I needed it. And so the way that we kind of compromised early on in First Fertility was to say, like Alison said, look, we have to meet certain criteria. Some of that is our criteria and some of it like is imposed upon us just regulatory criteria. And I said,


    You know, look, clinical decisions are your decisions. I respect the tools that you want to use for your clinical practice. But the administrative decisions are my decisions, are our decisions, and for fertility and, you know, the administrative team. And we need the tools that we need to do that work for you. And so we'll select those tools, right? So I'm not going to select your tools, but you're also not going to select my tools. And kind of once we looked at it that way, everybody thought, that sounds OK.


    So we've moved into a single billing system. Same thing. We'll do our last installation in the next month or so here on that billing system. I knew that the network was going to naturally move probably towards a single EMR. We're down to, for all intents and purposes, two EMRs in our network. I don't doubt that our journey eventually gets us there. But again, it will get us there, I think, in a more organic way. And I think that will be healthier.


    Griffin Jones (33:18)

    Let's


    talk about that overlap for a little bit because I ask every CEO that comes on when every CEO says we don't make clinical decisions for our doctors, we don't tell them what to do. And everybody except for Dr. Murty has pretty, pretty much said that. And I don't think that they're being disingenuous. I think that that's the way they view it. I just don't think that they fully really appreciate the overlap between administrative operations and clinical operations and that if I


    If I'm saying, okay, here's the pharmacy that we're using guys, you might think that's an administrative decision, but not entirely. That does impact what works with nurses. Or if I say, here's the patient software that we're going to use, the patient education software that we're going to use, that impacts how well patients are informed and they go through treatment and they might sound like administrative decisions.


    And again, I am a person that I like standardization. I don't think it's standardization is always good or always bad. These are trade-offs. But I do think that you're pointing to something, the MR being good example where there is that overlap between admin and clinical. at the end of the day, somebody's got to win. And in this case, you were willing to say, all right, we're just going to do the billing part and you make the decisions on the clinical side. But doesn't, isn't.


    their attention there.


    Cara (34:43)

    always, the way that I handle that is you gather the information holistically. What happens on the admin side? What happens on the clinical side? And then you look at it, you actually just ask the question, tell me how we can afford not to do it. And that's a hard question to answer when you put the right information together. So that makes the conversation a little bit easier. And when physicians


    finally get the opportunity to have dialogue around what it takes to be successful in the environment and support and provide everything that they want, they begin to understand that everything is a series of choices. And I'm perfectly willing to support their choices, but they have to tell me, you know,


    how we can do that under certain restrictions or limitations because I'm always willing to compromise. But oftentimes, what you have to compromise, you're not willing to. So you have to go back and re-examine your decision and say, OK, I understand now there's many more moving parts to this than I realized. And it requires me to be more thoughtful or critical in how I'm looking at something.


    ⁓ And then we come back to the table, we have another discussion and you know, I have yet to be confronted with a circumstance and I've been confronted with some very, very difficult ones that I haven't been able to navigate successfully. That doesn't mean that everybody's walked away happy, but I think it does mean, you know, we've all been able to walk away and say, you know, that, okay, I'm satisfied, I can live with this because at least I understand it.


    Griffin Jones (36:25)

    Some people might not have an answer to the question, tell me how we can afford not to do it because it's not their domain. But does that question sometimes help people to see that there are implications that are much more broad for the organization than just their domain?


    Cara (36:42)

    100%.


    Griffin Jones (36:43)

    have you all and Alison, maybe you've come to this or maybe you haven't yet, but you've talked a little bit about the there's benefits to ruin, ruling with an iron fist, but there's benefits to consensus. And you've talked about the benefits of coming to consensus and hearing people out. But there are also downsides to that. And I think ultimately, good leadership is about building the skills


    that allow you to hit the perfect spot on the X, Y axis. It's very, very hard to be perfect with that stuff. But I've definitely erred on the too much consensus in the past and realizing that I was involving people that it wasn't really their domain and they didn't really have consequences if the decision didn't pan out, yet they felt like they should have the say over certain things. that was a consequence of ⁓ poor management on my part. But I did see that


    Cara (37:12)

    you


    Griffin Jones (37:36)

    there is a way to build the consensus and then there's a time for saying, now we've made the decision and this is what we're doing. And there has to be a spokesperson for that. And that's the leader's job. So if you come to the point where you've gotten bitten from too much consensus or too slow to execution,


    Alison Bartolucci (37:58)

    Yeah, absolutely. I mean, somebody said to me once, you know, it's about giving everyone a voice. That doesn't mean that we are going to, that doesn't mean they have a decision, like they get to make the decision necessarily, but having a voice so that their opinion is heard is what is important. you know, yeah, I have certainly fallen victim to trying to get everybody's consensus, trying to...


    to sort of like make everybody happy. And we all know what happens. mean, nothing gets done and everyone is unhappy. So, you know, I think, yeah, it's a learning experience. It was important to me to form relationships with all the lab directors. But of course, at some point I need to say, and have had to say, no, this is not a non-negotiable.


    this needs, like for example, I mean, I'm not saying they were doing this, but we, know, some of the things that I have said are non-negotiables. There has to be, before we had electronic witnessing, double witnessing, there has to be, you have to be identifying patients and samples with at least two unique identifiers. The men have to be present when they bring their samples into the clinic. So there have been, and,


    You know, I did get some pushback on some of those things that, you know, down the line. But those were things that I, you know, in my experience will burn you. that those are the non-negotiables. And these things come up all the time.


    Cara (39:32)

    This has been an interesting evolution for Alison and actually I've loved watching it. I think she and I had some conversations early on about the tendency to be too nice, to want to build too much. And by the way, you know this is a female thing, right? This is completely a female thing. The desire to want, to make everybody happy and to please people and we're wired.


    to do this. And it really, I think, erodes our ability to be strong leaders sometimes, or to be seen as strong leaders sometimes, because you're too busy trying to please people. And you need to learn in those moments to be very clear and very confident in what you are willing and what you are not willing to either tolerate or accept based on what it means.


    for the team or for the organization. And those are really hard moments. So I've been super proud of how Alison has really embraced her leadership skill and developed that. Because she certainly, I think, stepped into this a little more timid. This was her first chief scientific officer role. So it's always hard to step into that first role and show up in a way.


    where you can walk into a room and have the command of the room. And she's worked very hard on it, and she's earned it with her team, and she's coming from the right perspective and direction. Sometimes you just need somebody behind you saying, why are you questioning yourself on this? Like, of course, this is the right decision and the right direction, and you just need to be clear about saying, like, hey, I appreciate your point of view here. You the rationale is the safety and the risk and all of those things, and we can't compromise on those things, and therefore, this is the process.


    There does come that time when you have to draw that line.


    Griffin Jones (41:16)

    I think that you're hitting on the balance of mature leadership, which is the balance of agreeability and disagreeability. And it's not being infinitely one or the other. think after Sheryl Sandberg wrote her book, it was like, let's just be disagreeable. just, it's like, you didn't like that from the old guard. Why would you like it from a new generation of leaders? It's more about, no, there are times where you have to be disagreeable. And


    in those times, you do it. And that's part of being a good leader. in those moments, like the examples you were illustrating, Cara, what I like to do is meet with the stakeholders that I know aren't bought in that prior to any group meetings individually, steelman their argument to them say, I understand this is important to you because of A, B, and C. And A, B, and C are important. We are going to go in this direction instead because of D, E, and F. And here's why I've got to


    I've got to prioritize D, E, and F over A, B, and C at this time. It helps a lot. I run a very small company. I imagine that would be really, really hard to do in a bigger organization. What's the limit to how much you can do that in an organization your size?


    Cara (42:26)

    I would tell you maybe the unexpected answer is I don't know there's a limit in terms of you know number of issues that you can do that with but I will tell you there's an emotional limit. It takes a lot to invest in you know just building the consensus across an organization because you are personally like you said Griffin you are personally showing up you know you are personally you know there to listen and learn and and you are


    giving that the airtime it needs and you're letting that inform your decision. And then, knowing you've put that much time, effort, emotion, care into something and know that you can never please everybody and there will always be people who no matter what are just gonna throw all the darts at you.


    can be super difficult because you know how much you put into caring about, you know, making the right decision and giving people the right platform, but also knowing like you're going to end up at a student. It can be hard. And so the more that you're navigating that, you know, if you're doing three, four, five different things, yeah, it's super hard, I think, to absorb, you know, that type of feedback because we're all human at the end of the day and we all have good intentions.


    ⁓ We hope that we can align and you know end up at good conclusions. But yeah emotionally I would tell you is the limitation like how much can you absorb as a single person in terms of you know, just Heat, you know, and sometimes it's very personal by the way, right? Somebody's not happy and they can be very personal with that Yes, as long as I've been doing it


    You know, I don't always have as tough of an exterior as I need to make it through, you know, kind of multiple different disruptive phases at the same time.


    Griffin Jones (44:22)

    When do you decide that, okay, we're beyond the point of having healthy debate and a consensus now somebody's this person's a saboteur, they're not letting this go forward. And therefore, we have to part ways with that person, because I've been there before, too. I want my team to bring issues to me, I want them to fight for what's important. And I want to hear them out. And I do that steel man steel manning. if they're if they're still fighting, I'd see like, okay, did I miss anything? But I don't mean to do this.


    to say that I'm doing this infinitely. We get to a point where it's like, okay, I've still managed argument back to you. You're not pointing out anything else that I've missed. This is the decision that we're going forward in. And if someone were to keep fighting against that, I'm going to part ways with that person more quickly than I would have in the past. at that point, it's not about, you haven't heard the opposing sides. It's


    that you have someone that is making a decision because they think they're at the top of the organization and they're not. When do you decide that this is somebody that you got to part ways with?


    Cara (45:28)

    Yeah, I think there's a dynamic that we have to acknowledge that is unavoidable, which is you can't part ways with doctors necessarily. I mean, of course you can, but you never want to get to that point. And that can be a major barrier. And so in those circumstances, what I rely on is the whole of the group has generally been very aligned. And so that's the strategy of look.


    we're all headed this way. We invite you. We invite you to be with us. But if you don't want to be with us, that's OK. But you will end up alone. And then we just have to be OK with understanding. We can't bring that person along. There are certain things that, again, what do you tolerate and not tolerate? That we won't tolerate safety, quality, risk, things of that nature.


    But generally speaking, those aren't the problems. And so we all just support each other and say, let's just keep moving forward because we can't let one person be an obstacle. On the administrative side, obviously, there's more discretion there. And Alison can maybe speak up for me here. But I believe I do a very good job of being very clear in setting expectations, not just


    know, directionally, strategically for the company, but just culturally, right? Like there are things that we can do as a team and there are things that we cannot do that I will not allow because they do not represent the team that we're trying to build here. And everybody gets to have a choice, right? Like, again, you can come with us, you know, or, you know, you'll be left behind. And if being left behind makes you very disruptive to what we're trying to accomplish,


    then we will have a conversation about what it looks like to be successful here. And I tend to try to handle those in a way that says, listen, this is what success looks like. It's your choice to show up and represent that because if you can't, you can't be successful here. And I've had that conversation in the organization and it means one of two things, which is you can decide that this isn't for you and that someplace else is a better fit, which is okay. Like listen.


    There's no judgment, right? Everybody has a fit for themselves and this is not the fit for everybody. This is a super engaged team, like we're all in it together and that's not for everybody. Or alternatively, right? Like if you can't come along, I owe it to the team, actually. I owe the organization the best team and I have a strategy or I have, it's not a strategy, it's just my way.


    I will fully invest in you as a leader. You get everything for me. You get one on one time. get, know, like call me when you need to bump something off of me. You know, like you will get it. And I will heavily invest in you. But if you can't come along and overcome the challenges that are natural to trying to, you know, step up into leadership, then there will come a time when I actually owe the team the decision. And I have to shift my thinking and my perspective from.


    okay, what do I owe this individual in terms of supporting their leadership growth versus what do I owe the team in terms of the leaders that are leading them? And you never like to have to get to that point, but it is a reality. And if you're not ready to make those decisions, like you're just not ready to be in an executive position. It means making tough decisions.


    Griffin Jones (48:45)

    Alison, I want to talk about how that parlay's to your team and then how you help your team to make arguments that are that keep the organizations, the other needs in the organization in focus. So as opposed to just thinking of this is beneficial because it impacts my lane, here are other areas and not to pick on XiltriX, but you gave that example of XiltriX's customer service.


    customer service is something where I could see a lot of executives, maybe even myself, if my team members were just like, but they have great customer service, I'd be like, that's nice. These guys are 20 % cheaper over here, or whatever it might be. Or these guys let us do annual terms as opposed to monthly or vice versa, or some other business consideration. That they would have to make it make sense from a business.


    perspective. And customer service, I'm not just picking on Zilltrix. I do think there are organizations that have really, really good customer service out there that doesn't end up being as much of a competitive advantage as it should be. How do you make the business case for something like that? Why is that important?


    Alison Bartolucci (49:52)

    Well, from a customer service specifically standpoint, mean, the thing to keep in mind is that a lot of, know, Murphy's law is that these things that will happen in the lab will happen on a Sunday at seven o'clock at night and or on Christmas Eve or something. so customer service does end up playing a really important role because oftentimes the person that's in the lab, you know, either


    needs help or doesn't understand how to work the, know, or something's happening with the equipment so they can't reach the lab director so they call the manufacturer. Or even like, even from a, you know, like for PGT, for example, like so many times we were like, I gotta call the lab. I don't know, like they didn't send me a box to ship the samples or they didn't send me a shipping label. And being able to like just pick up the phone and get in touch with someone.


    ends up having a real material impact on the operations of the lab. I mean, I see your point. It can't be that like it's double the cost, but the customer service is a really important part because the embryologists, you know, it's not like they have somebody just sitting there answering the phone, filing paperwork. I mean, they're also in the middle of doing ICSI and performing important procedures. So they don't want to be stuck trying to get through to somebody and they want to


    somebody that they can just count on to help them. Yeah.


    Griffin Jones (51:20)

    What is one thing that has really benefited you that the other person does or has done? So, I'll start with you. What's one thing that Cara does or has done that has been a big help to you?


    Alison Bartolucci (51:36)

    Well, in case you hadn't picked up on this, the concept of leadership has been transformative. And I've been able to, I hope, really convey that to the people that I work with. But I started this position thinking like, yeah, I'm a really good leader. I'm a lab director. I know what I'm doing. I am really good at ICSE and I can biopsy an embryo and therefore I am a good leader.


    But there's a book and a saying that the skills that got you into this position are not necessarily the skills that are going to make you successful. And I think what Cara has brought to me in my professional career is that she has driven home the importance of leadership and that it is something that we can teach and that you can.


    that you should be, or we all should be learning as we go and paying it forward to everyone else.


    Griffin Jones (52:31)

    What you, Cara? What's something that Alison does or has done for you that has been a big help?


    Cara (52:37)

    Alison's biggest responsibility is to ensure that she keeps her fertility out of the news. you know, we have an incredible group of, you know, centers and professionals that are part of the organization. And of course, everybody believes that they're doing all the right things. And yet,


    Griffin Jones (52:45)

    you


    Cara (52:58)

    Alison is able to spend time with those team members in those environments and immediately identify areas that people didn't even realize either were risks or were potential areas of affecting their lab environments. And who would even know that those circumstances exist?


    if you didn't have somebody who was responsible for that. And so I'm thankful every day. mean, Alison got on a call with us the other day, one of our team meetings, and she was in her scripts. And I was like, oh, where are you today? And she was in the lab with the team. And so being able to have the visibility into those environments for the purpose of ensuring that we just understand what do they look like? Are they aware?


    you know, of different developments that have happened or different standards or different risks, because who knows who they were trained by and, know, what did that look like for them? You know, now we're setting our own standard. And so, you know, I'm very thankful every day that I have somebody who is at the helm for us in that regard. And it just comes back to that appointment of the chief scientific officer role, which is if not that, you know, then then what you're relying on everybody's different perspective.


    of what quality, value, risk, et cetera means. But now with Alison here, you get to formulate that perspective together and establish it together and ensure that it's consistent. And everybody then has an opportunity to learn from that. So she's also, again, just very much present with her teams. She's not just sitting.


    in an ivory tower somewhere. She's traveling, she's spending time. She's developing leaders the way that I invest in developing our leaders in the administrative world. And I just think it makes for a good environment and experience and commitment to purpose for everybody.


    Griffin Jones (55:07)

    And now that I know that each of you are interesting enough to have your own podcast episodes, that's allowed now. We'll have each of you back on. You deserve your own shows because I could keep talking to each of you for a lot longer. Cara Reymann, Ellison Bartolucci, thank you to both of you for coming on the Inside Reproductive Health podcast.


    Cara (55:12)

    Yeah.


    Alison Bartolucci (55:12)

    Thank


    Cara (55:25)

    was a pleasure. Thank you.

    Alison Bartolucci (55:26)

    Thank you.

First Fertility
LinkedIn
Facebook
Instagram

Cara Reymann
LinkedIn

Dr. Alison Bartolucci
LinkedIn


 
 

262 The Pinnacle Operational Model. Pain. Progress. Payoff. Beth Zoneraich.

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


Beth Zoneraich, CEO of Pinnacle Fertility, is back on Inside Reproductive Health to share the hard numbers and the deeper philosophy behind what she calls the Pinnacle Operational Model.

We deep dive into:

  • Why they automate the back end of patient care (but never the front)

  • How 3,000 unanswered phone calls became 500 new patients

  • The “J curve” of operational change (where things get worse before they get better)

  • Whether business leaders can help achieve work-life balance for clinical staff

  • The build vs buy debate

  • How they saved $1M saved by building (not buying) a witnessing system


🚨 How UCSF Reclaimed 7 Hours a Day in the IVF Lab
Read The White Paper on How They Did It

What Every Fertility Executive and Lab Director Needs to Know About UCSF’s Radical Transformation.

Want to free up nearly an entire embryologist’s day every day? Without sacrificing success rates?

Download the Embryoscope case study to see how UCSF

✅ Saved 7 lab hours daily
✅ Increased embryo transfer capacity
✅ Improved embryo selection precision
✅ Boosted staff satisfaction & work-life balance
✅ Reduced risk, foot traffic & environmental exposure
✅ Enhanced patient trust with visual transparency

Just fill out the form to see how UCSF saw massive gains in efficiency and reduction of embryology time. Download the Case Study Now

No risk. See if your IVF lab is eligible to participate.

Don’t miss this exclusive opportunity!  Click here to see if your IVF center is eligible to participate in a 90-day Embryoscope trial to measure the impact it can have in your lab.

 
  • Beth Zoneraich (00:00.334)

    The model was meant to be a few patients at a time and this one to one to one cure. And now you have an exponentially higher number of patients that one to one to one is going to break. And the problem is the systems and the operational changes that need to happen. These are not things doctors can just self invent. The solve is actually in some back end operations and some large scale tech, which is why I think it's so critical networks get involved and help solve this problem with the clinic in partnership.


    Griffin Jones (00:44.366)

    3,000 unanswered phone calls at one fertility clinic in one month. 500 new patients scheduled as a result of fixing that problem. Clinic overtime expenditures reduced by 85%. A million dollars saved by building instead of buying a witnessing system. 18 months of transformation on average to make these sorts of things happen. This is the Pinnacle Operational Model, or at least some of the highlights from my guest and their CEO, Beth Zoneraich.


    I frequently tried away what I see as the pros and cons of corporate medicine. limited concentration of buyers, financial pressures that extract value from practices. Pros, not tolerating the waste and awful inefficiency that plagues patient care. That's Beth's wheelhouse. She talks about Pinnacle's decision to unify under one national brand their philosophy on build versus buy the J-curve where patient satisfaction and staff turnover get


    worse before they get better? Why they automate the backend of the patient experience, but not the front end? The necessity of technology to achieve a nice work-life balance for doctors and staff. And if we business people can realistically achieve that kind of work hours that others can. I share an anecdote about UCSF's transformation that saves seven embryology hours per day in no small part because they're using embryo scope. Why don't you see if you can save seven?


    hours of embryology time per day. They'll show you, isn't that a fun little challenge? No, fun? Here, I'll take the risk away for you. Three free months of embryoscope, if your lab qualifies. Three free months on me, GRIP, inside reproductive health. There, there you go. Who wouldn't want to take advantage of that with a pilot? Now I'm not a patient, I'm not a clinician, I'm not a pinnacle employee. If you're those things, you'll judge pinnacle through those experiences. Where I stand,


    That's back on the show because she's an operational polymath and you're loco. If you don't think we need that kind of thinking to serve way more patients without doctors having to work a hundred hours a week.


    Announcer (02:53.742)

    Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of inside reproductive health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

    Beth Zoneraich

    don't think that fertility clinics today already provide patients the best patient experience. I think they all very much want to, and I think anyone who works in a healthcare setting, specifically in fertility, our staff and our physicians, hear deeply about the patient and the patient experience. But the industry has changed, and while that caring for the patient and desire to help the patient has not changed, the methodology to which we need to mature models. And so when I go out and assess either new physicians, new clinics, or we...


    I have partnered with in a management services arrangement and or I visit clinic. I actually find that many of the clinics, while they desire to have good patient care, don't actually have great patient care and sometimes don't even realize how bad the patient care is at their own clinic. Doctors on a routine basis don't call in trying to schedule a new patient appointment at their own clinics. They don't try and wait for an appointment. They don't know what it takes for staff to get back to them.


    there being a way for them to know those things. So that while I feel like the doctors are trying very hard in their engagement, the system is actually right now set up for the physicians and the staff to fail with cases. And I think that's why we're seeing this fringe across, certainly across the Pinnacle Clinics and I would argue across the street.


    Griffin Jones (05:06.7)

    Is it because they view their piece of the system as the system? So I feel like when people are saying, we've got really good patient experience, they're thinking of their bedside manner. They're thinking of their clinical care, their clinical acumen. They're thinking of the good character of their team. That's only a piece of the puzzle. That has nothing to do with being able to get ahold of somebody or spending nine minutes on a phone tree or having to do your own case management, because you're calling the pharmacy and then you're calling the PBM. They're telling you to call the clinic and there's a triangle. Is it because they're seeing themselves as just a piece?



    Beth Zoneraich

    Yes, I think when our intentions are good and when we care deeply about the patient, we desire to have good patient care for our patients. But that doesn't mean we actually have a system in which we can provide that good care. So if you go, for instance, time, say even 10 years ago, right, very few patients had access to care through their insurance benefits. Therefore, because of the cost that fertility used to be, it was just unaffordable to most patients. And so as a result, we had very few patients and we had a terrible that was


    one patient, one nurse, one doctor, and it was set up for that. And if you transform, right, and you come forward, say 10 and 20 years from where we used to be, now, and we applaud this by the way, patients have much greater access to care. They can work at any number of large employers and get full access to care. You have benefit managers like Progeny and Maven and WIN and Carrot that are increasing access to care. And critical we think about is, example,


    And we want that to happen. And I would guess most of the networks, the clinics out there like this, because it gives more patients access to care. But what it does is it breaks the model, right? If the model was meant to be a few patients at a time and this one to one to one care, and now you have an exponentially higher number of patients that one to one to one is going to break. And so as people try and implement care in the same way that they used to with so many more patients,


    You know, things get missed, calls get unanswered. And I see clinics with, you know, high amounts of overtime and weekend work and night work, trying to get back to patients and unable to do so without the systems in place to do it. And the problem is the systems and the operational changes that need to happen. These are not things doctors can just self invent, right? It's not something where they've been trained to write code and to create better systems and processes. They've been trained to be excellent clinicians and help patients on their pregnancy journey. But Solve is actually in some backend operations and some large scale tech. And while that's both difficult and expensive, and the clinics are unable to self-solve it, which is why I think it's so critical that networks get involved and help solve this problem with the clinic in partnership.


    Griffin Jones

    I've seen you talk about a case study with one of your clinics where the before and after, I don't remember if it was unanswered voicemails or missed calls, but it was tremendous. Can you talk about that?


    Beth Zoneraich

    I can, in fact, we've seen this in all of our clinics. The first clinic that we went into to try and partner together, they had a history of, there were so many phone calls coming in and they could never answer them, that they would just turn the volume down to zero and everything would go to voicemail. And when they got to it, they would return phone calls. And so when we got to the second clinic and saw that the phones weren't ringing, we assumed it was the same story, that the volume was gonna be at zero.


    And for this clinic, the volumes were actually up. So we were confused and we realized they had bought and invested in a very complicated phone system with something called the ID lines. And with those lines, you actually needed every morning, just like you might sign into a time clock, you actually needed to sign into the phone system and dial a number so that you could be delivered at the phone you were sitting at that day, new patients on calls. Well, that clinic did not use that phone system. So nobody dialing it.


    They had over 3000 unanswered calls every month and didn't know that they were there. And the phone system was just not working for them. The third clinic we went to had a 31 minute hold time in their phone system. And most recently in one of our most recent acquisitions, people have to call different offices and leave phone messages and go through multiple sections of filling out different forms before they can get scheduled. And we have over 500 patients waiting to be scheduled that hadn't been scheduled until we were able to help with better technology and call center answers in the first or second phone call. So every single clinic we've engaged with, I struggle with new patients getting phone calls answered and they feel badly about it. It's not what they want to do. They just didn't know how to solve the problem.


    Solving that problem is one of the first steps in transformation. And it's not the only step. Unfortunately, I wish that was only step, because that's probably going to be easier once it's solved. But it is definitely something we see across most of the clinics we need to.


    One of the implications of that is going to be reduced patient volume. If you're just not answering the phone, you're not going to be scheduling those patients who are trying to schedule, but it's not just new patients who are trying to get in for the first consult that affects. If you look it up any fertility centers reviews, huge swaths of negative reviews talk about billing and then just talk about communication in general. Didn't get back to me, wouldn't answer my call.


    Griffin Jones

    Did you see any difference in reviews when you implemented that intervention versus from before? Talk about sort of the transformation that Pinnacle takes with their clinics and I think we should take a step  back.


    Beth Zoneraich (11:04.59)

    We recognize the need to change and we recognize where the operational model has been and where the cure model needs to evolve to. And we have a very thoughtful opinion and a model that we've been refining now for four or five years to help clinicians that should overcome this and have more concierge level care. it isn't something that happens overnight, it takes us 12 to 18 months. In every case, our clinics start with what is bad. Sometimes those reviews get worse during the transition period, but then they get significantly better. And so what we find is, is we need to pre-think patients' speech, we type the same upon analysis of patients coming through, we should know and understand where the patient is going to get caught. And we need to preempt that with wine chair or deeter that can talk to that patient from the minute they have.


    They're new cases, so they graduate from one of our clinics pregnant. They need to be able to two-way text that, that's how the gator three hours a week during any normal hours. Now, I think it is neat to pre-think the journey so that if you're supposed to come on cycle day one of your period, and we think you're going to get your period in a couple of days, we should be proactively reaching out to you in advance, saying, you know, are we good to go or should we push your appointment off? And so that requires a lot of pre-thinking.


    and a lot of automation to go on the high of his needs to make patient care and eat something truly concierge level and make the patient feel heard or stood and thought about it cared for. So we have to take the clinic where they started into this system and it requires the change of fundamentally higher operating model in the medical office. It does not require necessarily a change to the medicine. Prior it's changed to the technology and the way in which the cancer for us


    schedule and coordinate care, allowing the doctors just in more time with their shift, the more the doctory, because all of the administrative stuff is either taken away or found in a morgue sheet.


    Griffin Jones (11:04.59)

    When you first got into the field, were people using navigators, that a concept that was in play at practices?


    Beth Zoneraich (12:54.254)

    So can speak to all of the clinics and what people have done in the past. think I signed, everybody uses the same terminology in the fertility space and they talk about technology and they talk about things. But what we mean by that and the level of integration is often very different across clinics. So while we may use the same terms, I truly believe what we're doing at Pinnacle has significantly more depth and more integration than what I've seen across other networks. So the first...


    that it occurred to us that we needed this care coordination was actually in the four spaces and the right to those stay in a really high end hotel. You've got a two way app so that you don't go to the front desk and answer any more. You pay cash the front desk and say, hey, can you bring me some assistance? And so the first time I ever experienced that I said, our patients deserve this level of care. How could we put this level of care into the everyday person's children should be? It's so complicated.


    So trying to convince me, if there was a place to do checks every day, I think it makes it better. The second thing I want to do that led to the development in the pinnacle now, frankly, I am two children and one of them has health issues. And I was going through, mean, being the mom of a kid with some health issues, I was struggling to engage Frank's working mom with some large health system. it...


    As I did that, thought, gosh, what would be really helpful to me to help me navigate my child's health? And it was somebody to do, someone who would, you know, yes, I could leave a message and get something back two days later. But if I had a question that day that I needed the answer in an hour, it was very difficult to get that answer. And it was the definition of it and like whole child experience with being in child rights issues that came together for us to better like really dive in. What would a patient be?


    this many, many years ago and start developing layer upon layer upon layer on an operational model technology that would more patient-centric.


    Griffin Jones (14:58.326)

    Some companies in the past have tried to provide this sort of concierge navigator model, but as a third party, sounds like you built it in house. Why did you feel that was necessary?



    Beth Zoneraich

    I think that's a really excellent question. And we talked about this a little bit at a lot of the IGF summit. So when we look at all the technology options out there, they're all excellent. And different people who have had a fertility journey, want to create and innovate in the technology space. They create really good products that help in one section of a fertility journey. Maybe it's onboarding, it's doing texting, it's lab witnessing, maybe it's billing services.


    The problem is, is we only have one patient in one clinic and the patient doesn't want 16 different app. And they don't understand in their journey, when do I go to app number one? And then how do I switch to app number two? And how do I switch to app number three? And what is app number one and three don't talk to each other, but they give out different information. Very confusing. And so it's really important to us at Kinnacle and everything integrate into one medical record system, that everything go directly into the patient's medical chart.


    and that our staff and the pharmacy and all of our vendors get the same view of everything happening to this patient and the patient only has to have one and that's ours. And that's just a critical role that we go by. So if we integrate and create partnerships, which we do, we have very valued vendors and partners within the fertility world, but we make those apps integrated into ours as opposed to us sending our patients into someone else's environment. And we think that's really important.


    In order for tools to actually improve efficiency and deliver real value, they have to improve your profit margins and simplify your workflow. Clinics like Twig Fertility are expanding from Toronto to Vancouver and Care Fertility, the largest fertility network in the UK, expanding into the US, used Embryoscope to do that. They say the Embryoscope solves the biggest challenges facing multi-site fertility labs standardization. Right now,


    Griffin Jones (17:06.444)

    Your labs might be running completely different incubator protocols using different dish prep, following different observation schedules. That makes it nearly impossible to maintain consistent quality, train staff efficiently, or even compare outcomes across locations. You don't have to take the word for it though. You can participate in their Seeing is Believing program. That's a trial for embryoscope, three free months free of charge for those labs that qualify.


    So check out VitroLife's team. You can contact them through us. You can contact them in the places where you put them. Tell them that you heard on Inside Reproductive Health. And try seeing if it's believing a trial for embryoscope for three free months. See if your lab is eligible. How far do you think we are from AI navigators? I was telling Ravi and Manish I called the HVAC company for my service. And it was 30 seconds into the conversation before I'm thinking.


    talking to a robot? was like, I can't, it would be rude to ask her if she's not a robot. And then about a minute in she says, I'm a smart digital assistant. And I was like, oh, now I can ask. said, so you're a robot? And she says, no, I'm not a robot. I'm a smart digital assistant. I said, but you're not human. And I didn't know for the first several seconds of the conversation, it's a huge leap forward from


    what used to be the credit card phone trees of, I'm sorry, I didn't get that, where it generated more frustration than convenience. This was the first time where I thought, is more convenient or almost as convenient as talking to a human being. And it seemed to be real, real close. How far do you think we are from AI patient navigators?


    I think that's an excellent question. And while I'm a huge fan of automation, and in fact, my team calls me a serial automation addict, and I'm constantly pushing to automate routine tasks. I actually find we use a pinnacle automation to help take the no joy work and the administrative work off of our care team so that our care team can spend more direct time in front of patients. So our goal.


    Beth Zoneraich (19:22.57)

    is to use AI and automation on the backend so that our frontend team can directly engage with patients. But we don't have a desire at this time to put AI in front of patients and nothing we're doing right now connects a computer to a patient. That isn't our goal and not what we're simply trying to pursue.


    You mentioned that phone calls are easier or they were among the easier changes. I'm not saying they were easy, but they were among the easier changes that you helped to implement suggesting that some were harder. What were some of the harder changes?


    Well, to really drive improved patient outcomes in our clinics and need more standardization and standardization amongst REI physicians who have all operated independently and are independent physicians and HDLDs and labs that have all invented similar but different lab technologies, you know, is really challenging. But if you look out at what creates a success rate for an individual patient, more than 10 different people might touch


    that patients, aches, sperm, embryo, different embryologists might do the freezing of the thawing of the embryo, different doctors might do a retrieval or a transfer or a stint protocol. And so the more you can use data driven by what creates better patient outcomes and standardized, the fewer number, the reduced variation that you can get by standardization, the more you can actually improve outcomes. And so...


    I find that's the hardest part is to have the physicians get together and collectively decide on standard ways of moving forward using data. That's hard to do. Pinnacle is doing it every day through the medical leadership board. And our lab leadership board is taking those steps in the lab. So by the end of the year, Pinnacle will have all routinized standard media and dishes and processes and procedures in the lab that our own lab leadership board, our own lab folks,


    Beth Zoneraich (21:26.456)

    creating from scratch, using data of who has the best outcomes and visiting each other's labs and picking and choosing so that we reduce the variability that's happening. And our physicians are doing this with STIM protocols and other types of things. They self-discover the best of the best. We give them a statistician and access to really incredible rich data to make these decisions. And it is shown a huge ability to improve patient outcomes and improve standardization across.


    and what used to be disparate clinics. And so that to us is the secret sauce, but those are the harder things to do with an.


    You said there's a J curve with patient satisfaction, or at least there can be where it can get worse before it gets better. Is the same thing true with your team in terms of staff and doctors and embryologists of the changes being implemented that there's a resistance for an adoption and before they really understand and buy into the benefits of it?


    Yeah, I think you bring up a really excellent point. is no question that change is hard. It is not just expensive. It is emotionally hard to create change and people resist change because it's fearful. Maybe they're scared of new technology or they don't know how to type. Maybe it takes a lot of inertia to go from an old way to a new way. Oftentimes people are embarrassed to ask for help. Like, how do I get to this stage on a medical record system or how do I do it this way? And so


    People often fight to keep things the same and they fight very hard. And so as you go into create change, you go through almost a grieving process, like you would if somebody close to you has passed or if you've gone through a heart avenging your life and you will go through denial and you go through resistance and sort of maybe an awareness and then a resistance and an anger.


    Beth Zoneraich (23:24.194)

    Then you go through, I just want to out doubt, right? You heard on a recent podcast about Dr. Burnout and maybe doctors don't want to continue being doctors because their day to day life has gotten challenging. You add change on top of that challenge and you've made it harder for a period of time. The nice part about this change is it is only a period of time. It gets better because the J-curve really plays out, right? But there's that tail that goes so much higher than where you started because when you transform the clinic,


    The work-life balance gets better for the doctors and the staff, a lot better. Overtime comes down, weekend work reduces, hours normalize. But people can go home and feel comforted because if you have a checklist and there's no patient left behind and you're more routinized and you have more helpers, you provide a better patient experience. Patients also get much happier. And as patients get happier, they're nicer to the staff. Nobody wants to be yelled at all day or feel like they're providing bad care. So as patients get happier,


    staff gets even happier. And outcomes improve because as you get in front of patient questions, they are more compliant with their student protocols. They're able to ask their questions. There's less missed appointments. There's less missed any patient journey. So outcomes improve and then people begin to work collaboratively. When you see clinic after clinic transform and there is no question, they start thinking they're fairly happy. They go through a very negative physical time, but then they come out of it and they go.


    So Mike's turn there in terms of, says, uh, it's a happiness. All of the Google or produce turn over. She says, you know, I have better outcomes and the staff really turn around and just well. So in the middle, it is difficult. We acknowledge that we wish we could do it faster and easier. It, it, it was really, everybody would have done it. It's just not that easy, but it is doable and it is best. We are getting better and better. I right. And we do see the same results in clinic after clinic.


    I've fixed their stellate transformation already. And when you believe you see these changes play out again and again, it's very motivating. But the nicest part for us is that the folks who have resisted the hardest also need to become your best change agents. They go out to the next clinic and it's changed. know, one doctor will teach the next doctor out about 18 nights. And it's not overnight. I wish I could tell you it was overnight. It isn't, but it...


    Griffin Jones (25:42.378)

    How long does that take? That's not overnight.


    Beth Zoneraich (25:51.246)

    but it does happen. And we have an annual conference as host of the networks do. One of the clinics that has gone through the biggest struggle will get up and very vulnerably present to the group about what their path looked like and where they're at now and how happy they're at now. And we have seen clinics with 25 % of the staff walking out, turn around, they have almost no turnover, a year and a half a year. It really worked and it really did that.


    but it very hard. And anybody in the same sense, this is going to be easy on it. It just to end in a similar fashion. Either is it really doing or they're not really being honest with you about how difficult this changes.


    Does it get easier now that you have more ACE studies under your belt or is it still, you can show someone, look for clinic A, B, C, D, here's where they were before, here's where they are now, but people are just still resistant or is it easier once you have more proof under your belt?


    It is always a question that I get as we talk about these transformations. And the answer is both. It both, yes, gets easier every time. And two, it's still really hard every time. So doctors get bought in faster when they can speak to doctors respond to it. We do a lot of travel within the clinical network. We mainly encourage people at all levels, travel to other clinics and learn from each other. We would much rather someone travel to another clinic, work in another clinic and bring it back to them team.


    You get buy in a lot. Sure. Based on that when your clinic cuts changing and you're feeling threatened or vulnerable or nervous, you're still going to resist that change. Even if you were bought in at the beginning, then if you know it's going to end well, it's still nerve. So there is no way to take that J curve. We're just trying to reduce the time of a difficult nest lower to a shorter period of


    Griffin Jones (27:50.24)

    You had, I recall you talking about overtime and you could see that it had decreased. so it sounds like that work-life balance vision is coming to fruition. where it's probably not though, is I know you ain't working 40 hours a week. And so I see this possibility of doctors, even embryologists, nurses, staff.


    them being able to work 40 hours a week. But I don't see that happening for us business people. And I don't just mean you as a CEO and me as a business owner, but anybody that's like a VP level above, director level above, I just, think that so much of what we do is like, you have to put in the extra time because we are in such a competitive world that that's often the difference maker. Do you think that the work life balance that you're seeing


    for your clinicians and staff as ever possible for us business people.


    That is another great question. So I agree, some of the hardest working people that I know are the people I'm surrounded with every day working at the Pinnacle Support Team. They work tirelessly for the clinics. Our clinics are our clients. We use it that way very distinctly. And as we manage change management, that is really what we do. We change matters when a trust member at these large clinic organizations.


    that takes a lot of hours because it takes connecting one-on-one with doctors and doing a lot of coaching and counseling. It takes a lot of travel because very difficult to manage and be changed from afar. you're on site. And the most important critical people in the clinic may be the head of your front onset and the financial capsules and it may be your phlebotomist. So you need to know everybody at the clinic. You can't just focus on one group.


    Beth Zoneraich (29:43.278)

    All of the big groups fought in. The clinic is an entire organization, free member of it, is pretty great. so, clinical support, we feel like travel so that we know each individual in clinic and that we're doing this change management, not just with the doctors, but with the entire organization, because it's critically important. I myself was on a call with a number of our medical assistants at one of our clinics this week, because they're really important to us. And they were going through a tough time. And we wanted to talk, I wanted to talk directly to them.


    And so there is no unimportant person in the clinic. And so I think it's really important that we keep that communication. And we try clinical support to mitigate and manage hours. And so the same level of tech innovation that we're trying to do in the clinics, we're also doing back at clinical support. And it really does save a lot of time, automating the new cycle into bots and...


    using SQL and Python to close our book as opposed to Excel saves our financial funding and analysis and our budgeting group a lot of time. So we are definitely trying to pay the same tech innovation that we use in the clinics to help the patient journey to help our Pinnacle Support team on the back end.


    A couple years ago, Mark Siegel asked me my point of view on a branding question and he sounded torn. It was, you let the individual clinics, do you keep them with their own old names and this clinic is called this over here, this clinic is over here, or do you unify the brand? I have a strong point of view on that. It sounds like you might too because you all have made a change recently. Tell me about that.


    So we made the decision as a unified group to rebrand into a national identity. And Griffin, this isn't just changing one person's logos, it's really building a full national identity. Patients trust a unified, recognized brand. And on the back end, we need streamlined systems and consent forms and websites for better operations and flights. And so we wanna make sure that we have the very best in front of our patients.


    Beth Zoneraich (31:53.344)

    It is almost impossible to update 13 websites every time you make change. And if you have a consent form with a logo and you have 13 or 15 or 20 brands, imagine the ability to keep all of those at best to class. But from a culture standpoint, clinics want to feel part of something bigger. And we spend a lot of time and energy working with our clinics to create something bigger. are creating.


    something bigger and better. And we work as a unified group and people get really proud of what we're creating. It's sort of a national strength with localized care. I really thought we were going to get a lot of pushback when we went to the clinics and asked if you missed rebrand and asked if we had clinics by date for Cuckoo Goldsfors. And we were really proud of that. We did not have anybody pushback. There is a huge pride and buy-in within the Pinnacle Network.


    as to what we're doing and people are excited about it. And so it's been really important. It's been an important cultural moment for us that we were able to come from, you know, a difficult start with a difficult relationship with clinics that thought they were going to all operate independently to be here a couple of years later with unified systems and unified medical record systems and unified branding and one brand out and sign up a patient. It feels really good to come from


    where we were to where we are now in the past future is very great.


    Well, if they didn't give you a pushback, let me give you some pushback as devil's advocate. because even though I agree with you, I take that position fully. think that the whole point of brand is unity. That is what it's for. It is supposed to be that mark that galvanizes everyone around a particular cause and knows what we stand for and knows how we do things and sets the tone for the culture. It's how we got here as human beings. don't need a


    Griffin Jones (33:47.242)

    a brand to get 150 people to go to war in a tribe, but you do need a flag that means something for nation states to form and develop and go forth to all get thousands and millions of people around a particular cause. that branding is the same principle for companies. So let's pretend I didn't say that. Let's pretend I don't actually agree with you. And let me just take the devil's advocate view, which is I did have one CEO of a


    different network who has done it differently decided to keep the names. I also think it has a lot to do with what their name is being geographically specific. But this point was, you know, these clinics, they've got their reputations in their own markets, they've got their name, and we just want to keep that. If you didn't have pushback, it sounds like you were able to show people the benefits


    of going beyond that. But how do you respond to that?


    You know, I think with any difficult decision, there's valid arguments on both sides. And there's no question that most of the clinics in the clinical network have a 20 or 30 or longer year history of providing really excellent patient care to their patients in market. And we would never want to lose that. I don't think necessarily rebranding makes you lose that. I actually think you take that and build on it to build your national brand. So


    are clinics that are so well respected to be rooted. If you're proud of your new national brand, those doctors go out in the community and say, we were Clinic X, but we are now Pinnacle Fertility. And we are so proud because we brought all of the expertise and knowledge we had locally. And now look what I can provide you. I can provide you better technology for the patients and I can provide you expertise in labs all over the country. So if patients are traveling, they can get...


    Beth Zoneraich (35:45.654)

    monitoring at sister clinics with the same name and the same medical record system and the same methodology when they enter. And we can share records really easily. So while I fully understand and respect that there's two sides to this argument, for Kinnacle, it just was resoundingly the right place for us to head. we tried very hard not to lose local expertise and relationships as we move to a national. We tried to keep both.


    I feel like we've successfully done that. But if you've been created this unified culture and unified central national, not just brands, but identity, then there might be more resistance to change.


    Picture this, you're running one of the busiest IVF labs in the country or really busy fertility clinic network. Demand is high, staff are stretched, every minute counts. That's what UCF was facing until they restructured their entire workflow with the help of embryoscopes, time-lapse imaging. The result, they didn't just shave a couple minutes off. They're now saving seven embryology hours every single day. More transfers, faster XE, sharper embryo selection, less risk, and staff.


    They're happier, they're less stressed, they're more focused. You know, what else I saw recently on a group starting a new clinic group, they were three new doctors starting a new group and they talked about using embryo scope as a marketing advantage because they're showing the patients, look, now you're able to see what's happening with your embryo. I think that that is likely the future. The more that you can connect with patients, the better.


    They proved what's possible. UCSF proved what's possible. Now it's your turn. Reach out to Vitralife. Ask if your lab qualifies for a three month free trial of embryoscope called Seeing is Believing. Tell them that you heard it through us, but why not give it a try? It just might change everything. You've talked about leapfrogging technology before. What does that mean?


    Beth Zoneraich (37:54.542)

    So lethargy technology means when a healthcare industry or a fertility industry in general is behind and other industries have created something that is far ahead, maybe not one step or two steps, but completely a huge step forward, that you don't try and go through every step that older industries went through to get to where they are now. You simply jump over, you go get outside talent, and it's really good at sort of that.


    the thing that you're trying to leapfrog and you take yourself from behind the times to cutting edge overnight. We did this for instance in marketing. So as we went through our initial two or three transformations within our clinics and we did top of license model and all of the technology, we found that we could grow our retrievals and new patient growth by 30, 40, 50%. And our doctors still had open times now on their calendar, even if they had wait times before.


    So the need to lead drug our marketing technology became imperative to us. And we didn't want to go from what was really out of date within the Pinnacle system to, you know, one step forward each time. So I went out and we got an entirely new marketing group and we got a group that used to be in the travel industry. And the travel industry is known for selling time shares and cruises and other types of things, but they...


    understood Salesforce and customer relationship management and integration of technology and follow-up and email and we took sections of people from various groups and we put them in place and they completely with it. About nine months, we dropped our marketing capabilities from what I would tell you was out of date. So what I think is really exciting, I'm proud of what they found as a team and really find for my goal to them.


    but that would be an example of going from behind to right head and not having to each step along.


    Griffin Jones (39:51.724)

    When do you make the decision of this is when incremental improvement is needed or this is when we need to leapfrog or do you always want to leapfrog?


    It really depends on what we're talking about. If you're making changes in your lab, I believe in much smaller incremental changes too, so that you're not trying to do something disruptive and embryology to show engine hits. Something like marketing, I felt like we could be more disruptive without risk causing any... And so it really, when you're dealing with high signage of medicine, things that affect patients do explore.


    and really carefully in the studies and things that are maybe on the break going so you're using Excel to use in Python that go faster and you could lead far more. So we're very careful in what we do because it's really critical. You do not disrupt the patients.


    How do you pilot things? So innovation efficiency are often at odds and you're implementing efficiency in many places, but it's been proven through the trial and error of innovation. How do you put that trial and error in a vacuum? And then how does it then get ready for prime time when it is?


    So innovation might be my passion project or my favorite thing to read about. If you were to come to Pinnacle Together conferences, innovation is something that we bring in outside speakers to kind of talk about. And we have full clouds within Pinnacle and we read about why organizations often fail to innovate, then the answers are right in front of them. What stalls innovation? I believe in serial testing and very small


    Beth Zoneraich (41:42.638)

    incremental rollouts of lots of small innovations to get to exponential goals. So for example, if we're going to roll out on, as we did a centralized call center, we are not going to turn the switch one day from no clinics to all of our clinics. would never happen. We will start with two lines at our smallest clinic where we leave the old lines, open to build system, and we will start to take off 20%, 30 % of one small group of clinics into a system, test out the technology.


    phone calls where we'll make sure we'll work out the case. Then we'll paper one whole clinic and we'll study it. And when we have success, start with 20 % off maybe a larger clinic and we test out just a small portion and then we keep going. We write VNC testing, whole and science, not just in marketing, but in every area of what we do, but innovations that are going to exponential and start in very small, incremental test space so that we can be


    sort of incubating these technology test sites. It's also how you don't let technology get ahead of you. Big, scale rollouts are very difficult to manage. So we believe in as few of them as we believe in a lot of small little innovative things. And in fact, it is over the years, those build up and really big changes, but we don't roll them out in a big way.


    I noticed that when I try to make changes, even just to pilot something, I drive my team nuts. Even if it's, just say, Hey, I just want to test this out this one time. Like, but that's not part of the process. That's not how it works. And it, and it's like, it really throws them off track. When you do this ABC testing at different test sites, is it always the same test site or team test sites? Like here's my one or two that are, are the people that are willing to just.


    be crazy and try everything and then when it works with them we'll roll it out? Or how do you spread that?


    Beth Zoneraich (43:39.342)

    out. So in fact, I would tell you most small innovation and tests fail before they succeed, right? Someone who succeeds is just someone who tries harder and tries the fifth time after failing the same number of times. So innovation as a series of failures and so on, it could make it successful. We always test a different clinic. If you test all at one place, that tells everybody that only one group can innovate. It will lead that every person that works at Kennedy School is an innovator.


    And I believe they have something of value to us as a company. So we want everybody at every level coming up with ideas and innovations. So we try and roll out a different clinic. Now some clinics are further along in their pinnacle operating model that there's. So it does make sense to test more at clinics that have putted through the model than those who have it. But we are willing to allow anyone to test a courage culture throughout our work at clinics and throughout.


    I can see that a lot of Pinnacle's thesis is about bringing things in-house when possible. Am I reading correct on that and why is that?


    The technical we believe really strongly in one technology stack, which often makes it difficult to use a lot of disparate one off the shelf technologies because they all have their own apps and they don't necessarily integrate. But second, if you were to go out and look at the entire patient journey and every technology player along that journey and you were to add up the recurring fees they want to charge you per cycle or per patient that uses it, total amount of cost


    throughout that journey adds up to more than we get re-percycled. And we haven't paid our staff or our range or our supplies yet, we just paid our vendors. And so when you look at that, you realize the need for integrated solutions are critical and unfortunately, wanting to streamline this and keep costs down for patients and continue to increase the secure, we also have to be really thoughtful about waste and money on technology.


    Beth Zoneraich (45:45.598)

    and not sighing out with a lot of vendors who are just going to first either hold us hostage and once you get them integrated, they're going to charge you more and more every time you add another patient and or use them more. But I can't have the totality of our tech expense and our outsource vendors add up to more than we get reworsed for us. It's not a healthy way to run our business. So we're very careful to integrate. It's why we have a lot of internal resources who are very good and frankly not from healthcare that


    understand data informatics, data programming, and how to develop tech in-house. And often in partnership with our vendors, we don't do it all alone, but we do do a lot of it in-house. And I think that's a strategy of continuous we move forward.


    Doesn't that get really expensive though? I remember when I was in the marketing agency world, you would see companies trying to take like the building in-house marketing agency and it often wasn't more cost effective or you'd see companies building a software that cost them a lot of money to develop. And turns out of $50,000 off the shelf software was sufficient. It doesn't the resources that it takes to develop those really


    eat into your overhead.


    So in every case, when we're trying to decide how to move forward with the technology, we will do a pretty simple buy versus build economic assessment. And we'll move forward with sort of what makes sense from a financial standpoint and ease and how quickly we can move forward. So we're pretty good at just doing basic data and financial analysis on does it make sense to build versus buy.


    Beth Zoneraich (47:26.602)

    I will also share that we've been very good at rolling out technologies either on or under budget and on time. So I think our knowledge and skillset in our clinical support team is actually leading itself to being pretty good at developing and integrating these technologies. And as we've integrated more and more, our team has gotten better at the tech side.


    What are some of those things that have fallen into the, it's better to buy than build category? Like you're not making your own pipettes and dishes, I don't think. So what are those things that you've found, at least for now, make more sense for to be in clinics or networks buy category?


    So obviously we don't make any of our own supplies or our pharma medications. Those are all outsourced from, you know, leading hoax. So we try and standardize them, but we certainly don't try and make them in-house. And for like, for instance, long-term storage, we couldn't build our own long-term storage facility and we chose instead to partner with Smuro. Smuro has been a really excellent partner of ours and they integrated their technology into ours. And we chose not to build that in-house, we chose to...


    On lab witnessing, however, we found the costs associated with the lab witness systems that were out in the market to be excessively high. And we were able to build that system for significantly less cost than even one year would have cost us to outsource. And we were able to build a lab witness system and integrate it into network. It is fully rolled out in every clinic. And to quite quickly and very cost effectively. And that made a world of sense to do it on our own.


    So we go back and forth between outsourced versus not. We tried to outsource two-way texting, HIPAA compliant two-way texting platforms for a while. We've learned from that. And then we wrote our own program and integrated into our system. So some of the things we'll test out for a while and then try and figure out best way to integrate. Other things may stay consistently outsourced and work in partnership. And then others, we take a hybrid approach, but I do think each


    Beth Zoneraich (49:35.68)

    Each thing that we do needs to be a thoughtful consideration and a simple, most of these are pretty simple financial analysis that we've.


    You've told me how much money you saved on the witnessing. It was astronomical. Are you comfortable sharing that?


    that it would have been upwards of a million dollars a year for us to use a witness system and it cost us let's say under $50,000 to develop our own.


    What are you most proud of when you look back at the last couple of years?


    What I'm most proud of is that Pinnacle is building a unified platform that people are proud to be a part of that is improving the patient experience and patient outcomes. And that we're really creating something different and special. And that's taken so many countless thousands of hours by the doctors in the clinics and by the Pinnacle Support Team. And so many people have come together and many people thought it wouldn't happen, right?


    Beth Zoneraich (50:34.774)

    Many people thought that we would fail at this and to tell you we're not failing at it, it's really working. And I'm so proud of the unity that we're developing and creating as a network.


    Griffin Jones

    I love catching up with you to get these progress reports and if we're doing it once a year, should probably be even more frequent than that, because I really enjoy it. Thanks for coming back on, bud.


    Griffin, thanks for so much for show today. I really enjoyed talking and always love to be a part of your podcasts.


    Announcer

    Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser. Thank you for listening to Inside Reproductive Health.

Pinnacle Fertility
LinkedIn
Facebook
Instagram

Beth Zoneraich
LinkedIn


 
 

260 Avoiding IVF's Next Public Catastrophe

 
 

Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


They were lucky

The gas to the incubator stopped flowing, but XiltriX caught the failure in time, no embryos were lost… and no headlines were made. 

But what happens if the next failure isn’t? 

In this episode, Dr. Matthew “Tex” VerMilyea of Ovation and US Fertility, and Moises Eilemberg, CEO of XiltriX North America, return to Inside Reproductive Health to ask a hard question: 

What would your lab do in a crisis? 

You’ll hear: 

  • The catastrophic loss Sweden’s biobank suffered (and what you need to learn from it

  • Why embryologist shortages are reshaping the IVF lab 

  • What standardizing monitoring protocols could mean for your network 

  • Why Tex believes monitoring as a service is the future 

  • The steps to take after a public lab failure (and how to avoid needing them

  • How XiltriX helps fertility labs gain 24/7 visibility, rapid response alerts, and peace of mind 

This isn’t about tech. It’s about protecting the future of your lab, your brand, and your patients. 


“Tex” Loves This System. Here’s Why...
 > 23% of alarms are missed. See why Dr. Vermilyea doesn’t have that problem*

Dr. Matthew “Tex” Vermilyea gets 24/7 live assistance from XiltriX’s SafetyNet Team at his IVF labs. Request your free demo to see if your IVF lab can benefit from the same advantages; 

In your free demo, you’ll receive 

  • Tailored presentation to meet your priorities 

  • Software demo 

  • Real-life case studies 

  • 24/7 live support overview
    *Based on product claims 

Request your demo now to see how Ovation and other fertility centers are keeping their IVF labs safe!

  • Tex (00:03)

    Do it sooner than later. You know, this is not funny business. it's also doing it for your staff, right? Your staff needs to feel comfortable in a good system, So I'd get in touch as soon as possible, start exploring opportunities, really assess your current system, have a chat with the XiltriX team and see if they've already figured that out. I would not sit on it. I would reach out because a failure could happen tomorrow.


    Griffin Jones (00:35)

    Do it sooner than later. What could Tex be talking about?


    Here's what we're talking about overall. Workforce crisis and burnout, particularly in the embryology lab. 24-7 operations and the financial pressure of the efficiencies that labs need to yield. Public scrutiny and risk management and what the IVF lab of the future will have that separates the best in the field from those that are run of the mill.


    My guests are Dr. Matthew VerMilyea. You know him as Tex. Everybody seems to know Tex, the guy with the cowboy hat that has become the vice president of scientific advancement at Ovation and US Fertility. He oversees a lot of labs.


    And Moises Eilemberg CEO of XiltriX North America, XiltriX is a monitoring solution as a service.Might be thinking I've heard that name a lot now. That's because doctors Steven Katz, Eva Shenkman, Sangita Jindal. have we've all been talking about why they use XiltriX and what they like about it. And because Tex and Moises work with so many different IVF labs. they're able to go into some detail about what labs are doing to solve for these challenges. Challenges like severe embryologist staffing shortages, standardizing protocol, the right balance of autonomy for embryologists, and the standardization of best practices when you've got a lot of labs and a lot of liability.


    They talk about the hidden costs of cheap solutions, the role of monitoring as a service, standardization strategies to save cost, and head count and workflow hours. They talk about one situation that could have been really bad with an incubator, and how they caught that. They tell the story of what happened with a Swedish biobank last year that could have been prevented.


    Tex shares what he would do to restore trust after a public failure like that and how to prevent it in the first place, and they talk about the essential elements for new IVF labs being built in 2026. The equipment, the setup, and the integration with new technologies and the implication that AI is going to have with all of that.


    ASRM is going to be here sooner than you know it. You might just shoot XiltriX an email and set up a time to meet. You might schedule a demo or a Zoom meeting beforehand, because whether it's Dr. Jindal, Dr. VerMilyea, Dr. Shenkman, Dr. Katz, they're all saying the same things.


    And when I asked Tex if he thinks that network operators and lab directors should try to get in touch with XiltriX just to at least start the conversation, just at least to see what they've got. If he thinks it's worth it, what he thinks. And he said, do it sooner than later. Of course, it helps Inside Reproductive Health, if you mention that you heard about them through us.But even if you don't want to do that, just help yourself. Find a time to meet with XiltriX at ASRM or a little bit before, and enjoy this conversation with Moises Eilemberg and Tex VerMilyea


    Griffin Jones (03:49)

    Mr. Eilemberg, Moises, Dr. VerMilyea Tex Welcome to the Inside Reproductive Health Podcast.


    Tex (03:58)

    Happy to be here


    Griffin Jones (03:58)

    Gotta give a shout out to Moises and his people for putting us in contact, Tex, because I feel like I've known you for a long time because we always have been in each other's periphery. This is actually the first time you've been on the show. What's the biggest challenge in the lab right now or group of challenges or what are you seeing in the lab right now?


    Tex (04:18)

    Yeah, great question. You know, we are currently in a time where it is a struggle to find personnel in the laboratory, not only at the bench, but just, you know, kind of supporting, you know, support teams just to help us get the job done. So I think we're really in a little bit of a crisis of trying to identify where we can find some of these usable individuals to really kind of embrace the work that we do in the laboratory and stick it out with us. ⁓


    Griffin Jones (04:42)

    Was this the case before the 2021 labor shortages happening everywhere? Was it bad before then, Tex? Just got worse? Or had it been okay? And then that really put the finger on the scales.


    Tex (04:58)

    Yeah, I think it feels like it's gotten worse. And I think that's just because there's a surge of volume. COVID really put a lot of patients through our laboratories post-COVID. And I think ⁓ there's a lot of burnout and trying to find ways of how we can sort of standardize processes within the laboratory to kind of improve workflow efficiencies. it's always, I feel it's always been a growing problem. More labs are popping up. Patients are demanding services. So trying to keep up with supply and demand issues.


    Griffin Jones (05:24)

    Do you feel like, it still getting worse like since the 2022 era? Is it sort of like leveled off and now it's just like this constant challenge?


    Tex (05:35)

    You know, I feel that it's a constant challenge. really do. think that there's, you know, we have individuals that are retiring and we have, you know, others that are coming into the field wanting to be in the field. And it's just a matter of having time actually to spend to train these individuals and get them up to speed. You know, there's a lot of desire and will to be an embryologist, but just trying to figure out, you know, who maintains what they have to be able to stay within the field and really do good bench work.


    Griffin Jones (06:04)

    We'll go into this more deeply today, but kind of as an overview, what do you see as the consequences of that labor shortage?


    Tex (06:14)

    Yeah, ultimately, you know, unfortunately, we just can't get cycles in the laboratory. I think in addition to having physicians ⁓ availability to see new patients, think the last thing you want to do is have the laboratory sort of be the gatekeeper as to how many patients can be cycled through. But often that happens just based on pure shortages of personnel or lack of physical space to accommodate those numbers of patients and number of embryos within the laboratory.


    Griffin Jones (06:42)

    Moises, you work with a lot of different labs. have a lot of different IVF labs. There are customers. They're telling you stuff. How would you describe the challenges that they're telling you about?


    Moises Eilemberg (06:53)

    yeah, it's actually really interesting to hear Tex's perspective. We obviously see things from our end as a partner to a lot of IVF groups. And we absolutely see the stress on the staff. Shortage of human capital is a theme that we continuously hear.


    And there's a couple more that kind of come to mind. One of them is also financial pressure. There's been a lot of financial investment into the space. even though there is, as Tex was saying, a tremendous amount of demand, you can only do so much with a limit on human capital. And so


    I think there's also stress from the investment that has gone into the field that is looking for a return. And so that translates into financial stress that we see and feel. And then as we all know, there's a tremendous amount of scrutiny on the industry. Unfortunately, every time something


    not so good happens in the space, it becomes highly, highly publicized. So there's a lot of eyes on the industry from a regulatory perspective, from a just public perception perspective. So I think those areas are also ⁓ areas that are facing the space.


    Griffin Jones (08:14)

    All right. So you've got a shortage happening in the workforce and the stress that's caused from that, the burnout that comes from that. You have an additional financial stress of people that have made investments in either opening or buying labs and clinics. And they need a high efficiency because they have to return their investment. then Moises is like the external scrutiny of...


    Anytime there's a lawsuit, anytime there's a bad news story, anytime that heat gets brought on to the field. Let's start with that. Let's stay with the workforce for a second. And either of you guys can tackle this one. But how are labs addressing that right now? How are they dealing with burnout and shortages?


    Tex (09:03)

    Yeah, I can speak to that. what I see, it's a lot of investment into personnel and trying to get them to training centers, potentially, to learn and build those skill sets. It's extremely competitive with regards to trying to identify a senior embryologist with a full set of skill sets. And at end of the day, they're very expensive. And so to accommodate their compensation requests can be difficult.


    You know, we do, US Fertility does a lot of recruitment at universities, try to get students that are looking to enter the field and try to grab them when they're young and train them up accordingly. with that as well, I think we're seeing a revolution or an evolution of technology and some capabilities that will allow us to standardize some of the more repetitious processes within the laboratories.


    automation into the field, we're seeing some robotics into the field that hopefully can do some of the mundane tasks within the laboratory allowing for those embryologists to really focus on their skill set for the latter part of the embryo culture process.


    Griffin Jones (10:05)

    Yeah, because throwing bodies at the problem only works to one, to the extent that you can get the bodies and sometimes you can't even do that. And then two, then it starts to jack up that financial stress that Moises was talking about too. So you need technology to leverage. Moises, I'm guessing that's why a lot of people are coming to you. What are they coming to you for? And what are...


    What have you seen that you've been able to help them with from a standardization aspect of so that they're not just relying on having to throw bodies at the problem every time?


    Moises Eilemberg (10:42)

    Yeah, no, sure. That's the reality as Texas saying is you have you have the need to do more with inputs that are limited. So you have your human capital, you have financial capital, and those are not in endless supply, especially the human capital. As Texas saying, it just takes time. You can't just, you know, go to the store and purchase 10 embryologists. It takes time for


    Tex (10:45)

    Thank


    Moises Eilemberg (11:08)

    REI is to get education and train people and get up to speed. So I think really the way to go at this problem is to get more output out of the inputs that you have. And that's, I mean, that's the story of humankind, right? That's the way it is and the way.


    the way we solve hard problems not only in IVF but across industries. so I think the first thing that I would recommend and that we actually help our customers with is stop using scarce and very expensive human capital to address issues that are non-core to what they're equipped to do better than anybody else.


    Griffin Jones (11:57)

    What are those specifically?


    Moises Eilemberg (11:58)

    Yeah, so I often use the analogy of you used to have a Microsoft Exchange email server in your server room, and that meant you need to have an IT guy that would come in and would have to maintain that server and upgrade it and fix it when it goes down.


    Nowadays, you can take that server, can dump it in the trash, and you can use Gmail, or the corporate version of Gmail. And that way, you let somebody who specializes in email provision that solves all the problems for you, and you don't need to worry about having some of your own staff dedicated to managing


    a problem that is not core to your practice. So for us, we're obviously in the environmental monitoring space and I am shocked at the amount of very expensive and very specialized staff time that goes into troubleshooting, maintaining systems like the ones we provide.


    when we can provide a turnkey service and ⁓ free up the scarce human capital for things that are really going to move the needle for our customers.


    Griffin Jones (13:20)

    Tex, what does that look like in the absence of an environmental monitoring solution like that? What is it that embryologists are wasting time on or doing that they don't need to be doing?


    Tex (13:31)

    Yeah, so every day we kind of go through a quality control component whereby we're checking our systems in place, you know, making sure incubators are being maintained at the right temperature, making sure that our cryo storage containers are being held at the right temperature. And it can be a fairly labor intensive, you know, project or labor intensive process. So you can imagine, you know, having a senior embryologist come in the day and spending, you know, a good 30 to one hour potentially of their day.


    doing this sort of monitoring ⁓ if they don't have a auto monitoring system that's you know, truly identified to where there's validation in place and that it can do the process for them. So I think if we're able to sort of remove that human element and, you know, kind of put the time back at the bench, you know, for some of our embryologists so that they can just kind of allow some of these systems to go on autopilot. But I agree, it can be


    another one of these mundane tasks that doesn't necessarily require human capital to complete as long as the system is robust and trustworthy.


    Griffin Jones (14:33)

    What was it about XiltriX's solution that you thought was the way to go for you guys? Pretend Moises isn't here. Earmops, Moises. But I know how many people are calling on you because we work with almost everybody on the industry side at one point or another. And when you ask folks,


    Who you going after? Obviously, US Fertility Ovation is at the top of a lot of people's list. Your name is mentioned specifically. So I know almost anybody that's selling anything that has to do with the lab is trying to get your attention. And there's just only so many solutions they can get picked. the fact that you pick them tells me something. What was it about their solution that you felt like


    wasn't offered or as good with some other kind of solution.


    Tex (15:26)

    Yeah, sure. And I'll lead into that question with your previous question, like what's the main hurdle around laboratories? And yes, I agree about, I mentioned personnel, but one of them also is lack of standardization. And so we thought XiltriX offered a solution whereby we could standardize our alarming process, not only just for cryo storage, but our incubators, our VOC levels within the laboratory, our temperature, our humidity, our refrigerator door openings, all these aspects that really


    We're dependent on a system that we can trust. We're also reluctant to have a system that goes back to the boy who cried wolf, right? Occasional alarms that go off, you go 4.30 in the morning, 2.30 in the morning, you go and check and it's nothing or it's a false alarm. So we were very comfortable when we first installed XiltriX that we figured out the kinks, we got this system humming just the way we wanted it.


    And then based on that standardization process for one laboratory, we just rolled it out across the entire network. And with the further experience, and I can have a call with my lab directors, and we can all talk about the same system. We can go to XiltriX and say, hey, guys, can we adjust this particular parameter? And I can adjust that particular parameter for the entire network. And so we're all compliant. We're all consistent. We're all standardized. So that was a key element for us to go that route with XiltriX.


    early on and had been a value.


    Griffin Jones (16:47)

    Why not try


    it on your own? We're in an environment where every executive is faced with build or buy. You got to make that decision. Why not try it on your own?


    Tex (16:58)

    It's a lot. And I think we could do it well, but I think these guys do it, you know, super well. And the ability to have a third party involved in our monitoring, right? So system alarm goes off. Yes, all the lab stuff is notified, but they're also XiltriX notified. And we get a follow-up call from XiltriX saying, hey guys, there is an alarm. This is legit. You guys need to go respond to it. So having a partner on that sort of risk,


    risk management sort of component of what it is that we do is super valuable. Because you have a third set of eyes. We don't want to miss something. We're busy in the laboratories. just like any other staff, especially embryologists, they like to get their sleep when they can. So if we get an alarm in the middle of the night and it's not responded to, XiltriX is there to follow up and make sure that somebody is attending to that alarm and able to give us some context. I will say back in the days, there was an alarm system


    that the alarm would go off, but you would have no idea which incubator it was. You would have no idea what cryo system it was. You had no idea why it went off. Did the power go off? Was there a lightning strike? Was there a glitch in the system? Are you really out of gas and temperature? But this is able to dial down and remotely we can access to find out exactly what the issue is. And that's obviously an added benefit.


    Griffin Jones (18:13)

    So the alarm gets escalated to ziltrix if there's a not response. Moises, can you think of examples of how your systems have helped catch errors? Like what comes to mind?


    Moises Eilemberg (18:26)

    Yeah, that's what we do every day, multiple times a day. It is a huge part of the value that we bring to the table because failures are going to happen. Systems are going to have glitches. Internet connections are going to go out. And to have somebody there to help you understand and diagnose what the issue is and what you need to do about it.


    is a huge value added. So I was just actually listening to a phone call, because we record all the phone calls that we place out to our customers, where there was a failure with an incubator. And this was probably around 10 o'clock at night. Oftentimes, if you don't have a provider like XiltriX,


    it would be up to the staff to figure out what the problem is. And in this case, the person was convinced that it was a problem with connectivity. And they very much likely would have potentially not addressed the issue right away because oftentimes you get connectivity glitches and your staff


    learns to then ignore alarms. In this case, our team reached out to the person and they confirmed that it was absolutely not a technical issue. There was a problem with the incubator. That person got in their car, drove 45 minutes to the lab, and indeed the CO2 connection to the incubator was that the tank was out.


    So that could have been a pretty bad event. But because there's somebody there who does this like us for lots and lots of customers, we have a much better understanding of what we're looking at. We can help diagnose an issue and prevent a huge failure from happening. It was good.


    Griffin Jones (20:19)

    What would have


    happened if that error went unattended? If that CO2 issue with that incubator went unaddressed for the whole night, what would have happened?


    Moises Eilemberg (20:30)

    Well, Tex probably knows better than I do, but I think there would have been potentially a loss of some embryos in that incubator.


    Tex (20:37)

    Absolutely,


    yep. You'd have some pH fluctuations within the culture media and then basically could lead to degeneration of the cells and ultimately loss of embryos. And that would be a hard case to fight, especially if there is indication that an alarm went off and nobody attended to it. So that's where I say, going back to this boy crying wolf, like we take...


    every alarm, especially from ziltrax, we take every alarm seriously because we just trust in the system and know that we're not, you know, it's not a fluke and it's better to be safe than sorry and, you know, make the, make the way in. also, you know, you get tired of going on false alarms. And as Moisa said, kind of become a little bit, you know, not paying so much attention to some of those, but, ⁓ but yeah, it would have been devastating for the patients and ultimately for the laboratory as well.


    Griffin Jones (21:31)

    I think that's... To me, that seems why it's so useful having an external body too, right? It would be like... It's like fire drills at a school or fire drills in an office building, right? You take your sweet time getting out of the building because you're like, this is just another drill. It's not the real thing. And if there was... And that can cause serious issues to people if there was some sort of...


    It's third party that was like, this isn't a drill. Get your ass out of the building right now. To me, it sounds like a little bit of the value that you're playing. Moises, have you seen that impact workloads in any way? So that shifting workloads more equitably, preventing burnout in some kind of way?


    Moises Eilemberg (22:15)

    Yeah, I was actually gonna bring it back to the point of efficiencies. Again, there's a lot of pressure on providers and on IVF providers to be more efficient. So accommodate more cycles without the luxury of being able to add more staff at will. But not all efficiencies are created equal.


    There's a lot of criticism, I think, that I've read about in the industry about how with outside investment into the space, things are being forced into being more of a factory and not allowing the doctors to perform medicine. And I think, again, not all efficiencies are created equal. There's a lot of efficiencies.


    that you can implement across a network that make a lot of sense and have nothing to do with patient care. You can centralize finance, can centralize accounting, you centralize marketing, and you don't need a CFO per location. So you can create a lot of efficiencies. And so I think similarly for something like what we do, if you simply ⁓ purchase a piece of technology,


    and place the burden on your expensive and scarce laboratory team to manage, maintain, troubleshoot, diagnose that system, that is a huge burden. It's not just responding to alarms. know, technology sometimes has glitches and sometimes it's got to do with


    and not the technology itself, know, connectivity goes down, things of that nature. And relying on the lab team to handle that certainly takes away from time on the bench and serving patients. And so for us, when we partner with a customer and we take that burden off of the shoulders of the staff, it just, it frees up time.


    And it may seem a little bit more ⁓ expensive upfront, but in terms of the time that you're creating for your team, there's very few areas where I see more ROI than outsourcing things to a specialized provider, particularly when it comes to monitoring.


    Griffin Jones (24:43)

    text you and every other lab director, every other chief scientific officer out there, I have to make a business case to the rest of your organization to make investments like these. I think of yesterday, I go to the mechanic, mechanics telling me it's gonna be seven grand and and it needs this and that or the car is gonna fall apart and say, let me take a look. And I'm looking at like, I don't think so. I'm taking some video and and photos, sending it to my cousin who's


    mechanic and he's like, dude, that's not an emergency. Yeah, it's several months to think about it. You're probably gonna buy a new car anyway. And in this case, I am analogous to the business person, the auto mechanic. It might be an embryologist who wants everything. But then there are times where it's like, no, I'm the expert here. We need this for safety. And it's being ignored.


    Tex (25:17)

    Thank


    Yeah.


    Griffin Jones (25:40)

    The business person has to suss that out. They have to think, is this just one more bell and whistle that would be nice to have? Or is this something that we have to have as a business? How do you make that argument? Maybe using XiltriX as an example, but how do you show that? How do you make that business case to the business people when...


    It really is a must to have and not a nice to have.


    Tex (26:07)

    Yeah, great question. And it sometimes is a challenge, absolutely. These systems are not cheap, but I and I'll use XiltriX as an example because we're on the subject. Being able to further ⁓ vocalize that this company is actually a partner, right? It's not just a service provider. They've got skin in the game as well. Mojis has talked about you could buy an alarm system.


    off the shelf, install it yourself, and then it's me as the lab director to be responsible for any upgrades, updates, et cetera, et cetera. XiltriX does all that. That's on them, right? A new probe comes into the industry and it's more accurate. They're the ones that are gonna come and put it in because A, they want their system to be the best and B, they wanna make sure that we have the right appropriate services. showing that in this business case that we have a true partner in this assessment and I'm a stickler for anything we can do to reduce risk.


    in this day and age with the litigious environment, it's worth the investment. And one thing we have not spoken about at all, we're talking about monitoring and alarms and so on and so forth, the amount of data that XiltriX is able to also produce, All these systems are monitoring 24 seven, every 30 seconds, 20 seconds, and you've got actual data points that you can go back and start identifying trends before they even happen.


    if you're really into the data, which we should be. So we can even predict that, this incubator's kind of been warming up and creeping up over the last week and a half. Maybe we need to take it out of use and invest in something else. So showing that, it's not just an alarming system. We have hell of a lot of data that we can look back at. When to change air-conditioned filters, because our VOC levels are rising.


    versus just watching and seeing, hey, embryos are not looking so good, maybe we need to go change the filters. All these kind of additional aspects to the system that we can put in place and that I can propose and put in front of the real business decision leaders as to, this is more than just a nice to have. This is gonna potentially save our ass if there is an issue.


    Griffin Jones (28:07)

    jump on that for a second, Moise. Tell me not just about the data points but how they can be practically applied for a benefit.


    Moises Eilemberg (28:16)

    Yeah, absolutely. We create a tremendous amount of visibility as to what is actually going on in


    you know temperatures and cold storage, the number of times that you open a freezer, how often the tanks, the cryotanks are open, what the gas levels are in incubators. You know all of this equipment has internal sensors but ⁓ we have our own sensors and we sort of bring a third-party


    independent source of truth, if you will. So what we often find is, you know, a lab may rely on what the display in the incubator is telling you, and they will tell you that everything is at 5 % CO2 100 % of the time, but we know that's not the case. And so when we install our system,


    We identify that half of the incubators are at 4 point something and half of them are at 5 point X. And so we help the lab get that visibility so they can actually get more consistency and potentially improve outcomes. And that's just one example of the type of visibility that we create. It's like putting on your glasses and all of sudden you see


    a lot of things that you were not seeing before.


    Tex (29:34)

    Yeah. And to add to that, that's where you're able to start, you know, really getting to the nitty gritty of standardization. Especially on something like this, you know, I'm one very much of, you know, what the lab directors have some autonomy, right? We all were educated in this field. You know, we may choose a specific culture media. That's OK. But, you know, if we can standardize the alarming system, that's one less headache for everybody involved. And by having a lot of that data to be able to to churn through and better understand, you know, ultimately identify best practices and


    Better patient success.


    Griffin Jones (30:05)

    You had also alluded to the litigation that's happened in the field and you guys are making me think of an interview I just recorded with Matt Maruca. He's the chief legal officer of Inception. I don't know if his episode will come out before after your guys. I think it comes out before. What he's talking about is litigation is on the rise in the field. And it's not just because it's not like that more incidents aren't necessarily happening. It's


    A lot of it is being driven by the plaintiff's attorneys. So these law firms that make their money suing people have taken their playbook from the personal injury attorneys. can't drive 100 feet in any city without seeing a billboard for a personal injury attorney. That's happening in our field too. they know what they're going after. They know how to assemble these cases. They've got it templatized.


    and they're looking for any possible thing. And I'm not a lawyer, but to me, seems like the incident that you were describing where the lab director had to drive back and address that CO2 issue with the incubator had that resulted in a loss of embryos. It's like, if I'm the lawyer, I know every single solution that's out there. all I... Is part of my case prep. I'm just sharing like...


    Here's what they could have had, Your Honor. Here's what other clinics are using as the standard. And they didn't, therefore they're culpable. And I think lawyers are really good at being able to make that the case. It's why you've seen so many successful personal injury cases or settlements that are probably from frivolous cases because they've got that system buttoned down and they're doing it to us now.


    How much do you think about that Tex as a scientific director in your seat? Is that something that most lab directors are thinking like, well, that's kind of an... Is it an issue that haunts lab directors like this lurking litigation landscape out there? Or is it something that you think is more that they let the C-suite worry about?


    Tex (32:16)

    Short answer is all the time. And unfortunately, I shouldn't have to be thinking about that all the time. I should be thinking about improving patient outcomes and doing better in the lab. it is constantly on our mind, especially as we start thinking through new technologies. The first part is, wow, this is great. This is going to advance the field. This is going to help create better blastocysts. This is going to get more patients pregnant. What if it goes wrong?


    You know, what system do I have to back up? Do I have another tool in the toolbox that can show that the validation was properly done, that, you know, we've got approval on doing this, et cetera, et So it definitely causes one to pause, which is unfortunate, but now it's just part of it. know, we think full circle as to what could this get us into trouble, you know, with a lawsuit.


    can't, then we really push ahead. But if there's a little bit of hesitance, like, what if the battery goes dead? Then we start thinking through, OK, well, what's the backup plan? And it's just part of the daily thought now, unfortunately. But again, if I have a system in place and a good partner that's sort of behind me, that's one last thing I need to think about. And risk mitigation, that's a common topic on a daily basis, especially in my world.


    Griffin Jones (33:30)

    How much does standardization help to avoid that? So is your standardizing... What is it that you really want to standardize for? And what are the risks of not standardizing where it's like every lab is just doing it their own way?


    Tex (33:47)

    Yeah, great question. So again, you know, I'm a true advocate for some autonomy within the laboratories. But, you know, here's the scenario. Your US fertility largest network in the US. We've got, you know, 30 labs that are on ziltrex and we have two labs that are still using Sensiphone. Heaven forbid something happened in Sensiphone, in one of the Sensiphone laboratories, and we had, you know, loss of embryos.


    Imagine that court case. Well, why do you have XiltriX and all the other labs and not those two? That's negligence, right? You know it's a good system. You know you're using it. You chose it for a reason. You're on this initiative to standardize. Why did you leave out those two? was like, well, we're in the process of converting or something like that, or we just never did. So those kind of bits can save our butts in a bit of legal time. But other events of standardization with making sure that we're using


    Same consumables and and allows us to identify if there's any issues that are going along But also I want to I don't want to keep all my eggs in one basket especially on some of those bits and that's where it's nice to have a little bit of diversification within the laboratories, but I think on systems that systems that can easily be implemented and that can be standardized and that can improve workflow processes within the laboratory and outside I mean to me that's a that's that's a no-brainer it just makes life a bit easier and


    allows us to defend, heaven forbid, something but to go wrong.


    Griffin Jones (35:09)

    Moises, how do see AI playing into all this in the future for you guys more broadly? How do you think AI is going to impact monitoring?


    Moises Eilemberg (35:18)

    Yeah, mean, think AI, as in most other fields, it's going to allow us to do things much more efficiently and potentially do things that are very difficult to do today. I mean, for us, particularly in the monitoring space,


    Oftentimes when there is a problem or a failure in any of the environments that we monitor, there are usually some symptoms of a failure potentially occurring. And so I think with using AI, we're going to get a lot better at potentially predicting and picking up on those symptoms before a failure actually occurs. ⁓


    mean that's a clear area where I think there's probably a lot of low hanging fruit for us in the space.


    Griffin Jones (36:02)

    Tell me, was there a case study that you guys did, my sister, 12 incubator alarm case study, was that what you were referencing before?


    Moises Eilemberg (36:10)

    Yeah, that was the instance in which there was ⁓ a ⁓ failure of the gas input to the incubator. And there was a lot of confusion about what the actual issue was. And we were able to indicate and have the person actually pay attention to it. One of the things that I want to circle back


    to and maybe emphasize is look, this is an area where almost everyone I've met are talented, smart, well-intentioned, people working for a noble cause. But when errors happen, they are costly. They're very emotionally charged. And as you said, have the plaintiff's attorneys that are


    latch on to those those instances and get some pretty big judgments, so I think you know the level of scrutiny that is in the industry makes it so that You know when you talk about cost efficiencies Some short-term cost efficiencies can be very very expensive in the long run so when I see You know somebody relying on a


    on a very inexpensive but potentially not very reliable piece of technology to monitor what could potentially cost the business. That doesn't seem like a great short-term cost efficiency. It's almost like canceling your health insurance. Yeah, you're going to pay less this month, but you're probably not going to have


    Griffin Jones (37:37)

    But you better pray you


    don't get nailed.


    Tex (37:39)

    Yeah.


    Moises Eilemberg (37:39)


    So, look, we do a lot of work in the pharma and biotech space where we deal with good manufacturing practices. And the first thing that these organizations do when it comes to a GMP regime is they do a risk assessment and they figure out what's the risk of failure and what's the cost of that failure. Well, if you apply that to IVF, the cost of failure


    is can be tremendous. mean, the loss of reputation besides the financial cost. And so there are that would indicate that this is an area where you really want to try to mitigate risk. you know, when it comes to critical failures, more than 20 percent of the time, those critical failures result in us getting alerted because we're always right there with our customer when it comes to alarms.


    24 hours a day, seven days a week. And so 20 % of the time is a lot of the time. ⁓ It's probably more than you would want, but it makes all the difference. It makes all the difference to have somebody there to catch that alarm and then to help you, just like in the incubator case, figure out and identify that this is a real issue you need to pay attention to.


    Tex (38:35)

    Good.


    Griffin Jones (38:50)

    What happened with Swedish Biobank last year?


    Moises Eilemberg (38:53)

    So, yeah, so this was a highly publicized, just like there's been ⁓ others, instance of a loss of basically years and years of samples that had been collected because in this instance, I think there was an alarm going off and I believe a maintenance person silenced the alarm.


    because it was annoying and nobody who really needed to know was notified and the freezer failed and you lost years and years of invaluable research that you're never going to get back. As we often see, know, the technology is great and it's helpful, but usually when something like this happens, it's usually the result of


    combination of things and combination of failures, almost always one of them is human error. And so in this case, evidently somebody, a human, made an error even though the technology was there. The combination of the failure of the freezer with the human error of turning off the alarm with not notifying anybody resulted in a catastrophic loss.


    To have somebody there, a third party, that can reduce the likelihood of that human error, again, makes all the difference.


    Griffin Jones (40:16)

    Jax, let's say this happens at a lab that isn't one of your labs. It happens some other company and they're in a huge crisis mode, PR, public crisis. They bring you in because we need a new face and we need to show people that we're making this right. What are the first things that you're doing to restore trust?


    Tex (40:37)

    Yeah,


    getting a new system in place. I getting a reliable system in place, something that has historical evidence of being reliant, showing that, hey, we've got the best. This is not going to happen again. And really listing the reasons why. We've got state-of-the-art technology. We have another set of eyes. We have validated the system.


    I will say too, a bit of a sidestep, but having exceptional customer service to be able to work with us to identify those alarms. And every new tech is going to have a little bit of issue, but it's a matter of ironing it out and having, again, a partner to help us do that, that understands the value of making sure everything is humbling along accordingly. I think regaining trust on something of that scale is an uphill battle.


    There are some systems in place that can help revitalize that process or just the ability to show that we're taking this more seriously. And we should have taken it seriously the first time by having to.


    Griffin Jones (41:38)

    One of


    the other issues in the lab is just the space. I've been in some of these labs and there's just doers, doers, doers, and people are kind of weaving their way throughout the lab. And they can be pretty small spaces sometimes. And oftentimes putting on an addition is not an option. Moving a lab sucks. Tell us about the challenges created by space limitations in the lab.


    Tex (42:05)

    Yeah, I think a lot of the laboratories built previously didn't think through how frozen embryo transfers were going to take off or the evolution of cryopreservation and the ability to be able to freeze embryos in such a great stable state. Not only that, just our embryo culture techniques within the laboratories have very much improved. So we are getting more blastocysts. We are getting more embryos from a cycle. So therefore, we need to store accordingly. So I think the biggest bit is


    what to do with cryo storage and either send stuff off site or keep it on site. And those cryo containers and robots are all fairly big and take up a lot of space. But also just having incubator space to be able to accommodate not only the employees working around in a safe environment and making sure there's no blind corners when you're walking around with a dish in your hand with 10 embryos, but just the ability to, our incubators have gotten smaller.


    more desktop, more smaller foot space and footprint. And that's helped. But I think if we would go back and survey all the laboratories, I'm sure everybody would want a larger space. But having said that, installing an alarm system of this scale will not hamper that space. If anything, you can work around it to a point where you wouldn't even know it's there in your pre-existing space.


    So I don't, if there's ever an excuse of, I can't adopt this technology because of space constraints, I would argue against that statement because there's, where there's a will, there's a way, and certainly this is not gonna be, you know.


    inhibitor of spatial activity within the laboratory.


    Griffin Jones (43:38)

    How close or far do you guys think we are from a 24-7 operational IVF lab?


    Tex (43:44)

    I've got my opinion. I'll let Moises go first.


    Moises Eilemberg (43:47)

    Well, we may have ⁓ similar thoughts on this text. ⁓ mean, I think...


    Obviously human capital and having people work 24-7, I don't think is particularly in the horizon or viable. But, you know, there's companies which I'm sure we all know about, like Conceivable, who are developing, you know, what is presumably a much more automated process.


    ⁓ end-to-end and so I think technology is going to help us expand the capacity of the industry. I think there's no doubt that that's going to help a lot. Love to hear what you think Tex.


    Tex (44:28)

    Yeah, I would agree with that. We have gone down the path with having sort of shift work within the embryology laboratories based on just the volume. So we'd have an early team to come in and do the retrievals and kind of look at embryos and get things sorted out and then an afternoon team. And that's far from 24 hours, but yet based on the demand, we're having to provide the human supply to be able to accommodate accordingly. I do feel through


    no technology and if there was more of a robotic system that was truly validated and can do the stuff we do at the bench just as well, if not better, then that's gonna open up opportunities and a lot of the sort hub and spoke models whereby you've got spokes out where you do an egg retrieval, you freeze the eggs and then you send the eggs, send the sperm to the main mother lab and then you process and it becomes a bit of a


    processing factory-like system. How far are we away from that? Truth be told, I think none of us really know, but there's definitely been an acceleration of that sort of thought process through the development of some of this tech as of recent years. So it could be upon us sooner than we think, potentially, if it all pans out.


    Griffin Jones (45:41)

    You said most lab directors probably wish they had built their labs bigger. Those building a lab in 2026 have an advantage that those that built in 1996 didn't have. You're starting brand new. I'm talking complete new lab. It's going to be high volume. You're going to do between two and 10,000 cycles. How are you building it?


    Tex (45:54)

    So there.


    A massive embryology staff playroom is key. We're talking stadium seating, we're talking concession stands, we're talking absolutely, you gotta treat these people right. So that would be my first objective. Space for staff is super important, right?


    Griffin Jones (46:09)

    haha


    The Nespresso machine, massage chairs.


    Tex (46:27)

    they've got to be able to break away a little bit from the lab and go back and sort of decompress and either check an email or look at their phone for 10 minutes before they go back in to kind of take a break. I think a lot of just an area for them to break away from the lab is super important. Then it depends on which way you want to go with cryo storage. Are you going to keep it in-house or is it better just to outsource it and sort of move that risk to a third party repository?


    And I think that comes into play with a lot of it. Are we gonna have benches that are relatively higher that we can roll these doers or cryo-micro-nitrogen storage doers underneath? What about the footprint of technology coming through? We've seen some robots already. It was just an S-ray and they're pushing a dish-making robot. So what does that footprint look like? Is that gonna be the size of a Flowhood? Therefore we need to accommodate. ⁓


    find some space for that. And then obviously, what's the next evolution? Are we going to continue to do invasive ⁓ embryo biopsy? So do we need micro manipulation setups across the laboratory? Or is technology going to beat us where we're doing non-invasive? We're looking at cell-free DNA and culture drops. Therefore, we need to put more of an emphasis on incubator space and maybe larger incubators to accommodate single embryo culture so we can assess that spin culture media.


    Yeah, it's just keeping your fingers on the tab with where the tech's coming up. But I honestly say, priority number one is a good safe space ⁓ for our very dear embryology staff.


    Griffin Jones (47:59)

    Anything you'd add to that, Moises?


    Moises Eilemberg (48:01)

    No, think everything that Tex brought up sounds right on point. The one thing I would maybe add is you asked about how technology and better use of space can help alleviate some of the stress and some of the constraints and challenges that we're facing.


    And I think technology is a huge part of it. In our world, we call it internally here, it's like the, it's a technology paradox because when it comes to doing something like what we do, environmental monitoring, usually more monitoring leads to more alarms and more alarms typically leads to alarm fatigue and alarm fatigue leads to...


    more risk. So you started trying to address risk with technology and you ended up with more risk. And so when I think about the application of technology to alleviate some of these things, think they're going back to where we started partnering with specialized providers that can


    make sure that that technology doesn't add to the burden but instead reduces the workload and the burden is the critical difference here. And I think that probably applies to a lot of the things that Tex mentioned earlier.


    Griffin Jones (49:12)

    What do you guys think will separate the really, really successful IVF labs from the rest of the pack in the next 10 years?


    Tex (49:22)

    think being open to some of new technology coming down the pipeline. A lot of it still needs to be properly validated. The IVF and ART is one of those fields that just constantly evolving. And you don't want to be left in the dust, but you also don't want to adopt a new tech that hasn't proven its worth. I think there's also a more genuine focus on specialized patient care.


    and really treating each patient as an individual patient versus grouping them into our SART age groups, you know. And I think we're going to get to more of a precision offerings within the laboratory and clinically that is more catered to that individual patient as itself. And I think artificial intelligence is really going to allow us to dig through that data that we already have, you know, from


    the millions and thousands of cycles that we've already performed, how can we start identifying where those best practices are and applying them to specialized, personalized care for the patients.


    Griffin Jones (50:19)

    What do you think, while you work with lot of labs, not just IVF labs, what do you think is going to be the standard bearer in the next 10 years?


    Moises Eilemberg (50:28)

    Well, I mean, I think when it comes to what's going to drive the most success right now, it seems like a little bit of a longer term thinking makes a big difference because I think some of the pressures that we were talking about are leading to some short term focus. And I think that's that's risky. I think.


    you know, focusing on the factors that techs brought up, the long-term success of a particular practice, focusing on patient care, making sure that your staff is not overworked and burnt out and overburdened with non-core activities, and really investing for the long-term. I think it's gonna make a difference because any blip,


    as a result of short-term thinking usually has a pretty ⁓ negative outcome.


    Griffin Jones (51:18)

    This episode will probably come out like two months, six weeks, something like that before. As around this point, a lot of the people that are listening now, they've heard, well, Ava Shankman seems to really like XiltriX and Sangita Jindal really liked XiltriX and Steve Katz seems to think that it's a lot better for my insurance and for my legal liability in Texas and why he likes them.


    They sound pretty cool. I've got 900 other things to do. For somebody that's thinking, yeah, maybe I should get in touch with these guys and maybe I should schedule a Zoom or a demo before ASRM or at a bare minimum, find a time to meet with these guys at ASRM. What would you advise to somebody thinking like that, Tex?


    Tex (52:06)

    Do it sooner than later. You know, this is not funny business. mean, you've got to make sure that... And, you know, it's also doing it for your staff, right? Your staff needs to feel comfortable in a good system, you know, and most likely some of them are going to be, you know, having to attend to some of these alarms. So I'd get in touch as soon as possible, start exploring opportunities, you know, really assess your current system.


    and think, wow, this really sucks about this system. I wish this could be improved. And yeah, have a chat with the XiltriX team and see if they've already figured that out. These guys are always been open to suggestions of improvement. And that's been very, very helpful with us, especially as we standardize things across our laboratory and say, hey, can you do this? And can we do a blanket launch across the entire network? And ⁓ that's been amazing. But yeah, I would not sit on it. I would reach out because a failure could happen tomorrow.


    Griffin Jones (52:56)

    Moises, thank you both very much for joining me on the Inside Reproductive Health Podcast.


    Moises Eilemberg (53:01)

    Thank you, Griffin, and thank you, Tex. I learned a lot today. Appreciate it.


    Tex (53:05)

    Same here, my pleasure.

XiltriX North America
LinkedIn
Facebook
Instagram

Moises Eilemberg
LinkedIn

Dr. Matthew “Tex” VerMilyea
LinkedIn


 
 

259 IVF's Prior Authorization Hell. Dr. Ravi Gada & Manish Chhadua

 
 

What happens when managed care surges in IVF, reimbursements drop, and physicians are expected to do more work for less?

Dr. Ravi Gada and Manish Chhadua are back on the show, and they don’t hold back. Dr. Gada is a partner at one of the largest independently owned practices in the United States and he and Manish co-own and operate a firm called CloudRx, 

In this episode, they dig into:

  • What 70 fertility centers are doing to slash administrative costs from prior authorization chaos

  •  How medication side savings are shifting into the medical services side (and what that means for practices)

  • Changes in the payer market and insurer preferences you need to know about

  • Why Organon and Follistim have gained so much market share in the past 5–7 years

  • Why academic fertility center ratings are shockingly low (and what private practices can learn from that)


  • Dr. Ravi Gada (00:03)

    When insurance gets involved, it's a volume play. You've got to do more cycles for less money and try to make it up in economies of scale. And that just that sheer number of patients that need to go through and in order to keep overhead steady, you've got to figure out how to get the one thing all clinics hate doing is prior authorizations for insurance.

    Griffin Jones (00:35)

    Managed care is going way up in IVF, reimbursements are going down.

    How do you like that? Making less money.

    to do more work.

    you know, didn't like it.

    Ravi and Manish, they're back on the show. late night episode recording.

    Yes, mean, Dr. Ravi Gada and his business partner, Manish Chhadua

    Ravi's also practicing REI.

    and a partner, one of the largest.

    independently owned fertility practices in the country.

    Manish owns and operates 249 other businesses with Ravi

    Today we talk about what 70 fertility centers are doing to decrease their admin costs.

    for this prior authorization hell

    and how they've done that mostly on the medication side up to this point.

    now being asked to help on the med services side.

    They talk about changes in the payer market.

    They talk about changing preferences from insurance providers.

    why they think Organon and Follistim

    might be gaining so much of that market share.

    in the last five or seven years.

    and holy smokes I had no idea that academic fertility centers ratings were so bad

    I'm not trying to offend you if you work for an academic fertility center. There are probably some with really good reviews.

    and I know that it doesn't speak to your clinical care.

    But gosh, I am telling you what we discovered in this sample size.

    of Academic Fertility Centers.

    is very different from a sample of privately owned practices.

    And if it makes you feel bad,

    Ravi has me read.

    his newest one-star review that someone left this morning. In its entirety,

    to Inside Reproductive Health's audience of 300 million people.

    Enjoy this conversation of me hanging out with my buddies.

    Manish Chhadua (02:12)

    The biggest challenge with entrances at fertility centers is it's a growing part of our clinics. There's a lot of paperwork and administrative burden that comes with that. Generally reimbursements are going in the downward direction, but overhead is going up and we're struggling to find that balance to really.

    handling the overhead and the administrative burden that insurance companies and patients that have insurance coverage come with.

    Griffin Jones (02:38)

    Can you tell us how much overhead is going up? Like, it going up a couple percentage points? Is it going up a lot more than that? And over what period of time has this been happening?

    Manish Chhadua (02:50)

    Yeah, I mean, some of it's tied to insurance and the administrative burden there, right? Gosh, I graduated fellowship in 2012. And when I started down here in Texas, we were probably 30 % insurance, 70 % self-pay. Today, Texas is probably closer to a 60%, 65 % insurance state with 30%, 35 % self-pay.

    a dramatic shift in a matter of 12, 13 years. But you have other headwinds as well, Salaries have gone up, inflation has gone up, cost of buying products to service IVF patients. And so in the past, historically, that was adjusted for in the self-paid patients, but increasingly that's not adjusted in the managed care market.

    but they still continue to go up. In fact, the trend is probably in the downward direction in the managed care market for reimbursement.

    Griffin Jones (03:44)

    it's in the downward direction

    Manish Chhadua (03:46)

    I would say stagnant or downward, yeah. Especially if you compare it to the self-pay patients or the cash patients.

    Griffin Jones (03:52)

    So it makes sense that it would be less than them, but why is it, why is it, why is it projecting downward, do you think?

    Manish Chhadua (03:58)

    Well, I mean, and again, on the clinic side, in the IVF laboratory side, you're really down to probably five to seven big payers that really manage a majority of the insurance patients. And with their contract renewals, they come to you and say, here's our reimbursement, formulary, here's our fee schedule. And you're left with take it or leave it. You take it.

    great if you don't or you try to negotiate it, the leverage is no longer in the clinic side. I mean there are certainly MSOs that are getting larger and larger but even despite that they're able to say take it or leave it and you still have 10 other clinics in town that are willing to sign it and take the volume and play the volume game.

    Griffin Jones (04:39)

    And so where you used to if inflation went up or if your cost of labor or supplies went up, used to be able to raise prices because of self-pay patients. And that's no longer the case because you're being reimbursed from insurance and they're reimbursing less.

    Manish Chhadua (04:57)

    Yeah, and listen, this isn't unique to fertility. This is across the entire medical industry at large. And I would say.

    Griffin Jones (05:04)

    But it's been that

    way in the medical field at large for a while. It's relatively new to us.

    Manish Chhadua (05:09)

    And it's just new to us.

    Yeah, it's new to us and we're seeing it firsthand now ⁓ more than we have historically, certainly at all time highs in terms of managed care coverage today.

    Griffin Jones (05:20)

    Manish, the heck are you doing about this? What are you doing to make yourself useful with all this?

    Manish Chhadua (05:25)

    Well, you know, I'm a technologist, right? So what we're trying to do is just create process and efficiencies out of what is basically wastage or loss in the market. you know, one of the biggest components of how insurance companies work and basically the rest of that side of the industry is a lot of labor, a lot of manual hours, basically.

    putting paperwork together, creating justifications for why these more expensive treatments are required. And like he said, IVF is just kind of coming into this where it's becoming more and more of a problem. And obviously, as Ravi alluded to, labor costs are going up in the last five years pretty dramatically. And so what we do is, you know, we decided probably about five years ago, four years ago, to take that problem on head on.

    And basically, as opposed to hundreds of clinics figuring out how to train individual employees to do this work, we thought, well, why don't we just become as much of the experts as efficiently as possible in tackling that, and specifically the drug side of the Preroth process.

    Griffin Jones (06:32)

    What was the waste? You said there was a lot of waste. What was the waste?

    Manish Chhadua (06:35)

    It's mainly time, sitting on the phone with PVMs, going through paperwork, digging through insurance documentation, and then pulling that information from the EMR. The other interesting thing that's kind of part of that ecosystem is that the clinics were having to do a lot of this work. The pharmacies were having to do a lot of this work.

    And ultimately those prescriptions end up going to single source pharmacies. So even the pharmacies that are trying to help out in the clinics that are doing the work, it exists on the drug side and basically they're not going to be able to fill those prescriptions anyways. Well, and on the clinic side, the waste comes from who's doing the prior off at the clinic. I would bet you half of the clinics that we've onboarded at CloudRx is being done, the prior is being done by the nurse.

    and half is being done by the financial team. I mean, imagine a nurse whose job is to do clinical care day to day that's now stuck on the phone or filling out paperwork a third, a quarter of her day dealing with getting a prescription through versus taking care of patients.

    Griffin Jones (07:37)

    So I'm not sure if I'm understanding the challenges you were just describing, Manish. Can you go over that again?

    Manish Chhadua (07:44)

    ⁓ sure. mean, so again, labor, paperwork, know, time on the phone. Basically, there's a lot of this type of information and it follows the 80-20 rule, right? You you have 80 % of these patients that you can probably get through pretty smoothly, but 20 % of these patients basically working with their insurance, the appeals process, getting through all the minutia there really is a time waste.

    at the clinic and definitely not what nurses and physicians and everybody at the clinic are trained to do.

    Griffin Jones (08:17)

    So you see this going on in clinics across the board. There's 500 clinics, maybe all trying to figure it out themselves or a whole lot of different people trying to figure it out themselves. How are you streamlining it?

    Manish Chhadua (08:30)

    Yeah, so that's another, you know, big hurdle, right, for us to tackle. you know, our approach to a lot of that is building out workflows using robotic process automation, using AI where we can, and basically taking that process and trying to dissect it down, right? One clinic operating on, you know, 30, 40 patients a month gets exposure to

    maybe three of this plan, five of this plan, one of this plan. And so there's a lot of diversification, diversity in what that job entails over the course of a month. Whereas for us, now we're doing, you know, 2000 patients a week, 8,000 patients a month. We really do get fairly keenly focused in on, what particular plans need, what exactly we have to submit, how to basically do that efficiently. And for the most part, we try to do that with technology first.

    as kind of the easiest way to scale that process.

    Griffin Jones (09:24)

    And are you doing this for prior auths for IUIs and IVFs and things that are billed on the clinical side or just the meds?

    Manish Chhadua (09:34)

    It's mostly on the medications, right? Long-term, we're looking at doing the medications plus the medical benefits side. But in this first part of kind of launching this company since 2020, it's mostly on the medication side. Now we have a relationship with most of the clinics that we work with and their billers. And so we work kind of hand in hand with them, but they usually get the med off in first. But that's actually something that we just are the

    medical site authorization first, but we're actually just starting in the next probably year or two to start working on the actual procedural authorizations as well.

    Griffin Jones (10:10)

    Someone that I work closely with went through an experience with a center that I know and like a lot, but had a really hard time because she was calling the center and they were telling her to call the PBM, who was telling her to call the pharmacy, and she was just in this triangle and, you know, almost Mr. Cycle, and it was a nightmare for her. She's spending hours doing this. Is this something that would have been prevented with you all?

    Manish Chhadua (10:31)

    Yeah, that's

    Yeah, I prevent it is a too finite word or too infinite word. I'd like to say that we could definitely help. Now, and this is the travesty of this is typically it is the patient that's basically stuck in this whirlwind of trying to get information from their clinic, trying to get the pharmacies to be able to communicate with them, to be able to get this done, as well as working through their insurance. Like I said, we spend hours

    doing this all the time and we know how hard it is to do, imagining that a patient's having to do it one or two times or going through that process on their own, you know, that's just such a sad thought.

    Griffin Jones (11:11)

    You said that maybe you guys are up to 65 70 percent covered in in Dallas right now in Texas isn't even a mandated state so this is just by virtue of really large employers in the Dallas Fort Worth area that are offering These benefits now is it?

    Is it going up as much as it was? Are we going to reach a certain plateau where maybe 20 % are never covered? Are we still seeing the same growth of the PBMs? have they reached a... And I should say the employer benefits managers, are they reaching a plateau? What kind of growth are we seeing?

    Manish Chhadua (11:55)

    Yeah, you know, even in the managed care states, we are seeing them peak out at like 70, 75 % managed care, 25, 30 % is still self-pay, but where we're seeing the growth is the volume, right? So the percentage might stay the same, but as you know, the number of IVF cycles being done every year is going up. Other states that are probably hovering in the 30%, 40%, 50 % ranges are going to get to 70%.

    So there's still gonna be percentage growth across quite a bit states, right? Dallas is easy because it has such a high percentage. Houston also I'm sure is quite similar because we have so many large employers. But you get out into like Alabama, Mississippi, Arkansas, certain states, they're probably sub 50%, but that will grow. But the biggest growth is really just the sheer volume and number of patients. And again, this goes back to the economics.

    when insurance gets involved, it's a volume play. You've got to do more cycles for less money and try to make it up in economies of scale. And that just that sheer number of patients that need to go through and in order to keep overhead steady, you've got to figure out how to get efficient. And we looked at this model five years ago, we thought, can we help clinics get efficient? And I said, the one thing all clinics hate doing is prior authorizations for insurance.

    So

    Why don't we do that? I mean, that's really where the genesis of CloudRx came about. And we said, hey, Manish, listen, I can assure you if we figure out how to solve this problem, we can make patients and clinics very happy. And we've had quite a bit of growth. mean, we have 70 plus clinics on board at CloudRx. Like Manish said, mean, 40,000 plus prescriptions a month are going to CloudRx. So the growth has been phenomenal. In fact, I mean, for a clinic to get...

    signed on with Clouderx, there's a wait list right now because we have to scale ourselves in terms of just getting the number of employees in place. So it becomes economies of scale for us. And we think to Manisha's point, I mean, now we know these plans inside and out versus a clinic who might only see a certain plan every once a week, once every other week, and then they don't realize.

    what drugs are covered, what's not, what's the formula. I mean, there's so many nuances to this process. we thought we, some, you know, someone needs to become a subject matter expert in this and deliver a service at a leaner, a leaner model so that it helps to save time and honestly overhead costs.

    Griffin Jones (14:22)

    employees in place. What's up with that, Manish? What's up with that, Mr. AI? You don't have a digital assistant doing all this stuff right now, scaling this to infinity?

    Manish Chhadua (14:26)

    Thank you.

    You know,

    I don't think the employees, you know, are ever something that we would go without, honestly. I mean, we have really sharp people. There are certain things that still you need to have the double check. You need to have somebody that understands what the patient's going through, understands a little bit more than where AI is today. But, you know, they're...

    There'll be a point in time where most of our employees will be focused primarily on the touch aspects of it, mainly on the final approvals, and the rest of this will get fairly automated. I do believe that.

    Griffin Jones (15:06)

    How far are we away from that? Because I called for my HVAC annual servicing and it was about 30 seconds into it that I'm like, am I talking to a robot? And I'm thinking it would be rude to ask her if she's a robot. So I'm not quite going to ask. And then maybe like a minute in she says, I'm a smart digital assistant. And ⁓ then so that was like, all right, well now I can ask. you a robot? And she said, no, I'm not a

    Manish Chhadua (15:21)

    Ha

    Griffin Jones (15:35)

    I'm a smart digital assistant. But you're not a human. No, I'm not a human. it was like, wasn't, like, there still are some gaps and obviously in fertility you're talking about something more sensitive than HVAC, but the point is just the competence of that technology. It was not the old credit card phone tree, you know what I mean? Where it's like,

    Manish Chhadua (15:37)

    There you go.

    Griffin Jones (15:55)

    I'm sorry, I didn't quite get that. Five, four, three. It's not like that anymore. It's actually a competent system. Where it wasn't competent is integrating it with the rest of their workforce because then I got a call from a human to confirm everything and well, that totally negates the point. But I was pretty impressed. How close are we to that in the fertility space?

    Manish Chhadua (16:19)

    And I think we talked about this a little bit more about how fast these things are happening. What we see as consumers or as people in industry, and we see AI moving really fast even in just what we're interacting, under the cloak or under the table and basically everywhere else where we don't see what's going on, it is moving at a lightning speed pace.

    I don't think people realize it. It's not quite there yet, just like you were alluding to. We can still kind of tell, but I can almost assure you we're not very far off from not being able to tell the difference. And basically getting to the point where now these bots that you're talking to are actually talking to bots that you put in play to do different things and knock out different tasks for you. So we'll have bots talking to bots.

    Griffin Jones (17:07)

    Yeah, the insurance bots will be talking to your bots, right?

    Manish Chhadua (17:10)

    Yeah. Well, and I would tell you, right, so if you dissect out

    healthcare in general, investigation of benefits, looking up what someone's coverage is, looking up their deductible, almost all of that is automated in-house now, not just for us, for other hub services, other companies, but getting a prior authorization done for IVF is still a very manual process.

    requires a lot of phone calls and looking into a plan. You can't just log into a portal for most insurance companies and understand it. It's on the side of the insurance company. mean, you can have certain ones like ⁓ Optum actually has a portal that is a lot easier to look up what benefit it is, but then others have no codes for ICSI, for PGT, for Cryo, for all the different.

    Griffin Jones (17:38)

    Why is it so manual?

    Manish Chhadua (17:56)

    Codes that are required for IVF that you end up having to call a plan and talk to some

    Griffin Jones (18:00)

    Do you think that this will help the employer benefits management companies, like the fertility benefit carve out companies, because they have codes for all that stuff, right? Like Progeny's got codes for all of those fertility specific things where some of the traditional insurance carriers might not, right?

    Manish Chhadua (18:19)

    Yeah, I mean, they both have the codes. do think that the fertility benefit managers, whether Maven, Progeny, Kind Body, Carrot, know, the big four probably in our space, they have figured out a way to help streamline that to a certain degree. So there is some benefit there. The question will be as they continue to grow, still the traditional PBM and insurance companies are also growing at the same pace. So I don't know that they're going to replace

    all of the traditional models that going that are out there.

    Griffin Jones (18:48)

    Now somebody was asking me this question recently and I could only speculate.

    And so I thought maybe they'll continue to grow for those reasons. But I also wonder if we actually do get a federal mandate or we do see a much, much higher volume of IVF. Will the insurance companies, the traditional people, the United, the Blue Cross, the Atenas, will they start to want to try to get some of the

    market share back from those carve outs.

    Manish Chhadua (19:19)

    Yeah, it's entirely possible, but I think what we're seeing right now is more so that they try to partner with the carve-outs because, and I do think, you know, these carve-outs are doing a much better job than even those insurance companies feel like they can do themselves right now. And fertility is such a unique space with different needs, different demands that, you know, even then, you know, we talked about this, you know, there's plenty of other pharmacy hubs that do this kind of work in other disease states, but it's so unique that

    basically it requires someone with fertility focus to really do it right. But I think actually I think it's the opposite. I think as it scales, I mean you follow the money, they're going to see what they're giving up and they're going to ask to bring it back in house. Definitely quite possible.

    Griffin Jones (20:02)

    We have point counterpoint with the cousins here. Where do you think, all right, Manish, let's pretend that Ravi's wrong because I like pretending that Ravi's wrong and that you're right on this and that they're gonna continue to partner with the carve-outs. Do you think that it will be like one...

    Manish Chhadua (20:05)

    Yeah.

    Thank you.

    Griffin Jones (20:21)

    insurance company treated like like United goes with progeny for example and Blue Cross goes with Maven. Do you think it will like it'll be exclusive deals like that or they'll each work with each other?

    Manish Chhadua (20:33)

    Can I just point,

    before Manish answers, can I just point in order for me to be wrong, we have to pretend. I just like that. I'm gonna record this bit. ⁓ You know, I think, you know, and again, this is not a formal opinion, but you know, at the point in time when a lot of the carve-outs were growing and this was kind of a few years back, it was like there was maybe 20 of these out there in the market.

    Griffin Jones (20:40)

    Ha ha ha ha

    Manish Chhadua (20:59)

    I remember seeing job postings for employees to apply for XYZ employer's job, and they would list the fertility benefits that they provide in the job posting. And so the reason why I think that this might persist, and again, this is not a formal opinion, is that so long as employers are trying to recruit top talent and employers have to say so,

    of how exactly they market or build this product of recruiting top talent, they're gonna basically try to differentiate themselves by saying, hey, we have access to the XYZ carve out benefit as opposed to a traditional benefit. And I think that'll persist for a little bit longer. You can't argue with the money argument, I don't think, because I do think that that's a pretty big factor. So there you have it.

    Griffin Jones (21:48)

    You heard it here on Inside Reproductive Health, Manish's official unabashed, unapologetic, certified opinion. Do all the insurance companies cover the same drugs or do some companies cover other drugs? How does that work?

    Manish Chhadua (21:50)

    you

    Well, most of them have a formulary. So they cover IVF drugs as an umbrella, but they have a formulary, which is essentially a preference or to a certain degree, you could even say a mandate that it needs to be one drug or another. example, Follistim is on formulary for United Healthcare or Optomrx. So if you're a patient who has United Optomrx and that's your

    That's who your employer has chosen for their insurance company. It's Falisten. Aetna and CVS Caremark is also Falisten. So a lot of employees that are in that have to use Falisten. Men appear a little bit different. They're usually on most plans. Avadril HCG triggers, it depends. Interestingly, that you asked that question recently, CVS Caremark changed their formulary from

    Avadril to HCG and so even your trigger shot can be determined, but it's usually a GonaLef or Falastin formulary at the top, but as you get further down into the other drugs, it just depends.

    Griffin Jones (23:07)

    I know that faring makes men a pure I know that the way I remember Falisdem versus gonna laugh is EMD Serrano you think of the letters gonna laugh Oregon on one brand name Falisdem one brand name. That's how I remember who makes Avidrill and ACG triggers

    Manish Chhadua (23:23)

    So Avadril is made at EMD and then Pregnil, which is the HCG is made at Organon. Navaril is another HCG it's made at Faring. So it's still the same three drug manufacturers for those. Then antagonist, which are like Ganarellix, Cetrotide, those are made at Organon makes Ganarellix, EMD makes Cetrotide. Some generics have come into the market. So, but mostly you're still

    dealing with the three major fertility manufacturers in the United States make up 80, 90 % of the IVF drugs.

    Griffin Jones (23:58)

    So those insurance companies have a, what did you say? It's basically a mandate, but what do they call it? So is a formulary just a euphemism for a mandate, or is it sometimes not a mandate?

    Manish Chhadua (24:04)

    Formulary.

    Well, it's a euphemism because when it's on formulary, something may cost $100. You can get the non formulary, but it's going to cost you $1,000. it's essentially you have options, the second option too is a magnitude higher in price.

    Griffin Jones (24:28)

    So some of these insurance companies have a strong preference for follow-stem. Has that always been the case?

    Manish Chhadua (24:33)

    Um, it, it, you know, it kind of goes up and down. It's interesting. would say if you go back eight, seven years ago, it was maybe a more of a gone a left heavy market. If you look at today, uh, I think the market has shifted and, it's probably leaning fallast in, um, they've had some big wins in the last five years with a couple of major, um,

    So it's probably now leaning Organon-fallastin, but they're close.

    Griffin Jones (25:02)

    why do you think organ has had the i'm probably asking you speculate why you think they've had those big wins in the last five or seven years

    Manish Chhadua (25:10)

    You know, it's a variety of things. I mean, it's hard to really pinpoint, but I mean, they do, you know, with a lot of different things, they've been a lot more present in the market. They've been a lot more aggressive with winning plans back. think, you know, they realized that the managed care market helps out in the self-pay market as well. So just ⁓ maybe a little bit different tact, a little bit different level of aggression in trying to those plans over. You know, the other one is

    it wasn't always organ on, don't know, Griff, if you remember, but probably when did that change? Three, four years ago. I think four or five maybe, but it used to be under Merck. Yeah. So it used to be under Merck, but even before that it was organ on. it went from organ on, then it went to Merck. Merck really grew with a product called Keytruda. It's an oncology drug and their oncology and vaccine divisions exploded. mean, they were so

    Griffin Jones (25:40)

    Six or eight years ago. No, I was longer than that

    Manish Chhadua (26:01)

    ultimately, let's call it in the last five years, they spun off Fertility and Women's Health to a new company. That new company, they could pick the name and choose whatever they wanted to. The nostalgia from when Organon was around, and this was probably even before my fellowship, was high on the list. So when it came back out, it came back as Organon. And it's very much a women's

    it's one of the largest, if not the largest women's health pharmaceutical company globally. And so I think spinning that off, making Organon a women's health pharmaceutical company on its own standalone separate from Merck also plays some role in it, to what extent, I don't know.

    Griffin Jones (26:40)

    Well, is that like the rule of the rule of business of do a couple things really, really well, as opposed to trying to do everything that they're in the one space so they can focus on.

    Manish Chhadua (26:51)

    I think so. Yeah, I mean,

    it makes sense, right? It makes sense to the three of us, at least.

    Griffin Jones (26:55)

    It makes sense to the three of

    us. That's our story. That's it. No further explanation needed. Are all clinics struggling with the same things that you guys are seeing? Are they all having the same challenges? Or do you notice that some clinics really have this challenge and other ones really have a different one?

    Manish Chhadua (26:59)

    You

    No, I think it's the same. know, I've gone to a handful of these advisory boards and this and that, and you get, it's fun because you get into a room with doctors and nurses and administrators from all over the country and everyone starts talking. And I think the three, four things that percolate up to the top is insurance managed care, you know, dealing with that. HR has a huge problem in clinics and maintaining staff and just

    all the things that come with HR, and then cost and overhead. mean, these really are almost universal. Obviously, everybody has their own little things here and there, but if you really ask everybody sit in a room and keep talking about it, it does come down back to these handful of things.

    Griffin Jones (27:56)

    Some people, do some people see the urgency more than others though? Do you think everyone understands that we're moving to a much higher volume field of medicine and that managed care is going to take up a much larger piece of their business than it is now?

    Manish Chhadua (28:12)

    I think two, three years ago, I don't know if people really, where they stood on it, I think today. Yeah, I think it's pretty prevalent. I think efficiency is the name of the game, optimizing your workflows, basically figuring out how to train staff faster, making them more efficient. think there's a handful of clinics that are maybe in their sunset phase that are just like, I'm going to ride it out and see where it goes. But I think for the most part, all of them are.

    fairly active. The NSOs especially, know, name of the game is efficiency. Yeah, the big networks definitely understand this, right? You look at Pinnacle, Prelude, First for Time, and these guys are really pushing the growth model, which is, I think, helpful to really service the number of patients that are in this space. And interestingly, those, some of those large, large networks are

    some of the first people to sign up for CloudRx because they realize they've got to become more efficient. So we service a lot of MSOs.

    Griffin Jones (29:10)

    Yeah, for them, and I wonder if that's skewing your view a little bit, Manish. Like, what about those independent wahoos out there, like Dallas Fort Worth Fertility Associates?

    Manish Chhadua (29:21)

    Who are they? They're

    not allowed on side RX actually. Yeah. ⁓

    Griffin Jones (29:25)

    Look them up on Yahoo!

    But our

    independent groups because I've been interviewing a couple recently and And and I do like that everyone doesn't have the same focus on efficiency But some of them I worry like you don't have it. You're not paranoid enough for me, man Like you're not you're not focused enough Quite enough on the efficiency and I like that it they're not looking at it as numbers that they have to hit or quotas but I just worry that they'll get

    that steam rolled if there's a big jump in managed care in their area. what do you think? So obviously the MSOs, they're really hyper-focused on this efficiency. What about independent practices? And what about the university systems?

    Manish Chhadua (30:12)

    I mean, I know I'm probably closer to that, the individual clinics, like all things, I think it's a very heterogeneic population. Some clinics are still getting more more efficient scaling. Others are kind of like Manish said, might be like in a phase where they're trying to finish out their 10 year career. Academics is where it really gets interesting. And I think that the...

    clinicians and ⁓ nurses and embryologists that practice in the university settings are isolated from it because they have a huge team of coders in terms of billing coders and as well as software coders running in the background. Some of them that are kind of privademic might know it, but like the ones that are purely academic, I don't know that they're doing a whole lot of these processes that are happening in the background and

    those, it just kind of almost happens magically. Now they probably get stuck in the nuance of it's not approved, patient can't go forward. Okay, fine, call the billing office and then come back to us. That's probably one of the beauties of being practicing in academic medicine is maybe you don't have to deal with that as much and you've got an army of people, but certainly the finance team.

    Griffin Jones (31:22)

    But the patient still

    does, though.

    Manish Chhadua (31:24)

    The patient's still 100%. The patient still does the finance. People in the background still see it. And the patient gets caught up in that. We have had a little bit of a hard time onboarding academic university centers at cloud for these services. Interestingly, I think there's a benefit for all kinds of clinics for this, but the red tape in just contracting and outsourcing certain parts of their ecosystem is very hard. So

    of all the clinics that we've onboarded and the numbers that I've shared with you before, very little is actually in the academic university setting. So they're still doing a lot of this on their own. Well, and just one other thing to kind of touch on the earlier question is, we do this every day. I can't imagine a nurse or a clinical staff that would volunteer to want to do this job every day. So from that point of view,

    You know, some people are just change averse possibly. But again, it's not something anybody I think is volunteering to do outside of us.

    Griffin Jones (32:22)

    I can't believe I've

    never done a little analysis on this before, but just in the last 20 seconds, I pulled up six different academic fertility centers. I'm not sharing my screen and I'm not going to. They're horrendous. These are good programs. These are the programs that everyone would know. I'm Googling University Plus Fertility

    Manish Chhadua (32:38)

    Ha

    Griffin Jones (32:45)

    So I'm getting the fertility centers Google my business listing, not the entire system. are,

    Manish Chhadua (32:53)

    What's horrendous? What are you saying is horrendous?

    Griffin Jones (32:55)

    like

    threes, 2.9, 3., yes, yeah, their overall rating. And not from small sample sizes either, but sample sizes of 50, 100, 150, that you could, that just, don't, I never see that. I shouldn't say never. I seldom see that in private practice. And if I were to click on those, I bet you, I bet you a lot of it is about billing stuff.

    Manish Chhadua (32:58)

    the reviews, the reviews, the reviews. I got it. Understood.

    Well, it's just a-

    Well, it just shows you how useless Google review ratings are because I mean, I'm sure these centers are excellent and it's just, you know, this is the problem with the Internet.

    Griffin Jones (33:30)

    we well

    You can see how useless reviews are because you have really good ones, Ravi. So obviously something's not working out. No, they're not useless though, because people aren't reviewing clinical outcomes. Online reviews, feedback, patient experience is not SART data. It is something apart or overlapping, but it is people's overall respective of their

    Manish Chhadua (33:35)

    Exactly.

    Griffin Jones (33:56)

    perspective of their entire experience at that fertility clinic and they don't like it. the redeeming quality for them is the clinical team, right? Like when you see good things, they're talking about the nurses, they're talking about the doctors, but these things...

    that people are giving them one star reviews on are like, they don't answer the phone. I got this bill, nobody explained. Yes, correct. But I...

    Manish Chhadua (34:20)

    It's their experience, obviously not their pregnancy rates.

    This is interesting to see this

    debate from this point. We're gonna get sidetracked here for a minute, but I want you to Google the South Lake location and Go and click on the newest review it came in at 330 this morning 330 a.m

    Griffin Jones (34:45)

    South Lake office Dallas Fort Worth fertility. Let me make sure that I get the right listing. OK. 71 Google reviews and clicking on I'm clicking on newest this clinic. This clinic is busy. But yeah, that was all right.

    Manish Chhadua (34:51)

    This is my problem with the internet.

    newest.

    You can read it out loud.

    No, no, okay, go to the next one. That was a five star. Go to the next, sorry, the

    one after it.

    Griffin Jones (35:09)

    My private medical is the one star. My private medical info is being given to a complete stranger who used my name on a different email server. I am not getting any of the emails about what I am supposed to do in preparation for egg freezing, which means an enemy of mine is potentially attempting to sabotage my opportunity.

    Manish Chhadua (35:30)

    An enemy is...

    Griffin Jones (35:36)

    Biological children of my own, that's incredibly evil, jeopardizing me potentially being the mother of my own biological child. You're a monster,

    Manish Chhadua (35:44)

    An enemy has stolen my email and is sabotaging it and therefore we are clinic out at one star I'm like just good you can't rate the enemy anyways

    Griffin Jones (35:51)

    Yes.

    So if your point is that there are sometimes frivolous reviews, yes, you cannot take the credibility of any one review at face value, but you have a 4.7 rating overall. So this one star review of someone taking their cybersecurity issues out on you, which is great, is not supported by

    the body of evidence of other reviews. We've already established that the fact that you have a 4.7 means that it isn't valid.

    Manish Chhadua (36:32)

    It's just amazing. Grip,

    I hope you're impressed that Ravi knows his reviews were Yeah, look at that. knew exactly what the last two reviews came in at. That's how little value he thinks Because it pisses me off when people write these things.

    Griffin Jones (36:40)

    See? That's...

    except for when it's amusing, right? ⁓

    Manish Chhadua (36:49)

    Right. But

    anyways, you're so, hey, listen, that bodes well for us, right? Because we want people to get good ratings and we want good experience at the patient level and at the clinic level, which is why a system like CloudRx to help really get these patients through and an insurance and not getting your prescriptions on time is where the frustrations come in. So.

    mean, it's a great segue back into this whole thing about prior authorizations. And so I think it's partly why we've had a lot of success. think it's why, honestly, the process is very onerous. We had a former nurse that is a nurse at OptumRx, and she didn't know that we were part of CloudRx. And at some point, we were talking on a weekend about CloudRx.

    And she was like, that's, that's you guys. That's you in Manish. And I said, yeah, I mean, we're yes. That's a lot of that is from a company that. And, ⁓ she told me she thinks 20 % of all phone calls that the fertility division takes at OptumRx is from CloudRx calling them 20 % of all of OptumRx fertility division. She's like, they receive more calls from you than anybody else by far.

    Griffin Jones (37:43)

    Yes, we own 30 businesses and that's one of them.

    Manish Chhadua (38:04)

    And partly that's because of how arduous the process is, the phone calls, but also they know us pretty well at every single one of these insurance companies now. I mean, we can't really be ignored. And therefore, when we call, we have now account managers, we know we have relationships there. We can find out why have you not gotten this through? What do we need to send you? I mean, it's a friendly relationship, but it's also everybody on that end is trying pretty hard to get these things through to you as well. don't really.

    At an individual level, they're not really trying to delay the prescription, but it is so time sensitive because you get your menstrual cycle start date and all of a a lot of things have to happen and one of those is getting your medications on time. And so, you know, that's the advantage of having a company that's niche is to try to get this through fast.

    Griffin Jones (38:53)

    So are you taking it? You said you got a waiting list. Can fertility centers still work with you or are you making them sweat?

    Manish Chhadua (39:00)

    No, no, we're signing up clinics. There's a process. I mean, it's not, you know, I wish it was just as easy to sign people up. So there's a process. There's an onboarding process. There's a lot of agreements, legal documents, because we're talking about patient information, patient files, as you know, BAA agreements, that you name it. So there's a whole process that when you decide, hey, we want to, we want to join and use CloudRx services, then we have to go through all the paperwork that needs to happen.

    probably a two month onboarding process to get a clinic primed and ready. And for us, because it is not fully automated, it's not all robotics, we have to hire employees for those roles, right? We can't just bring on a clinic, especially a large volume clinic, a thousand retrievals a year type of clinic without really getting on, ⁓ helping grow on our end too to accommodate that. So.

    We're certainly taking on clinics and we try to scale that and grow as fast as we can. mean, the wildest, craziest things are November, December, January, it turns into a little bit of a nightmare because December flipped to January when most plans change over for clinics, they'll all tell you, I mean, it's the highest burden month because everybody's got a new insurance plan, a new carrier, a new formulary, new design benefit.

    And so at CloudRx, I mean, have a role we really won't onboard and scale in November, December, simply to brace for January, January into February. And then you're back into kind of a normal cadence again. So there's a lot of nuances for that. But no, our goal is to continue growing. I mean, you look at the growth trajectory, it's been on a rocket ship the last probably two years. And we have people calling on offices explaining what services we offer.

    ⁓ you know, jumping on the pod like this, making sure people know that there's a service like this that's out there. And just, you know, but if there's a clinic that you want, you have in mind, we'll let them jump to the front of the line.

    Griffin Jones (40:53)

    Especially if they've got a 2.9 Google rating. They get to jump to their need of help stat. Before we sign off on this, you guys are my early adopters. What's new in your tech stack, like your personal tech stack? What are you using now that you weren't three or six months ago?

    Manish Chhadua (41:14)

    Well, I mean, listen, it's a, for me, it's pretty much a rolling ball. mean, we're constantly adopting a lot of new tech. I could tell you that a good 80, 85 % of all the code that's being built at Rheon and CloudRx is all through AI. And, you know, we just adopted Copilot as part of that solution. And it's really is amazing how fast it can move and what all it can do.

    basically how clean the code is afterwards. mean, it's geeking out a little bit, but fairly impressive. On my side, it's interesting ambient listening. I mean, we're getting better and better at having these ambient listening devices and recording meetings, minutes, but even I'm starting to try to play with this in the clinic side. so ambient listening devices are

    are really, I think, also going to be quite important. And they really do help you keep track of the action items that are needed during consultation or meetings. So I think that's also something that we'll see a lot of over the next 12 months.

    Griffin Jones (42:15)

    For personal use, what's each of your favorite LLM right now?

    Manish Chhadua (42:19)

    I'm still, mean, there's a risk factor for a lot of LLMs that are out there. So we stick to mainstream right now. So, I mean, we're still on chat GBT for the most part. Chat GBT also, have you heard of notebook? What's it called? Notebook AI from Google. Notebook AI from Google. It's a podcast.

    Griffin Jones (42:36)

    now use is

    clod no no

    Manish Chhadua (42:39)

    No, it's a podcast. You can upload four or five PowerPoint presentations, two, three articles, a couple of websites, and two people will come on and create a 30 minute podcast completely like voice inflections, everything. You should check it out. It's pretty cool.

    Griffin Jones (42:55)

    Well, there goes my career. It's down the toilet. so when it is when it when that does happen, though, then all of my episodes would just be hanging out with you guys because nobody will pay to do that. So I'm looking forward to it because it's always a blast having you guys back on. Maneesh, Ravi, thanks for coming back on the program.

    Manish Chhadua (42:57)

    Yeah.

    Yeah.

    Yeah, thanks for having us. Thanks a lot. Love listening to the show. take care, bye.

Manish Chhadua
LinkedIn

Dr. Ravi Gada
LinkedIn


253 Booming IVF Innovation. What the US and world can learn from Mexico. Daniel Madero. Juan Moctezuma.

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


What if 25–35% of patients in the U.S., Canada, or Europe left for equal-quality IVF at a quarter of the cost?

In this episode we take you back to Mexico City, ground zero for what may be the next global IVF surge.

Juan Esteban Moctezuma, Co-Founder and Co-CEO of Reina Madre, and Daniel Madero, CEO of Fertilidad Integral, join the show to discuss:

  • The hub-and-spoke model fueling their growth

  • How they plan to scale egg freezing and IVF nationwide

  • Why they’re betting big on automated IVF labs from Conceivable

  • How tech, capital, and Ob/Gyn funnels could transform IVF care across Latin America

  • Why this may be one of the biggest untapped investment opportunities in global fertility care.


Get Exclusive Updates on the Future of the IVF Lab
100 Patients Enrolled in Groundbreaking IRB-Approved Study

  • Follow Conceivable Life Sciences on LinkedIn for exclusive updates from the AURA IRB study.

  • Measuring AURA’s automated IVF lab against today’s clinical benchmarks

  • Designed to improve consistency, efficiency, and outcomes

  • Get early insights before results are widely published

  • Be first to see what could redefine embryology

The revolution is underway. Don’t miss the data that could change your lab forever.

Follow Conceivable Life Sciences on LinkedIn today.

  • 00:00:02:21 - 00:00:15:10

    Speaker 1 - Juan Moctezuma

    Mexico is already, a third or even less of the cost. Us as in the US. Right. And then, other has always been and will be about access and about delivering the best quality, but at lower cost.

     

    00:00:15:12 - 00:00:45:12

    Speaker 2 - Daniel Madero

    That means that even though we used evidence based medicine at the treatment level, we are supporting the patient throughout. The experience with wellness is what we call it. So we have a psychologist and, nutritionist. We do acupuncture and massages.

     

    00:00:45:14 - 00:01:09:10

    Speaker 3 - Griffin Jones

    What if a quarter or a third of your patients left the US or Canada or Europe to get equal quality IVF for a quarter of the cost in another country? What country could that be? If you saw what I'm seeing here in this stunning district of the largest city in North America, the answer would be heir apparent. Juan Moctezuma is the co-founder and co-CEO of Reina madre, which among other specialties, is one of the largest ObGyn networks in Mexico.

     

    00:01:09:12 - 00:01:34:04

    Speaker 3 - Griffin Jones

    Daniel Madero is the CEO for Fertilidad Integral, one of the largest IVF groups in the city with two labs and three clinics. They talk about the hub and spoke model that each of their organizations are developing, how they plan to multiply the number of IVF and egg freezing patients in Mexico, how they plan to use technology like conceivable to scale IVF care and fill patient pipelines.

     

    00:01:34:06 - 00:01:57:02

    Speaker 3 - Griffin Jones

    Starting with the ObGyn, they discuss the capital markets in Mexico and why it's one of the biggest opportunities for investment in health, tech and IVF on the planet. They're both sold on this automated IVF lab from conceivable, but why? They talk about why it's such an integral part of their strategy for vast expansion. Joy.

     

    00:01:57:04 - 00:02:18:23

    Speaker 4

    Today's advertiser helped make the production and delivery of this episode possible for free to you, but the themes expressed by The Guest do not necessarily reflect the views of inside reproductive health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest appearance is not an endorsement of the Advertiser.

     

    00:02:19:01 - 00:02:44:14

    Speaker 3 - Griffin Jones

    Mr. Moctezuma, Juan, welcome to the Inside Reproductive Health podcast. Mr. Madero, Daniel, Danny, my friend, welcome back to the Inside Reproductive Health podcast. This time in person, this time on your turf. Looking forward to talking to both of you. Tell me a little bit, Juan, about the business model of Reyna madre, which is a large ObGyn group, a large group, a few different specialties as I understand.

     

    00:02:44:14 - 00:02:52:03

    Speaker 3 - Griffin Jones

    But tell me a little bit about Reyna madre at the global level. And then specifically in in an area.

     

    00:02:52:05 - 00:03:20:08

    Speaker 1 - Juan Moctezuma

    Of course. It's a pleasure to be here. Thank you for the invitation. So, both Reyna madre and Maria Linda, we are the largest network of ob gyn pediatrics and dermatology in in Mexico. We have a chain of 14 clinics throughout four states with a plan of going national in the years to come. And entering into ob gyn, we have a network of over 120 abortions.

     

    00:03:20:10 - 00:03:55:15

    Speaker 1 - Juan Moctezuma

    We have, five areas recently, in the last five years, and we are hoping to increase a lot. Our outreach, in terms of fertility, right now, we provide about 500,000 consultations in the three specialties that I mentioned at the beginning. Fertility is a very nascent, niche that we are covering, today. But with the help of of conceivable, we are sure that we will be able to, expand our access and reach much more, families.

     

    00:03:55:17 - 00:04:03:15

    Speaker 3 - Griffin Jones

    And that's so right now with those five areas, no IVF labs, you use other folks, IVF labs. That. Right.

     

    00:04:03:15 - 00:04:23:15

    Speaker 1 - Juan Moctezuma

    Exactly. So, so we mainly, are partnering with Hope IVF, nowadays and these five areas, we've given over 10,000 consultations in over three years, about 350 treatments on more than 100, IVF. But we we're hoping to increase the number significantly.

     

    00:04:23:17 - 00:04:44:12

    Speaker 3 - Griffin Jones

    Of those 120 OB GYNs. How much of what they're doing involves gynecological surgery related to fertility? Are many of those 120? Are they just practicing obstetrics? Are they doing delivery in hospitals? Tell me about what they're doing and what they might be doing. As you go further down the road of Roe, I sure.

     

    00:04:44:12 - 00:05:15:21

    Speaker 1 - Juan Moctezuma

    So today, are over. Provide about 25,000 consultations per month. And that's mainly, prenatal care that that's our core. We, deliver about 500 new babies per month in a chain of on a network of partner hospitals that that we have in the 14 clinics. And the other half is normal ob gyn. So they're they are not really doing any fertility, specialized fertility nowadays.

     

    00:05:16:02 - 00:05:21:06

    Speaker 1 - Juan Moctezuma

    But we are hoping to change that then. And we'll talk about that. Here.

     

    00:05:21:08 - 00:05:36:11

    Speaker 3 - Griffin Jones

    Denny, when you were last on the podcast, I couldn't believe it had been that long. You weren't even the CEO of Fertilidad Integral yet. I think you may have been in talks with them, but for the last year and a half, you've been running one of the biggest centers here in Mexico City. Thank you for increasing my Latam audience.

     

    00:05:36:11 - 00:05:54:21

    Speaker 3 - Griffin Jones

    Last time you were on the Latam audience increased. And so like to see those numbers go up some more hit subscribe. So tell me a bit about what you've learned in the last year. And a half. What have you seen from this IVF center that maybe you hadn't seen before or or just now that you're running one?

     

    00:05:54:21 - 00:05:55:23

    Speaker 3 - Griffin Jones

    What's it been like?

     

    00:05:56:01 - 00:06:21:16

    Speaker 2 - Daniel Madero

    So we are three clinics now. We have two full clinics, and we have a satellite clinic hub and spoke in Toluca, the same place where they have a hospital. This past year and a half has been very eye opening. So coming into Fertilidad integral, I had a view of IVF that's more traditional and in line with what we are used to seeing in the US.

     

    00:06:21:18 - 00:06:59:15

    Speaker 2 - Daniel Madero

    But Fertilidad integral is focused on providing integral treatment. So holistic treatment, that means that even though we use evidence based medicine at the treatment level, we are supporting the patient throughout the experience with wellness is what we call it. So we have a psychologist and, nutritionist. We do acupuncture and massages, and we include this as part of the treatment for patients going through IVF, be it freezing their eggs for preservation or trying to conceive.

     

    00:06:59:17 - 00:07:09:10

    Speaker 3 - Griffin Jones

    You talked a little bit about hub and spoke. So right now to IVF labs with those three clinics. Is that the case or where do you see the hub and spoke model going?

     

    00:07:09:12 - 00:07:33:17

    Speaker 2 - Daniel Madero

    One of the things that we've seen with our satellite clinic is we have a big population of patients that. So for context, Mexico City is a country. It's massive. And then when we talk about Mexico City, you also have Mexico State, which is basically the surrounding area around Mexico City. But it's a different state.

     

    00:07:33:17 - 00:07:36:23

    Speaker 3 - Griffin Jones

    So like LA and LA County, but bigger, correct.

     

    00:07:37:01 - 00:07:38:19

    Speaker 2 - Daniel Madero

    24 million people.

     

    00:07:38:21 - 00:07:40:14

    Speaker 3 - Griffin Jones

    In the city or in the state.

     

    00:07:40:16 - 00:08:15:07

    Speaker 2 - Daniel Madero

    In city and state. So we are seeing that a lot of people within the state are still two, three hours away, drive from Mexico City from our main lab. So we want to disrupt their everyday life as little as possible. So we're building this satellite clinics to try to get closer to them. So that drive is no longer two hours, but 30 45 minutes where they're going to have to do most of the treatment, their stimulation, follow ups, and then only be at the clinic for retrieval and transfer.

     

    00:08:15:08 - 00:08:22:21

    Speaker 2 - Daniel Madero

    That means that they only have to travel twice if they're doing IVF, or ones if they're doing egg freezing.

     

    00:08:22:22 - 00:08:36:17

    Speaker 3 - Griffin Jones

    Juan, do you see Reina madre getting into this hub and spoke model as well? Do you see yourselves being more of the spokes funneling into hubs like Hope, IVF or Fertilidad Integral. What's your vision for this?

     

    00:08:36:19 - 00:08:59:09

    Speaker 1 - Juan Moctezuma

    Yeah, sure. So we're thinking of doing something that has worked, very well for us in new deliveries. So we started in Toluca having our own hospital inpatient clinic with 20 with 20 rooms. And the way we expanded, we we were talking to the owners of these big, hospital groups, such as the Star Medical Center in Killeen.

     

    00:08:59:09 - 00:09:23:20

    Speaker 1 - Juan Moctezuma

    And they said, like, okay, if you bring me all of your volume, of course we'll give you, great prices. So we like that idea. We see ourselves. That's our very low CapEx, model going forward. And we don't want to own a single lab in IVF, but we want to do hundreds or even thousands of IVF. And I think that's where where, hope IVF and conceivable enter for us.

     

    00:09:24:00 - 00:09:37:17

    Speaker 3 - Griffin Jones

    So you've we're here at hope IVF and conceivably ora is here on site. What have you been looking at the past couple of months and how do you see it growing into your system.

     

    00:09:37:19 - 00:10:00:23

    Speaker 1 - Juan Moctezuma

    Sure. So so I think the key for us is to empower our OB GYNs to be able to be the first point of contact and, training them and giving them all the tools so they can refer to our areas and, and then, to patients to come to one of the spokes, such as hope, IVF. So the main, main point is our doctors.

     

    00:10:01:01 - 00:10:05:19

    Speaker 3 - Griffin Jones

    Don't you see that going the same way? Do you see the OB GYNs being the front line?

     

    00:10:05:21 - 00:10:35:07

    Speaker 2 - Daniel Madero

    This is a place where most of the markets that I've seen are similar. There is a clear break between rise and OB GYNs, and one of the biggest challenges that we have anywhere really, is how to actually bring that gap closer together. Here in Mexico, we are starting to pilot some programs with OB GYNs in order to empower them as well.

     

    00:10:35:09 - 00:11:01:04

    Speaker 2 - Daniel Madero

    In this case, as you know, I've worked I was working with Levy last time I was in this podcast. So with Levy with translated the product, and we're going to start putting it in the hands of doctors so they can be kinds so they can start, doing more with less, meaning they don't have to get educated in order to get to a concrete diagnosis.

     

    00:11:01:06 - 00:11:23:09

    Speaker 2 - Daniel Madero

    But we can give them tools so they can get there faster. And once we have, diagnosed patient with a treatment line that we need to follow, then we work with those who begins to either bring those patients to Fertilidad Integral or work with them in the stem, and then doing the retrieval and everything else, and certainly integral.

     

    00:11:23:11 - 00:11:49:17

    Speaker 2 - Daniel Madero

    But this is a pilot and I'm hoping this works. And you've seen it one. Right. Like you have access to hundreds of OB GYNs that are seeing patients on a daily basis. And in fertility, it's 1 in 6 that, in fact, that's affected like 1 in 6 patients that will be affected. So a lot of patients that are getting to your OB GYNs will either today or down the line, need treatment at some point.

     

     

     

    00:11:49:19 - 00:12:03:00

    Speaker 2 - Daniel Madero

     

    So bridging that gap is going to be key for the success of, I guess, what you're doing with what we want to achieve with conceivable as well. And for us moving forward.

     

    00:12:03:02 - 00:12:23:09

    Speaker 3 - Griffin Jones

    Do you see these pilot programs being able to replicate in the United States, or is there anything specific about the health care system in Mexico that makes the testing of this hub and spoke model either easier, or just makes Mexico more logical place to do it? First?

     

    00:12:23:11 - 00:12:42:22

    Speaker 1 - Juan Moctezuma

    Sure. So so I mean, Mexico is already, a third or even less of the costs us as in the US, right. And the other has always been and will be about access and about delivering the best quality, but at lower cost. So, so for us the game means volume. And with volume comes, lower costs on lower prices.

     

    00:12:42:22 - 00:12:56:17

    Speaker 1 - Juan Moctezuma

    Talk to our patients. So, today I don't see, that that's so clear. In the US, I see more for the US patients to come to Mexico. Really to be, to be honest. But that's my opinion, I don't know.

     

    00:12:56:19 - 00:13:11:19

    Speaker 2 - Daniel Madero

    And I'm going to speak from experience of working in the U.S here. I think that one of the bottlenecks that the US currently has is the amount of rice that are coming out every year. You know these better than I do.

     

    00:13:11:20 - 00:13:13:01

    Speaker 3 - Griffin Jones

    60 last year.

     

    00:13:13:03 - 00:13:14:22

    Speaker 2 - Daniel Madero

    And how many retired?

     

    00:13:15:00 - 00:13:17:08

    Speaker 3 - Griffin Jones

    I don't know, I actually want to find that number.

     

    00:13:17:09 - 00:13:41:18

    Speaker 2 - Daniel Madero

    Exactly. So I think the we're going to get to a point in which we might have in the US more rice, retiring than those coming into the market. But talking about Mexico, we actually have a steady flow of rice. The main challenge that we have in Mexico is that a lot of those rice and the practicing traditional ob gyn as well.

     

    00:13:41:20 - 00:14:18:16

    Speaker 2 - Daniel Madero

    So there are things that we can bring from the American market, which is something that we are trying to do vertically integral focus those rice in doing what they're best at and putting those acquired that acquired knowledge into action. So just focusing on, fertility and then augmenting them. So we're thinking about augmenting or begins trying to get more people in through the door to, fertility treatments, but also here in Mexico, we need to get more rice doing just reproductive endocrinology.

     

    00:14:18:18 - 00:14:23:06

    Speaker 3 - Griffin Jones

    Why is it the case that there's a steady flow of rice in Mexico? What's producing that?

     

    00:14:23:08 - 00:14:54:03

    Speaker 2 - Daniel Madero

    Multiple programs across the, across the country. But this is more of, particularity of the of Mexico. So in the US, if you just had more programs graduating, rice, that would be great. Here in Mexico, we just have more programs graduating rice. And you'll have, you know, 2 or 3 areas graduating from where I'm program and other ones turning out like 4 or 5.

     

    00:14:54:05 - 00:15:01:21

    Speaker 2 - Daniel Madero

    So we have, compared to the population, a lot more graduating than in the US.

     

    00:15:01:23 - 00:15:13:16

    Speaker 3 - Griffin Jones

    Why is it the case that so many of them are practicing obstetrics? Is that because there's not enough economic demand for IVF, or is it just what they're used to?

     

    00:15:13:18 - 00:15:50:00

    Speaker 2 - Daniel Madero

    The latter is a good one. I think it's that's a multi-pronged answer. Tradition is one of them. I think they like to, you know, they do this subspecialty, but they also like surgery. So they still do surgical procedures and they also have their own patients. So they like to do ob gyn. And what that creates in the market is also this dynamic in which a lot of the OB GYNs don't like to send rice their patients because they think and it sometimes happens, that they will keep those patients all the way to delivery.

     

    00:15:50:02 - 00:16:11:21

    Speaker 2 - Daniel Madero

    But it's market dynamics. That's one thing. The other one is there aren't enough places that are hiring rice just to practice reproductive and archeology. So that's the second particularity here. We are not seeing enough places where those areas can just focus on IVF.

     

    00:16:11:23 - 00:16:20:17

    Speaker 3 - Griffin Jones

    Is that because there's something broken in the pipeline, or that there's not a pipeline established for bringing in IVF patients?

     

    00:16:20:19 - 00:16:48:01

    Speaker 2 - Daniel Madero

    That, and also the market has been somewhat stagnated over time. So there needs to be a push in making that pie bigger. And I think with Reno already starting to make a push with conceivable, we're also excited about joining forces with conceivable, we can increase that potential and open doors for rice to just do, IVF.

     

    00:16:48:03 - 00:17:17:14

    Speaker 2 - Daniel Madero

    Getting one IVF patient is costly. Going out there and finding an IVF patient is expensive. If you're going to be doing direct to consumer marketing. And you know this because you work with a lot of clinics, but if we can generate a steady flow of patients for those areas, I think we can shift that dynamic into one that we can have them practice solely.

     

    00:17:17:16 - 00:17:22:09

    Speaker 3 - Griffin Jones

    Hence the pipeline. Is there any major? Is that a private equity backed group?

     

    00:17:22:11 - 00:17:24:21

    Speaker 1 - Juan Moctezuma

    Yes. Family office from from Monterrey.

     

    00:17:24:23 - 00:17:47:12

    Speaker 3 - Griffin Jones

    So I want to talk a little bit about the capital. That seems to have been injected in Mexico City. Last time I was here was 2010, and it was a pretty city and had great universities. And there have always been nice neighborhoods. But here we're basically in Bel-Air. We're basically in Beverly Hills. You walk around in the nicest of restaurants, the nicest of cars, the nicest of houses.

     

    00:17:47:14 - 00:18:09:12

    Speaker 3 - Griffin Jones

    It seems like a lot of capital has come in that the capital has caught up to the size of the city, to the educational infrastructure that's here. Is that been the case? Is it is this is this money mostly coming from Mexico? Is it coming from outside of Mexico? Tell me about the capital ecosystem.

     

    00:18:09:14 - 00:18:32:13

    Speaker 1 - Juan Moctezuma

    Sure. So so something to remember in health care and particularly in Mexico, is that only 8% of the population is is insured. Right. So probably of all the IVF cycles in the entire country, 90 to 95% I would say is out of pocket. So the insurance part of it is still still very nascent, with a lot of opportunity.

     

    00:18:32:13 - 00:19:00:10

    Speaker 1 - Juan Moctezuma

    If you put your optimistic glasses, there's a huge market opportunity out there, for a rainy day, for example, we are 100% out of pocket. All our population based out of. And we're targeting the middle income segments, but there's a huge, need and a huge demand for IVF and reproductive services. So, capital is there ourselves are in the process of of making another, round of capital.

     

    00:19:00:10 - 00:19:11:10

    Speaker 1 - Juan Moctezuma

    And there's, a lot of the men that and a lot of, people interested. So I think, we're at a prime time in Mexico, as you are mentioning, to raise capital and to enter healthcare in particular.

     

    00:19:11:15 - 00:19:21:08

    Speaker 3 - Griffin Jones

    For context for the audience. Normally when we talk about a percentage of the population having insurance, we're talking about IVF coverage. But in in our case, we're talking about health insurance, period.

     

    00:19:21:12 - 00:19:21:23

    Speaker 1 - Juan Moctezuma

    Private.

     

    00:19:22:00 - 00:19:25:07

    Speaker 3 - Griffin Jones

    8% of the Mexican population has health insurance.

     

    00:19:25:07 - 00:19:26:05

    Speaker 1 - Juan Moctezuma

    Has private has.

     

    00:19:26:05 - 00:20:06:00

    Speaker 3 - Griffin Jones

    Private health insurance. And so you're asking me will probably be 1% or fewer. Have any kind of coverage for IVF. So the capital is there. Tell me about the technological infrastructure that has been, has been happening because Trump tariffs aside, it seems that there's been this this reshoring and this re industrialization of North America and that part of the strategic plan for the US at least, has been that lower cost but higher education workforce from Mexico, particularly on the tech side.

     

    00:20:06:02 - 00:20:12:15

    Speaker 3 - Griffin Jones

    Give me give us some background on, the tech investments in the tech workforce here.

     

    00:20:12:16 - 00:20:41:22

    Speaker 2 - Daniel Madero

    I'm going to lead that off with did you know that Nvidia is building the biggest mega factory in Guadalajara, Mexico, which is where conceivable, was developed? That gives you an idea of the way that big tech is looking at Mexican talent, and also the injection of capital that you're seeing into the market. You also have a lot of Mexican capital, so you're backed by a family offices.

     

    00:20:42:00 - 00:21:12:10

    Speaker 2 - Daniel Madero

    Family offices here have big pockets, and they have the capacity to fund a lot of these technical technological innovation that's going to be happening. And moving forward. We have conceivable to how to but from the healthcare perspective, you can see big hospital groups as well. You are becoming one of them. There's your competitor called plena, but they're VC backed, as we are.

     

    00:21:12:10 - 00:21:44:13

    Speaker 2 - Daniel Madero

    But you also have hospitals, Mike, you have star medic, Arjuna coming in from Peru. So you have a lot of capital coming into Mexico, either from Mexican capital, but also because the Mexican market is incredible. So I'm going to speak from my perspective, one being Colombian working, having worked in the US, in in Europe before, the Mexican market is incredible in terms of the opportunity that you see.

     

    00:21:44:15 - 00:21:50:02

    Speaker 3 - Griffin Jones

    Mexico, not just the capital market, but you're talking about the entire the opportunity in the marketplace, right?

     

    00:21:50:04 - 00:22:17:02

    Speaker 2 - Daniel Madero

    Mexico City is 22 million people, 24 million people. Their margin of error is a city, a big city in Europe. That's how large Mexico City is. Chilean goes the people from Mexico City, they talk about provincia, which is this like smaller cities, the smaller cities are 6 million people. Monterrey. Well, O'Hara and then you have other populations like Puebla, 2 million people.

     

    00:22:17:04 - 00:22:32:17

    Speaker 2 - Daniel Madero

    That's a large European city. That's a large city in America. So the market, be it capital or for any type of product that you can come up with, will work in Mexico so that you.

     

    00:22:32:19 - 00:23:02:04

    Speaker 1 - Juan Moctezuma

    Well, I like that foreigners are always so optimistic, but I share that that view and I think we're in, prime time. That's why I'm mentioning a lot of investments, not only in health care, but also, neobanks, emerging and being, strong competitors such as Clara and, clip and, and a lot of, of businesses that are already reaching, unicorn status and, are growing quite successful.

     

     

     

     

    00:23:02:05 - 00:23:27:08

    Speaker 3 - Griffin Jones

    So you have this talent base, there's a large gap in cost, as you mentioned, healthcare costs very often. A third, and in the case of IVF might even be a quarter, but it doesn't seem to be that gap in quality. So you have a lot of people from the United States coming to Mexico for care. And Alejandro Chavez very well has said that a third of the patients that is Guadalajara, Guadalajara office come from the US.

     

    00:23:27:10 - 00:23:31:14

    Speaker 3 - Griffin Jones

    Tell us about the US patients that you're seeing.

     

    00:23:31:16 - 00:24:04:10

    Speaker 2 - Daniel Madero

    So we're seeing US patients come from the US, but also we are serving the expat market here in Mexico City anywhere. And a fourth of our patients come from the US. They fly down to get treatment. And about 35% are non Mexican. We are right now at Benchmark in Vienna consensus meaning that we're up there with the best clinics in Europe, and we can compare our numbers to the best clinics in the US as well.

     

    00:24:04:12 - 00:24:28:07

    Speaker 2 - Daniel Madero

    One of the beauties in our space is that when you have the right technology, the right training, medications are going to be the same. Stimulation protocols are going to be caught up on pretty quickly. You just need to go to ESRI or SRM to learn the latest, and then you can bring that knowledge and implement it in your probably state of the art lab.

     

    00:24:28:09 - 00:24:55:00

    Speaker 2 - Daniel Madero

    So across the board, IVF numbers are going to be like outcomes are going to be similar. We pride ourselves in being very meticulous, both at the Evidence-Based, treatment level, but also within the lab. So we have a state of the art lab, and this means that we can track at a granular level, temperatures in all our services, in all our equipment, be it.

     

    00:24:55:02 - 00:25:03:21

    Speaker 2 - Daniel Madero

    Thanks. We had incubators, be it, stations, but we are at the highest level of outcomes that you can find.

     

    00:25:04:02 - 00:25:06:20

    Speaker 3 - Griffin Jones

    Are you able to share the costs for an IVF cycle?

     

    00:25:06:20 - 00:25:42:09

    Speaker 2 - Daniel Madero

    For sure. It would be $120,000, which is about $6,000 in meds is going to be between 2 and $3000, actually less between. Yeah, let's say $23,000. And then if you want to do PGT, that's going to set you back about $400 per embryo. All in all, you're going to end up spending with trip stay everything 11 to $12,000 for your whole IVF treatment.

     

    00:25:42:11 - 00:26:06:20

    Speaker 1 - Juan Moctezuma

    And if I may add something important like, we've been hearing that in the States, for example, wait times, are six months or even a year, right? In, in Mexico, it's extremely fast. You can have your appointment, the next day or the next week at the most. And you have a very personalized care, like all the way since entering, like, as Danielle is saying, we're going to pamper you.

     

    00:26:06:20 - 00:26:13:14

    Speaker 1 - Juan Moctezuma

    We're going to be with you all this step of the way. We really, really, take care of you from start to to finish.

     

    00:26:13:16 - 00:26:36:19

    Speaker 3 - Griffin Jones

    It's it's incredible. I can't yeah, if you could have that price for an IVF cycle and be in Bel Air and it's, it's almost like why not if you're, if you have to go through something extremely stressful, why not go do it in a very nice setting for less, for also for less money. So I see that opportunity.

     

    00:26:36:19 - 00:26:55:13

    Speaker 3 - Griffin Jones

    I don't think wait times are that long in the US, or at least they haven't been since Covid. I mean, it's probably a couple lucky doctors with really long waitlists like that, but in Canada that that does tend to be the case in some places where they can't get to see you very then four months or so. And so this is an opportunity for some of these folks.

     

    00:26:55:15 - 00:27:11:13

    Speaker 3 - Griffin Jones

    What opportunities are you seeing with regard to AI in emerging technologies, or what specific applications are you seeing for them across your health system? What are you really paying attention to? What are you investing in now, specifically?

     

    00:27:11:15 - 00:27:37:17

    Speaker 2 - Daniel Madero

    I think I might name a few of the companies that we work with that a lot of your audience is going to know. We recently, started, working with eLife. So we're using their embryo tool. And it's it's been great because we've actually have access to the full AI capability of the tool. I think that's an advantage that we have as a market compared to the US.

     

    00:27:37:17 - 00:28:19:19

    Speaker 2 - Daniel Madero

    We can use a lot of these AI tools at their full capacity, even prior to any clinic in the US. We are also using AI to better communicate with patients. And we're leveraging AI to look at our data. We're using Foley scan from MIM to make the process of follicular counts friendlier for the patient. So instead of it taking ten minutes, this takes a three second video that you can get done in three minutes or less, and then spend more time with the patient sitting in front of you.

     

    00:28:19:21 - 00:28:39:15

    Speaker 2 - Daniel Madero

    So we are leveraging AI in improving the patient experience through communication, through making the treatment more efficient, and also in improving outcomes with tools like a life and some others that we are starting to test out.

     

    00:28:39:17 - 00:29:00:06

    Speaker 1 - Juan Moctezuma

    In our cases. Mainly we have a very big team, in call center, we have over 60 people and we are streamlining that with, with third party company. But in order for us to be able to have a much better interaction, with the patient and of course, with conceivable, we're very excited as well to, to join forces with them.

     

    00:29:00:11 - 00:29:20:02

    Speaker 3 - Griffin Jones

    Does that include does that call center investment, does that include scheduling. So you automating scheduling is that is that part of what's happening. And then are you automating the patient journey in certain places so that you know, if they need labs or, any, any of the next steps are, is that happening in automation or not quite yet?

     

    00:29:20:04 - 00:29:50:05

    Speaker 1 - Juan Moctezuma

    So the first phase, let's say it, it's going to be appointment that agenda scheduling and so forth. We were last week in, in Brazil meeting different companies. And for example, we were thinking of partnering with a company, care code. And they are building their own agents and we are, pilot testing in a few months time, probably having our own agents to have an interaction and to be able to, have the first diagnosis and to be able to, talk to the patients as a first, step.

     

    00:29:50:07 - 00:29:57:23

    Speaker 1 - Juan Moctezuma

    Yeah, we like, at, 1 a.m. or 2 a.m. or if it's, kind of on an emergency then.

     

    00:29:57:23 - 00:30:01:03

    Speaker 3 - Griffin Jones

    And you said you're excited about conceivable. What are you excited about?

     

    00:30:01:05 - 00:30:40:03

    Speaker 2 - Daniel Madero

    One of the things that absolutely blew my mind when I first saw the robot at work was its capacity to make very specific changes at a, microscopic level in the process of doing things like moving the micro manipulator at this speed instead of that speed. When you walk into an IVF lab, what you're seeing is a very manual way of doing things, and one of the most amazing things of seeing this happen is seeing the embryo at the end of the day.

     

     

     

    00:30:40:05 - 00:31:14:20

    Speaker 2 - Daniel Madero

    But when you start having standardization within the lab, you can start playing around with the amount of things that, that you do. So I was talking to Alejandro Ro, a few months back, and there is I used to watch a lot of, biking bicycles. And in the UK, the Sky Team Ineos now used to be like the laughing stock of biking, until they hired this guy called Sir Richard Brailsford.

     

    00:31:15:00 - 00:31:16:02

    Speaker 2 - Daniel Madero

    If I'm going to say Richard.

     

    00:31:16:02 - 00:31:16:22

    Speaker 3 - Griffin Jones

    Branson, is.

     

    00:31:16:22 - 00:31:17:10

    Speaker 2 - Daniel Madero

    It. No. No.

     

    00:31:17:10 - 00:31:19:11

    Speaker 3 - Griffin Jones

    But okay, so somebody that we haven't.

     

    00:31:19:11 - 00:31:51:06

    Speaker 2 - Daniel Madero

    Heard of know. So this guy they made him the team lead. And he came with this philosophy of saying let's find incremental gains, let's say marginal gains. And by changing small things like nutrition, sleep, standardizing and personalizing training for each one of their athletes, within two years, they became the best team and they had this hedge money hegemony.

     

    00:31:51:12 - 00:32:10:21

    Speaker 2 - Daniel Madero

    Is that word? Yeah. Think so. Okay. Good in biking for almost 8 or 9 years where they were not be they were not beat by any other team. And this was because they were making small changes. Now imagine being able to do that in the IVF lab all at once.

     

    00:32:10:21 - 00:32:23:17

    Speaker 3 - Griffin Jones

    Because when you're automating the entire process and you have robotics and AI throughout the entire process from retrieval to transfer, it's riddled with potential incremental, correct opportunities.

     

    00:32:23:17 - 00:32:50:22

    Speaker 2 - Daniel Madero

    So it becomes, 1% or a point 5% times appalling, 5.5%. So 1% times up 0.3%. It's compounding. So the final effect might be 30% higher than what we're seeing today. Anywhere from finding more eggs to getting more embryos to having more accurate PGT, you name it.

     

    00:32:51:00 - 00:33:17:16

    Speaker 3 - Griffin Jones

    Quan. Where do you see the capacity for the market going? So you've got 120 ObGyn. You're a half a million consultations across your different disciplines. You got five eyes and that that can plug into this system for those 120 organs. How big can the market grow in terms of numbers? What do you think that you all will be able to do with conceivable.

     

    00:33:17:16 - 00:33:19:06

    Speaker 3 - Griffin Jones

    How long do you think it will take?

     

    00:33:19:08 - 00:33:42:17

    Speaker 1 - Juan Moctezuma

    Sure. So so I mean, what excites us the most about conceivable is really going back to the costs. And how can we really lower the prices to our consumers that are limited with their resources? So I think as, as we become, more innovative on how, we price it and the scale that we reach today we're doing, 6000 deliveries.

     

    00:33:42:19 - 00:34:00:21

    Speaker 1 - Juan Moctezuma

    Per year. I think we can reach 15 or 20% of of that number, with IVF, probably in 2 or 3 years, if we are able to really communicate our product and, and leverage what already, hope IVF conceivable. I know the players are doing fantastically.

     

    00:34:00:23 - 00:34:26:06

    Speaker 3 - Griffin Jones

    Do you see the insurance market in Mexico growing? Do you think that IVF will become a part of that? Might we grow from 8% to 20% to 25%, or is that not likely? Do you think it's more likely that clinics will will offer benefits directly to those larger employers that are interested?

     

    00:34:26:08 - 00:35:02:13

    Speaker 2 - Daniel Madero

    Yes, all of them. That's a really great question, Griffin. Because what we are seeing at Fertility Integral and shout out to both Carrot and Maven, who are our partners, they're providing benefits for their companies in the US. But those companies have to extend the benefits here in Mexico. So because of that, there is now these push from other companies to start finding out about fertility benefits.

     

    00:35:02:15 - 00:35:31:14

    Speaker 2 - Daniel Madero

    So we work with, Netflix, for example, we see Netflix, employees because they're covered by carrot. But some of the companies that are not covered are starting to come to us and say, hey, what can we do? And to be honest, Griffin, I don't want to become a benefit provider, but if I have to, I will because we will.

     

    00:35:31:16 - 00:36:01:14

    Speaker 2 - Daniel Madero

    I can't do it myself. We will because the need is there. More and more companies are asking for this. And backstage we were talking about the size, the sheer size of some of the Mexican companies. So Grupo Modelo or Grupo Bimbo, these are companies with thousands and thousands of employees across Mexico, and they're going to have a need for this type of benefits at some point.

     

    00:36:01:16 - 00:36:32:19

    Speaker 2 - Daniel Madero

    So I'm not going to talk about insurance per se, like private health insurance, but I can talk about the need for fertility benefits starting to rise within the market. And we are talking to a lot of companies just doing informational talks. So we I'm going to say 2 or 3 times a month, we'll be going to companies and speaking to their employees because the company came to us asking if we could do something with them.

     

    00:36:32:21 - 00:36:50:23

    Speaker 2 - Daniel Madero

    The market is there now. What the future of it looks like, I don't know, but if we have to become a fertility provider benefit provider, we will. If we can do it through Carrot or Maven. I'm happy to talk to you guys. I've already told them, but yes.

     

    00:36:51:00 - 00:36:58:23

    Speaker 3 - Griffin Jones

    Juan, how much is Reina Madre paying attention to? Egg freezing? What volume do you think you could grow that market to?

     

    00:36:59:00 - 00:37:25:18

    Speaker 1 - Juan Moctezuma

    Yeah. So? So, with the recent conversations also with, with Josh and, people, experts in the field. Alejandro, we were highly encouraged, with the concept and with, increasing the volume because, unluckily for Reina madre, people are having less and less children. Right. So when we started putting them out of there ten years ago, there were 2.5 million babies in Mexico per year.

     

    00:37:25:20 - 00:37:53:22

    Speaker 1 - Juan Moctezuma

    And today it's about 1.9 million. So it has been a huge decline. This is happening globally. But what's shifting in the mindset of, of many, women is, okay, I don't, want to have babies or right now, but what if the what if it's something that today is, is a reality? And I think that if we can be there to support them and to tell them this is kind of like an insurance, right?

     

    00:37:54:00 - 00:38:21:13

    Speaker 1 - Juan Moctezuma

    Like you don't want to have babies right now. You think you don't want to have them, in the next five years. But one of you find the love of your life. What if you decide to be, a mom on your own? Like, why don't you have the option, right? And also with scale and with costs being, lower year after year, I think the market could be, two or even three times as big as the IVF, market, person.

     

     

     

    00:38:21:13 - 00:38:29:07

    Speaker 1 - Juan Moctezuma

    So we as a mother are looking forward to really doing a compelling product in increasing market.

     

    00:38:29:09 - 00:38:48:01

    Speaker 3 - Griffin Jones

    What do each of you want the global market, the US market, your colleagues in other countries to know about IVF in Mexico or women's health tech in Mexico, or what do you want them to pay attention to?

     

    00:38:48:03 - 00:39:13:13

    Speaker 1 - Juan Moctezuma

    I would probably, repeat that Mexico is showcasing extremely high quality, extremely good outcomes and results at a fraction of of the cost. So really pay attention. Maybe come, do your egg freezing. Or maybe do the whole IVF. Then come to one of our great, vacation places and come and see Mexico with fresh eyes.

     

    00:39:13:15 - 00:39:46:06

    Speaker 2 - Daniel Madero

    And I'm going to see the talent here. And the people that are working in this are trailblazers. So as a country, Mexico usually gets a bad rap in the news and with everything that's going on. But once you start seeing the city, knowing the people, seeing the talent that we have here in Mexico, your eyes are opened not only because of the sheer size of the market, but the things that are being done anywhere from fintechs.

     

    00:39:46:08 - 00:40:12:19

    Speaker 2 - Daniel Madero

    So Juan was mentioning the names of probably half of the cards that are in my wallet from the tech side, Nvidia building, you know, the mega factory and also and medicine. I'm a huge fan of what trainer Maria has built, and I'm very excited to see what they're going to be building into the future. And these are business models that are not unique to Mexico, but they're being born here.

     

    00:40:13:01 - 00:40:48:04

    Speaker 2 - Daniel Madero

    And people can learn from what we're doing in Mexico, either in the fertility space with conceivable, with Fertilidad Integral, or even in general in women's health as well. I would like for people to give Mexico a chance. We have incredible outcomes. We have an incredible country overall, like pick a place from Cancun, Oaxaca, San Miguel and Mexico City to the high quality of our health care.

     

     

    00:40:48:06 - 00:40:56:21

    Speaker 3 - Griffin Jones

    Juan Moctezuma in Madero, thank you both for joining me on this special in person edition of the Inside Reproductive Health podcast.

     

    00:40:57:02 - 00:40:58:20

    Speaker 1 - Juan Moctezuma

    Well, I'm here, thank you very much.

     

    00:40:58:22 - 00:41:04:20

    Speaker 2 - Daniel Madero

    My pleasure. Griffin, as always, thank you very much.

     

    00:41:04:21 - 00:41:26:03

    Speaker 4

    Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of inside reproductive health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest appearance is not an endorsement of the advertiser.

     

    00:41:26:05 - 00:41:28:22

    Speaker 4

    Thank you for listening to Inside Reproductive Health.

     

Fertilidad Integral
LinkedIn

Reina Madre
LinkedIn
Facebook
TikTok

Daniel Madero
LinkedIn

Juan Esteban Moctezuma
LinkedIn


 
 

252 The Evolution of RMA. Dr. Thomas Molinaro

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


IVIRMA is so large that they had 1,400 attendees at their international congress alone.

But what does it take to implement change, scale care, and keep the patient experience high inside an organization that large?

This week’s guest, Dr. Thomas Molinaro, Chief Medical Officer of IVIRMA North America, shares what’s working, what’s still being figured out, and what challenges fertility networks of every size should be preparing for.

Tune in to hear about:

  • The AI solution they’re using to save REI time (and how it’s going so far)

  • What they’ve learned from piloting patient journey platforms

  • Their APP-to-REI ratio and how they approach shared workflows

  • The evolving debate over who performs ultrasounds (REIs or sonographers?)

  • The marketing on behalf of REIs before the patient walks in that is critical to care

If you’re curious about the operational future of large fertility networks—or want a blueprint for scaling thoughtfully—don’t miss this episode with Dr. Molinaro.


Improve Patient Experience. Reduce Doctor Burnout
See Why Other Fertility Doctors Love These CRNAs

Fertility doctors from across the country are getting support from this one CRNA firm. 

  • Fertility doctors across the US are using Kaleidoscope Anesthesia

  • Kaleidoscope Anesthesia’s CRNAs are known for clinical excellence, their calm bedside manner, and enhancing patient care experience.

  • Avoid burnout by offloading this responsibility to professionals you trust.

  • Scalable, agile staffing, from daily coverage to full perioperative system design.

  • 200+ seasoned CRNAs. Nationwide reach. Fast onboarding.

We’ll show you how other fertility centers are improving patient experience, reducing doctor and staff burnout, reducing cancellations, and improving workflow.

  • Thomas Molinaro (00:03)

    At every level of the organization, we want a physician and a business leader to be working hand in hand, you know, to balance each other out. We obviously need organization, we need structure to be able to

    run the company, but we also need to make sure that patients are brought along with us. And I think one of the unique aspects of our organization that sets us apart is that we really believe that our path to success is through our patient success.

    Griffin Jones (00:41)

    Many fertility networks don't even have 1,400 employees. IVIRMA is so big, they had 1,400 people just at their international congress. Dr. Thomas Molinaro is chief medical officer of their North American operations. How do you make change in an organization that large? How do you grow? Some of the things that Dr. Molinaro talked about, the AI that RMA is using to save physician time, the patient journey solutions they've piloted and why he isn't totally sold on

    one just yet, the ratio that RMA uses advanced practice providers for and how they use them, the internal debate on to what extent REI should be performing ultrasound scans versus having them all done by ultrasonographers, the limit to how much you can scale an REI's time, and IVIRMA's point of view on mergers and acquisitions.

    I hip you to an anesthetist staffing solution called Kaleidoscope Anesthesia Associates. They improve the patient experience, they support fertility clinics so that they don't have to worry about those staffing issues. Check them out at kaleidoscopeanesthesia.com. Finally, Tom shifted my point of view on some of the marketing that needs to be done on behalf of physicians ahead of time because of his thoughts on the openness of patients that is so critical for the REI to be able to do his or her job.

    Enjoy this conversation with Dr. Tom Molinaro, Chief Medical Officer of IVIRMA North America.

    Griffin Jones (02:29)

    Dr. Molinaro, Tom, welcome to the Inside Reproductive Health podcast.

    Thomas Molinaro (02:34)

    Thanks for having me, Griffin.

    Griffin Jones (02:36)

    How has IVIRMA North America evolved the past couple years?

    Thomas Molinaro (02:41)

    That's a great question. I think we've grown pretty significantly over the past few years. Started a few clinics, had a few other clinics join us. I think that growth has been really great for the organization. It's also allowed us the opportunity to work on our infrastructure, building that out. We have a great leadership team led by our CEO, Wyn Mason.

    And I think we're building a really strong culture here. And ultimately, it's an opportunity for us to continue to scale, to grow, and to help more patients achieve their dreams of having a family.

    So this has been a really interesting time.

    Griffin Jones (03:17)

    Why has the growth been great?

    Thomas Molinaro (03:19)

    So this has been a really interesting time.

    Griffin Jones (03:19)

    Why has the growth been great?

    Thomas Molinaro (03:21)

    You know, I think it's an opportunity to learn so much from the people that we've come into contact with.

    you know, the more experiences you have, the more new people you bring into the organization. Everybody has their own strengths that they offer. Everybody has their own perspectives. And ultimately, you know, we want to bring the best out in all of our, all of our clinics, all of our teammates. And so the more opportunities you have to cross pollinate, the more

    you'll learn from each other. ultimately, I think it makes the organization stronger to have so many different viewpoints, so many different experiences.

    Griffin Jones (03:56)

    You hear about different competing axioms in business. One being that businesses grow too fast all the time and it puts a strain on the quality of delivery. Another one is if you're not growing, you're dying. Now that you've been at this for a couple years, how do you think about growth? How do you mitigate it so that it's the right growth?

    Thomas Molinaro (03:59)

    Hmm.

    Yeah, I think that's great question. And certainly we don't want to grow just for growth sake. I think what we want to do is continue to expand in the right ways. We want to look for like-minded partners. We want to be able to bring the services that we offer to more patients. Clearly in this country, there's an access to care issue. And so more patients can benefit from infertility care than ever before.

    There's more opportunities for insurance coverage and for other ways to access care. And so it's incumbent on us as providers to figure out how to meet those needs. And so as we've grown, we've looked for partners who share the same philosophy of putting patients first. And that's really what has helped us grow in the right way, is that we've always looked for ways in which we can deliver

    the best care to patients and keeping them at the center of everything that we do.

    Griffin Jones (05:12)

    So you don't want to grow for growth sake, you being Tom Molinaro, but I wonder if a more accurate characterization is that you're going to grow as a company, but you have constraints on how you can grow, meaning that you have to maintain a quality of care or either maintain or improve the standard. not picking on RMA, but you're one of many networks that is owned by companies that are seeking to

    Thomas Molinaro (05:17)

    Yeah.

    Griffin Jones (05:40)

    return and investments, not a nonprofit. So these organizations have to grow. You're a physician, you need to be the standard bearer of not letting quality slip. How do you do that? How do you balance that?

    Thomas Molinaro (05:55)

    Yeah, that's great question. mean, I think, you know, our organization has really grown through, you know, we've been developing a dyad infrastructure. And I think Lynn spoke about this with you when she was on the show. But the idea is that at every level of the organization, we want a physician and a business leader to be working hand in hand, you know, to balance each other out. We obviously need organization, we need structure to be able to

    run the company, but we also need to make sure that patients are brought along with us. And I think one of the unique aspects of our organization that sets us apart is that we really believe that our path to success is through our patient success. If our patients can be successful, we'll be successful, right? And so ultimately we're willing to do anything and everything to help our patients achieve their goals. And really, how do you measure patient success?

    part of this. It's not just about how often do they get a positive pregnancy test, which is a big piece of it. That's something that we focus on, but it's also time to pregnancy. It's dollars to baby. It's patient experience along the way. And these are all of the essential components of how we run the business with those in mind first, patient safety, patient success, everything else follows from there.

    Griffin Jones (07:14)

    We'll link to the episode that we did with Lynn Mason, who you're referring to a few months back, and she talked about dyad leadership from her side of the dyad, the business side, and she gave some examples. What's a specific example that you can think of how you and Lynn approach a decision together?

    Thomas Molinaro (07:19)

    Hmm.

    You know, I think we're at every opportunity, we're trying to figure out what do we need to make sure that patients have the best outcomes. So if we have a clinic that's growing and we had a clinic that saw a tremendous increase in volume last year, we had to make the right organizational decisions around staffing and support. What kind of embryology staffing did we need to be able to go from a batch center to a continuous center? And at the end of the day, how many nurses did we need? How many clinical staff did we need?

    And so this is where I think the organization really excels because we have these discussions around what's best for patients and then ultimately try to understand how do we scale the organization so that it's cost effective, right? At the end of the day, we wanna make sure that patients are having the best opportunity to be successful.

    Griffin Jones (08:17)

    So in the case of the center that grew rapidly, is it about replicating those practices so that you have other centers that can also fulfill that type of volume? Or is it about now you have perhaps staffing needs, resource needs at a place like that that you didn't before and now you're trying to accommodate it?

    Thomas Molinaro (08:37)

    So it's a complicated question for sure. We do have staffing models that help sort of dictate what we think is normal for different sized clinics. At the end of the day though, every clinic is a little bit different. The geography might be different, the patients might be different. And so we have to understand how to customize that to the clinic in question. The other opportunity that we have is as we're growing regionally, the opportunity to share resources.

    Right? So when you have two clinics that are close to each other, they actually can share staff. And so if you need to borrow an embryologist and the embryologist is two hours away, that's an opportunity where you can sort of help bridge some of the growing pains to make sure that patients get the care that they need. The lab, the staff are all taken care of. And at the end of the day, it will continue to develop best practices for the organization.

    Griffin Jones (09:31)

    How do you approach the speed at which change is implemented?

    Thomas Molinaro (09:35)

    Yeah, that's a great question. And I think part of it is in planning, right? We really are trying to anticipate. We're not looking at next week. We're barely looking at next month. We're looking at three, six, 12, 18 months down the road, trying to predict where we're going to be. Because if you wait until the volume is here, it's too late. We really need to be thinking proactively about how the clinics are growing. What are we seeing as the evolution of our patient needs?

    and how can we prepare ahead of time so that we're not caught behind the apple.

    Griffin Jones (10:06)

    My only semi educated opinion of thinking about the market for the last few years and then where I think it will go in the next 10 or 20 is that REIs aren't gonna be doing 200 cycles a year on average or 150 cycles a year on average. They will be doing much, much more than that and they might be case managers of teams of

    advanced practice providers, maybe of OBGYNs, having a lot more AI support, having a lot more automation. Do you think that that's the case? Do you think we're headed for, not next year, but in the next decade or so, a field where REIs are doing an average of a thousand, two thousand cycles a doc?

    Thomas Molinaro (10:48)

    Yeah, I mean, that's a lot of cycles and I certainly can't see the future. What I can say is that there is an opportunity to leverage technology, to leverage APPs, to really help our providers take care of more patients and operate at the top of their license. That's really what makes an efficient provider is when your providers are doing the things that only they can do, that allows you to just take care of many more patients. so part of that is

    surrounding physicians and APPs with the right support staff. Part of that is physicians and APPs partnering together and trying to understand what are the patient needs that require the physician and what can be taken care of with APPs. And certainly we see it changing the model of care across our field. I personally think that our patients who have APP providers as part of the team benefit from having more eyes

    looking at the chart, more hands to touch them in the clinics and making sure that they're having the best outcomes. And I think that most of our patients who have teams that involve both physicians and APPs have a great experience and really good outcomes.

    Griffin Jones (11:55)

    How has the use of APPs at RMA evolved in the last five years or so?

    Thomas Molinaro (12:01)

    Yeah, we have been big proponents of APPs in our clinics. I think that they have transformed in many ways how we are able to take care of our patients. We have different APP types. have procedural APPs that focus more on ultrasounds, saline sonography, different sort of in-office procedures. And then we have the majority of our APPs are paired with a provider, paired with a physician, really.

    So I work with an APP. We see patients together. We talk every single day. And basically, she helps to direct me in the right ways. She helps to make sure that there's a second pair of eyes looking at everything. And that ultimately, our patients are hearing from one of us pretty frequently, whether it's me or her, kind of updating them on their progress, answering their questions. It really allows us to cover more ground.

    And ultimately for me as a busy physician, it helps me to prioritize which patients are most in need of my attention on any given day. So I think that it's been really an extension of the physician to have that EPP. And that's what's allowed us to scale, I think pretty significantly as teams. But again, your team is stronger than any one individual player.

    And so the fact that the APPs are really tied to a physician in such a tight way, think, has been a game changer for us.

    Griffin Jones (13:21)

    Is it a one to one ratio? there's one REI for one APP?

    Thomas Molinaro (13:27)

    For now, that's what our model looks like, for sure.

    Griffin Jones (13:31)

    Does she see patients at the new patient visit and then you see patients at the follow-up or vice versa?

    Thomas Molinaro (13:36)

    Yeah.

    We do it all different ways. sometimes we see patients together, which is great because I love having her with me and she, her name's Rennie. So Rennie does a great job with me, kind of seeing patients in the clinic. Sometimes she'll do the initial visit and I'll do the follow-up, which can be really helpful for a patient who hasn't had a lot of evaluation ahead of time. You know, I can talk to them once all their test results are back.

    right? And I can sort of come together with them and formulate a plan. but Reni did the introduction. She did the, the educational aspect. She's really good at making sure that patients have a good understanding of their situation. What are the tests? Why are we doing them? And what are the potential treatment options so that I can come in afterwards with the actual test results and formulate a plan. and we get lots of positive feedback from patients that they, you know, they recognize the value of the team.

    Griffin Jones (14:25)

    What do you like about doing it different ways? Sometimes doing the new patient visits, sometimes doing the follow up. Why not have it be all one or the other?

    Thomas Molinaro (14:33)

    I mean, I think it's just, it's a different way of doing things. Sometimes variety is interesting. You know, doing a new patient infertility consultation is something that I've done many times. It's a little more interesting to do, you know, a follow-up where you have test results and you can really speak to more specific aspects of care. Sometimes the really complicated patients that come around and having...

    an opportunity to spend more time with the complicated cases really is rewarding as a physician.

    Griffin Jones (15:01)

    Teamwork, top of license, these are things that need to happen across the practice because fertility care demands precision, compassion, and coordination, seamless coordination. That's why many of the chief medical officers you know, including Dr. Lynn Westfall, Dr. Angie Beltzels, partner with Kaleidoscope Anesthesia. They focus on what they do best, the doctors do, and then Kaleidoscope helps patients with their specialized anesthesia care.

    They have over 150 highly trained CRNAs across the country. Kaleidoscope provides more than just the staffing. They have licensed CRNAs in all 50 states, yes, but their periooperative systems analysis identifies workflow efficiencies. So that means that clinical teams can focus entirely on patient outcomes while they're improving their scheduling predictability and their patient satisfaction because Kaleidoscope CRNAs integrate smoothly with your existing team.

    bring specialized expertise in reproductive medicine procedures, a proven history of clinical excellence. They work with other fertility specialists and a dedication to compassionate patient interaction, and that helps patient satisfaction and engagement go up. So from daily staffing solutions, comprehensive budgeting support, Kaleidoscope Anesthesia ensures your fertility center has reliable quality anesthesia care. It elevates the patient experience.

    while you optimize your clinic's resources, visit kaleidoscopeanesthesia.com to discover how their CRNA staffing solutions can support your fertility doctors. Tom, what key lessons have you learned that other centers should copy?

    Thomas Molinaro (16:40)

    Yeah, I mean, I think.

    A lot of what we've learned has been around communication. I think it's really important to communicate. And if you think you're communicating enough, you should probably communicate more. I always feel like there's more and more opportunities where we can get the right messages out to providers, to staff, with respect to the direction that the organization is taking, how we're focused on patient care.

    getting everybody on the same page with respect to what are the priorities of the organization. For us, it's about helping patients achieve their goals. And so we always want to put patients at the center. We want patients to be the driving force behind our organization. And that means that our research is focused on how do we improve the success rates? Our patient experience team is focused on how do we measure and improve the patient experience through our clinics?

    Communication for patients is just as important, right? mean, patient portal, all of the things that patients want access to, we're trying to make sure that they can access it within the app on their phone because communication is so important. So I think you can't underestimate how important communication is.

    Griffin Jones (17:49)

    Tell us about the investments either that you've made or that you're considering for the communication for patient side, because I think it's still one of the biggest pain points for clinics. I had Eloise Drain, the owner of a surrogacy agency called Family Inceptions on, and she was very blunt from her perspective. She thought that patient experience is getting worse, at least in the regard for patient communication across the board.

    I still see the same negative reviews that I saw 10 years ago. And I know how difficult it is because you have so much going on in the clinic. Nurses have to do so much. You can automate certain things, but there's an exception to almost everything. And it becomes really hard to have an automated solution for, so you're back to the man hours and that burden. And it's extraordinarily difficult.

    Yet we know that one of the biggest pain points for patients is just not knowing what's going on and feeling like they're gonna, or having an expectation that they're gonna get an answer by a certain date and time and then a couple of days goes by and they still don't have that answer. There are so many of these tech solutions. I need to do a better job of mapping them out like these patient triage and patient concierge, different types of companies, because I don't totally know all of the ways that each of them overlap, what they do differently.

    But people are trying to solve this problem. What are you vetting or have you vetted? What are you looking at?

    Thomas Molinaro (19:19)

    Yeah, I mean, it's really important to understand that there's no simple answer to that question. I think that's one thing that we've learned is that there's lots of different ways in which patients communicate and lots of different expectations. Part of it is incumbent on the physician or the provider to set the right expectations for patients upfront. I think that's a huge part of this is

    setting the expectation of how you're going to communicate with us. What's the turnaround time on some of these messages? And certainly that's something that our teams have tried to do. We have a patient portal app. our EMR is called Artemis. It's a proprietary EMR that EBRMA has built over time. It has a patient portal app, you know, and we're trying to put as much information into the patient portal app as possible.

    Some of it self-serve, right? I mean, one of the questions that we get all the time is how many embryos do I have left and what's the sex of the embryos I have and, you know, et cetera. So the more that we can service that to patients in the app themselves, they can get those results, test results, embryo reports, all of those things right there. We have, you know, a chat function within the patient portal that nurses are answering. And again, trying to set the right expectations for what's an appropriate turnaround time for a message is important.

    It's not an instant message. It does take time for nurses to get there. So on the other side of it, trying to understand how can we speed up that process with templates, with chat GPT instances. So we have a beta version of the chat GPT instance that will help the nurses write their answers back faster. And I think that that's just one way to try to bring efficiency.

    to drive efficiency in terms of responding to patient needs and patient expectations. We're obviously interested to see what other technology is out there. We've embarked on a couple of pilot projects with some of those patient services that you mentioned. We haven't decided sort of how that's going to integrate with our system in the long run. We're still kind of feeling our way through that process. We're getting some initial positive feedback.

    from patients, but at the end of the day, I think a lot of patients want access to their providers. And so how can we create the right patient touch points, sort of studying that patient journey and understanding that there's certain times in the journey when patients really benefit more from hearing from their provider, whether it's a physician or an APP, you can really maximize the impact by checking in at certain times, right? You I want to make sure that I'm checking in with my patients at some point during your IVF stimulation.

    I don't want to do it too early, maybe in the middle of the cycle, kind of project where you are, what I thought you were going to get, when retrieval might fall. That one phone call has a huge impact on that patient's outcome if I can set the right expectations for the rest of the cycle. So that's just one example. I think it's hard because it is labor intensive. So the other aspect here is how can we automate the other parts of care that don't require my voice on a phone, right? And sort of surrounding...

    surrounding our providers with the right support staff and the right tools to make these interactions more viable.

    Griffin Jones (22:22)

    That's my axiom for automation. Everything that should be automated must be automated. Everything that should not be automated must not be automated. Are those tech solutions that you're piloting or communications triage, concierge solutions, none of

    Thomas Molinaro (22:41)

    I think it's too early to tell with some of them. It's really still early days in terms of trying to figure out how all the pieces fit together. It feels a little bit like a jigsaw puzzle that you're trying to put together, but you don't know what the picture is. So we're still trying to figure out which patients benefit most from different types of care. And sort of the understanding has always been that there's one size fits all.

    And I don't think that that's the case today. I think you definitely have patients who are looking for a different type of experience. so are patients looking for more information upfront? Are they looking for more handholding? Are they looking for more statistics? How do you create different journeys for patients to go on to get to the same place, right? Most of them want the same outcome, but it's a question of along the way, what kinds of tools and you know,

    what kind of information do they need? And I've had patients who don't want to know anything. They just say, I don't want to know how the sausage is made, just get me to the end. And you have other patients who want to know why did you pick this particular dose for me? What are the characteristics that made you think of this? And so kind of somewhere in between is where we all kind of live. part of the way to solve that is actually asking patients, right? So spending more time at that initial visit is something that I think has become

    really, really important to me as a provider to sort of see what is it that this patient needs? And I will ask, I mean, I've gotten to the point now where I'm not trying to read the tea leaves. I just say, hey, what are your biggest concerns? I want to make sure that we address that as we're going through the process. And I want to make sure that we're creating the experience that is going to help you achieve your goals because most patients are going to achieve success as long as they don't drop out of care, right? I mean, I think we're in a really good point of fertility care where, you know, the

    vast majority of patients will be successful if they just keep at it.

    Griffin Jones (24:28)

    Would you describe that as the biggest challenge, that being finding solutions that are customizable to the varying needs of patients, or is integration a bigger challenge?

    Thomas Molinaro (24:40)

    No, think patient care is always the biggest challenge that we face, right? And trying to understand how do you create that experience for patients that makes them continue in their journey and ultimately that leads to a high level of patient engagement. And I think patient engagement is really the right word for what we're looking for. We want patients to feel empowered. We want them to understand where they are in the journey. We want them to feel free to ask those questions.

    But ultimately to understand that we're on the same path together, we want the same outcome, right? As their providers, we want them to be successful. It's not fun to call patients with negative pregnancy tests, right? And so how do we partner with them? How do we make sure that they're engaged in that process? And ultimately that's what leads to great outcomes. That's what leads to patients who are really satisfied with their care is when both the physician and the patient are engaged in formulating that plan.

    Griffin Jones (25:34)

    Integration is tough though. Every one of these tech companies that I talk to when they talk about implementing with these networks, they say, we'll have eight different people, somebody from nursing, somebody from the lab, somebody from a couple of people from ops, maybe somebody from the C-suite, a couple of docs, and maybe from a couple of different practices from across the country. And they're all looking at how to integrate the solution differently.

    Thomas Molinaro (25:39)

    Yeah.

    Griffin Jones (26:01)

    How do you approach that with this dyad leadership? Are people coming individually and then it's coming up from like your team or Lynn's team and then it gets out of committee like in the House of Representatives and you bring it to the floor only after it's passed committee? How do you approach integration?

    Thomas Molinaro (26:14)

    Yeah.

    You know, I'll be honest, you know, it's not that Lynn has a team and I have a team. We're all one team together. you know, and that's the way that we really focus, you know, at every, in every meeting there's both clinical representation and operational or just organization. you know, that's, that's present. we have a great chief operating officer, Edith Gonzalez, who really, understands that, patient care drives all of this. And so, you know, we can have conversations around,

    patient-centered experience and how do we drive those outcomes? With respect to integrating any new solution, it's a series of trial and error, right? I you have to really try to understand and be willing to fail, right? Be willing to make mistakes and then reiterate and try again. And that's one thing that I think we're good at is really getting in there, taking our repetitions to try to understand what works and what doesn't.

    Ultimately, we also think that there's an opportunity to try to standardize certain aspects of care, which helps to integrate, right? If every physician is doing things differently, then it makes it hard to integrate new solutions. But if we can all come to agreements and we try as physicians to say, okay, here's how we want to practice, here are the things that work for us, then ultimately, I think that allows you to integrate better. It allows you to set the EMR up the right way and all of those other...

    aspects that streamline care.

    Griffin Jones (27:34)

    getting doctors on a page like that where they are so integrated is not easy. One of my favorite little bits from all of the podcasts I've done was a doctor named Kishits Murdiya, who's the CEO of Indira IVF, which is one of the largest networks in India. And he says, I hired 250 docs and it's not like they have REI fellowship there. So hiring 250 doctors might be more tenable. He's like, got 250 doctors.

    Thomas Molinaro (27:38)

    Yeah.

    Griffin Jones (28:03)

    I made sure all of them are younger than me and I told them, here's the protocols and we make decisions as a group together of how the protocols adapt over time. But this is the menu of protocols that we follow. We don't have somebody over here doing these couple of protocols and somebody over here doing a completely different set of protocols. Is that the future in the United States?

    Thomas Molinaro (28:05)

    Hehehe.

    I don't think so. I mean, think there's lots of different ways to practice and some of the protocols matter and some don't. And we certainly don't tell physicians what protocol to use or how to take care of patients. I think what we've, yeah, it's a question. Because everybody has a different way of practicing and ultimately if you can achieve the same results, that's all that matters, right? And so that's where it really comes in is we want to be a data-driven organization.

    Griffin Jones (28:40)

    Non rhetorical question though, why not?

    Thomas Molinaro (28:55)

    Physicians practice evidence-based medicine every day. We should be looking at the literature. We should be evaluating treatments and trying to understand what works best. And ultimately, we should carry that over into our practice every single day with what we're doing. So as a data-driven organization, our EMR allows us to ask questions and try to understand what works best and what doesn't.

    and ultimately try to come to some agreement around different treatment protocols. So we have a medical affairs group made up of different physicians, nurses, APPs that are looking at the literature. They're looking at our data, trying to understand what are the best practices. And we want to create opportunities for our clinics to take advantage of that knowledge. We don't force it down your throat. We sort of say, hey, look, this is what's working. This is what shows the best outcomes. And, you know, our physicians want the best for their patients. At the end of the day, why wouldn't you adopt

    certain treatments or certain protocols if they lead to really great outcomes for your patients. And again, it's not just patient pregnancy rates, it's their experience along the way, their time to pregnancy, all of those other things that we're looking

    Griffin Jones (29:57)

    Improving patient care is critical across the board when procedure days get backed up, patient anxiety rises, teams get stressed, something has to give. That's where Kaleidoscope Anesthesia's specialized teams come in with over 150 experienced CRNAs across the country. They integrate seamlessly into your practice. They handle all the anesthesia needs. They do so with precision and they do so while you focus on successful outcomes for your patients.

    Fertility centers that partner with Kaleidoscope report fewer scheduling delays, fewer cancellations, improved patient satisfaction scores. They report significantly reduced physician and staff burnout. Kaleidoscope's local anesthetists build lasting relationships with your patients across multiple procedures, creating a continuity of care that patients notice and they appreciate it. They write about it in their online reviews. They write online reviews about their anesthetists.

    From egg retrievals to hysteroscopes and TSEs, kaleidoscope CRNA's bring specialized expertise in reproductive medicine procedures like IVF that manage patient safety and comfort so you can concentrate on technical precision doing the things that matter. Be prepared for the continuing shift of anesthesia resources and availability to, I'm talking like mass waves of retirement of anesthesiologists.

    So be prepared for this sort of thing before fees go through the roof or you just don't have adequate coverage. Support your fertility doctors. Visit kaleidoscopeanesthesia.com and discover why leading fertility doctors like Dr. Ben Harris from Shady Grove trust Kaleidoscope with their anesthesia care. That's kaleidoscopeanesthesia.com. I want to go back to the concept of automating all of those things that

    can be automated or should be automated so that doctors can do those things where they need to provide more individualized patient care. I think... I don't know if this is a consensus yet, but it seems like the really bad news should be delivered by the doctor. And there are other times where the doctor probably needs to make themselves available. And then there are other things. It's like, why is the doctor doing that? So what are those things that

    should not be being done by an REI or any physician.

    Thomas Molinaro (32:18)

    Yeah, I mean, I think, you know, it's obviously important for physicians to be available when patients have bad outcomes. They have lots of questions. It's a really pivotal time in their care. And it's an opportunity to not just answer those questions, but hopefully provide encouragement for patients to continue in their fertility journey. I think, you know, there's opportunities to increase

    throughput if physicians don't have to make as many of the less important calls around, know, estrogen levels and medication dosing, those kinds of things, obviously. And nurses have done that traditionally for many years and moving more and more of that into electronic portals, I think has been helpful. Although patients do like to hear from their nurse, they like to know that they're doing well or that things are as expected. You know, I think, you know, ultimately,

    just trying to understand what's the best use of physician time is a difficult question. And I think it varies from physician to physician in terms of what are the parts of their practice that they enjoy, right? I I would love to call a patient with a positive pregnancy test. I don't think I've called a patient with a positive pregnancy test in a few years because the nurses jump on those phone calls first. And by the time I get to look and see what's happening,

    it's the middle of the day and the only phone calls left are the negative pregnancy tests. So, you know, I think we all need to figure out what's the best use of our time. And it may not be the same for every position, but certainly automating tasks like, you know, progress note writing, right? So, I mean, how long does it take to write a progress note after you have a conversation with a patient for 45 minutes? You know, we're, we're, are looking at, you know, AI scribes for that type of work, reviewing records, right? You get,

    100 pages of old records from somebody who's coming for a second opinion. There's automated solutions that allow you to summarize those records and, you know, means less work for the physician to go through each and every one of those pages and try to summarize and extract the important, you the important points. So I think there's great opportunities for, you know, technology to improve the efficiency of physicians and

    and other practitioners, APPs as well, so that we can spend more time doing the hand holding, making the important phone calls, spending time with patients, and that's what keeps them engaged in care.

    Griffin Jones (34:28)

    Progress Notes is a major time suck as someone married to a physician knows. It doesn't just end at the office. And reviewing the records, having the AI to summarize that. What about ultrasounds? Should doctors be doing ultrasounds?

    Thomas Molinaro (34:30)

    Yep.

    That's a great question. And in our network, we do have some clinics where we use sonographers and we have a lot of clinics that use providers. And it is double-edged sword. I mean, think it is a large use of resources to use providers for scans, but I think it improves patient experience. So I'm pretty torn about it, Griffin. I won't lie to you because I enjoy scanning. I scanned yesterday. I got to see a lot of my patients in care.

    provided them immediate feedback, got to do some pregnancy ultrasounds, which is always fun. And so for me as a provider, it's rewarding to have that patient touch point. I think it's rewarding for patients to get that immediate feedback and to also be able to ask questions. So what we've tried to do in our clinics where we use providers is have more providers rotating through. So no provider is doing scans more than

    twice a week at most. I think that really helps to sort of balance the burden because it does take three hours of my morning when I scan and that's three hours that I could be using for other things. But to me, it's important to have those touch points and to be able to interact with my patients and offer them my own sort of perspective on how their cycle is going, give them a little bit of hope, a little bit of optimism, hopefully, or if it's a cycle that's not going well, it's an opportunity for me.

    to sort of have a little discussion with them face to face. You know, and always it's, okay, we'll follow up later this afternoon with a phone call after we see your, you know, your blood work, but at least we've set the stage for some of those difficult conversations that we're gonna have later in the day. So I certainly think it's a benefit to patients.

    Griffin Jones (36:16)

    You're torn though. It sounds like you haven't totally come to a conclusive decision. And on one hand, you feel like it's sometimes you really like doing the scans. It's a meaningful touch point with the patients. To me, it's like maybe there's a case for the efficiency of using stenographers. And I wonder if there's a way to systematize getting that benefit that the patient feels from

    when the doctor's doing their scan in terms of like that really warm and personalized care, if there's a way to extend it and systematize it to stenographers. And I think of an example, one of my earliest clients back when we were doing marketing for clinics was Fertility Institute of Hawaii. there was a phlebotomist there that was like responsible for just an insane number of their positive reviews. They really just loved, I remember her name, her name was Zoe.

    And so shout out to Fertility Institute of Hawaii and Zoe because people loved this phlebotomist. And I'm thinking there's no reason for a nurse or anybody above a nurse to be having to stick people when you've got phlebotomists like that because the patient experience and personalized care has somehow been transferred to her. Do you see any way of being able to do that, to systematize that for stenographers to where

    Thomas Molinaro (37:05)

    Hehehe.

    Griffin Jones (37:34)

    So docs aren't doing it just because they need to feel this individualized care, but somebody else can provide that to the patient. Is there a way of being able to scale that?

    Thomas Molinaro (37:44)

    Yeah, I mean, it's good question. mean, you know, you're always going to have outliers. sounds like the Phlebotomist is an outlier in all the right ways. The question is, can you train other people to be that way? And I don't know that you can. I think some people just have it in them. You know, they're outgoing, empathetic people who really connect with patients. You know, it's not to say that it can't be done, but certainly it requires, I think, extra training in

    in terms of helping the sonographers understand more of what's happening. But I don't think there are ever going to be a substitute for a provider. I think an APP or a physician in particular really understand the treatment on a different level. And patients are really looking for that validation. That's one of the biggest things that I see is just the fact that they hear it from a provider makes a big, difference.

    Oftentimes I'm saying the exact same thing that the nurses told them, but because it's coming from me in this certain situation, it resonates more with the patient.

    Griffin Jones (38:42)

    Are there any things that really just chap your ass that doctors are doing though? Any example in family medicine, I go see my family medicine doc. I've been on a very small dosage of a controlled substance forever that is a very minor part of my life. She's gotta spend 15 minutes going through all these New York state rules and then I don't even have to sign anything. So it's not even like for informed consent. It's like.

    Thomas Molinaro (38:52)

    Hmm. Hmm.

    Griffin Jones (39:05)

    One, I wasn't paying attention to you. We could have had some maybe video modules, some engaged MD type thing where I have to sign off, at least like get informed consent. I could have done this in a video module that has, that doesn't take up your time. And then she's asking me like, do you want this vaccine? Do you want this vaccine? And I'm like, I don't know. Like, am I at risk for it? Like you tell me, like I'm about to be approaching middle age. I'd kind of like it if my family medicine doc was able to be.

    Thomas Molinaro (39:07)

    Yes. ⁓

    Griffin Jones (39:32)

    a little bit more proactive of here's what's gonna come up and I think part of the reason why they can't do that is that they're doing all of this crap. Is there any examples like those that you see in REIs that like, this is a waste of our time?

    Thomas Molinaro (39:44)

    No, I I think we're fortunate in REI that we're in such a sub-specialty of medicine and we have a great opportunity to help so many patients. I don't think that there's anything that we do that necessarily is a waste of time per se. I do think that it's great when physicians have more ability to ask patients the right questions, right? To really...

    give them the time and the opportunity to communicate their concerns, their fears. I I start every new patient consult with some very open-ended questions. What brought you in today? How did you get here? And trying to understand the journey that they've been on, because it's been, for most of these patients, months, if not years, of trying at home and talking to their OB-GYN and talking to their sister or their friends. And so for me to catch up on that journey, I need them.

    to really open up. I need them to really speak all the thoughts that are in their head. Number one, it helps me understand them better, right? Number two is that they're not actually gonna hear anything that I have to say until they've emptied their brain, right? Until all of those thoughts that are in their head are out on the desk in front of us. And then we can say, okay, let's put all these pieces together into a plan. And so I think that if physicians took the extra time to ask those questions, to really hear what patients are saying,

    They would be much more effective at formulating the right plans and speaking to their concerns. And I actually try to repeat back to the patient what I heard to double check myself. So at the end of all of that, before I launch into any of my explanation about the testing or the treatments or anything else, I just try to repeat back. you're 34, you've been trying for a year, you went to your OB, they did these tests. Right now, it doesn't seem like there's any issues. Your biggest concern is around insurance coverage. Am I missing anything?

    And yeah, I'm missing stuff. They correct me all the time that I forgot, you know, there was some important key aspect that didn't register with me that they're going to correct me on right there and they say, no, but you I also have this family history that I'm worried about. Okay. Once we get all on the same page, now we can work together. I can partner with that patient. We can engage in a conversation about testing, about treatment. We can formulate a plan. And that's really, really important to patients is that they have a plan, that they know where they're going.

    right, that they understand the journey that they're about to take. And that ultimately helps us to engage in the right kind of care.

    Griffin Jones (42:08)

    Did you guys, meaning you all as an IVIRMA Global, just have a mini conference or not so many? My notes say 1,400 experts. You had a meeting of 1,400 people? That's like PCRS, MRSI, like CFAS. It's bigger than those meetings put together. It would probably be like the fifth. It's probably somewhere in the top 10 of largest meetings.

    Thomas Molinaro (42:18)

    We did. Yeah, so...

    Griffin Jones (42:34)

    in the world for fertility if I had to guess. What was this all about?

    Thomas Molinaro (42:38)

    Yeah, so every other year, EBRMA puts on the ED Congress, which is a three day meeting in a city in Spain. So this year was in Barcelona two weeks ago. We invite REIs from all over the world to attend. We invite a lot of the top minds in the field to come and give research presentations around different aspects of care. We had some male infertility, we had some...

    AI, had some ovarian rejuvenation, some in vitro gametogenesis talks. It was a really well attended conference in a beautiful city and just really allows many of the experts in the field, many of whom are IVIRMA physicians, to speak on their area of expertise.

    It was a really great conference and I think everybody had some really positive feedback to give every other year in Spain. ⁓

    Griffin Jones (43:29)

    What were the biggest takeaways? What did you leave with saying,

    we've got to implement this the next year?

    Thomas Molinaro (43:34)

    Yeah. I mean, think the biggest takeaways were around, certainly around AI. AI is here. There's ways to use it in the clinic that can make you more efficient. There's certainly opportunities in the laboratory that are going to come around and make us more successful. It's really exciting to see some of the work being done on in vitro gametogenesis, right? And so understanding the ability to

    to grow sperm or eggs in a dish. I think that it's something that's probably gonna happen within our lifetime, that these researchers are making big strides and certainly that will change the face of how we take care of patients. It's interesting that there's still a lot of talk around endometriosis and gnatomyosis after all these years and looking at new and novel ways to treat it, both surgically and with medicine.

    And I think we're all looking forward to the automization of the IVF laboratory and seeing what's coming down the pike in terms of robotics and sort of really making the laboratory more efficient.

    Griffin Jones (44:34)

    Do think that's pretty close?

    Thomas Molinaro (44:36)

    I mean, I think it's certainly on its way with some of the organizations that are putting this forward. And I think time will tell how easy it is to implement in the clinics. And ultimately, we're excited to be a part of it, I think in general. At IVIRMA, we've always wanted to push the envelope. We think that there's tremendous opportunities within the field to improve.

    our success rates to improve our ability to care for more patients. And so we've always had a dedicated R &D division that looks at the latest technologies, partners with different startups and tries to really understand how we can improve the delivery of care. until we get 100 % of the patients pregnant 100 % of the time, we can always do better, right? And so I think that's what drives us as an organization is to always want to be better.

    And the way that we practice IVF today is different from how we practiced it five years ago. And I know that it's going to be different five years from now. We'll look back and say, can you believe we were doing it that way for all those years? And the answer is, yeah. Because until you do the research, until you push the envelope, until you're willing to step outside of your comfort zone, you can't change. And change is uncomfortable, but change is absolutely necessary if we want to continue to deliver the best outcomes for our patients.

    Griffin Jones (45:57)

    Part of the reason why the meeting is so big is because the organization is so big and that's partly because of acquiring merging with other clinics, clinic networks, Boston IVF, TRIO. What have you learned from those acquisitions? What are future acquisitions that might happen in the RMA ecosystem?

    Thomas Molinaro (46:03)

    you

    Thank

    Yeah, well, I don't have a crystal ball to know what's coming down the pike. Certainly we are interested in working with the best clinicians that are out there, the best clinics that are looking to partner with us. I think every step of the way we try to learn from the organizations that join us and really understanding what they do well. And certainly from Colorado Conceptions in Denver, we learned a lot about

    efficiency in the laboratory. From Boston IVF, we're learning a lot about their organization, their efficiency as well. How do they approach patient acquisition? There's a lot of opportunities for us to learn more from the other clinics that join us. And certainly we want to form a new way forward, sort of learning from all of the clinics that join us to understand

    what will drive the best outcomes. And we are, you we have always been as an organization unafraid of change. You we're willing to change tomorrow if we think it'll get a better outcome. And so I think that's really refreshing to get to meet other REIs, other clinic leadership, understand what they're doing and try to figure out what we can steal in order to get better outcomes for our patients.

    And honestly, having a data driven approach allows us to do that. It allows us to sort of do A and B testing and see which one leads to better results. And, you know, I think that's what keeps me going to sort of meet new people and understand better ways of taking care of patients.

    Griffin Jones (47:43)

    Any breakthroughs that you plan to unveil this year? Research or otherwise?

    Thomas Molinaro (47:47)

    You'll just have to wait to see.

    No, think, you know, we have, I think 40 or 50 abstracts that we submitted to ASRM, you know, some pretty good projects. You know, we'll see what gets accepted and, you know, hopefully we'll have a good representation of the meeting in October.

    Griffin Jones (48:03)

    If you could give an assignment to all the people listening that there's someone in the audience that has a magic wand, it can make it happen. What challenge do you still feel like really needs to be solved in this space? What do you want to have a market improvement in the next five years or so?

    Thomas Molinaro (48:17)

    Thank

    Yeah. I mean, I think we're still scratching the surface of embryo diagnostics. We still don't know what makes a good embryo, right? Even when you have a genetically normal embryo in a young patient, the chance it turns into a baby is still less than 70 % in most cases. So we're missing a lot when it comes to embryo diagnostics and whether it's something that has to do with genetics or whether it's metabolism, I think there's still a lot of work to be done.

    understanding what makes an embryo that's capable of implanting and turning into a baby. So we're certainly working on it in our research organization, but I think there's a lot of opportunity for others to help us figure out what makes a good embryo.

    Griffin Jones (49:00)

    And there's a lot more that could be discussed in this podcast that we'll have to wait for another episode when we have you back. Dr. Tom Molinaro, thank you very much for coming on the Inside Reproductive Health Podcast.

    Thomas Molinaro (49:12)

    Thanks so much, Griffin.

Dr. Thomas Molinaro
LinkedIn


 
 

251 OB/GYNs, REIs, and their roles in IVF. Dr. Stephanie Kuku

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


OB/GYNs are entering the IVF space—but what role should they play?

This debate is heating up in fertility medicine, and Dr. Stephanie Kuku, a former OB/GYN surgeon in the NHS and now Chief Knowledge Officer at Conceivable Life Sciences, offers her global, tech-forward perspective

In this episode, she talks through:

  • What REIs and OB/GYNs really need from each other

  • Where the line is on fertility care qualifications

  • What REI oversight could look like in different countries

  • How new tech may expand REI roles (not replace them)

  • How Conceivable is building collaborative care models (including their current 100-patient IRB study)

The field is changing. How will REIs lead the way forward?


Get Exclusive Updates on the Future of the IVF Lab
100 patients Enrolled in Groundbreaking IRB-Approved Study

  • Follow Conceivable Life Sciences on LinkedIn for exclusive updates from the AURA IRB study

  • Measuring AURA’s automated IVF lab against today’s clinical benchmarks

  • Designed to improve consistency, efficiency, and outcomes

  • Get early insights before results are widely published

  • Be first to see what could redefine embryology

The revolution is underway. Don’t miss the data that could change your lab forever.

  • 00:00:02:23 - 00:00:48:20

    Dr. Stephanie Kuku 

    If we increase the number of cycles to meet demand of the 1 in 6 people who suffer from infertility, we we need the physician care to meet this demand. Because of course, you know, there's a laboratory element, but there is a sort of clinical care. And the current capacity in really care does not meet that. And so we need a collaborative model where Obagi is supported and supervised by RTI, is a part of the sort of fertility care model, the future fertility care model.


    00:00:48:22 - 00:01:11:07

    Griffin Jones

    What should OB gyns be doing in fertility care? They're coming into IVF, but they're not our eyes. This debate rages on in this field, and I want to keep exploring different angles and hearing different voices. My guest, Doctor Stephanie Kuku, was a practicing ob gyn surgeon in the NHS in the UK. She's been an adviser to some 75 health tech startups.


    00:01:11:09 - 00:01:38:12

    Griffin Jones

    Now she's the chief knowledge officer of conceivable. She's not trying to do IVF. So from my point of view, she doesn't seem to have a dog in this fight. So I ask, what do OB GYNs need from rise? What do rise need of OB GYNs? What's the oversight that you guys have over OB GYNs in other countries? What are OB GYNs qualified to do with regard to fertility care and not qualified to do without our AI training?


    00:01:38:12 - 00:02:03:05

    Griffin Jones

    And I make Stephanie describe what in our eyes work might look like when he or she is overseeing far more cases and potentially teams of providers in apps underneath him or her doctor who thinks we'll need more areas, not less. The career opportunities will be more, not less. The livelihood they make will be greater if they embrace the necessary changes and are part of leading the way.


    00:02:03:07 - 00:02:26:07

    Griffin Jones

    Doctor Kuku is talking about the research that OB GYNs and our allies can collaborate on, including the 100 person IRB study that conceivable Life Sciences is running right now. How will technologies like conceivable bring OB GYNs and our eyes closer together? Listen in on my conversation with Doctor Stephanie Kuku.


    00:02:26:08 - 00:02:47:23

    Announcer

    Today's advertiser helps make the production and delivery of this episode possible for free to you, but the themes expressed by The guest do not necessarily reflect the views of inside reproductive health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest appearance is not an endorsement of the advertiser.



    00:02:48:01 - 00:02:52:20

    Griffin Jones

    Doctor Kuku, Stephanie. Welcome to the home edition of the Insight Reproductive Health podcast.


    00:02:52:21 - 00:02:55:02

    Dr. Stephanie Kuku 

    Thank you Griffin, I'm so excited to be here.


    00:02:55:04 - 00:03:15:21

    Griffin Jones

    Now, as you can see, it's like being in my living room, except if I had a camera crew with me. And the more this must be how naturally beautiful people or seemingly naturally beautiful people feel all the time. All the work that goes into the most natural setting, setting up, a couch and being very self-conscious about how I turn my jacket.


    00:03:15:23 - 00:03:27:02

    Griffin Jones

    I want to talk to you about the relationship between our eyes and OB GYNs. In your view, what do OB GYNs need from our eyes in order to be more involved in fertility care?


    00:03:27:04 - 00:03:54:15

    Dr. Stephanie Kuku 

    Griffin so firstly, I love to remind people, and I'm sure a lot of people know this, that our eyes are OB GYNs who have specialized in reproductive endocrinology and in fertility, hence ry ob gyns, obstetrics and gynecology doctors. We all go through an ob gyn residency program and then we subspecialties. So I, for example, chose to do a specialization in oncology.


    00:03:54:21 - 00:04:23:23

    Dr. Stephanie Kuku 

    Therefore, I am not a fertility specialist, but a gynecological cancer specialist. The area I fellowships traditionally in the U.S. and abroad, have been few and far between. So if you look at the numbers of ROE as compared to ObGyn, there are under 1500 ROE ice in the U.S and there are over 40,000. Begins the problem. And the reason we're having this conversation is that there is a supply and demand mismatch in IVF care.


    00:04:23:23 - 00:04:48:13

    Dr. Stephanie Kuku 

    In infertility treatment, 1 in 6 people suffer from infertility, yet we are not meeting the needs of over 90%. And so therefore we we are at a at an inflection point when we need to be able to increase supply, increase access to fertility care. And obviously one of the most important things there is increasing lab operations.


    00:04:48:15 - 00:05:20:13

    Dr. Stephanie Kuku 

    And that's what we're doing, we're trying to we're automating the IVF lab so that we can increase the number of cycles that we do per year. Now, if we increase the number of cycles to meet demand of the 1 in 6 people who suffer from infertility, we we need the physician care to meet this demand. Because of course, you know, there's a laboratory element, but there is the sort of clinical care and the current capacity in re care does not meet that.


    00:05:20:13 - 00:06:01:07

    Dr. Stephanie Kuku 

    And so we need a collaborative model where Obagi is supported and supervised by RTI, is a part of the sort of fertility care model, the future fertility care model. And I think what OB GYNs need is this support. And this a collaborative hybrid model where they sort of can be part of fertility care. They see the low risk patients, obviously complex cases go straight to the eyes and they have, you know, training support, virtual hybrid support with red eyes to really be the first point of care for fertility care and fertility patients.


    00:06:01:09 - 00:06:23:06

    Griffin Jones

    I think many areas have a hard time visualizing that, because this debate's been going on for a while. I have it in person with people whenever I can stoke the fire a little bit and get people debating. And you have very eyes that say, listen, this is not that complicated. We could teach a monkey to do egg retrievals, and then you have the other camp that says it's not just about egg retrievals.


    00:06:23:06 - 00:06:43:23

    Griffin Jones

    There's a lot more that goes into AI. And it seems to me that even the folks in that camp see your point about the need, that there's just not enough our eyes, and they'll say things like, we need to add more fellowships. It's like, well, yeah, but how many more fellowships are we going to add? And like it's a drop in the bucket compared to to what needs to happen.


    00:06:44:01 - 00:07:02:10

    Griffin Jones

    But I think that camp has a hard time seeing what that support system looks like. It seems to me like their worry is that OB GYNs are just going to start taking over IVF without any oversight. You talked about a support system and some oversight. What does that look like?


    00:07:02:12 - 00:07:28:09

    Dr. Stephanie Kuku 

    So I think again, I think it's important to remember that obligations are trained in obstetrics and gynecology. Eyes have gone through early Gyn residency to put things in context. And I think David Sable and Eduardo Harrington published this, last year in a paper titled Meeting the Demand for Fertility Services in the U.S, OB GYNs have to perform very technical surgical procedures.


    00:07:28:09 - 00:07:51:18

    Dr. Stephanie Kuku 

    So to get signed off as a board certified ob gyn, you need to have done almost 100 hysterectomies. And so the argument that it's, you know, ObGyn unqualified, you know, you have to have training in ultrasound, you have to do hysterectomies, which are far more complex and technical. The egg retrievals doesn't really stand. I think we need to go back and think about why our eyes are cautious.


    00:07:51:18 - 00:08:17:03

    Dr. Stephanie Kuku 

    I would hope that the first, the first reason is patient care. We must do everything to maintain and improve patient outcomes in IVF, and that means making sure that we are very clear about how the model will work. As I said before, it's very simple. OB GYNs do low risk cases. I think a lot of people will have, you know, a happy with OBC ones during the clinical part of care.


    00:08:17:05 - 00:08:45:23

    Dr. Stephanie Kuku 

    So they do the assessments, they do the triage, they do the holistic look, they do the follicular monitoring and medication management. I think to say that I know that you will and can't manage, follicular stimulation, ovarian stimulation, is incorrect. But the important thing there is everything will be done under supervision. What people need to understand is we need to increase supply.


    00:08:45:23 - 00:09:17:00

    Dr. Stephanie Kuku 

    We need to make IVF more accessible. And to do that, we need technology. And we're going to do that with automating the IVF lab, which means that there'll be more cycles and there'll be more work. Now, rise alone cannot meet this demand. Clinical efficiency is the goal. And with Ob-Gyn starting this process, being involved in the very low risk elements of this under supervision with strict protocols, I will say OB GYNs.


    00:09:17:06 - 00:09:39:14

    Dr. Stephanie Kuku 

    We love following protocols. It's the most litigious specialty. We are very good at sort of triaging high risk, low risk. Any ob gyn would know this is out of my remit. You know, it's time to get the right, you know, telemedicine, the sort of hybrid tech enabled, you know, model is the future we'll have. But it's not a it's not an if it will happen.


    00:09:39:14 - 00:10:00:04

    Dr. Stephanie Kuku 

    We need OB GYNs who are ready. The first point of contact for the patients. Patient first patients trust their ob gyn says continuity of care where you go to your area, you come back. The areas you know and the ob gyn is involved in this care model. And that's that's the future.


    00:10:00:05 - 00:10:26:14

    Griffin Jones

    We want to come back to what that supervision in that caseload distribution looks like. But I want to talk about the complications that arise sometimes feel. And I had this debate going on in a, in a different dinner and one very, very high volume. I said, I've been doing this for years. I've never had a complication with internal bleeding, but another one said, you know, I've had maybe three over the course of my career.


    00:10:26:14 - 00:10:42:22

    Griffin Jones

    So they're rare, but they can happen and it would be a really big concern. I'm going to try paraphrasing something you said yesterday. So you're going to correct me if I, if I got this wrong, but and you don't really have a dog in this fight because you're not a practicing ObGyn right now, you're not trying to do IVF.


    00:10:42:22 - 00:11:01:12

    Griffin Jones

    But you were, you know, began surgeon. To me, it sounded like if you had a complicated organ that maybe the guy isn't the first person that you would want, to to be on the scene there. You might want, you know, a bigger surgeon. I'm paraphrasing, so clean up what I'm saying.


    00:11:01:12 - 00:11:27:04

    Dr. Stephanie Kuku 

    And of course, well, it depends on the area, but I think, you know, generally in surgical practice, they say don't do a procedure for which you can't deal with the complications. And so if you think about the fact that resources specialize in egg retrievals and that they definitely do less emergency laparoscopy and laparotomy than OB gyns, ambulatory gynecologist I by the way, I trained as a cancer surgeon.


    00:11:27:09 - 00:11:50:04

    Dr. Stephanie Kuku 

    So I can guarantee you that even though I haven't practiced for five years, I could probably deal with an acutely bleeding patient. Now, even now, better than, you know, a lot of my friends who haven't done emergency laparoscopy for years. In fact, I was speaking to, an area friend in New York. And, you know, they said if I, if I ever did have a complication, I wouldn't try and deal with it.


    00:11:50:04 - 00:12:11:15

    Dr. Stephanie Kuku 

    I'll put them in an ambulance to the nearest Guinea unit, because I think that would be best, best for the patient. And so I think this idea that OB GYNs will not be able to deal with a complication of an egg retrieval, say unique pelvic artery in the patient is bleeding, doesn't really hold because nobody wants a gynecologist.


    00:12:11:16 - 00:12:16:19

    Dr. Stephanie Kuku 

    We do more gynecological surgery on a day to day basis than our eyes do.


    00:12:16:19 - 00:12:19:19

    Griffin Jones

    OB GYNs do retrievals in the UK and.


    00:12:19:19 - 00:12:30:12

    Dr. Stephanie Kuku 

    Europe and UK, some obese ones who've had additional so who have a specialist interest in fertility can have had some additional training. Absolutely, yes.


    00:12:30:14 - 00:12:46:05

    Griffin Jones

    What does that training typically look like? Because a fellowship in this case tends to be more of an American context, right. You've got a three year area fellowship training in the US, two year fellowship area training in Canada. But does that exist in the UK in that form or in Europe?


    00:12:46:07 - 00:13:07:16

    Dr. Stephanie Kuku 

    Do we have a subspecialty training program for fertility, for oncology? But within Europe, in the UK you have what we call clinical fellows. So you all you don't go through a three year training program, but you have a sort of truncated training program where you are a gynecologist with a special interest, you are under supervision of an area.


    00:13:07:16 - 00:13:31:07

    Dr. Stephanie Kuku 

    You go through sort of years of practice and training and practice. You do lots of cases supervised by NRI. And yes, there are a lot of gynecologists in Europe and UK who are already involved in egg retrievals. I don't advocate that. Gynecologists you do embryo transfers. I think the most important part, if you if you think about.


    00:13:31:09 - 00:13:34:13

    Griffin Jones

    When I was the difference between transfer and retrieval, in that sense.


    00:13:34:15 - 00:14:05:18

    Dr. Stephanie Kuku 

    I think that the transfer, denotes, the, the embryo transfer is comes in sort of under the infertility, the fertility care, embryology laboratory services. I think that we must separate what is clinical gynecology and what is sort of embryology laboratory and IVF. And I and I really believe that the best person for a job should do the job.


    00:14:05:18 - 00:14:31:03

    Dr. Stephanie Kuku 

    So if we are thinking about embryo transfers, we should leave that to the eyes, because at that point you're trying to return the embryo. I think as a patient, I would be very comfortable with my re with my gynecologist dealing with my initial fertility care, managing my stimulation. You know, my gynecologist is brilliant, is scanning. She's a PhD in ultrasound.


    00:14:31:05 - 00:14:54:12

    Dr. Stephanie Kuku 

    But I would want my re doing everything from the point to which my eggs are retrieved and the embryos transferred, just that separation. And then, of course, I'd want to go back to my ObGyn. I, I think that it's we must have and I don't know who's going to set it just very clear protocol. So nobody's stepping on anyone's toes and accountability can be very clear.


    00:14:54:14 - 00:15:16:10

    Dr. Stephanie Kuku 

    And I don't want to go into how that model is going to look like because there are lots of debates. But I think that, collaborative model also has to have very clear delineations. And we want to make it very clear what gynecologists should be involved in and where their role is, which is the patient care, the assessment, anything that can be done.


    00:15:16:10 - 00:15:38:10

    Dr. Stephanie Kuku 

    If you think of patients who live an hour from the fertility center, anything that can be done without you having to travel an hour to the fertility center, for example, ultrasounds, follicle monitoring, and then all you have to do is go to your fertility center for egg retrievals and embryo transfer. I think that that's how the model in reality is going to work in the future.


    00:15:38:16 - 00:16:03:23

    Griffin Jones

    I think that travel is such a big piece that we don't talk about. So I took the number of IVF labs in the US and from the CDC report from the latest data, which is 2022, there's 450 something like 470 something like that. And I told ChatGPT to look up what county, what number of U.S counties or county equivalents each of them are in.


    00:16:04:05 - 00:16:17:00

    Griffin Jones

    And then I told ChatGPT, look up how many counties there are in the United States. Guess what percentage to take a wild guess what percentage of U.S counties have an IVF lab?


    00:16:17:01 - 00:16:19:03

    Dr. Stephanie Kuku 

    Probably less than ten.


    00:16:19:05 - 00:16:20:17

    Griffin Jones

    To 8%. Yeah.


    00:16:20:19 - 00:16:22:03

    Dr. Stephanie Kuku 

    Pretty good.


    00:16:22:05 - 00:16:43:21

    Griffin Jones

    8% of US counties or county equivalents have an IVF lab. So that means that there are people in in large parts of this country that are traveling hours to, to, to get IVF and that it turns out there might not even be an IVF lab in Alaska, that previously there had been people doing remote monitoring. And then you've got to fly to Seattle to get IVF treatment.


    00:16:43:23 - 00:17:11:14

    Griffin Jones

    So there's this there's this big access problem. There's far more OB organs to the tune of 40,000 in the UK, in Europe, for those ObGyn that are doing retrievals under the supervision of an RTI, is the ROI in the room physically or is is there a number of OB gyns doing a retreat retrievals? And in RTI, is there a case manager that's always on site?


    00:17:11:14 - 00:17:12:09

    Griffin Jones

    How does that work?


    00:17:12:11 - 00:17:38:14

    Dr. Stephanie Kuku 

    I think it's safe to say that majority of retrievals. So I know you we we're back to each of the retrievals are done by our eyes. There is a percentage which I'd say is under 50% that are done by gynecologists with a special interest in fertility who have had additional training, especially in places like Spain and in that there's always an ROI in, in the unit.


    00:17:38:14 - 00:18:25:17

    Dr. Stephanie Kuku 

    Absolutely. Who is accountable? But of course, you know, I think that, again, you know, we keep coming back to the sort of the retrievals. I don't think that the retrievals are where we should be focusing on. I think it's the point of care for patients. We talked about these fertility deserts, underserved areas. How do we get this sort of streamline to get patients through faster pathways, increased clinical efficiency, the waiting times from being referred from your gynecologist and ROI without having these for ObGyn led fertility hubs, where essentially where begins a starting the process of trials, the assessment, then making sure that they know which patients are high risk and low risk, they


    00:18:25:17 - 00:18:49:02

    Dr. Stephanie Kuku 

    send the high risks on straight off to the ice is less waiting times. So imagine a world where we have automated the IVF lab and we are seeing, you know, thousands of cycles more so than the current rise in the US and globally and globally can, you know, can manage. And so we need the ObGyn as the first point of quarter A must start.


    00:18:49:02 - 00:19:09:04

    Dr. Stephanie Kuku 

    The first part, the clinical care, the ovarian stimulation and then patients travel again just for those sort of lab operations as a way to centralize, you know, send centralized IVF centers powered by technology, so that we can meet this demand with more cycles.


    00:19:09:04 - 00:19:19:21

    Griffin Jones

    Sorry. Guys are seeing complicated cases. They're doing the transfers. Who's setting the protocol? So in Spain are the OB gyns tending to set protocols? Are they choosing from a menu?


    00:19:20:00 - 00:19:49:15

    Dr. Stephanie Kuku 

    Absolutely not. You know, infertility care will always be led by re eyes. I think that much is clear. Reset protocols. Yeah. The specialists but non ry professionals who are have adequate training follow safe protocols to be involved in part of this fertility Catholic care. I think we have to be very you know doctors especially the big ones are very good at following protocols.


    00:19:49:21 - 00:20:23:11

    Dr. Stephanie Kuku 

    So we must make sure that we don't get into the you know, I think the debate over fertility can arise is sort of losing focus. We need to bring it back to patient care, care delivery, collaborative models, setting clear boundaries and making sure we can meet the demand and meet the need of patients. I think that patients want that for their OB GYNs involved because they're the first point of care, but I think they also wanted their rise to be leading this care.


    00:20:23:13 - 00:20:44:12

    Dr. Stephanie Kuku 

    And so nobody's saying that our eyes are going to take over. And I think that that's where we're not making progress, because it's always about what Aria should do. It's it's that the debate has turned into the sort of turf war, but it shouldn't be. It's it's a collaborative model to increase clinical efficiency. OPG wins over big wins and rallies, especially.


    00:20:44:12 - 00:21:14:11

    Dr. Stephanie Kuku 

    So how can they do what they already doing, which is assessing fertility patients, deciding who needs go straight to fertility care, deciding who can, you know, be tested on simple of ovulation induction protocols, hybrid models of care whereby, you know, you have RTI college, you colleague who says, you know, if you can manage the stimulation and then you can send, send the patient to us for, you know, egg retrieval and transfer.


    00:21:14:13 - 00:21:26:08

    Dr. Stephanie Kuku 

    That's what's happening in Europe. So I think, again, you know, we need to be clear that GYNs, OB GYNs will have their role, but our eyes will always lead fertility care.


    00:21:26:08 - 00:21:29:15

    Griffin Jones

    Talk about the research you've been working on the last year or so.


    00:21:29:15 - 00:21:51:17

    Dr. Stephanie Kuku 

    So what we're doing conceivable and obviously, you know, we've we started this conversation talking about Ob-Gyn sun rise and this sort of the future collaborative model of care. But I think it's important to remember that in order to meet this demand, lots of things have to happen. So first and foremost, everything happens in the lab. The miracle happens in the lab.


    00:21:51:17 - 00:22:22:06

    Dr. Stephanie Kuku 

    And that's why conceivable we are automate automating the IVF labs so we can increase the demand. The goal to increasing access of courses, reducing cost, improving outcomes, and making sure that we can meet the demand for everyone in the U.S and globally. And so what we are doing is trying to show that we have the real world evidence to prove that automating the IVF lab is safe and effective.


    00:22:22:08 - 00:23:09:20

    Dr. Stephanie Kuku 

    And even, our hypothesis is that we can improve outcomes from the current standard. We have started with, you know, pre-clinical testing and have gone through very, very rigorous effort, evidence generation steps. And a lot of our work will soon start to be published. We started with, you know, mouse, animal gametes, donor samples. We went into an IRB proof of concept study, where we, you know, we have 12 life births, 41 patients from our experimental, which shows that our prototypes, which have automated sperm, egg and Icsi, sperm preparation, egg preparation and Icsi, using one of those prototypes or in combination can get the outcomes that we desire.


    00:23:09:20 - 00:23:36:09

    Dr. Stephanie Kuku 

    And, and we've had a 51%, pregnancy rate, which is comparable to, you know, the best clinics in the world. We've now started, this hundred patient validation study, IRB to go to take patients through, line up of automation. So aura is a full, complete, automated lab workstation. And our goal is to show the world that it's safe.


    00:23:36:11 - 00:23:42:01

    Dr. Stephanie Kuku 

    It's, you know, and it can improve outcomes. And that's the that's the sort of the study we're doing now.


    00:23:42:01 - 00:23:48:05

    Griffin Jones

    How far are we into that study of those 100 patients? Have some of them cycled or all of them somewhere?


    00:23:48:05 - 00:24:04:07

    Dr. Stephanie Kuku 

    So we just started we have 33 of the 100 patients already recruited, and we just started treating our first patients. So, you know, we have six months to go. But you know, we're hoping that we have some really exciting, data to show by the end of this year.


    00:24:04:09 - 00:24:05:23

    Griffin Jones

    By the end of 2025.


    00:24:05:23 - 00:24:08:06

    Dr. Stephanie Kuku 

    Yeah, absolutely. That's the goal.


    00:24:08:08 - 00:24:20:09

    Griffin Jones

    That's the goal. Some data to share. What else do you hope to research in the future? If you had your druthers, what would you if if funding wasn't an object, what would you like to see more data?


    00:24:20:11 - 00:24:48:01

    Dr. Stephanie Kuku 

    I think that there is so much potential. I think one of the most important things to accept is that especially when you implement new technology, you never stop reaching to continue to improve outcomes. So one of the beauties of our technology, we have a cloud system that records over 100 data points that we are going to have world class data that no one has on all the confounders.


    00:24:48:03 - 00:24:56:11

    Dr. Stephanie Kuku 

    And so that we can take this data and look and continuously try to improve on the outcomes of IVF. And I think that that is key.


    00:24:56:11 - 00:25:04:09

    Griffin Jones

    How do you see collaborating with other OB GYNs or areas who might want that data or involving them in future studies?


    00:25:04:09 - 00:25:32:22

    Dr. Stephanie Kuku 

    I mean, we are speaking to so many partners at the moment from big, IVF groups to ObGyn small practices who are super excited about partnering with us, but also excited about the possibility of improving outcomes for their patients. One with automation too. With the data that we can use to harness to continue to improve outcomes. But three with, you know, making sure that we can try and get, you know, couples babies on their first IVF cycle.


    00:25:32:22 - 00:25:34:09

    Dr. Stephanie Kuku 

    Not that third.


    00:25:34:11 - 00:26:02:09

    Griffin Jones

    Do you think I'm sort of picturing in the future this sort of minority report, if everybody remembers that movie, but we had this giant screen movie, Matt Damon, Tom cruise, it's pretty similar, though. You're you're thinking of The Bourne Identity. It's it's it's pretty similar. Action 2000. Never a juristic technology. The protagonist overcomes adversity to show us how humanity and technology can come together.


    00:26:02:11 - 00:26:28:06

    Griffin Jones

    And he's got this big screen and he moves things around. And I'm sort of picturing the eye of the future looking at multiple cases for different ObGyn and maybe advanced practice providers, folks that are doing retrievals or that are seeing patients. Do you think it could be to the tune as technology advances to to dozens of patients at a time, hundreds of cases that, in our eyes, overseeing?


    00:26:28:06 - 00:26:32:07

    Griffin Jones

    Do you think it's too soon to be able to picture that?


    00:26:32:09 - 00:26:59:12

    Dr. Stephanie Kuku 

    I think that if you look at history and trying to implement technology in medicine, from laparoscopic surgery to AI diagnostics and decision support tools, we have now, the cycle is the same, whereby, you know, we start with a kind of skepticism, you know, cautious exploration. Then we have the forward thinkers and the early adopters has started testing to evaluate.


    00:26:59:13 - 00:27:23:13

    Dr. Stephanie Kuku 

    Then we get the real world evidence, you know, building like we're doing with a study now, and then you eventually get implementation whereby people have seen the data and the naysayers are suddenly like, great, this, this can improve outcomes. It's not a, an if I think it's a when that automation of the IVF lab will become the standard of care.


    00:27:23:13 - 00:27:26:09

    Dr. Stephanie Kuku 

    I mean, look at the Da Vinci robot. It's the same. So tell me about.


    00:27:26:09 - 00:27:27:10

    Griffin Jones

    Your experience with that.


    00:27:27:12 - 00:27:44:14

    Dr. Stephanie Kuku 

    Well, you know, I trained on the Da Vinci Robot. I think it's such a great analogy because, you know, when I was in training and you'd say to you, just as you said, this futuristic world in an IVF lab where we have 100 data points, our eyes are overseeing thousands of cycles meeting the current demand. We have lots of data.


    00:27:44:14 - 00:28:11:04

    Dr. Stephanie Kuku 

    We can use to select patients. It will happen. And in the end, you know, the early 2000s when it was, you know, surgeons were saying, oh, we can do robotic surgery. Most people said, come on, that's ridiculous. You know, who wants to do robotic surgery? And of course, you know, there were the early adopters. People started to see that, especially urologists, that you could reduce blood loss, you could reduce hospital stay, you could improve patient experience.


    00:28:11:04 - 00:28:58:00

    Dr. Stephanie Kuku 

    And those same naysayers and skeptics became, you know, the proponents of robotic surgery, more so now, you know, they say, come to our hospital, they use robotic, services to market their hospitals. We we offer robotic surgery. And so I think that it will be it's the same cycle where we will see this futuristic area, who's got an, a conceivable powered or a lab who's got tons of data points and screens, who has, you know, 24,000 cycles a year and who has a collaborative kind of fertility care delivery team that has the OPG and the nurse practitioners and areas being able to meet this demand.


    00:28:58:02 - 00:29:18:07

    Dr. Stephanie Kuku 

    Yeah. I think, you know, the, the, the sort of implementation and the sort of cycle of implementation of the, of the da Vinci robot is sort of it's a great analogy. Now, it's standard of care for urologists, gynecologists because it's better precision, better outcomes. Cardiothoracic surgeons use the robotic surgery now.


    00:29:18:07 - 00:29:21:12

    Griffin Jones

    So it's all the all the surgeons are trained on da Vinci.


    00:29:21:12 - 00:29:44:08

    Dr. Stephanie Kuku 

    Now not all surgeons are trained. Again, this is you know, if you think of how many studies around the world, but not, you know, well, we we when technology is implemented, the cost is high. And as you start to get, you know, you prove the business case, you get competition in the market economies of scale. You know, we now have the Medtronic's Hugo.


    00:29:44:09 - 00:30:03:07

    Dr. Stephanie Kuku 

    We have CMS versus versus. And so essentially what you have is as the cost also come down, more and more hospitals can afford to buy. Da Vinci wrote of of well, da Vinci, the other competitors, the robot and then also it's expensive, but it's pretty much standard of care for certain surgeries.


    00:30:03:07 - 00:30:10:03

    Griffin Jones

    To people go back. So if surgeons get good at using da Vinci, do they say, I'm going to go back to the old way?


    00:30:10:03 - 00:30:32:12

    Dr. Stephanie Kuku 

    Or I think, I think the use case is always going to be there. So for example, not, you know, the robotic surgery is not appropriate for all surgeries. But you know, IVF, Icsi in a lab is quite standard. You know, and that's why it's such a beauty to automate standardize eggs preparation, sperm preparation, Icsi vitrification is pretty straightforward.


    00:30:32:12 - 00:30:37:13

    Dr. Stephanie Kuku 

    It's almost easier than, you know, implementing robotics into surgery.


    00:30:37:15 - 00:30:56:13

    Griffin Jones

    I just don't see a world where the AI goes away. I think there I think many of the people who are opposed to OB gyns having more involvement in fertility care, they just can't visualize what they're going to be doing. And I think OPG wins or running away with it, or they think, oh, you OB GYNs are going to make all the money on these easy cases.


    00:30:56:13 - 00:31:10:19

    Griffin Jones

    We're going to be stuck handling a few of the complicated cases. But to me, it seems like there's so much for them to be able to do. There's still a major upside to the career they're going to be overseeing. Many more people.


    00:31:10:21 - 00:31:36:12

    Dr. Stephanie Kuku 

    Are. The eyes will never go away. We don't we don't want our eyes to go away. We need to train watery eyes because we're going to have demand that needs more eyes. And a number of OB GYNs who are supporting this demand. And I think, again, we are approaching this all wrong because of course, everybody's scared about changing, change their existing practices and making less money.


    00:31:36:12 - 00:32:03:19

    Dr. Stephanie Kuku 

    But we need to go back to the to the to the ultimate problem. We need to scale. IVF technology can do that. If we scale IVF and we have an additional 12 million cycles, we need more people to do this work and nobody's going to make less money. What we need to do, though, is make it cheaper for patients so that more people can.


    00:32:03:19 - 00:32:40:16

    Dr. Stephanie Kuku 

    You seen the work of David Adamson? Cost goes down, utilization goes up. The demand is there. We know that the data is out there. Not just in fertility. The increasing need for family building in LGBTQ communities for co miscarriage, over 3% of people, genetic diseases. The fear and I think, you know, innovation breeds fear initially. And I think that this fear in our eyes is as soon as we automate the IVF lab to increase demand, I think that will be a real domino effect.


    00:32:40:16 - 00:32:50:07

    Dr. Stephanie Kuku 

    And everyone will see that there's nothing to worry about, there's enough work to go around, and nobody's going to make less money because let's face it, I think that's what a lot of people are worried about.





    00:32:50:09 - 00:33:02:09

    Griffin Jones

    Doctor Stephanie Kuku. You know the famous Mexican expression Alejandro's oficina a su casa. Welcome to thank you for coming on the living room edition of Inside Reproductive Health. I've had a great time talking to you.


    00:33:02:13 - 00:33:04:17

    Dr. Stephanie Kuku 

    Thank you. So nice to be here. Thanks.

    00:33:04:19 - 00:33:28:18

    Announcer

    Today's advertiser helped make the production and delivery of this episode possible for free to you, but the themes expressed by the guests do not necessarily reflect the views of inside reproductive health, nor of the advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest appearance is not an endorsement of the advertiser.

    Thank you for listening to Inside Reproductive Health.

Conceivable Life Sciences
LinkedIn
Facebook
Instagram

Dr. Stephanie Kuku
LinkedIn
Instagram


 
 

249 The Biggest Thing In IVF Right Now. Joshua Abram, Alan Murray, Dr. Alejandro Chavez-Badiola

 
 

Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control, but in the case of this episode, the Advertiser chose not to make any edits. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


What’s the biggest thing happening in the IVF lab?

It might just be automation. This isn’t hypothetical. It’s operating now.

We visited Hope IVF in Mexico City to see AURA, the fully automated IVF lab created by Conceivable Life Sciences. We sat down with co-founders Joshua Abram, Dr. Alejandro Chavez-Badiola, and Alan Murray to ask the questions you submitted—and some of our own.

Tune in as the founders share:

  • The origin of AURA and what problems they set out to solve.

  • How a team of 3 embryologist technicians could run 2,000+ cycles per year.

  • What IVF cycles really cost (And why CFOs should pay attention)

  • The commercialization strategy behind automation.

  • How this might change costs, outcomes, and the embryologist role forever.


Get Exclusive Updates on the Future of the IVF Lab
100 patients enrolled in groundbreaking IRB-approved study

  • Follow Conceivable Life Sciences on LinkedIn for exclusive updates from the AURA IRB study.

  • Measuring AURA’s fully automated IVF lab against today’s clinical benchmarks

  • Designed to improve consistency, efficiency, and outcomes

  • Get early insights before results are widely published

  • Be first to see what could redefine embryology

The revolution is underway. Don’t miss the data that could change your lab forever.

Follow Conceivable Life Sciences on LinkedIn today.

  • 00:00:03:13 - 00:00:37:10

    Joshua Abram

    We are entering the digital age of IVF. I mean, if you think in the first 40 years of flight, we went from the Wright brothers to propeller planes, but we only entered the jet age after 40 years of history. We're about to enter the jet age of IVF in the best sense of the word. I don't think any of us can look at the field and not say, we are poised on a moment of remarkable innovation. The innovation that we're doing here conceivable is going to, I think, fundamentally change the field.

     

    00:00:47:10 - 00:01:09:10

    Griffin Jones

    The biggest thing happening in the IVF lab. We use that title for the LinkedIn live. I think it might have to be the title for this podcast. Episode two what's bigger than end to end automation of the IVF lab? I'm here in the Bel Air of Mexico City at an IVF center called Hope IVF, where Conceivable Life Sciences has installed their automated IVF lab, Aura, and I came with questions.

     

    00:01:09:11 - 00:03:20:10

    Griffin Jones

    Questions provided by you, the inside reproductive health audience. I sit down with the three co-founders of the company Joshua Abram, Dr. Alejandro Chavez-Badiola and Alan Murray. Joshua and Alan have been in the venture capital and entrepreneur space, co-founding and investing in companies together for decades. About ten years ago, IVF caught their eye, and they founded Tomorrow.

    Alejandro is a founding partner of Hope IVF. He's an MD, PhD, and together they took on this challenge of automating the IVF lab. Why? We discussed the human and commercial tragedy of the fraction of the total addressable need for IVF that's currently being served.

    How big should this field of medicine be? And it's supporting industry. What are the numbers behind that? We talk about the mechanics of this automated IVF lab. No more zigzagging back and forth, no more embryologist bumping into each other. They detail the steps that allow a team of three to operate a state-of-the-art IVF lab that they're hoping will perform 2000 cycles per year.

    That's three embryologist technicians, a team of three. What is an IVF cycle though? I never really thought about I'll blank out of a term. IVF cycle is for the widely differing IVF work orders that are all categorized as IVF cycles. Alan Murray talks about the research they're working on with regard to the costs associated with these different work orders.

    For the CFOs, listening, you need to hear this. It will give you a better understanding of your operational costs and the wide variance that happened after retrieval.

    How did all this happen? What's the adjacent possible? What are all the technologies that came together to build this system? How are they going to make money off of it?

    What's their commercialization strategy? Will it bring costs down? Will it improve outcomes? How? Why has there never been a better time to be an embryologist? I couldn't get enough content while I was down here. I don't have the qualification to say that the future has arrived here or conceivable, but everyone I've talked to that has visited here seems to think so.

    And I did try to press on those questions that you gave me. You'll decide for yourself, but you're going to want to listen to this whole episode, because I don't think things will ever be the same.

     

    00:03:20:10 - 00:03:42:12

    Announcer

    Today's episode is paid content from our feature sponsor, who helps inside reproductive health to deliver information for free to you. Here, the Advertiser has editorial control, but in the case of this episode, the Advertiser chose not to make any edits. Feature sponsorship is not an endorsement and does not necessarily reflect the views of inside reproductive health.

     

    00:03:42:12 - 00:03:56:05

    Griffin Jones

    Doctor Chavez-Badiola. Hola. Mr. Abram. Mr. Murray. Alejandro, Joshua, Alan. Bienvenido, and welcome to the first ever in-person podcast episode of Inside Reproductive Health.

     

    00:03:56:07 - 00:04:00:07

    Joshua Abram

    Is it not the first international podcast of Inside Reproductive Health?

     

    00:04:00:09 - 00:04:21:10

    Griffin Jones

    Certainly not the first with international guests, but certainly the first where I have been abroad. All right. We've been waiting offshore. You've taken me offshore, and I am interested in exploring. Tell me, Joshua, what's the tragedy happening in IVF right now? How might you be able to fix it, be a part of fixing it?

     

    00:04:21:12 - 00:04:47:11

    Joshua Abram

    Well, I think there's a tragedy, but first of all, I think there is a lot of glory to talk about. here we have a Nobel Prize winning therapy, that has the ability to cure people of a disease, that, has plagued mankind, humankind, since the beginning of recorded history and features prominently in the Bible.

     

    00:04:47:13 - 00:05:16:22

    Joshua Abram

    And, in this disease strikes people uniquely in the prime of their life, curing this disease. will change the course of their life forever. And when Bob Edwards was awarded the Nobel Prize with the very fulsome, comment from the from the committee that said he had achieved a milestone in modern medicine, I think the Nobel Committee thought for good reason, done and dusted.

     

    00:05:17:03 - 00:05:44:22

    Joshua Abram

    We've got this behind us, certainly the science. And it's a blessing to be involved in this field. I'm surrounded by the brilliant people who drive it. certainly the science has improved dramatically over the last 40 years. it's our our rate of innovation is stalled a little bit of late, but historically, we have improved success rates 1% year over most in four decades.

     

    00:05:45:00 - 00:06:13:03

    Joshua Abram

    but the reality is that, with the awarding of the Nobel Prize, we did not in the problem, with Edwards, we had a we did not in the problem. We have a therapy that has failed to scale 95% of infertile people around the world, will never receive treatment, even in the very rich West, even in America, 80% of patients will go in treated.

     

    00:06:13:04 - 00:06:50:20

    Joshua Abram

    And I don't think that any of us can or want to be satisfied, with that kind of situation. It's a ethical disaster. It's a clinical disaster. And frankly, it is a commercial disaster because this is one of those problems that if we all work together, which we will to solve it, we at once are going to have a clinical triumph and ethical triumph in terms of access to care and the commercial moment.

     

    00:06:51:00 - 00:07:19:19

    Joshua Abram

    IVF will enter a renaissance there. There'll be, more opportunity for more people to do more good work and to profit by doing that work fairly. And in the history of IVF, we are entering the digital age of IVF. I mean, if you think in the first 40 years of flight, we went from the Wright brothers to propeller planes, but we only entered the jet age after 40 years of history.

     

    00:07:19:21 - 00:07:48:11

    Joshua Abram

    We're about to enter the jet age of IVF in the best sense of the word. And I don't think that anyone can look at the field right now and looking at the statistics and the situation I just described, you described it as a tragedy. I agree with you. It's also an opportunity. I don't think any of us can look at the field and not say, we are poised on a moment of remarkable innovation.

     

    00:07:48:13 - 00:08:16:16

    Joshua Abram

    The innovation that we're doing here conceivable is going to, I think, fundamentally change the field. But we're not alone. We're surrounded by innovators. There are innovations, in other parts of, AI and service delivery innovations. Again, however, that pay for this. Companies like Diya make it more affordable. And I think that there's never been a more exciting time to be involved in

     

    00:08:16:16 - 00:08:17:18

    Joshua Abram

    IVF.

     

    00:08:17:20 - 00:09:03:23

    Joshua Abram

    We have the demand. 12 million babies want to be born every year rather than the less than 1 million a year that we're achieving now and an equitable, just and fair world. We will reach at 1 million babies, about 12 million a year in fertility. And then once we have together innovated sufficiently to reduce the price by having to streamline service delivery, we can address Asra emphasize, as the true demand for IVF, which is 20 million babies a year, an 80 fold increase in the number of children IVF is delivered in its entire 40 year history.

     

    00:09:04:01 - 00:09:08:20

    Joshua Abram

    Think of the opportunity and think of the number of people who can be helped.

     

    00:09:08:22 - 00:09:37:02

    Griffin Jones

    1 million IVF babies per month is a lot more than 30,000 or so currently in the United States, or far less than that, because I'm thinking of cycles. We're talking 1 million IVF babies per month. That brings us here to hope IVF in Mexico City. Your state of the art clinic, Alejandro, where you have decided to be the first to raise your hand and install conceivable aura in your IVF lab.

     

    00:09:37:02 - 00:09:54:16

    Griffin Jones

    I got to see it yesterday. What I've been hearing from people and a little straw poll when I ask, is the IVF lab ready to be automated? The majority of people and those folks that haven't been here yet, they say no. When I ask everyone who's come before me to visit here, they say, this is not a prototype.

     

    00:09:54:19 - 00:10:27:04

    Griffin Jones

    This is either ready for primetime or we're talking months away, not years from from being everywhere. Tell me, what did I see yesterday? I saw a single line assembly that, it seems, goes from retrieval to transfer. the size of a small IVF lab, with where robotics takes the the egg from that face. When? When it comes from the patient all the way back to the patient.

     

    00:10:27:04 - 00:10:35:10

    Griffin Jones

    So describe what I saw, because I want to try to match it to some of the footage we might be able to capture today.

     

    00:10:35:12 - 00:11:17:19

    Dr. Alejandro Chavez-Badiola

    So would you had a chance to see yesterday is an end to end system that can now automate the full process of the IVF lab. From this preparation, egg finding, preparing the egg for for ICSI, preparing sperm fertilizing, going through culture with time lapse capabilities and beautification. So that is the full process. So the system was built to support with this space and and with a capacity of, 2000 cycles per year with three operators.

     

    00:11:17:21 - 00:11:49:15

    Dr. Alejandro Chavez-Badiola

    So to the point of our Joshua saying this is the only way to improve access and scale IVF to be performed capacity, we know that embryology is passionate about what they do. They're passionate about getting better, doing things better because they care about patients. I don't think of any embryologist that sign up to work for 2 or 4 hours preparing a dish.

     

    00:11:49:17 - 00:12:25:20

    Dr. Alejandro Chavez-Badiola

    They want to focus their attention, to work in an intellectual space that allows them to think how to get results better. So this is what the system is about. Eat is preparing dishes. It is preparing sperm. So the embryologist can work along with that and make it better and better. But that's what you saw. Of course I'm biased, but in a word, I think that what you saw is what the future of IVF is going to look like.

     

    00:12:25:22 - 00:12:46:15

    Griffin Jones

    Tell me a little bit about the role of the embryologist in this system, because the first room that we walked into, there were some screens. I believe you explained to me that if for whatever reason, the embryologist needed to take control of the machine, the embryologist is right there in the control room. Tell me about that.

     

    00:12:46:17 - 00:13:17:16

    Dr. Alejandro Chavez-Badiola

    So safety is priority for us. So we have very strict protocols and processes to make sure that the system is working, that we can identify when we need intervention. And we have trained people to run the proper interventions in the system like these. And I think that this is true for the foreseeable future. A human, the embryologist, the senior embryologist is the agent is responsible of what is happening.

     

    00:13:17:18 - 00:13:47:03

    Dr. Alejandro Chavez-Badiola

    They are assisted throughout so they can. In any case, let's say that they don't like the sperm that was selected by the system and immobilize. They can always request for another sperm to be selected. If for any reason which is highly unlikely. and we saw the paper from Colombia showing how automated this preparation is, ten times more consistent than than humans.

     

    00:13:47:08 - 00:14:18:04

    Dr. Alejandro Chavez-Badiola

    But even if this senior biologist doesn't like the dish that the system prepared, it can just as if it was if it were a junior biologist, ask it to repeat the dish. So what you were saying, we have different levels of of safety that are people that is in charge in the control room. Next to the lab, are able to overrule and take full control over the system digitally from the room next door.

     

    00:14:18:06 - 00:14:21:14

    Dr. Alejandro Chavez-Badiola

    So that's the first level of safety.

     

    00:14:21:16 - 00:14:33:14

    Griffin Jones

    Describe the key handler and how that works through the system and the built in. You witness thing that comes with that in the QR codes.

     

    00:14:33:16 - 00:15:02:23

    Dr. Alejandro Chavez-Badiola

    So as you know, there are different ways in which embryologist identifies samples. Because I think that the one thing for which we have zero margin for error in IVF is sample misidentification. So that's been a top priority for us. So again, when you go to labs they can use different systems tags with QR codes or RFID or writing with these diamond pens.

     

    00:15:02:23 - 00:15:35:05

    Dr. Alejandro Chavez-Badiola

    Then the information that is relevant to identify the samples, what we have done as part of our preparation system is that, the system automatically engraved with laser, the dish with the information that is relevant to the embryologist. And he also, imprints, QR code that is unique for that. These in such a way that the system always know where each sample is at any given time throughout the entire process.

     

    00:15:35:07 - 00:15:58:23

    Dr. Alejandro Chavez-Badiola

    Once that the dish is prepared and this is moved from one station to the next, the C handler, which is a system that is moving samples from one station to the next, is making sure that the right sample is there, and then before it access any station, it reads a QR code from the station, making sure that the right sample is entering the right station for the right procedure.

     

    00:15:59:01 - 00:16:04:14

    Dr. Alejandro Chavez-Badiola

    So that's top priority for us. Sample identification.

     

    00:16:04:15 - 00:16:14:05

    Griffin Jones

    Elen, how the heck did this all happen? What's the concept of the adjacent possible? Maybe explain the concept for those that are unfamiliar with it. But then how is it applied here?

     

    00:16:14:05 - 00:16:41:23

    Alan Murray

    sure adjacent possible for us means borrowing from other industries, standing on the shoulders of massive investment that have perfected individual things. Maybe it's better explained by looking at examples. So within the AR system, we have a many stations that use, image recognition technology, a form of the I. This did not exist ten years ago with the quality and velocity that we needed to run an IBM.

     

    00:16:42:01 - 00:17:05:11

    Alan Murray

    if we think about, IVF at its most core, we're building self-driving pipe that. So we borrowed A.I. systems where hundreds of thousands of guys are. We all see it today when we use ChatGPT V and other image generators, we see image recognitions and self-driving car that are trying to isolate basketballs or baby carriage or stop signs.

     

    00:17:05:13 - 00:17:37:21

    Alan Murray

    So the technology we're using to recognize cocks, eggs, embryos and position instruments around it comes directly from standing on that massive investment. when you saw the robots that were using these are industrial robots that didn't exist ten years ago. Robots that have been perfected to assemble things like an iPhone, they're cramming ever smaller components together, testing circuits that are getting smaller and smaller.

     

    00:17:37:23 - 00:17:56:00

    Alan Murray

    So we're using robots that come out of, the electronics assembly, industry. They're extremely precise. Some micron precise repeatability, high reliability that have been cycled, tested way beyond the needs.

     

    00:17:56:00 - 00:18:03:18

    Griffin Jones

    Of an IVF lab. When we look at that, tell me a little bit about that cycle testing. What when what went into that.

     

    00:18:03:20 - 00:18:28:12

    Alan Murray

    So when we think about the number of cycles, the different term that IVF cycles, of course, but the number of repeated motions a robot needs to make. So when we look at industrial scale stuff, it's doing assembly of iPhone ons. And to get in an iPhone factory, these things have to be doing high repeatedly for millions and millions of cycles without failure.

     

    00:18:28:14 - 00:18:59:07

    Alan Murray

    So how many cycles to failure are these things going? What environment are they being used in that if that factory gets shut down because that robot broke down, it's lots of dollars on the table. another area we've picked out is and looked deeply into is advanced optics. Today's IVF lab is using effectively the same microscopy with the same lenses, the same focusing mechanisms of 20 years ago.

     

    00:18:59:09 - 00:19:32:16

    Alan Murray

    But over the last, with AI systems combined with, you hear about lidar in cars, we're using effectively light our system to find eggs. So we've looked not just to use conventional microscopy, but let's build better models based on resolution of advanced microscopy that in some cases, more than 100 times the information that we get from a kind of a two dimensional view coming out of a simple inverted microscope.

     

    00:19:32:18 - 00:20:12:15

    Joshua Abram

    Data is not a good one. Allen, just said I mean, you asked about the adjacent possible, which is a theory of a of a, I named Stuart Kaufman, who's on the shortlist for the Nobel Prize. And, he, he describes adjacent as an important word in that. And it means that, innovation is only possible, when there are precedents around that empowering, Uber and Lyft were both established within 12 months of the introduction of an iPhone with a GPS and an App store.

     

    00:20:12:17 - 00:20:28:17

    Joshua Abram

    that was an adjacent, hospital. Steve Jobs didn't invent anything on the iPhone. He didn't invent the MP3 player. He didn't invent the phone itself. He didn't invent GPS. What am I missing out? all the all the great, all the great features of the iPhone.

     

    00:20:28:20 - 00:20:31:20

    Griffin Jones

    He didn't invent compasses. He didn't make an LCD.

     

    00:20:31:20 - 00:20:32:17

    Alan Murray

    Screens.

     

    00:20:32:19 - 00:20:33:15

    Griffin Jones

    And but but.

     

    00:20:33:15 - 00:21:06:21

    Joshua Abram

    He did what, one and exactly what Allen would say he did with one very, very senior lab leader who came here, said Allen. Describe what we had done. He said, what you guys have done is string the pearls. You've taken the best of innovation from around the world, in industry, in science and medicine, and all proven in their own field, backed by Bill and outset, backed by billions and billions of dollars of research and practice.

     

    00:21:06:23 - 00:21:23:10

    Joshua Abram

    And you strung the pearls and you may have made a beautiful necklace from things that were never contemplated to be together. But just like in the iPhone, once we assembled, everyone thought, wow, why didn't we do that before?

     

    00:21:23:12 - 00:21:44:03

    Griffin Jones

    I want to come back to maintenance and and talk about that and, and talk about the schedule and the different possibilities, because that was one of the categories the audience has been most interested in. But I think they've been even more interested in how are you going to commercialize this pretty necklace? they really want to know how it's going to be implemented.

     

    00:21:44:03 - 00:21:56:14

    Griffin Jones

    They want to know who's going to be buying it and, and, and how that's going to work. So I want to unpack this and get my head around it. Wants to tell me about the plan for taking the Or the market.

     

    00:21:56:14 - 00:22:26:16

    Joshua Abram

    And we'll have something to say on this. But let's start with with the simple facts. we've decided as a business model to bring the technology, to market in a lab as a service model. This is nothing new to advanced medicine. So Quest Diagnostics, a great company. Roughly a third of its revenue comes from operating labs and a service basis within great hospitals.

     

    00:22:26:18 - 00:22:55:03

    Joshua Abram

    and bringing the efficiency of quest experience and centralized function and all the rest. They do it better than any hospital to do it. So, lab is a service, and we are absorbing, the cost of installing the technology. it will be a collaboration between our people and, our clients people to run the the, machine in rough numbers.

     

    00:22:55:05 - 00:23:26:10

    Joshua Abram

    each or, will do about 2000 cycles a year and will require three people, an engineer who will be a member of our team, senior embryology is probably initially a member of our team, but increasingly involving, our partners and maybe even involving our partners. By the way, we are very collaborative by, my nature, and find me a lab technician, who will probably be supplied by our partner.

     

    00:23:26:11 - 00:23:47:05

    Joshua Abram

    So lab is a service is the first thing to understand about this. Not new. Widely used in medicine. Lots of benefits for, our clients. Reduced CapEx. We're always there to, guarantee the success. Nology on and on and on.

     

    00:23:47:07 - 00:24:10:08

    Griffin Jones

    And some doctors do that. Now. They all use one person's lab. And in larger cities you might have someone that has a lab, and then you have four doctors that each use that lab, and they've got a boutique practice. And so I could see how you could really scale that lab as a service. Will you start there? Will you do you think you'll work first with some of the large fertility clinic networks that be on.

     

    00:24:10:08 - 00:24:44:17

    Joshua Abram

    Premise at first? So we'll be on premise with our partners. And I think, as you started, the podcast by saying, we've been blessed to have a who's who, innovators and leaders from both the commercial side, the C-suite and the science side. The lab leaders come down, and spend time with us here often a day or two, really digging into what we're doing, the business model and the, the science and the response to that.

     

    00:24:44:17 - 00:25:04:20

    Joshua Abram

    And just incredibly gratifying. I think people see the logic of what we were doing, how it's going to help them in their business. I was going to help patients, and it's how it's going to help the field. address what you described as a tragedy, what we think of as finding the missing on to demand.

     

    00:25:04:22 - 00:25:26:11

    Griffin Jones

    Some of the questions have been about who's going to want to have a whole bunch of equipment and these big machines, these big, expensive machines installed in their IVF lab and have to move things around and have to incorporate all of this? Well, next to me, I have the guy that's done it.

     

    00:25:26:13 - 00:25:53:09

    Dr. Alejandro Chavez-Badiola

    So me, I am the first one to do that thing that, you know, IVF doctors and biologists, we always have patients as our top priority. Patients interests are our interests and we want to make sure that we're offering the best medicine possible. So if we have a system that is consistently every cycle performing at its best, why wouldn't you want to have this system?

     

    00:25:53:11 - 00:26:21:05

    Dr. Alejandro Chavez-Badiola

    So I think that. For me, the decision was very easy. I've been in this field for two decades now. This clinic has been in Mexico for 15 years. I built a reputation which is very hard to build, and I needed to make sure that the system was ready to treat patients, at least to the level that I'm used to treating patients.

     

    00:26:21:07 - 00:26:48:09

    Dr. Alejandro Chavez-Badiola

    And then with the first results we have from our first IAB study, I mean, it's like, wow. I mean, the question is why was not why not is the question for me was, how soon can we get so I know that for embryology, for existing clinics, there will be a lot of questions. And how we implemented, how we adopted, how do we learn.

     

    00:26:48:11 - 00:27:18:14

    Dr. Alejandro Chavez-Badiola

    And that's one of the reasons why we're operating, the, our system ourselves. We want to walk hand in hand with our partners so they can learn how to use it. We want to make sure that we keep top service, top trained people, to make sure that they want they have results that can match results from 5% of the top best clinics in the world.

     

    00:27:18:16 - 00:27:43:06

    Dr. Alejandro Chavez-Badiola

    So just think about this. An embryologist, as a clinic owner, whether you are just opening a new clinic, planning to expand or planning to improve the results you're offering to patients, imagine I knock on your door and I tell you they want. I can offer you results that can compete with the top 5% clinics in the world. Would you take me on board.

     

    00:27:43:08 - 00:27:48:00

    Griffin Jones

    If I saw a whole lot of evidence that said so?

     

    00:27:48:02 - 00:28:11:08

    Dr. Alejandro Chavez-Badiola

    We're working on that. We are having. I mean, the first IAB study is showing that we were there. These were prototypes. And of course, with this, study that the pilot that we just launched here in Mexico City is one of the objectives that we can show that the results that we had last year can be scaled at larger, with a larger number of patients.

     

    00:28:11:10 - 00:28:13:10

    Dr. Alejandro Chavez-Badiola

    Yeah. We don't have the data.

     

    00:28:13:12 - 00:28:31:17

    Griffin Jones

    How do you think you might counsel them on change management? What challenges did your own team have you? I think you took part of your andrology lab and part of your conventional Ed, but you still have your andrology lab and you still have your conventional lab, and you're able to fit Ora in there. What challenges did your team have?

     

    00:28:31:17 - 00:28:40:20

    Griffin Jones

    How do you think you might counsel these folks that start to take on Ora in the United States in 2026, and this change management?

     

    00:28:40:22 - 00:29:11:21

    Dr. Alejandro Chavez-Badiola

    So the first step that I think that made or helped make things as fluent as possible was incorporating the team stands at the Andrology team and biologists, to work with Alda before the system was installed. Then before we started running patients, we ran drills for safety. So when we had the first patient, all the lab team, then nurses that doctors were already familiar with the system.

     

    00:29:11:23 - 00:29:39:20

    Dr. Alejandro Chavez-Badiola

    So this collaboration, this communication is critical, is crucial. As you were saying, yes, we had to make modifications because our lab was not. In this clinic has has been here for 11 years. I didn't even dream about the existence of this technology ten years ago. As Josh was saying, the technology was not there, not even to to imagine this.

     

    00:29:39:22 - 00:30:09:01

    Dr. Alejandro Chavez-Badiola

    So it was very easy to accommodate again, because of the layout. We still have some space constraints, but again, this is the first automated lab in the world. And the idea is that we're learning a lot with intention to make the transition way more, fluent for our future partners. And the conversations that we've had so far have been very positive.

     

    00:30:09:03 - 00:30:13:04

    Dr. Alejandro Chavez-Badiola

    They see this base, they have an idea about what they need.

     

    00:30:13:06 - 00:30:46:00

    Joshua Abram

    And yeah, I think I mean, to your point, I look, change management is always an issue. And, addressing the concerns and the needs and the ambitions of our partners is paramount. But I think one thing is to point out, particularly to the science and biology side, that we are bringing tools to them that simply could have been dreamed of, three years ago that, our, chief science officer, abused one of their own.

     

    00:30:46:00 - 00:31:11:04

    Joshua Abram

    Jack Cowan. We started talking about the Nobel Prize. was, Jack, of course, was the, person, the young man, in his lab, who Edwards had enormous confidence in and turned to Jack and said, Jack, in this science experiment, I've created you clinical medicine. Of course, Jack has been in the forefront of doing that ever since innovating.

     

    00:31:11:06 - 00:31:53:08

    Joshua Abram

    throughout, associated with many of the key developments, whether it's Icsi or of education, either. Is it a mentor or the advocate practitioner? So we are automating many of the steps that Jack and other leading embryologist created, but want to make. And, what we're really doing at the end of the day is providing embryologist. The job I'd be says, is trained us to think a single cell surgeons your job lectures us and says you are not to think about the demands of this field as anything other than surgery.

     

    00:31:53:08 - 00:32:39:20

    Joshua Abram

    These are single cell surgeons under enormous pressure, and they need the same tools that great surgeons have in other parts of medicine. And what the da Vinci robot, for instance, has done to, surgery, the kind or conceivable is going to do, for IBM. We are the da Vinci robot of IVF, putting the tools needed by these brilliant single cell surgeons in their hands for the first time, and relieving them of a lot of the pressure, that goes in running lab and operating the lab and letting them focus on the key decisions that now our I was started by talking about in person the loop at all times that

     

    00:32:39:20 - 00:32:54:18

    Joshua Abram

    only an embryologist to make. so a lot of change management is making clear how we are empowered with the latest technology, but none of us could have dreamed of just a few years ago.

     

    00:32:54:20 - 00:33:24:06

    Dr. Alejandro Chavez-Badiola

    I think that this is a very good point. any embryologist that, walk into our lab and look at the hybrid system working, they wouldn't be surprised with what the system is doing. We're not inventing new processes. We are following the processes that have been proven for decades with millions of treatments and liberties. The only thing that we have done is we have automated these steps.

     

    00:33:24:08 - 00:34:03:14

    Dr. Alejandro Chavez-Badiola

    Everyone will recognize the dishes that we're using, the pipettes, the Icsi needles and the protocols that we're following. So there are no surprises there. There's no magic, which is automating and increasing the precision, the accuracy of these processes. so again, no surprises. The other thing that, I forgot to mention in taking again, the example of the of the Da Vinci problem, if you have a recently graduated ObGyn wanting to work in operate, we did the robot.

     

    00:34:03:16 - 00:34:34:15

    Dr. Alejandro Chavez-Badiola

    They wouldn't be able to do it. They would be able to recognize everything the same technique, the same equipment that they would use in laparoscopy, but they would need to get special training. And after that, there is no turning back as a doctor or as a patient. And as an example, if I had a need for prosthetic surgery, I wouldn't go to a doctor that is not going to operate me with the robot just because of the precision.

     

    00:34:34:17 - 00:34:43:04

    Dr. Alejandro Chavez-Badiola

    And yes, that doctor had to undergo extra training to improve the quality of of medicine that he's practicing.

     

    00:34:43:06 - 00:34:50:22

    Joshua Abram

    90% of prostate surgeries in America for 90% of patients demanded doctors money.

     

    00:34:51:00 - 00:35:14:21

    Alan Murray

    I was going to have the, I think 100% of our visitors who are in clinical operations are here. They're looking at ways to grow their business. They're looking at ways to grow their business. In some cases where we how do we double in the next five years? How do we provide more points of care? What is the technology and tools that need to be baked into our disruptive business models?

     

    00:35:14:23 - 00:35:48:18

    Alan Murray

    So it's not been about growth and pulling costs down. Cost per maybe laboratory efficiency, ability to generate more embryos with fewer eggs. So our conversations haven't been so much about retrofitting an existing laboratory environment, but what does the future look like? How do we grow? How do we integrate increased enterprise value to our networks? How are we on the on the forefront of technology to recruit more patients?

     

    00:35:48:20 - 00:36:15:17

    Alan Murray

    So it hasn't been so much about within the lab and how to change a current lab. It's been how do we grow our network aggressively? We are chasing we all agree that 80% of patients in the United States, 95% worldwide, are not getting treated. That's our opportunity. And so Josh left it off when you said that missing opportunity is also commercial opportunity.

     

    00:36:15:19 - 00:36:43:06

    Alan Murray

    That's a total focus of our conversation is what's next. How did they take advantage of this new technology? Yeah I think this this conversation we're talking a lot about change management, as though our target was to retrofit current labs into an oral system. with the visitors we've had down almost all, all of them are looking at how do we grow and expand our network.

     

    00:36:43:08 - 00:36:49:05

    Alan Murray

    We have aggressive growth plans. You know, smaller growth patterns is how do we double in the next five years?

     

    00:36:49:05 - 00:37:15:00

    Alan Murray

    There's a huge untapped market. We're only servicing 20% of the population need in the United States. What new business models can we come up with to expand together using this new technology? We need things that are enterprise scale that can grow with us at the pace we want to grow and bring quality levels.

     

    00:37:15:02 - 00:37:39:06

    Alan Murray

    how many, you know, our time to pregnancy down our success rates per cycle? all of that comes through automation. So it's been much less about change management in the existing lab, but changing the vision for the future of how IVF can be delivered to service at population scale to get more of that 80% that's unserved.

     

    00:37:39:08 - 00:37:43:12

    Alan Murray

    And that's where Ora fits in as a key part of those strategies.

     

    00:37:43:14 - 00:38:05:18

    Griffin Jones

    How do you do that without driving up costs? Earlier, you gave the examples of smartphones, which are among the best example of how you had a very primitive technology that broke phone that was several thousands upon thousands of dollars, couldn't be afforded by the average consumer. And now people can buy a supercomputer for a few hundred dollars. And almost everyone on the planet has worked.

     

    00:38:05:18 - 00:38:30:09

    Griffin Jones

    So that's an example of where scale has really brought costs down. But there have been other things in in education and health care where, oh, now we have online education so that you bring the cost of college tuition down. And yet college tuition skyrockets. How do you make sure that you're able to make costs go down when some doctors think there's there's nothing that will make costs go down.

     

    00:38:30:09 - 00:38:40:06

    Griffin Jones

    Costs will just keep going up. And this is this might improve quality and it might improve, capacity. But but how do you make costs.

     

    00:38:40:11 - 00:39:03:09

    Alan Murray

    So let's turn it let's turn it to consumer demand. And they're looking at cost per baby. So we can talk about cost per cycle, cost per lab flow. But the end point here is cost for baby. In the US we're averaging about $75,000. Is the out of pocket cost to have a baby. That's two two and a half cycles.

     

    00:39:03:11 - 00:39:26:12

    Alan Murray

    And of course, you know, that varies by age and other, issues. But $75,000 is twice the take home pay of the average American. It's an impossible thing to enter the market. Biggest lever we have to pull costs down out of IVF is to pull down the number of cycles. Let's take two cycles, make it one and a half for that demographic.

     

    00:39:26:12 - 00:39:53:13

    Alan Murray

    Let's take two cycles. Let's make it one cycle. And the laboratory is the key driver for that. How many eggs come in to how many usable blastocyst go out? How many shots on goal do we have a transfer? If we take and we stack up the principle of IRA and we map it toward the Vienna consensus, we are mapping to be at the very top.

     

    00:39:53:13 - 00:40:21:13

    Alan Murray

    The aspirational levels of DNA consensus and continue to improve from there. The average lab in the United States is producing two usable blastocysts for every ten eggs that come into the laboratory. Can we take that from two usable blast per cycle to four usable Blast per cycle? That is our vision, and that's directly mapping to that over the coming years.

     

    00:40:21:15 - 00:40:45:09

    Joshua Abram

    And that ties back into at 100 point earlier in that, with automation and what we're seeing, given our very early tests, that we can be at the very top and share with our partners a lab at day in, day out through automation is at the very top of the pyramid. Consensus. The top 5% and a lab in the top 5% performing day in and day out.

     

    00:40:45:09 - 00:41:03:16

    Joshua Abram

    And that will gets us to the kinds of ratios that Allen has described. Human beings have done this on good days. It's not impossible. But what we haven't been able to do is replicate it day in and day out and just scale. That's the power of automation, and that's how we're going to reduce costs.

     

    00:41:03:23 - 00:41:29:03

    Griffin Jones

    You mentioned that very rough numbers and or and do 2000 IVF cycles with three technicians, embryologist for those that might be thinking, well, that has to be more expensive than the number of embryology, I don't know if it's ten or 12 or 15 that would normally to to take to do or even more. I don't know what the number is to do 2000 cycles.

     

    00:41:29:05 - 00:41:40:05

    Griffin Jones

    They think that the technology must be more expensive than that. How does the and what volume does or makes sense

     

    00:41:40:08 - 00:42:10:12

    Alan Murray

    We are looking at it in large scale opportunities. or makes sense at some threshold over a thousand cycles per year. the economics and cost per embryo produced goes down the higher that throughput number is. So we can take one or line, we can amp it up. We don't have to operate eight hours a day like a normal lab, or it can operate 16 hours much easier.

     

    00:42:10:14 - 00:42:40:15

    Alan Murray

    so it's easier to double shift an instrument. We talk about a team. One team can operate two or a line simultaneously. So we can increase capacity there. So we can pull labor costs down. We're pulling CapEx down. We're pulling the price of consumables down. Just like all large scale manufacturing or the higher the scale, the lower the price.

     

    00:42:40:15 - 00:43:12:16

    Dr. Alejandro Chavez-Badiola

    thinking, as the owner of an IVF clinic that is expanding, that's pretty much a dream come true. I don't have to put down money to buy new equipment, which is part of the highest expenses in IVF. I don't have to worry about the leasing costs. It is conceivable is putting the machine in my lab now, we were talking about the complications or the challenges of adopting out of system.

     

    00:43:12:17 - 00:43:44:21

    Dr. Alejandro Chavez-Badiola

    This is the first one, and there's a lot of redundancy, but the system is capable to stand on itself. Each unit, which some unit has all the air filtration to guarantee top quality of air, even if you are in an unprepared room. We have ups at every single station for backup. You don't need to invest in extra ups for it for your system.

     

    00:43:44:21 - 00:44:15:20

    Dr. Alejandro Chavez-Badiola

    So again, I don't have to worry about that. I don't have to worry about if I if I'm planning to double the number of cycles over the next 12 months, I don't have to worry about hiring new embryologist. How many more? 1015? 20 when there are no embryologist, I don't have to worry about making sure that the results from this new expanded lab are up to the level of the results that I had yesterday.

     

    00:44:15:20 - 00:44:29:06

    Dr. Alejandro Chavez-Badiola

    I know that day one I'm going to have at least the same, if not even better, results than the ones that I had yesterday. So expansion is easier in that sense.

     

    00:44:29:08 - 00:44:39:21

    Griffin Jones

    How will or how might or, take the average lab from two usable blasts to 40 blasts?

     

    00:44:39:23 - 00:45:16:04

    Dr. Alejandro Chavez-Badiola

    Let's start with this preparation. And I mentioned something about this earlier on. There's a paper from, Columbia showing how improved automated these preparation can improve than 11%. The number of usable blastocysts for a then next step, you need to prepare sperm. With our system, we have reduced DNA from station. We are using a system that is centrifuge free, so that in itself has a potential to improve.

     

    00:45:16:06 - 00:45:46:17

    Dr. Alejandro Chavez-Badiola

    But if we take it one step further, we're not now selecting sperm based on how I feel the sperm is looking, whether I think that he's moving good or not, whether I think that the morphologies of the or not. Now we're selecting the best sperm based on a quantitative analysis and the results that we've shown. And we have the bodies, we can improve last generation by about 15% just by improving sperm selection.

     

    00:45:46:19 - 00:46:18:20

    Dr. Alejandro Chavez-Badiola

    Now taking another example, PSA is not used in in Western countries because of many different reasons. The complexity of setting up the system to concerns about dumping fluid. But the papers coming out from Japan and now Australia show improved results. With the use of PSA. Fewer eggs get generated, higher rates of normal fertilization. Now, with the precision of the robots, we don't need a dumping fleet.

     

    00:46:18:22 - 00:46:47:17

    Dr. Alejandro Chavez-Badiola

    We don't need specialized bipeds for PSA. We use conventional needles, and the level of precision means that we just need one PSA movement to break the axis and bring down dramatically the percentage of degenerated eggs through XY. And with this increase, the proportion of eggs that get normal fertilization. And I think the idea is at each system, each step is doing this again vitrification.

     

    00:46:47:19 - 00:47:27:07

    Dr. Alejandro Chavez-Badiola

    Another example, the modifications that we've done that automated vitrification system allows to 55 up at 30 times 40 times faster than manual beautification using the same protocols, just standardizing what we're doing and including some, improvements. So if you add all these and you do these consistently, then you can easily explain how can we get from two blastocyst recycle to four again, you have an embryologist.

     

    00:47:27:08 - 00:47:53:21

    Dr. Alejandro Chavez-Badiola

    Your best immunologist is not going to have the same fertilization and blast formation rates every day. It's not going to get the same places formation rates from different cycles throughout the day. We have variations within our practitioners in this clinic. I have another clinic in Valhalla. There are variations between the clinics and we have our patients month after month.

     

    00:47:53:23 - 00:47:55:15

    Dr. Alejandro Chavez-Badiola

    How can we start to dissect?

     

    00:47:55:17 - 00:48:34:10

    Joshua Abram

    We had one major lab. They could come here and say, look guys, I am convinced, I think you would good for results. Having heard Alejandro go through the data on improvements in each one of these steps. But then he said, it's for God's sakes, if you could just normalize within my own network performance because on some key indexes and he cited two American cities, and the, the benchmark for fertilization to be key and the, the success rate at one clinic was an 82 wedding, 3%.

     

    00:48:34:12 - 00:48:39:01

    Joshua Abram

    And at another clinic, also in the United States, it was 50.

     

    00:48:39:03 - 00:48:40:06

    Dr. Alejandro Chavez-Badiola

    Just over 50.

     

    00:48:40:06 - 00:49:08:16

    Joshua Abram

    So it was a 50% swing. But this is a great operator. And the same protocols, the same, technology, the same good intention, the same training. And on a month to month basis, they're just seeing these kind of swings. I mean, it's the devil in the system. And it goes back to the point that I think Clovis made that is very difficult to scale this manual, artisanal analog system.

     

    00:49:08:18 - 00:49:16:19

    Joshua Abram

    This is the job of automation. And to put it at the top of the beginning, consensus every single day of the week.

     

    00:49:16:21 - 00:49:40:22

    Griffin Jones

    I'm glad you had to do a question about the answer protocol two, but that was a question from our audience, from Simon Lumsden, who wanted to we wanted that question answered. So thank you for answering that. Speaking of swings, Alan, you got me thinking about swings in costs, and I know you're still doing some research into this, but you got me thinking that the the term IVF cycle is a really general blanket term.

     

    00:49:41:01 - 00:50:01:06

    Griffin Jones

    You know, anything with a retrieval, any time an egg is retrieved, that's an IVF cycle. But sometimes you might retrieve it eggs, sometimes you might retrieve 21 eggs. And you could you could have big swings in the number of eggs that are retrieved and therefore the the amount of embryology work. How are you thinking about this?

     

    00:50:01:07 - 00:50:28:08

    Alan Murray

    I think in helping our partners understand their cost basis. We've done something with, twin brothers. Close the paper very soon. We're in the final publication of something called an activity based costing of an IVF lab. You know, it's basic. Think about putting a stopwatch on an embryologist, looking at what they're doing, looking at what they consume. so when we talk about a cycle, we talk about some kind of a generic cycle.

     

    00:50:28:10 - 00:50:56:13

    Alan Murray

    I don't know what it is anymore. what's coming into the laboratories? Our demands for an IVF are UI preparation. It's a work order coming into the laboratory. Now, their work order comes in. We're going to do egg preservation for a patient. So. And we looking throughout this roughly seven different definitions of work orders that are coming in the lab from an AI UI to prepping for an embryo transfer.

     

    00:50:56:15 - 00:51:17:18

    Alan Murray

    So as in this body of research, we've looked at the cost associated with each of those work orders or procedures that are coming into a laboratory. and we start looking at swings on it, number of eggs for, call it a standard cycle in the US that might include,

     

    00:51:17:18 - 00:51:29:07

    Alan Murray

    patient gametes going through an XY cycle with a biopsy and then freezing all the, resulting embryos.

     

    00:51:29:09 - 00:51:53:22

    Alan Murray

    I mean, look at the cost swing if it was a lower stem or lower response, and we saw ten eggs come in a lamb versus a high responder or a high stem protocol, it's all 30 eggs coming in. The cost of a cycle varies by more than 60%, just on the number of eggs per cycle. We look at, the time of day utilization.

     

    00:51:54:00 - 00:52:18:11

    Alan Murray

    How well balanced is the workload on the daily basis? Some days the embryology team is just crammed or the andrology team is quiet. Other days they've got some time to breathe and catch up, so they're not operating at peak times. We look at clinics that are large and have scale. Labor doesn't move that much. Labor overhead of supervision stays constant and can be spread.

     

    00:52:18:11 - 00:52:49:08

    Alan Murray

    So there's some economies of scale on labor. They've got more purchasing authority on supplies. so defining the cost of the cycle is more complex than just thinking about the rules of thumb. we needed this work so we could understand. So we're doing simulations on the throughput capacity for an Or system, and it's really, dumbed down to say it does 2000 cycles a year.

     

    00:52:49:09 - 00:52:56:01

    Alan Murray

    It's doing close to the 4000 work orders that come into a laboratory every year.

     

    00:52:56:03 - 00:53:17:22

    Dr. Alejandro Chavez-Badiola

    So, I'm going to try to answer as a doctor every time. And again, I have plenty of experience every time that I face a patient. And I have to make a decision about when is the best time to trigger, whether I push a bit more to get a few more follicles to mature, and trying to get a few more eggs or not.

     

    00:53:18:00 - 00:53:59:04

    Dr. Alejandro Chavez-Badiola

    I think that I am doing the best to get the best. But then how do you define the best time when we don't have the technology just want to make sure that they fertilize and that they make embryos. And that's how we assess equality. Now imagine what we can do with a system that standardizes everything, how we'll be able to learn a lot about whether one particular protocol is working better for one set of patients, whether triggering with one medication or another is better for certain group of patients because your patient endometriosis patient older patient younger patient.

     

    00:53:59:05 - 00:54:26:18

    Dr. Alejandro Chavez-Badiola

    So I can start personalizing these key decisions. The other important thing is that right now, we're only as good as the quality of the gametes that we're working with. So the key in the lab is making sure that we're giving each of these gametes the best opportunity. And the bottleneck is eggs. Now, right now in the lab, because of the way in which we work, we treat eggs as batches.

     

    00:54:26:20 - 00:54:53:00

    Dr. Alejandro Chavez-Badiola

    So I collect the eggs, put them in the incubator for a couple of hours, let's say. Then we go for XY. I will do need all the eggs one 1012 eggs at once. And if they were not ready. So then I will inject every year with a polar body. That doesn't mean that the cytoplasm was mature. It's an indirect measure telling me that they could be ready.

     

    00:54:53:02 - 00:55:30:12

    Dr. Alejandro Chavez-Badiola

    Why then do I the new the different times? Why don't we inject at different times? Because we don't have that capacity. We can't have our embryologist occupying stations at different times and then bringing Rd. I mean, they're busy with the next case with the technology that we have implemented without anything like modern microscopy, we can actually evaluate the presence of a polar body before denuding the egg so we can stop treating eggs as batches.

     

    00:55:30:14 - 00:55:55:05

    Dr. Alejandro Chavez-Badiola

    We can define which hacks can be the new now, which other eggs should keep. It should be kept in the incubator before then, using to give them a better chance for hydration. We can actually identify this. We need to decide when is the best time to inject, and those that don't show this being at the right time can be it could be injected later.

     

    00:55:55:06 - 00:56:24:08

    Dr. Alejandro Chavez-Badiola

    So this level of individualization in the decision process can transform what we're doing into giving each egg the best opportunity to become an embryo, which could make the difference for a patient between having a baby or not. And these can only happen throughout the nation. Or unless you duplicate the number of embryologist and the workstations that you have on European.

     

    00:56:24:10 - 00:56:47:13

    Griffin Jones

    Machines, don't have the variants that humans do. Machines can work. Double shift machines don't call in sick. Machines don't bump into each other in the lab. Crossing back and forth. But machines break. We were yesterday doing a LinkedIn live in my freaking microphone that I use for every podcast. Just doesn't work for LinkedIn live. But we did the test at home.

     

    00:56:47:13 - 00:57:14:21

    Griffin Jones

    I come here with stupid microphones not working. That has been among the biggest worry that people have with any technology. And certainly here is what is maintenance look like? What happens if we have Doctor Emily Thacker ask some questions about what maintenance looks like? Of course, Steve Rooks has more very specific questions about median time to repair and median time between failure.

     

    00:57:14:23 - 00:57:21:07

    Griffin Jones

    What's maintenance look like? How frequently do errors happen? What happens when they do? What are the proactive measures?

     

    00:57:21:08 - 00:57:44:15

    Dr. Alejandro Chavez-Badiola

    I'll let Alan answer this one, but I just want to give an example. I think that is about that how flexible you are with mistakes. How what is your threshold? A few months ago I saw that that,

     

    00:57:44:17 - 00:57:47:11

    Dr. Alejandro Chavez-Badiola

    How do you deal with pilots after their instrument?

     

    00:57:47:11 - 00:57:48:14

    Joshua Abram

    Cockpit? Dashboard? Cockpit?

     

    00:57:48:14 - 00:58:24:09

    Dr. Alejandro Chavez-Badiola

    Yes. And I haven't seen these for decades. I remember when I was a kid and these were open or were analog instruments. This time, for the first time ever, 100% digital. When I flight transatlantic our flights, I know that the pilots are not behind the wheel. During the 12 hour flight, I know that is how the pilot. It's just that the aeronautic industry has practically zero margin for error.

     

    00:58:24:11 - 00:58:49:15

    Dr. Alejandro Chavez-Badiola

    So where are we? And that's the key. And we're dead and in. And I will be able to tell you more about the team that we have dedicated to quality control and quality assurance and to my maintenance and all these. But that's the key. What's how tolerance for error. And we know that in medicine is or should be zero.

     

    00:58:49:17 - 00:59:15:14

    Alan Murray

    Yeah. Look up. and I think we begin with culture and we totally recognize the need for high reliability laboratory that is you know, it's it's table stakes for us. So from culture led to our recruiting philosophy. We have a team of incredible engineers and we can think of roughly half of them are come from an R&D world.

     

    00:59:15:16 - 00:59:50:19

    Alan Murray

    Experimental mechatronics, experimental optical physics, coders, AI people all very experimental. Move fast. Let's get things done. Other half of the team comes out of the automotive industry. The quality control programs in automobile component manufacturer are so far beyond anything we've ever seen. Close to the IVF community. So the guys we brought in out of suppliers to the automotive industry, who were responsible for bringing products to market that drive cars.

     

    00:59:50:21 - 00:59:52:10

    Joshua Abram

    Autonomous driving.

     

    00:59:52:12 - 01:00:23:01

    Alan Murray

    Including autonomous driving, the guys that are making the lidar systems that have to work every time that are doing the controllers. For power, speed, engine management, all of these things. And in that culture, it has to work. They are supplying to BMW, Chrysler, Ford, Hyundai, big wide. These corporations are putting out millions of cars that are that have passengers inside of them.

     

    01:00:23:03 - 01:00:57:00

    Alan Murray

    Anything goes wrong. There's a huge problem. So we've got recalls which bankrupt companies. So what we come from is a culture of validation, verification, design, organizational flow that goes all the way through testing. And you mentioned Steve Brooks. Meantime, the failure testing for a component going into a car is 100 million times or more. So before they release full production, they do a limited run and run.

     

    01:00:57:00 - 01:01:31:05

    Alan Murray

    These things. So that's the culture of our team that transcends down to then what do our suppliers are doing? Are they under this rigorous quality program? so we've looked at our supply chain training and we're looking for quality suppliers. So when I mentioned our robots came out of electronics manufacturing, we're going to robot manufacturer that are making a thousand a month or 100,000 a year robotic components and selling them into lines that are doing assembly of electronics.

     

    01:01:31:05 - 01:02:02:16

    Alan Murray

    And that line goes down. They're losing million dollars a minute. So it's not the human cost, but there's an economic cost. So have looked for rigid quality control suppliers and everything from our optical movement to our optical component to our robots, to our linear motion devices, to our micro robots, to our anti vibration tables that are all being sold at scale into environments that are 100 to 1000 times more demanding every day.

     

    01:02:02:18 - 01:02:05:06

    Alan Murray

    Than running 12 human cycles through a lab.

     

    01:02:05:06 - 01:02:15:15

    Griffin Jones

    mentioned, it can vary so much between clinics. What will it be for it? Will there be remote monitoring? And will someone come on site to inspect every three months, or what will routine.

     

    01:02:15:15 - 01:02:22:06

    Alan Murray

    You know, so we're starting it ourselves. So we have an on staff engineer. behind that engineer is a team.

     

    01:02:22:11 - 01:02:23:14

    Joshua Abram

    Every hour of operation.

     

    01:02:23:17 - 01:02:26:14

    Alan Murray

    Every hour of operation. And this is a,

     

    01:02:27:17 - 01:03:05:11

    Alan Murray

    Embryo engineer cross-trained in embryology. They know our systems. They know how to swap out robots or robotic components. They know the service and maintenance schedules. We've got a QMS department that's actively, developing very detailed maintenance, whether it's, daily, weekly, monthly program or annual program for each component. so the systems are coming live today that, both predictive maintenance, because we know from our optics whether a robot is is hitting as precision every time.

     

    01:03:05:13 - 01:03:15:11

    Alan Murray

    So we've got early indicators, through the digital components. And then we have, of course, very rigid schedule maintenance procedures.

     

    01:03:15:13 - 01:03:45:00

    Griffin Jones

    We talked about how increasing the number of usable blasts and decreasing the cost for manpower, they reduce the cost for IVF and certainly cost for baby. so I think we answered most of Mark Evans question, but he wondered about a regression model that correlates to to price in the patient adoption of IVF. So I wondered, do you have any way of how will you be thinking about this a year or two from now to see, did we actually bring cost down?

     

    01:03:45:04 - 01:04:19:15

    Joshua Abram

    I would start with a landmark paper by David Adamson, through his organization, A command, which was published a couple of years ago. it's the only, W.H.O. affiliated NGO, econometrics, economists involved, the paper physicians involved in the paper. And they documented that for every, point reduction, in cost against disposable income, it was a 3.2, 3.3 increase in utility of the service.

     

    01:04:19:17 - 01:04:55:21

    Joshua Abram

    So we've actually mapped this out. But and I would not scope the figures here, but I'm happy to supply the data, which was interesting that as the cost of IVF begins to drop, there is more leverage in pricing than in almost any other field that we have seen. I mean, this is a credibly price I field field and the big opportunities over time in the future, we think with providing high quality IVF at scale and undoubtedly many innovators are going to choose models that are less expensive.

     

    01:04:55:21 - 01:05:13:05

    Joshua Abram

    I mean, it's just inevitable our innovation will beget other innovations. so I think there's a very, very fair path between, automation, the ability to innovate across the field, but particularly on price. If that's what you want to do.

     

    01:05:13:07 - 01:05:26:23

    Griffin Jones

    People will be thinking, good luck getting FDA approval, but you've gone a route where they have everything that touches the embryo is already FDA approved. Tell me why that's important. Tell me more about that.

     

    01:05:27:01 - 01:05:52:02

    Alan Murray

    So let me jump in. I mean, it's, our governing body, as we come into the US, will actually they'll be doing inspections here as cap college American pathologist. So we've engaged with them. They've been down here, started looking at our systems. And how do we make protocols or clear lab protocols here. And using their international program, which is a mirror of the US program.

     

    01:05:52:04 - 01:05:56:02

    Alan Murray

    we're working with Cap, which is the gold standard of laboratory.

     

    01:05:56:02 - 01:06:07:14

    Alan Murray

    certification and inspection. we have components which are going to go through an FDA 510 K if that's a piece of it. So we have a few elements that will be going through an FDA 510 K.

     

    01:06:07:14 - 01:06:36:07

    Alan Murray

    And then as you started the conversation, we have built for a version one to use petri dishes coming out of IVF, general suppliers. So they've gone to FDA. We're using media produced and commonly used throughout U.S labs. Our micro tools. We've adapted the robots to use existing micro tools to everything that's happening within the dish, or 1 or 2 degrees away from a cell.

     

    01:06:36:08 - 01:06:39:11

    Alan Murray

    Are FDA cleared components.

     

    01:06:39:13 - 01:07:17:03

    Dr. Alejandro Chavez-Badiola

    Imagine you hire me as a consultant. You wouldn't because I am a doctor, not an embryologist. Can you imagine? You hire me as a consultant to design and equip your new IVF lab. I will choose the equipment that I think that is the best. I will lay the equipment down based on whatever I think is most efficient. And nobody's going to come and assess the equipment that I have that I selected, or the layout.

     

    01:07:17:05 - 01:07:51:00

    Dr. Alejandro Chavez-Badiola

    Would, cap is going to come into maturity is that everything is working according to protocols and all the things that we're meeting. So what we're doing is that we're equipping, designing, equipping IVF labs with 21st century technology. And the protocols, again, are the same protocols that have been that have demonstrated safety and results with media inside of libraries.

     

    01:07:51:02 - 01:08:02:16

    Dr. Alejandro Chavez-Badiola

    So this is where we are. The other thing again is it makes a difference, is that we are not selling the equipment we own and operate, that we're assisting.

     

    01:08:02:18 - 01:08:12:12

    Griffin Jones

    I'd like each of your thoughts on this, but you said there's never been a better time to be an embryologist. Would you be better at.

     

    01:08:12:14 - 01:08:43:15

    Joshua Abram

    look, I think the market demand is extraordinary. as we said before, if you take the sort of boring banker, analysis of demand by 2034, we're going to be doing globally 6.5 million cycles. if you, take the SRM approach, and think about what represents, true consumer demand, 12 million, babies are waiting to be born annually just for fertility.

     

    01:08:43:17 - 01:09:15:16

    Joshua Abram

    20 million. If we include things like, making miscarriage and other valuable uses for IVF, that's if they don't happen. It's too expensive and too hard to access. So I think be hard to find whether you are a clinician of any kind or a businessperson of any kind. Involvement. Yeah. I think it'd be hard to imagine a more golden moment to be involved in the field, but, people at the front lines are better remain, and biologists are treasure single cell surgeons.

     

    01:09:15:18 - 01:09:46:00

    Joshua Abram

    And, we are going to give them as many, intervention robots as they need to meet this demand. And I think together, we've got to march into a future where, you know, we're not giving birth to 1 million children, per year or 10 million to over 40 years. We're doing, providing meeting to demand for 10 to 12 million children every single year.

     

    01:09:46:02 - 01:10:28:21

    Joshua Abram

    I mean, it's just self-evident that there's never been a better time to be an embryologist. It's not. Is it more, is going to eliminate the need for embryologist. We are embracing embryology. So we're going to need embryologist involved in every single station. I think the only thing embryologist, should be worried about. and I don't know any Brighton biologist you feel this way is, what happens if I don't train, if I don't change, if I don't embrace innovation, what happens if I'm the person in my office who said no, lambs and chat GTP and having them integrated into my business life is not for me.

     

    01:10:29:02 - 01:10:53:05

    Joshua Abram

    I'll leave it to all the rest of my colleagues and see what happens. Well, that person I worry about, I worry about that we. But I don't think that is true of many people in the field. Should be not many of the leaders in the field and people at the front lines doing very vital work every day. So never a better time with coming technologies coming, stress is going to be relieved.

     

    01:10:53:07 - 01:11:14:13

    Joshua Abram

    Opportunities are going to grow. And I don't know of a single embryologist who doesn't want to help as many people as they can. They've chosen to be in a helping profession and to go from one field. So to, a year to 12 million, that's a lot more people to help. So we're going to do this together.

     

    01:11:14:15 - 01:11:16:01

    Griffin Jones

    What do you see?

     

    01:11:16:03 - 01:11:37:00

    Alan Murray

    you know, it's hard to add much to that. from the embryologist perspective who embraces change, is curious, is intellectually curious, who takes advantage and learns about AI system and understands robotics and that intersection with the evolving embryology lab.

     

    01:11:37:01 - 01:11:40:06

    Joshua Abram

    And we're going to help in that education process.

     

    01:11:40:08 - 01:11:59:19

    Alan Murray

    It's a fantastic and it's a growing population need. We're going to need more and more embryologist. I think it's great time, man in the field. If you're curious, if you embrace technology. And I think that's broadly, you know, every job in America almost fits into that category.

     

    01:11:59:21 - 01:12:07:16

    Griffin Jones

    What do you still value now that you have this automation? What do you still value from your human embryologist? As a clinician?

     

    01:12:07:18 - 01:12:19:22

    Dr. Alejandro Chavez-Badiola

    Exactly the same that I value today. From my perspective, embryologist are scientists. They're not human. Roberts is down by 15. Or they they are scientists.

     

    01:12:20:00 - 01:12:50:22

    Dr. Alejandro Chavez-Badiola

    I still value the same. I want people that want, that I can just or discipline who put patients care is top priority or diligent. It's exactly the same values that I use. And it branches today are the ones that I'm looking for in the biologists of the future. Now, I'll just add to your previous question. And biologists are scientists.

     

    01:12:50:22 - 01:13:32:07

    Dr. Alejandro Chavez-Badiola

    That's what they are. If I think about Edwards and Jack Coleman, he was a fantastic time to be an embryologist. Anything. Everything that you did was new. You were discovering. Today, I think that most embryologist are overwhelmed by administrative chores and manual are additional steps that leave very, very little room for their imaginations to run wild and create and test what they can do to improve patient's results.

     

    01:13:32:07 - 01:13:39:23

    Joshua Abram

    30% of their time is spent on paperwork. I mean, who wants to do that? And something robots do very well, I think.

     

    01:13:39:23 - 01:14:07:17

    Dr. Alejandro Chavez-Badiola

    I don't know if it's going to happen ten, 50 or 100 years, but imagine the time when 99.9 to 100% of the patients get pregnant. That's a very important time to be an embryologist. But right now, as Joshua was saying, we're entering digital era in in the IVF lab right now, we have the toys, we have the technology so we can become scientists again and start improving.

     

    01:14:07:23 - 01:14:37:21

    Dr. Alejandro Chavez-Badiola

    And with this system, without a system, without a nation, now, you don't have to spend that much time, hopefully zero time with administrative chores and these additional steps. Now you have time to create, to imagine, to become a scientist again, and then to apply that those improving patients results and getting to these 100% when becoming an allergist will be more.

     

    01:14:38:03 - 01:15:15:17

    Joshua Abram

    Than doubling on our description of embryologist as scientists, scientists do research. And one of the things that every senior scientist embryologist has struck by coming down here is that, we are going to unleash a entirely new era of science and scientific innovation in IVF, because one of the things that automation does is removes the hungry hundreds of confounders involved in creating a sperm, an egg into an embryo.

     

    01:15:15:19 - 01:15:40:16

    Joshua Abram

    Each of these individual steps, which are hard to account for and hard to do with exacting precision to maintain the control. And so everything will be standardized. And then and this was the comment of, Mitch Rosen, who came down here and he was not alone in saying this. Mitch Rosen, who he spoke to in HDL day, and in Ari, I one of the few, be immersed in California, San Francisco.

     

    01:15:40:16 - 01:16:04:05

    Joshua Abram

    He was down here, I guess, ten days ago. And Mitch said, you guys don't understand just how important this is going to be for science, because it is isn't obviously an academic institution. This was hardest, you were going to take noise out of IVF research. You're going to take the noise out and allow me to listen to one variable at a time.

     

    01:16:04:07 - 01:16:30:05

    Joshua Abram

    And if I can have that environment, I and my colleagues can make progress. It's going to make the world's head spin in the best possible way. So, you know, we've actually talked about promoting x percent of the time on the robotics to research projects. We're absolutely fascinated by this. We are committed to it. It's it's something that we want is part of our legacy.

     

    01:16:30:06 - 01:16:37:13

    Joshua Abram

    And we are looking, to our embryology scientist partners, to help us move this forward.

     

    01:16:37:15 - 01:16:59:22

    Griffin Jones

    I'm not a clinician or a scientist. I'm not the validate. I'm not the one to validate everything that you've done here. But what I can do is come and see everything working harmoniously, and I can see the team and how invested they are in this. And when you were taking me through or yesterday, does your embryologist and your technicians, how much pride they had in explaining to me, you can see that something is working here.

     

    01:17:00:01 - 01:17:23:08

    Griffin Jones

    And the other thing that I can do is talk to all of the people that have come down thus far, and I've talked to Ari Ice, talk to the business folks, I've talked to the lab folks. They're all blown away. You should be very proud of what you've done thus far. I'm impressed. And thanks to your and Watson and her team for making this first in-person podcast episode possibility. It's been a pleasure.

    01:17:23:10 - 01:17:24:16

    Joshua Abram

    Thank you so much for being here.

     

    01:17:24:16 - 01:17:46:18

    Announcer

    Today's episode is paid content from our feature sponsor, who helps inside reproductive health to deliver information for free to you. Here, the Advertiser has editorial control, but in the case of this episode, the Advertiser chose not to make any edits. Feature sponsorship is not an endorsement and does not necessarily reflect the views of inside reproductive health. Thank you for listening to Inside Reproductive Health.

Conceivable Life Sciences
LinkedIn
Instagram

Joshua Abram
LinkedIn

Alan Murray
LinkedIn

Dr. Alejandro Chavez-Badiola
LinkedIn


 
 

244 The IVF Orchestra: Winners & Losers In the Patient-Driven Marketplace. Dr. Cristina Hickman

 
 

Today’s Advertiser helped make the production and delivery of this episode possible. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, nor does the Advertiser's sponsorship constitute an endorsement of the guest or their organization. The guest's appearance is not an endorsement of the Advertiser.


Who’s adding the most value in IVF today—and who might not be here tomorrow?

This week on Inside Reproductive Health, Dr. Cristina Hickman, founder of Avenue Center for Reproductive Medicine in London, breaks down the fertility field’s evolving landscape. As a PhD embryologist and clinic owner, she shares her perspective on industry leaders, automation, and the shifting role of technology in fertility care.

Tune in to learn:

  • Why some clinic networks might be overextending by bringing too many verticals in-house.

  • How automation could scale embryologist efficiency to 2,000+ cycles per year.

  • The surprising relationship between robotics and AI in embryology.

  • Which companies are providing the most value right now--in lab automation, EMR, financial management, and cryo storage and more

  • How new intelligence could challenge the current standard of single embryo transfer.

Listen now to hear Dr. Hickman’s take on where the field is headed—and who’s leading the way.


The Future of IVF Is Here—Fully Automated, AI-Powered, and Game-Changing
Meet AURA by Conceivable Life Sciences—the first robotics-driven IVF lab designed to revolutionize fertility care.

  • AI & Robotics: Precision-driven automation for every step of the IVF process.

  • Scalability & Efficiency: Higher throughput, lower costs, and consistent results.

  • Accuracy: Minimize human error and optimize embryo outcomes.

  • Accessible & Innovative: A bold leap toward the future of fertility care.

Be among the first to see what’s possible. Visit Conceivable Life Sciences today.

  • Dr. Cristina Hickman (00:03)

    It will make you unemployed if you don't adapt to the new technological infrastructures and you don't acquire the necessary new skills that are needed for the embryologists of the future. Okay? So that generation of embryologists will be struggling to find a job, but all of us can learn, all of us can evolve, all of us can adapt.

     

    Now with Conceivable, we finally get this level of efficiency that allows us to better understand, to better treat more patients per embryologist. And the numbers are great. We've now gone in this journey that I've just told you from 80 cycles per senior embryologist to 2000. It's a completely different scale.

     

    Griffin Jones  (00:57)

    Who's on their way to becoming obsolete in the IVF space? Who are the players adding the most value in the fertility field right now? My guest names names, at least for the second question she does. I'm talking with Dr. Christina Hickman, the founder of Avenue Center for Reproductive Medicine in London. She's a PhD embryologist who, as the owner of her own practice, finds herself as the maestro of the orchestra. These seats in the IVF orchestra

     

    are all of the different companies in the fertility sector, from AI clinical prediction tools to witnessing companies and every point solution in between. She explains the relationship she sees between different point solutions and the end-to-end ecosystem that the consumer-driven patient marketplace demands.

     

    Dr. Hickman issues a warning to fertility clinic networks who are trying to take every last service in house. She explains why robotics improve AI, not just the other way around, and what new intelligence means for the concept of single embryo transfer and patient success rates. Does it flip the concept of single embryo transfer on its head as we know it today? She shares which companies she thinks are the best right now in each of the categories of EMR.

     

    financial management, cryo storage, clinical prediction, and more. And if the status quo is 80 IVF cycles per embryologist per year, how is Dr. Hickman's clinic doing 500 IVF cycles per embryologist? What is she doing? And what did she see in her visit to Conceivable Life Sciences, the lab in Mexico City that's automating the IVF lab, that will scale that 80 cycles per embryologist number to 2,000? Enjoy.

     

    This is my conversation with Dr. Christina Hickman.

     

    Griffin Jones  (03:05)

    Professor Hickman, the conductor, welcome back to the Inside Reproductive Health podcast.

     

    Dr. Cristina Hickman (03:11)

    Thank you Griffin for having me, it's a pleasure to be back.

     

    Griffin Jones  (03:15)

    Are we going to get to 10 million IVF babies born worldwide per year with point solutions, or do we have to blow the whole thing up and replace it with a new end-to-end solution?

     

    Dr. Cristina Hickman (03:30)

    Yeah, I definitely am on the end-to-end camp here. We've been trying the point solution for years and it's worked for us until today. you know, building up one solution for looking at sperm assessment, one solution looking at the egg assessment, having this artisanal approach to practicing embryology.

     

    It's okay, but it's not going to allow us to scale to the level that we need to go to. So a full end-to-end approach is the only way that we're going to solve the entire journey that this patient is going through. Not looking at information in a siloed manner. Bringing all of it together so that we can make decisions which are specific to the entire concept that this patient is experiencing.

     

    This for me has been something that throughout my career we've been trying to provide this end-to-end solution and Really it hasn't been until it clicked to me that this is not going to happen with a single company Doing the end-to-end it's too big a journey. The fertility is too complex We need to create this ecosystem of different companies working together So that we can tackle every single challenge at once

     

    Griffin Jones  (04:46)

    So when I hear multiple different companies in an ecosystem, to me that sounds more like point solutions. Tell me about how you see the difference.

     

    Dr. Cristina Hickman (04:56)

    Yes, so at the moment what we have is companies who are looking at focusing on what I call it the what's in it for me, right? So they're trying to build their own proprietary solutions to their patients. So I'm thinking of this at the clinic level. So rather than going off to bring in a commercially medical grade robust AI solution, they're trying to build it in-house with limited data, which leads to

     

    all the challenges that we see associated with AI, know, biased information that's not generalizable, that doesn't provide an explanation and traceability. So this means that you're trying to kind of provide yourself with one, everything under one proprietary company. But what, what the approach that we've been giving is, okay, why don't we go out there and try to find all the different instruments in the orchestra, so to speak, right? So

     

    who is the best violinist out there? Who is the best cellist out there? And put them all together. Now we need to orchestrate it all so that it doesn't feel like a single instrument playing. When you get everybody in an orchestrated manner, it now feels like a completely different music. And this completely different music is the end to end approach. So yes, there's multiple companies, each one focusing on an instrument to get you there, but...

     

    The experience that you provide by stitching it all together allows you to provide a whole new experience to the patient, a whole new experience to the doctor. So that you're not just getting embryo assessment or sperm assessment, you're getting a holistic approach to the patient.

     

    Griffin Jones  (06:36)

    So is it the clinic's role in your view to be the end-to-end solution and then every potential partner are those different point solutions that end up being the seats in the orchestra?

     

    Dr. Cristina Hickman (06:47)

    Not necessarily. The clinic could be one of the instruments as well. So in a truly community-based approach, it becomes less clear who is the maestro, because everybody is playing a role in that. what I say that determining who is going to still be alive in the future, who are going to be the dinosaurs who are going to cease to exist,

     

    is going to be determined by how integrated in this ecosystem you are. it's now about, in the past it was about, I'm building my own proprietary thing. But the problem of doing that is that your own proprietary thing is no longer the best in the market. So it's really within this ecosystem that we start understanding what is the true end-to-end solution. And this is when we start looking at certain tools that provide you

     

    this end-to-end in a way that has never been able to do before, such as the conceivable system.

     

    Griffin Jones  (07:49)

    So who's the maestro or is the patient the maestro?

     

    Dr. Cristina Hickman (07:53)

    The patient is the one who benefits from it first and foremost. So we have everybody saying that they have patient-centered care, right? And so this is something that they say, a patient-centered care, but I'm not gonna use the best product in the market because I wanna use the one that we built ourselves, right? And this now means that you're not patient-centered care, you are clinic-centered care, right? I'm gonna keep the patient waiting in the waiting room because it makes me feel like an important doctor.

     

    you're definitely not patient-centered care when you're thinking in those terms. I'm going to create a waiting room that doesn't feel like, that feels like a hospital because that's as cheap as I can get it. That's not patient-centered care. Patient-centered care is you're sitting down and you're thinking strategically, what is the best way to apply the global resources so that we can achieve the best for this patient? If what I've built,

     

    is inferior to what's out there in the market, let's get that thing that's out there in the market. And now let's find a way that it doesn't feel like it's separated from everything else. Let's give the transparency of this information to the patient. And this means allowing things to become obsolete quickly. In a world of fast innovation, you need to be prepared to let go of things that are no longer at cutting edge, right? And in the world of digitization and AI,

     

    this is happening incredibly fast. Right. So what, what analogy that I heard from, from Alan, from one of the founders of Conceivable, he was telling me, Chris, I don't care about where the puck has been. He was talking about hockey, right? I don't care where the puck has been. I care about where it's going. Okay. And then I care about being prepared for when it gets where it's going. Right. And it's this, this adaptability to be able to

     

    to foresee where things are going and letting go of the past, letting go of the old technology and starting to embrace what is the way that we should be in the future. I know I'm using past and future tense at the same time, but that's the point. The point is that we accept that technology moves fast and this requires a community approach.

     

    Griffin Jones  (10:07)

    So it's a lot more of an adaptable system. Is this what David Sable means when he says ditch the travel agent model of care where you used to have a travel agent plan your entire vacation and now you go to a Priceline or an Orbitz and you might get your rental car over here or you might get an Uber or Lyft over here. You might get a hotel over here. You might get an Airbnb over here or find some other accommodation and then you might get your

     

    and you might bundle it in or you might get your airfare somewhere else. And so what I think what he's suggesting is that as opposed to having the everything done in one place that patients have a lot more to be able to shop if it's able to all integrate together. Is that the way you see it?

     

    Dr. Cristina Hickman (10:53)

    Yes, but also having it in a way that the patient has full visibility of what's going on. Gone are the days where it's a doctor-led approach. It's now consumer-led. And we need to figure out a way that we create this level of transparency that didn't exist before. And having this ability to get fertility care on the palm of your hands and empowering the patient to be able to make those decisions.

     

    in a more involved manner, in a more data-driven manner, in a more visual manner, in a more engaging manner. This is the direction that things are going, right? So this is what I kind of expect and what our patients are expecting from us as well.

     

    Griffin Jones  (11:34)

    You talked about conceivable life sciences and there are some people that probably seen some of what's going on with them in our news coverage and or on LinkedIn. And there might be other people that don't know what conceivable life sciences is. So I want to ask you about your visit. But conceivable life sciences is a venture automating the IVF lab from right after retriever retrieval to right up to the point that it goes back to the clinician for transfer from ICSI from

     

    dish prep to everything that's happening in the IVF lab being automated by artificial intelligence and robotics. You just went to see their lab in action at a fertility center called Hope IVF in Mexico City. What was that like?

     

    Dr. Cristina Hickman (12:19)

    It blew my mind. Honestly, I had seen all the previous creations from the same founder team in the tomorrow.

     

    I have seen their proposals that we're going to be putting this together, but to see it in reality, you know, it's no longer just a slide on a PowerPoint. It's no longer a CGI. This is a three dimensional, full reality existing machine. And just to watch the capabilities and the potential, you know, we were just sat there just talking about, do you guys realize what you've created here? you know, give you some numbers. Okay. So the British society here.

     

    They just published a guideline last year talking about how we should have 80 cycles per qualified embryologist. 80 cycles. I know this in my mind that was like no way because in the technologies that we've created we've published already at ASRM and also at Escherich that if you're using the AI solutions you can achieve 300 cycles per embryologist, right? Because you're removing a lot of that administration that is spending

     

    precious embryology time. Now in avenues what we've done is a full end-to-end approach using the best products in the market, having everything talking to each other. So we achieve 500 cycles per embryologist. Why? Because we are making data-driven lessons, so we remove the administration. Everything is data-driven decisions, but you're still doing the artisanal work.

     

    So if you ask the embryologists, what were they doing before avnios? They were doing administration. What are they doing now in the majority of their time? They're doing artisanal embryology. Now, when you move on to conceivable, you're not talking about 500 cycles per embryologist, you're talking about 2000 cycles per embryologist. Now, they're no longer doing the artisanal side. The artisanal side is replaced by robotics, but that data-driven approach remains.

     

    And a data-driven approach now, the amount of information you're capturing because you removed the variation that comes from artisanal work means that you now have to spend more time doing more intellectual decision-making. So less artisanal, more intellectual.

     

    And the ability for you to go to 2,000 cycles per embryologist, this is the solution. This is the true end to end that we need to achieve to be able to serve all the patients out there that need our support.

     

    Right? So going the way that we've been going is not scalable to the level that we need it to be. Now with Conceivable, we finally get this level of efficiency that allows us to better understand, to better treat more patients per embryologist. And the numbers are great. We've now gone in this journey that I've just told you from 80 cycles per senior embryologist to 2000. It's a completely different scale.

     

    But what really kind of made it special is when we started looking at the movement and precision of the robot. We started kind of coming up, wait a minute, there's more that we can do here. It's not just about efficiency. It's not even just about the precision, right? It's the possibility that we might be able to enhance embryos and not just use AI to predict what's going to happen.

     

    we might be able to use AI to identify issues with the embryos that we might now be able to rectify. some of these potentials are only possible in a robotic scenario. So examples of that are at the moment in avenues when we're vitrifying and we're warming, every single procedure that we do, we record. We're very proud of the fact that we may not have the biggest data set in the world.

     

    but we have the biggest number of data points captured per patient. So this means that we have videos of everything that happens in the lab. When they warm, when they freeze, when we icksy, when we biopsy, we have all these videos which are all geared towards training future AI. Now what you have here are some challenges that are, okay, so maybe the embryo just zooms in a bit more and it zooms less, you know, or maybe it's at the edge of the image as opposed to in the center.

     

    And that's the issue with the fact that it's quite artisanal. So this makes it harder for our AI to learn from it, which means that we're slightly limited of how much AI we can apply because of this limitation of the artisanal aspect. The moment you apply robots, now you're able to capture every image with the egg in the center, every image with this level of focus, every image with this particular filter. You remove all the artisanal aspects. You bring a level of standardization.

     

    that will now allow us to pick up things about these embryos that we've never been able to before. And one example of that would be like when we've done a lot of work where we use AI to track not just each embryo, but each individual cell of the embryo. We know that this cell derived from this one and the grandfather of this cell was this one. So we can do the cellular linearity tracking.

     

    Many clinics do more for kinetics. We're doing something else, you know, looking at the cell lineage so that we can look at individualized care, not down to each embryo, but each cell in the embryo, which is pretty cool. You can't do that without AI, right? But the beauty here is that with the robotics, potentially, you might be able to identify these are the cells that are too far away from each other. Okay, so maybe a slight nudge.

     

    on the embryo, a slight little hug, little squeeze on the embryo might be able to fix that gap between those two cells that might now lead to a blastocyst when before it wasn't going to be able to. And this level of intervention, this level of micromanipulation cannot happen without robotics. So this is when I saw the system that had been built by the conceivables team.

     

    all of these ideas started popping up going, well, if you're able to do that, by doing just get the arm of the robot to do this movement instead, we now are creating a whole new way of practicing embryology. And that would be a complete game changer.

     

    Griffin Jones  (18:37)

    How do you do this on the clinical side though, Christina? So I see in the lab side, you have human beings currently doing a lot of robotic tasks, and therefore it makes sense for a robot to do those robotic tasks. In the case of the clinic side, we're talking about human beings and a lot of different things going on, probably a lot more variables in the order of operations. How do you begin to get this level of efficiency and scale?

     

    on the clinic side.

     

    Dr. Cristina Hickman (19:08)

    So really it's getting that balance between the three David Sabel parameters, right? Yes, we want efficiency.

     

    But because we've got so much savings because of technology that we're incorporating our end-to-end solutions, can let go of some of that efficiency in order to provide better convenience to the patients, right? So it's a balance between the two. So an example of that is, yes, our embryologists are not doing as much administration, but they spend more time with the patients. So the patients get full access, they get to see their embryos developing live, okay? So they're sitting at home and

     

    through their phone, they can see the moment that the cells have divided, the moment that it reached the eight cell stage. Now a lot of embryologists tell me, don't your patients get anxious? Don't your patients get, know, does this actually help? Well, we know from data, including from KindBody, including from Institutes Smart Cares, including from our own clinic, that around, on average, across these clinics, around 78 % of patients see this as reassuring and help them better understand their care.

     

    a fifth of patients, they find that it makes them anxious. So it is true that it does make patients anxious, but it's a minority of them. The majority of them, this allows them to better understand their care, but it cannot be offered to the patient on its own. So we use the time from the embryologists that we would otherwise have wasted on administration to be face to face with the patient, having a call just like we're having now because they're sitting at home. And then we share the screen.

     

    with the embryos developing using the fertility system and showing all of the different things that AI is highlighting for you. Right? And that extra information may not get that patient pregnant, but it's going to help them better understand their care and better understand their personal fertility potential. Right? So this is kind of where we see the shift in time of the embryologists. So when I see Conceivable coming in,

     

    I see there being a further switch where we are going to be capturing so many more data points on these particular embryos. We're going to have these huge data centers where embryologists sitting watching all sorts of camera and additional data points about these embryos and eggs that will need an additional level of explanation and human contact. It's getting that balance right between technology and compassion.

     

    Technology on its own does not work, not in reproductive care. It's too human, it's too important a moment in your life. You're creating a person during this care. So this means that we're going to have to have more compassionate embryologists in the future who are not hidden away in a locked up lab. They're going to be involved in this communication of this data and information coming over to the patient.

     

    Griffin Jones  (22:02)

    You have an embryologist speak to every patient who's going through IVF?

     

    Dr. Cristina Hickman (22:07)

    multiple times. So on day zero, on the day of our collection, this is when we find out whether this is going to be one of the 22 % of patients who don't want to see their videos live. So we give the patients, we personalize whether they get access to the link or not. So that happens on day zero. So let me explain what is going to happen the next few days. Then on day three, that's a video call. On day one, we give a phone call and we release the link.

     

    On day two, we may do a call or not, depending on whether the patient wants daily updates or not. But what's routine is a day three call. On day three, we sit down with the patient and we can already tell them accurately, is this going to form a blastocyst or not? And then at this point, we already giving them some further determinations of an example would be I got a patient with 17 eggs.

     

    and we can tell them already with certainty either day two or day three we tell them we don't think you're going to get blastocysts. I know you have 17 eggs but looking at the AI assessment the chances of or our level of confidence that a blastocyst will be formed is extremely low. And then we have another patient who has one egg and that patient we get a score of 10 so we tell them we're extremely confident that this is going to form a blastocyst.

     

    Usually I would have given that advice the other way around to these patients, but now I can manage their expectations better. Avoiding that roller coaster of emotions, right? And this means that I can have this discussion with them with all the little color coding showing on the embryos. Here's your inner cell mass and here's a morphokinetics that was right or wrong. You just need to understand the traffic light system to know this is green, this is good, this is red, this is not good, right?

     

    so, so we're able to kind of sit down with the patients. It's not about alarming or raising concerns, but it's about managing their expectations with their own data. And this maintains the trust in the clinic. Now imagine doing that, not just on the embryology side, imagine doing that with bits of information that's coming from the cumulus, from their uterus, from their follicles, from their, so this is kind of going,

     

    with that complete package to the patient so that for that two thirds of patients that don't go home with a baby, have a reason, we have the key information, this is what we're going to do next because we have all this information from your past, right? So every cycle becomes a diagnostic tool that contributes towards making the right decision within the journey of this patient.

     

    Griffin Jones  (24:42)

    So what if the patient has questions that are more on the clinical side than the embryology side? So the embryologist explains it's day three, it doesn't look like this is gonna grow to blast. And what if the patient asks a question like, well, how are we gonna change my protocol next? And it's a question for the REI. Is the embryologist just stuck saying, sorry, you're gonna have to wait to talk to the doctor?

     

    Dr. Cristina Hickman (25:03)

    So the beauty is that within our ecosystem, we have the communication tool with the members of the team. So the patient has access through their app to the different departments. And within that, we can very easily connect the patient with the relevant departments to support. Because it might be a genetics question that we can send to the genetics. It might be a donation. Can you tell me more about the donor eggs that I've just received? I know they've been matched. It might be a...

     

    It might be looking at, okay, can you tell me how this compares with the cycle I've had in the past? You know, so this sort of thing allows us to have this direct contact with the different members of the team. And this...

     

    Interestingly, we give the patients the option that they can call us or they can use a chat like function within the app. And the chat like function is by far the preferred method of communication by the patients. This I found surprising, but they like it because they have everything that they can refer back to what's been written. So even when we do a verbal communication with them, we have the AI tool that's recording it and then create a little summary to them so that they know what's been

     

    communicated to them in writing at all times, which is extremely helpful for the patient.

     

    Griffin Jones  (26:18)

    Have you been able to measure yet what this has done to conversion to treatment? Or patient dropout?

     

    Dr. Cristina Hickman (26:25)

    So yes, do have, the beauty of what we have at the moment is the live KPI system. So all the information, all the data that's being captured during the care goes into this live. We don't have to wait for the KPI meeting at the end of the month to know what our FERT rates are or how many cycles that we have or how all the conversions are. And we can see the differences between the different doctors and so on. And there are...

     

    actually widely different from one doctor to the next. We're able to identify who needs further support, who needs further training, and so on. So this is the beauty of the live KPI system. I haven't been able, what I haven't done is done a comparison of before and after because we've developed the clinic around this technology and infrastructure. So it's the first clinic in the world to be fully end-to-end AI driven. So this has made

     

    it's hard for me to be able to answer your question to prove improvement. What we have is a lot of feedback from the patients going, wow, compared to my previous clinic, I seem to know more about my care than I knew before. you know, having this approach to the patient of seeing their journey as a whole, not on a per cycle, not per embryo transfer, we're looking at, we're going to do a triple-I collection for this particular patient. We're going to, or the other one,

     

    to just do frozen embryo transfers for her or for this one we're going to cancel these embryo transfers because AI is telling us the chances are so low let's go straight to another egg collection to save on time. So we're making some some more bold decisions regarding the journey of the patient. For me the measure of success

     

    is does this patient go home with a baby within two years of knocking on your door? So nine months of that is lost with carrying the baby. And then so this leaves you with a year and a bit to get this patient pregnant. And this includes them going on holiday, having a break in between cycles. But you need to have that patient with a baby in their arms, every single one of your patients within two years. And this is something that I think should be the measure of success for everybody.

     

    Griffin Jones  (28:26)

    I was gonna say it's a much more patient centric way of thinking about it, isn't it? Because you wouldn't report to SART that way, you wouldn't report to the CDC that way, and that's the way we often think. But of course, that's the way the patient thinks. How long is it going to be before I have the bundle of joy in my arms, including pregnancy, including all of the things that might disrupt life during that time?

     

    Dr. Cristina Hickman (28:40)

    Yeah.

     

    And we use that from a financial perspective as well, right? So how can I reduce the cost of care by not spending the patient's time on transferring a DUD embryo, right? So an example of this is our measure of success in the UK that ranks all the clinics is per embryo transferred. But if the AI is telling me this got a low chance of implanting,

     

    The best odds are either I cancel the transfer altogether or at least transfer a couple of embryos because we know that they're not going to get twins with these particular embryos. Our AI is giving us confidence in that. But I'm not going to waste their time doing two transfers with two embryos that are not going to lead to an implantation. Right. So we start making these decisions that if that is the right decision to the patient, but in terms of the success rate that the UK uses per embryo transfer, that's going to put us lower in the rankings.

     

    but that is not the right success rate to use, right? So if we're making the right decisions in identifying these embryos should be transferred in pairs and these embryos should be transferred in single, and I am 100 % accurate in identifying when multiple pregnancy will not take place, then this should be the better measure of success for the patients. Do they go home with a baby later? And I don't want them going home with twins and I want them to be healthy babies on their arms.

     

    Griffin Jones  (30:11)

    this AI clinical decision making tool might be one seat in the orchestra. Do you think that it should generally be different companies occupying different seats in the orchestra? Do you think it's a mistake for one company to try to occupy every seat in the orchestra itself?

     

    Dr. Cristina Hickman (30:29)

    I think that the approach, if you look at it as a model, the Apple approach, they didn't try to go out there and build every single app. They created a platform that the other apps came in and used the Apple system as a platform. So this is what we should be focusing on. If you consider the clinic using conceivable, so conceivable coming in as an example, that's a change in your orchestra, right? You're going to be removing all of those traditional

     

    laboratory equipment that you have in the lab and you're to replace it with this robot that does everything. Right? So this is one change in your orchestration that's going to happen. But there are other examples as well, because yes, it might be that you're using the conceivable tool to do the assessment of the egg, but then I don't know, fertility might come in and they have a better way of assessing the embryo.

     

    So this ability to plug and play and interplay between the different companies allows you to get the best of all the systems and also puts the pressure on the companies. It is up to them to stay cutting edge. It's up to them to maintain the evolution. Are they still using old fashioned AI or are they using LLMs now? Right? LLMs are going to become obsolete very, very quickly. What's the next thing that's coming in? Right? So

     

    what the way that we've been building AI five years ago, that's gone. You know, the RCT that they did on the VitroLife tool, by the time the RCT finished, they're using two versions later, right? There's no point in us delving in digital tools for more than one or two years. And that timeframe is going to get shorter and shorter. And for companies to survive, they're going to have to focus on a certain niche. And then that niche,

     

    needs to go into this bigger platform that brings it all together. And so for me, that's how I see the future of our ecosystem coming. It's going to be lots of companies willing to work in an integrated manner. No more of those old fashioned EMRs that are not integrated with anything, right? Those are dying. are, their days are counted. Now it's not thinking about a digital solution. It's thinking about

     

    an integrated approach of non-proprietary, lots of open source materials that come together to create a whole new synergistic approach to patient care. And that's not, I don't say that as something that should be in the future. This is happening today. This is how we work here at Avenues. And I just see like what Conceivable is bringing as a whole new layer of exponential evolution.

     

    to what has already come into play.

     

    Griffin Jones  (33:13)

    Who gets to be Apple?

     

    Dr. Cristina Hickman (33:14)

    Who gets to be apple? Do we need to have a single apple? Can we be multi-sourced? I think there's going to be an apple in each area, right? There's going to be an apple of who is in front line with the patient. There's going to be an apple that's doing the robotics aspects. So I think Conceivable will obviously corner the robotics side of things. But I see others playing the role of kind of being the maestro.

     

    Traditionally, the person who or the entity that controls what reaches the patient and what doesn't is the clinic. But now we're seeing more consumer led brands coming in who are actually connecting with the clinic, with the patients better and bringing them to the clinic. So they're partnering with the clinics so that the clinics are no longer the maestro in that scenario.

     

    At the end of the day, determines what meets what reaches a patient or not is the front, the trusting face that the patient has chosen for them, which increasingly, I don't know if that's a good thing or a bad thing, we can have a whole debate on this, but increasingly we're seeing more diverse front lines than just the traditional doctor.

     

    Griffin Jones  (34:28)

    So I'm seeing your point that there might not have to be an apple, that if everyone is able to integrate with everyone else, then you wouldn't necessarily need to have that central sort of apple. But then the analogy breaks down if everybody's an apple. And it seems to me that some of the fertility clinic networks, maybe particularly in the United States, are trying to occupy that apple space.

     

    Dr. Cristina Hickman (34:54)

    Thanks.

     

    Griffin Jones  (34:54)

    where they

     

    themselves are the ecosystem. And so now we're making our own EMR, and now maybe we're making our own AI solution, and now maybe we have our own genetics

     

    Dr. Cristina Hickman (35:05)

    the irony there is that the more they try to be the apple, the less of the apple they are.

     

    Okay, because the more that you're trying to make it what's in it for me what's in your proprietary the more that they trying to to say I'm going to build my EMR and I'm going to be the clinic and I'm going to be the the robot and I'm going to be the more they try to do all of that the less they're good being the best at any particular aspect so in comes somebody else who who turns around going who's the best in robotics I'm going to use conceivable who's the best on embryo assessments I'm going to

     

    is fertility. Who's the best on X, Y, and Z, right? So you start putting it all together, that can now create something that feels different to the patient. Remember, we're leading into consumer-led. So if this becomes noticeable to the patient, that, wait a minute, but they can see the eggs with a completely different visual. They're giving me an explanation to why I am not getting pregnant. You're just giving me a ranking, right?

     

    So when you start getting this difference in care, the market eventually notices it. And this is why I think that this approach of, I'm going to do, this is a difference between the what's in it for me and the consumer-based, sorry, the community-based mindset. So what's in it for me is going to lead to the dinosaurs of tomorrow. The consumer-based mindset.

     

    The maximized interconnectivity within the existing best technologies in the market is what's going to maintain you in existence for the future.

     

    Griffin Jones  (36:40)

    What about in your view the limited concentration of buyers? Does that disrupt this ability to have a community type of orchestra where you have so many different companies innovating in different seats because you might have a really good EMR solution, for example, but if 60 % of the clinics are owned by six or eight companies, then it's really hard to get that scale as an EMR company.

     

    to where previously maybe you would have had 500 to 1,000 buyers and all you need is 20 and so you could carve out your own little niche. But now getting 20 clinics or especially if there are certain volume of cycles, that's a lot harder to do because of this limited concentration of buyers. How will these companies in this community based system be able to get through that?

     

    Dr. Cristina Hickman (37:33)

    Yeah, so the roles of each of the community players are going to become more more defined and the niche of each of the community players is going to be very, very focused. So I do see that as being the case, but I'm not saying that nobody should have the ambition to be able to fulfil the whole role. I'm just saying that if you're going to do that, make sure that you have the right instruments in your orchestra, right?

     

    It's a big gamble and I've tried doing it myself and I've tried doing it with companies that raised more than a hundred million and when you start putting it all together, all the different companies that we put in our ecosystem, it's billions of investment that have led to the ecosystem that we have brought to the patients, right? But it's not feasible to raise billions to be able to build an equivalent product in the market. And I think that's why

     

    It's not either we're going to see a change in mindset or we're going to cease to exist because they're players now who are doing the whole community approach. It sounds like a socialist approach. I'm not a socialist, okay? It's just trying to think not at the level of what's best for my company, but look up from a field and say, if I were to put the best players in these different places, how can I get the maximum return for the patients?

     

    How can I get the maximum KPIs from David Sabel in terms of the convenience and the cost and the success rates? How can I really kind of play those to the maximum level? And you're going to have to do that through partnerships.

     

    Griffin Jones  (39:03)

    do you label these different seats in the orchestra either in your head or on paper somewhere? Like do you think, okay, this is the cryo storage seat and this is the patient triage seat and this is the clinical AI seat. How do you think about that?

     

    Dr. Cristina Hickman (39:19)

    So we do, but what I find is that sometimes what I thought was one seat gets split into five different seats. So what I thought was the equivalent to the patient facing app, I now find a whole bunch of other tools that I incorporate into that to try and create more, a different experience to the patient, right? To get a different dynamic. So for instance, yes, there's

     

    a place where all the data gets recorded from the consultation, but it's a completely different player that's doing the recording and then turning that into summary notes that get sent left, right and center so you don't have to use the old-fashioned dictaphone. So the communication that we're having with the patients going back and forth, having that in a centralized data set that now uses a completely different tool that measures the positivity and negativity of each word.

     

    so that we can predict when a patient is going to think about maybe having a complaint. So these are what I thought was one tool, which was a patient app, turns out to be a dozen tools within that. So I don't want the patient having to write their name during the registration. So we have a different partner that all the patient does is take a picture of their passport. And from the passport, it takes their name, the date of birth. No more incorrect data names, no more having to...

     

    you're on the area with an I, not a Y, you know? So this is something that you take the information directly from the source every step of the way. And this then allows you to have a a more streamlined, less mistakes. You're spending less time on these mistakes. And the patient is not seeing mistakes coming from your side, which gradually erodes the trust as they're going through care, right? So yes, we do have very specific seeds.

     

    but we find ourselves that the number of increases as new technology comes in. We had somebody else who just popped in into our ecosystem where they're working on WhatsApp tools that communicates with our central database, creating new ways to communicate with the patient. So this wasn't a seat before, but it's become a seat as this new technology kind of emerged.

     

    Griffin Jones  (41:29)

    So you are the maestro because you're the one saying who's playing in a given seat or not. And I remember in conversation you told me that if you're not the best violinist, you're out of the orchestra. Tell me about a time where you've made a decision like that.

     

    Dr. Cristina Hickman (41:40)

    Right.

     

    We've changed our data capture point. We've changed the patient app has changed. The EMR has changed. The AI tools that we're using in the clinic have changed. I don't want to name the companies that have been replaced, but we have had several examples where we've made major changes in our ecosystem.

     

    and sometimes quite central. Very recently we changed the central core of the data because the data set was not being stored in a manner that would allow us to use AI to learn quicker. It made it harder to integrate into. I'm not even talking about EMRs now. I'm talking about two generations later after EMRs where we modified the entire central structure. We had before...

     

    Each of our individual doctors had their own sub-dataset. We've now created a system where they've all merged into one, still providing the independence and the and the privacy within each of the doctors within their ecosystems. So we have already replaced, I mean, we've only been open for a year. We've just had our first birthday cake, first year birthday which is aligned with a lot of the...

     

    the babies coming through as well now. It's a nice stage to be at. But the point is you have to have this mindset of being comfortable with change. And we recruited a team here at Avenue's that is not just comfortable with change. They're looking for the next change. They're excited about the next change, right? They're going, woo-hoo, look at this tool that we have just...

     

    Griffin Jones  (43:00)

    I bet it is.

     

    Dr. Cristina Hickman (43:22)

    brought into our ecosystem two months ago, but there's something better coming in and they celebrate it. But there's also a way for us to be able to feedback the companies that have been removed from the ecosystem. come back to them to say, go back and I needed to get better. The bar has raised. Okay. I needed to get better. So we actually provide the feedback to say, this is what you need to go with next. Okay. Why don't you focus on this particular niche?

     

    I have an empty seat on our orchestra. I need that seat taken by someone. Why don't you guys focus on that? You're really good at something slightly off. You divert your attention to this. You can come back to the orchestra. So we have violinists that become cello players, right? And this is something that, look, I know you're not the best anymore in the market for this, but you have this particular strength in your team. Use it. Okay. And we will, we will provide you the data to help you develop that.

     

    We will provide, we will open our doors. I'll put a team of my embryologists sit down with you to help you develop it. Right? So it's creating that relationship with the suppliers so that we are here at their beck and call to help them succeed. Cause if they succeed, we succeed. Right? So this, is kind of the approach that we've had all the way through.

     

    Griffin Jones  (44:38)

    Who would you say are some of the best players in the orchestra right now? And you can name names of companies and we know that we're recording this in February of 25 and it might not be the same answer as what you have in February of 27 or even February of 26. But right now in February of 25, who would you say some of the best players are?

     

    Dr. Cristina Hickman (44:58)

    Sure, fertility is one that's full disclosure. I have worked with them for two years as their chief clinical officer. I don't work with them at the moment. Now I am their customer. And I think when it comes to embryo assessment and egg assessment,

     

    and they are by far the best ones in the markets in terms of the experience we can create to the patient in terms of the efficacy of their tools. The patient facing side we're using Wawa at the moment, so Wawa Fertility is one to look out for. I like the ability to create these customizable

     

    notes all the way through. So our team likes the fact that they can just create their own templates. So it's not as rigid as a traditional EMR. But we're able to pull the relevant information that we need from that. Their financials and their billings work really, really well. In terms of managing our financials, we're going with Xero. So Xero at the moment, I still think is the best product in the market, but we're still no lookout for other tools out there.

     

    When you look at the follicular assessment, believe Folliscan is the leader in the market at this point in time. Also when it comes to the assessment of your endometrium, that would be with Folliscan. Tomorrow is still the leader for cryo storage. So the robot captures the data in an automatic manner. We have the full traceability coming through and then you can connect it back with Wawa.

     

    to provide the patient-facing cryostores. Right now, in terms of time lapse, we're using the embryoscope, but I believe that this will then be replaced with the conceivable system. So this is just some of the many, many players. RFID, we're using the RI witness, but not using the RI witness in its traditional sense. We've rigged the backend of the data capture.

     

    so that the embryologist no longer needs to go to computer to document their procedures and so on. So effectively we have this whole range of tools. We have Fertile Eye at the moment who looks at their assessment and determining what is the right day of doing your egg collection so they can maximize success rate whilst improving your efficiencies on your day-to-day operations in terms of volume of egg collections per day. So these are, it's not...

     

    I'm sure I feel like I'm in the Oscars trying to name everybody who was involved in the movies. I'm sure I have missed a lot. But there are some fantastic tools out there and a lot of these that I'm naming are startups, right? They're not huge companies that have been with us for the last decade. So I think this is the thing to look out for, looking out for tools that are new, that may not quite be as robust.

     

    Griffin Jones  (47:18)

    It is like that.

     

    Dr. Cristina Hickman (47:38)

    as we wish it to be, but we can fill that extra little gap that will bring it to the level of medical robustness that we want that our patients deserve.

     

    Griffin Jones  (47:47)

    So you really have these different seats and pulling people and you talked a lot about conceivable in the beginning and how much that blew your mind. How close to a prototype does it seem to you versus how soon do you think we're gonna see conceivable automating the IVF lab all over the world?

     

    Dr. Cristina Hickman (48:09)

    I went down there expecting to see a prototype.

     

    When I got invited to come and see the system, was, I'm going to see a prototype. It's going to be like, you know, band-aided together and some things will be working and some are not. No, it was a fully functional system end to end. Patients were already stimulating to have the first cycles through. They have a hundred cycles planned to provide the demonstration of the level of robustness. So I can't call it a prototype. It was a fully functioning.

     

    egg collection, to sperm preparation, to dish preparation, to vitrification. It was quite impressive. You're going soon, right?

     

    Griffin Jones  (48:49)

    I'm going down in less than two months to see for myself.

     

    Dr. Cristina Hickman (48:53)

    Okay, don't expect a prototype, but I also feel like I am spoiling the end of the movie for you. You're about to come and see the best movie that you've ever seen, and I've already told you the ending. But it's more robust than I expected it to be. And I expect this to be in clinical use elsewhere. Later in 2025 or early 2026, we're not talking about five years down the line.

     

    we're talking about within the next, so this first birthday that we've had, by the next birthday, I want to see this here in our clinic.

     

    Griffin Jones  (49:27)

    That blows my mind because when you think about how quickly things have moved to this point, but one, you answered a question that I've had out for a little bit and, and I've sort of wondered, okay, once humans are no longer being robots and right now, embryologists are treated like robots for a large percentage of their jobs, what do they do once they're not robots?

     

    You answered that question of this is how you have embryologists be humans and interface with other humans in addition to advancing the science. I'd never heard that before and I imagine that somebody's listening to that and being like, there's no way that I want my embryologist talking to all of the patients about the growth of their blastocysts. How would you respond to that skepticism?

     

    Dr. Cristina Hickman (50:12)

    Look, there's been a letter that's gone out from the ARCs, this is the British Society for Embryologists, And this was a letter that went out which...

     

    exemplified to me the biggest challenge of technology entering the market, the biggest challenge of technology reaching the patients, which is the human factor. It's the human barrier to technological implementation. It's the fear of change, it's having this mindset of positioning technology as a competitor to the humans. There's been no example in the human innovation era

     

    where technological innovations have led to unemployment. They have led to a shift in the workforce. They have led to a diversification on the skill sets that had to be acquired. But look, if you look at our own innovations in our field, I don't miss the days where, yes, I've been around long enough now, I'm going to be displaying my age, but I've been long enough.

     

    that I was pulling my own pipettes and I was mixing my own culture media, right? I don't miss those days where I was doing those swans with my glass pulling, right? I love the fact that I've got now commercial tools that are much better than what I've had access to before that made me more successful in making babies than before. And, you know, quite frankly, I am still busy.

     

    I still don't have enough hours in the day to do everything I want to do, despite the fact that those aspects of my professional life have been automated. And I know it's hard for us to, as embryologists, to see that somebody has created a robot that goes from 80 cycles per embryologist to 2000 cycles per embryologist. And the first thing that comes to your mind is, is this going to make me unemployed? And the answer is a flat out no.

     

    It will make you unemployed if you don't adapt to the new technological infrastructures and you don't acquire the necessary new skills that are needed for the embryologists of the future. Okay? So that generation of embryologists will be struggling to find a job, but all of us can learn, all of us can evolve, all of us can adapt. And this is what I see should be the responsibility of the letters going out to the membership.

     

    So I disagree with what ARCS has set out in the letter they've sent. They should have sent out, this is how we embrace the new technologies coming in. you know, this is how we support, we understand the challenges that human artisanal embryology leads to or cause. And we embrace technologies that start eliminating a lot of these challenges. And this is good for embryologists, these technologies.

     

    It's good for patients. It's good for doctors. It's good for everybody. Right? So the fears that we're having are not reality and there's absolutely no basis for them whatsoever.

     

    Griffin Jones  (53:16)

    Dr. Christina Hickman, think it's been two years since I last had you on the show. And as we're talking, I'm thinking it can't be two years before I have you on the next time. It's going to be much sooner than that. I look forward to following you as this changes. will send you some updates when I'm down in Mexico City of what I'm seeing. And thank you so much for coming back on the program.

     

    Dr. Cristina Hickman (53:35)

    Thank you for your time and we appreciate the invite.

     Now with Conceivable, we finally get this level of efficiency that allows us to better understand, to better treat more patients per embryologist. And the numbers are great. We've now gone in this journey that I've just told you from 80 cycles per senior embryologist to 2000. It's a completely different scale.

Avenues Social Links
LinkedIn

Dr. Cristina Hickman
LinkedIn


 
 

241 Embryologists Demand Standardization. Time Lapse Now a Must-Have in the IVF Lab

 
 

Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


Are time-lapse incubators a necessity or just a nice-to-have? 

While the clinical improvements may seem incremental, three IVF lab directors—Ms. Christine Yeh, Dr. Mina Alikani, and Prof. Alison Campbell—explain why they are essential for the future of standardized fertility care.

Tune in to hear:

  • How EmbryoScope helps scale IVF volumes with small teams.

  • Why standardization is crucial for both labs and networks.

  • How an IVF system at CARE Fertility saves six months of embryology time per year.

  • The role of AI integration in automating embryo assessments.

  • Key mistakes to avoid when implementing time-lapse technology.

Listen in to learn how leading labs are leveraging EmbryoScope to drive efficiency, and find out how your clinic may be eligible for a free 120-day trial through Vitrolife.


120-DAY FREE TRIAL FOR QUALIFIED FERTILITY CENTERS!
Experience the future of embryo evaluation with a risk-free 120-day trial of EmbryoScope

  • See all the benefits that EmbryoScope’s time lapse technology can bring to your clinic, including: 

    • Continuous uninterrupted culture

    • Improved embryo development 

    • Streamlined workflow for maximum lab efficiency

No risk. See if your IVF lab is eligible to participate.

Don’t miss this exclusive opportunity—email here to see if your IVF center is eligible to participate in a 120-day Embryoscope trial to measure the impact it can have in your lab.

  • Dr. Mina Alikani (00:03)

    Time lapse as a tool in the embryology lab is moving from a nice to have toward a must have. And I think that that is really rooted in the desire to make what we do in the embryology lab more objective rather than

     

    subjective, so more precise embryo assessment. We also want an AI driven embryo selection tools, which time-lapse makes possible. And of course, there's the aspect of undisturbed culture conditions that are also important. So yes, I agree that we are moving from time-lapse incubation being nice to have.

     

    toward a must-have.

     

    Griffin Jones (00:59)

    Scalability and standardization. Are time lapse incubators a nice to have or a must have? Every time I ask this of embryologists, I get some version of the same answer. There's nuance, but it's a must have, they say. The nuance? Obviously, embryoscopes aren't a panacea, right? Some benefits might be more important than others. The clinical improvements may only be incremental right now. Even my guests on this episode say that some labs will be just fine without them. And yet, virtually every embryologist I've asked

     

    has said time lapse incubators are a must have for the future of the standard of IVF care. Why? Thanks to my guests, three different IVF lab directors, Ms. Christine Yeh Dr. Mina Alikani, and Professor Prof. Alison Campbell, I now understand why. It's all about standardization and consequently scalability. How can you scale your fertility clinic or network if you haven't standardized your best practices across labs?

     

    Listen to how each of my guests keep coming back to this need for standardization.

     

    Christine Yeh shares how she uses embryoscopes to manage standards between one small team on the East Coast and another on the West Coast. She talks about how she uses embryoscopes to grow IVF volumes with a small team because you probably can't hire a bunch of extra embryologists either. She shares how she uses embryoscope to maximize the space she has in a small IVF lab because you're probably working with limited space too. Dr. Mina Alikani Alikani talks about the necessity of standardization.

     

    as the operative shared word in the concept of standard of care. She reframes the question for all the C-suite listeners. She talks about her first uses of embryoscope, things that she had never seen before in an embryo.

     

    Prof. Alison Campbell shares how Care Fertility invested one million pounds in a complete embryology system that also included embryoscopes and how that system saves six months of embryology time per year.

     

    They talk about how their IVF labs scale care by reducing time for FERT checks, embryo assessments, and integrating with AI to automate annotation.

     

    They each share mistakes they would avoid and what they would do to take advantage of an offer that VitroLife has for eligible clinics to try Embryoscope for free for four months. Listen to what these lab directors have to say and then give it a try for free for four months to see if you can replicate the success that they were each able to standardize. Contact VitroLife to see if your clinic is eligible and enjoy this conversation about the standardization of best practices in the IVF lab with Ms. Christine Yeh, Dr. Mina Alikani and Professor Prof. Alison Campbell.

     

    Griffin Jones (03:59)

    Ms. Yeh Christine, Dr. Alikani, Mina, welcome to the Inside Reproductive Health Podcast. And Professor Campbell, Alison, welcome back for your third time, I believe, on the Inside Reproductive Podcast.

     

    Dr. Mina Alikani (04:12)

    Thank you very much for having me.

     

    Prof. Alison Campbell (04:14)

    Yeah, thanks. It's great to be back.

     

    Christine S Yeh (04:15)

    Yes, thank you.

     

    Griffin Jones (04:16)

    Mina, I see different embryologists starting to have a consensus. One of our audience members said that time-lapse imaging in the IVF lab is increasingly moving from a nice to have to a must have. What do you suspect that person means? Do you share that view and why?

     

    Dr. Mina Alikani (04:37)

    I actually do share that view. think that time lapse as a tool in the embryology lab is moving from a nice to have toward a must have. And I think that that is really rooted in the desire to make what we do in the embryology lab more objective rather than

     

    subjective, so more precise embryo assessment. We also want an AI driven embryo selection tools, which time-lapse makes possible. And of course, there's the aspect of undisturbed culture conditions that are also important. So yes, I agree that we are moving from time-lapse incubation being nice to have.

     

    toward a must-have.

     

    Griffin Jones (05:28)

    Christine, you're nodding your head.

     

    Christine S Yeh (05:29)

    Yes, I would agree with that. I also think there is the aspect of the procedures that are going on in the laboratory and being able to take out a portion of observing the embryos and evaluating them out of the physical laboratory allows that space to be used for other techniques. The world of fertility is just growing and laboratories are getting busier and busier. It's a big overhead in general, each square footage of your lab compared to other areas of the clinic. So

     

    being able to remotely do, remotely meaning outside of the laboratory perform some of those techniques that we would typically need a microscope station for just makes it possible to do more in that same space and for the embryologists to have more area to work in.

     

    Griffin Jones (06:15)

    I want to go into each of these buckets as we talk more today, the clinical outcome side, the workload improvement side. Alison, do you feel that it is neck and neck between those two of what's tipping the balance towards time lapse becoming the standard or is right now, is it more about one of those buckets than the other?

     

    Christine S Yeh (06:19)

    Mm-hmm.

     

    Prof. Alison Campbell (06:35)

    I think there are so many benefits as we've heard, but I think in terms of nice to have, best to have, think it's a much better system. And I think the main benefit, if I had to choose one bucket, would probably be embryo selection, assessment and selection together. Because as we know, we've heard the human is so subjective.

     

    And this information that we get from the time-lapse systems allows much more objectivity and much more information. You can't compare the quantity of information you get from a snapshot, morphological, microscopic evaluation, and the time-lapse system, a series of images collected over five, six days.

     

    Dr. Mina Alikani (07:19)

    I definitely agree with Alison on this, how she described it. And I do want to kind of look at your question in a slightly different way, which will probably make the answer much more obvious. And that is, do we want to move toward more subjective?

     

    assessments or do we want to move toward objectivity? And then the answer is quite straightforward. We don't want subjectivity. We want objectivity and we want a certain level of standardization so that, so that we can actually be

     

    Griffin Jones (07:49)

    We don't want subjectivity, we want objectivity, want a certain level of standardization so that we can actually be

     

    Dr. Mina Alikani (08:05)

    able to predict outcomes more reliably, regardless of where we are in the world, which laboratory we're practicing in.

     

    Griffin Jones (08:05)

    able to predict outcomes more regardless of where we are in the world, which laboratory we are practicing in.

     

    Dr. Mina Alikani (08:15)

    And that, in the end, is to the benefit of the patients.

     

    Griffin Jones (08:16)

    In the end, it's to the end that's the question.

     

    Christine S Yeh (08:17)

    Mm-hmm.

     

    Griffin Jones (08:20)

    Explain to me how subjective it can be right now between embryologists versus the objectivity that AI and other tools by way of time lapse provide. Objectivity for someone who's not an embryologist, for the business people listening, why is that significant?

     

    Prof. Alison Campbell (08:41)

    we know as embryologists when we look down the microscope at a blastocyst at a late stage embryo it has a couple of main features, maybe three main features. It has a diameter, it has two cell types, the inner cell mass and the trophectoderm, but they can look broadly different. The diameter can change, it does.

     

    And we don't have a measuring tool down on microscope while we're looking. So you've got nothing really apart from your experience and what you've seen before to calibrate it on is just a really momentary assessment. And it's just so subjective because the lighting might be subtly different. There are other embryos might be around in the same field of view that could influence your opinion. You may have met the patient in the morning just.

     

    So many human factors and different elements that could subtly but significantly change your opinion. And also if you were to look at the same embryo half an hour later or half an hour before, or even five minutes, it can look substantially different. It doesn't very often look substantially different, but sometimes it does. So you may give it a completely different grading. And this grading consists of three letters or numbers.

     

    And based on that, big decisions are made. Is this embryo going to be transferred? Is it going to be cryopreserved? And then down the line the following year, maybe if it has been cryopreserved, is it going to be warmed and transferred now or shall I choose a different one? So it's such a simplistic assessment and momentary assessment that has major impacts on what's going to happen to that patient.

     

    and even future decisions for that patient. So if you've assessed a group of embryos, you've given them these simplistic scores, which do relate to clinical outcomes somewhat. They're not absolutely useless, but they're very simplistic. But if you've done that, then that information could and will dictate what happens to that patient, and it could make or break whether they will have the baby they want. Many patients give up.

     

    Griffin Jones (10:30)

    which do relate to clinical outcomes somewhat. They're not absolutely useless, they're very simplistic. If you've done that, then that information could and will dictate what happens to that patient and it could make or break whether they will have it. Maybe they want many patients to

     

    Prof. Alison Campbell (10:51)

    because they've not had a success first time with cryopreserved embryos still in the tank. So this is heartbreaking. Had we chosen a different embryo potentially based on our quick assessment, they may have the baby and they may go on to have another one from the same cohort. it's, yeah, it's a, don't want to put too much pressure on the embryologists, but it's a very important piece of their work.

     

    Christine S Yeh (11:15)

    Just to add on to what Alison was saying as well and to bring it, Mina had made a comment about standardization between laboratories. And I think bringing time lapse into more laboratories standardizes the tools that people have to evaluate. So in certain laboratories, they might only have a stereoscope to do their observations of their embryos, which the embryo

     

    features are not going to show up as much. can't see as much detail whereas other laboratories will have an inverta-scope which you can get a higher magnification. You can see more granularity in the cells. So their grading is going or could be vastly different. You think of looking at a picture that's extremely pixelated and trying to make a grade on that versus one that's high definition. I mean we look at TVs. What we can see on the actor's faces are completely different nowadays because the resolution is so much better.

     

    So if we're looking at different technologies in different laboratories, evaluation of the same exact embryo is going to be different simply because of the resolution that you can see. So if you put time-lapse incubators in each one, one, there would be the ability to share pictures of that embryo. So even if grading schemes are slightly different from laboratory to laboratory, the new laboratory that receives those embryos, if we're talking about transfer of embryos from one lab to the next,

     

    could look at the picture image and say, okay, do I agree with what the previous laboratory graded this on paper? Or would I choose a different embryo based on the pictures that we have and the grading scheme and the way that we decide things internally from lab to lab? So I think that standardization would also be extremely beneficial on just the technology side.

     

    Griffin Jones (12:56)

    Mina, tell me about the papers that you've been involved in with regard to research on the topic.

     

    clinical outcomes being different with time lapse versus with traditional incubators.

     

    Dr. Mina Alikani (13:07)

    Right, so I think to some extent the jury is still out on whether time-lapse microscopy and the use of this instrument actually leads to a significant improvement in outcomes. There have been many publications on that topic and

     

    Some will say yes, others will say no. Unfortunately, comparing these studies is actually quite difficult because they are heterogeneous in the design of the experiments or the studies and also measuring the impact. Is it live birth? Is it cumulative live birth? Is it fertilization? Is it development?

     

    you have a whole spectrum of outcomes that have been assessed during these studies, many of which, if not most, are retrospective. is this impression that we need more proof that this instrument will lead to improved

     

    outcomes. But you know, if I could just talk about it in a more philosophical way, and the way I normally talk to physicians to try to convince them that this is actually a good way to go, is that, you know, it really it takes more than a single technology to improve outcomes in IVF. And

     

    At this juncture, you know, in 2025, the future really is about automation and standardization and integration of artificial intelligence in all aspects of IVF. And time-lapse is a step toward that future. In fact, that future is here already.

     

    we are seeing it unfold, although somewhat incrementally, we are seeing it unfold. again, don't we need to question, do we need actually to question and move from subjectivity toward objectivity? And, know, in terms of looking

     

    at outcomes. Is the technology being applied properly? You some people have it and just use it as an incubator, which is nice because it's great incubator. But it's supposed to do more. You're supposed to use the data that it generates for development of algorithms that will help you.

     

    Griffin Jones (15:33)

    Is the technology being applied properly? Some people have it and just use it as an incubator, which is nice because it's a great incubator. But it's supposed to do more. You're supposed to use the data that it generates for development of algorithms that will help you

     

    better select your embryos.

     

    Dr. Mina Alikani (15:59)

    better select your embryos, but if they are not using

     

    Christine S Yeh (15:59)

    Mm-hmm.

     

    Dr. Mina Alikani (16:02)

    that feature, it's not going to be helpful to them, is it? And are the right expectations being set? you can't suddenly using one instrument improve your outcomes by 20 percentage points. It's just, especially, especially in labs where

     

    good outcomes are being produced already, it's very difficult to reach that differential and fulfill that expectation. It's just not the right expectation. So you have to look at it holistically and looking at workflow, looking at environment for development of embryos,

     

    Christine S Yeh (16:34)

    Thank

     

    Dr. Mina Alikani (16:56)

    looking at the ability to select embryos more objectively and looking at outcomes to see if you can improve incrementally. So this is how I look at it. But this is not exactly how it's presented very often.

     

    Griffin Jones (17:14)

    Then why is time-lapse such an integral part of the holistic picture Christine you're opening a new IVF lab. Are we allowed to talk about that?

     

    Christine S Yeh (17:23)

    Yes. Thanks most people now. Yes.

     

    Griffin Jones (17:24)

    You're opening a new lab. You've been managing your lab in Toronto. You're opening up a new one in

     

    Vancouver. From what I understand, you really wanted embryoscopes in that lab. One, is that the case? And two, if so, why?

     

    Christine S Yeh (17:39)

    huh.

     

    Yes, that is the one, as Mina mentioned, it's a fabulous incubator. They're very sound. They work extremely well if you just use it as an incubator. From my experience starting the laboratory in Toronto, we opened in 2022. Most laboratories start with a small team and we don't batch cycles. So they come as they come. And one thing that's the

     

    embryoscope or a time lapse incubator has allowed us to do is grow more naturally with less stress with a small group of embryologists. Your timing, you don't have to be as exact on timing for FERT checks in the morning. And being able to retrospectively watch how the embryos grow, one, gives you a great insight to how your culture system is doing. Especially with an early stage laboratory, when you don't have a lot of cycles, you can spend a lot of time and look at

     

    optimization of your culture system based on the morphokinetics of your embryos based on how they're growing, what's coming, your time points. We know that embryos can make it to a blastocyst, but certain time points aren't as ideal if they're not getting to the cleavage stage at a certain point or the blastulation stage. Maybe there's things that you can tweak. So having that extra data and information to be able to analyze can really help, and I believe it helped us.

     

    to get great success rates right off the bat. Also with an offsite laboratory, having a time lapse is very helpful to be able to support from offsite. You can have somebody remote in and evaluate embryos together. If you have a new team or new embryologists, it's a great training tool because you don't need to leave your embryos out longer. You don't need to be switching people at the eyepieces.

     

    of your microscope to look at an embryo, you can look at it for five minutes and really dissect everything that you're analyzing and teach the people that are eventually going to be doing that as well. And having the ability to do that off site is instrumental. And then also we're really pushing for wanting to integrate seamlessly an AI system. Again, that's here and it's available and that's something that

     

    myself and my team at TWIG is very passionate about and being able to do so seamlessly with a time-lapse incubator is necessary. And if we went with a bench top incubator or box incubators, that integration is much more difficult and we're right on the precipice of it. So why go with something that is going to be harder to advance into the future? Does that make sense?

     

    Griffin Jones (20:14)

    I keep hearing about FERT checks and saving time not having to do FERT checks at a certain time and how important that is to embryologists and they really like embryoscope for that reason. A business person might not understand what the implications of that are. you tell me specifically why do embryologists keep saying that as a benefit? How does that impact the rest of the management of the lab?

     

    Christine S Yeh (20:39)

    So the timing of looking if eggs have been fertilized or not is very specific. There are what we call pronuclei that show up for a very small window of time. And that's how we know if the sperm has fertilized the egg. If you're looking at an Ixie case or where you inject the sperm directly into the egg, typically a fertilization check you would do between 16 to 20 hours.

     

    post-fertilization or post-IXI because this is the most likely time point that you're going to see those two pronuclei, which is the morphological features that an embryologist evaluates to know if that egg was fertilized. So if you have a very early morning retrieval and you do your IXI at eight o'clock in the morning, that fertilization check is going to be happening at four, five, six o'clock in the morning.

     

    getting embryologists into the lab at that time can be difficult. And if you miss those signs of fertilization, because there's two pronuclei, eventually they disappear. And then every egg looks the same. So if you don't see those pronuclei, then you might deem an egg unfertilized when actually you just missed it. In the case of conventional IVF, this window is a little bit more in flux because we don't know the exact

     

    time that that sperm entered the egg to fertilize that egg. So there could be a heightened chance of missing that sign of fertilization, whether you look at the egg too soon or too late. But with time-lapse, you're able to know exactly when fertilization happened, when those pronuclei appeared, how long they stayed, and when they disappeared as well. So it's very beneficial to be able to do those FERT checks and not feel as

     

    strapped for time of I need to look at exactly this time point to make sure that I don't miss it. And Mina and Alison, please, you have much more experience than I do. Please add to this if you feel.

     

    Prof. Alison Campbell (22:36)

    Yeah, you're quite right. It gives this flexibility. So how it can impact the wider team is that the lab can be more flexible. So if we need to schedule the egg retrievals at different times, we're not restricted by this specific window that we were before. So it has benefits throughout the whole clinic.

     

    Griffin Jones (22:55)

    Did you want to add anything to that Mina?

     

    Dr. Mina Alikani (22:58)

    I agree with everything that was said. I do want to point out though that even though the use of ICSI has increased significantly over the past decade or so, we still have somewhere

     

    between 30 and 40 % of the cases that have standard insemination and not all laboratories have switched to a 100 % XC model. So in that case, you still have to stick with the timings and observe those requirements for fertilization checks when

     

    eggs have been inseminated via standard IVF rather than ICSI. And those eggs are not put into the time-lapse incubators until the day or a day later after insemination on day one, after fertilization has been checked already and

     

    we know which eggs have been fertilized and which have not. So that caveat is still there.

     

    Griffin Jones (24:32)

    it seems to me that probably only 10 % of clinics maybe 20 % of clinics in the US have

     

    time-lapse incubators. know that number is a lot different in Europe and in the UK. Is it that way in Canada as well, Christine?

     

    Christine S Yeh (24:48)

    the exact number, but I would say more and more clinics are adopting the time lapse in Canada. Whether they use it for all cycles or not is another question. I think there are some clinics who have a time lapse incubator and they use it for select cycles or select patients. But just anecdotally, I would say probably 50 % have time lapse. It's not more in Canada.

     

    Griffin Jones (25:04)

    Alison, do you?

     

    That's many more than I would have thought. Alison, do you think we're at a tipping point in the US now that you're part of a network that has a presence in the United States and you get to see a lot of the US market? Do you think that we're going to see an upward trajectory of adoption or is something standing in the way?

     

    Prof. Alison Campbell (25:29)

    I don't see it being at a tipping point, to be quite honest. It seems to just be a really slow trickle to me in the US. In the UK, we must be more than 90 % of clinics, I would say, have at least one time-lapse device. And we've been using it at Care Fertility since 2011, so it's such a long time. In the US, it seems to me that the primary embryo selection

     

    technique is PGTA and that the mindset generally speaking is well, this is superior in terms of embryo selection to time lapse. we don't, why would we need both? But actually we know from the data and the evidence that we can distinguish between euploid embryos. So for PGT patients who are fortunate enough to have multiple euploid embryos, then let's add the time lapse to really

     

    Christine S Yeh (26:00)

    Okay.

     

    Prof. Alison Campbell (26:26)

    aid selection between them just to get these additional marginal gains and give the patients the best possible success rate as soon as possible.

     

    Griffin Jones (26:35)

    Do you think from the network seed, Alison, that it's possible for networks to test out time lapse in certain labs? So if you have enough labs in your network, should every network have at least some of their labs with some embryoscopes or how do you think about that?

     

    Prof. Alison Campbell (26:52)

    Well, I prefer within a network to have a standardised best lab practice, so time lapse in all of the labs. But saying that, it's not always realistic. They are very expensive. So I'd rather spread them out and have at least one in each lab than some of the labs being 100 % time lapse. And that's how we are at Care Fatility. We don't have capacity for all patients to have time lapse.

     

    So there is some selection and some patient choice there. But what we have done is use the knowledge that we've learned from the time-lapse systems over the decade or so to apply it to our standard practice. So we've learned, for example, that we really don't need to be disturbing the embryos from the standard incubator at all after Fert Check right through to the blastocyst stage. So we don't make observations like we used to in the...

     

    interim at the cleavage stage just to see how they're getting on and try and anticipate how the blastosis will be. There is no point in doing that. And again, with the fertilization timing we've learned and we've published this and it's fed into the new Istanbul consensus guidelines coming out soon, that to assess fertilization should be bit earlier than we originally thought in order to maximize the chance of observing them in a standard system.

     

    Christine S Yeh (28:10)

    Okay.

     

    Prof. Alison Campbell (28:13)

    So it has benefited standard practice, even if you're not fortunate enough to have time-lapse yourself.

     

    Griffin Jones (28:21)

    So maybe this business case is part of what is a little bit of what I see just as an outsider is a bit of a divergence between the business side and the lab side. Because I have every embryologist on, I ask them, I ask them a handful of things. One of the questions I go to every time, time lapse a must have or a nice to have. So far everybody said must have. And that if even if they feel like, well, it could be a nice to have in these circumstances now.

     

    We think it's a must have for the standard of care going forward. It seems to me like that consensus is firming in a way that wasn't even some years ago on the lab side. But yet at least maybe other countries have caught up on the business side. But in the US, they're still viewing that as, all right, we have to judge that investment against other investments that we're making. You sitting in the network seat, Alison, owning equity in your company.

     

    How long does this take, if properly utilized, to return the investment? If we're buying a handful of embryoscopes, are we looking, relative to cycle volume, are we looking at a three, four year return on investment?

     

    Prof. Alison Campbell (29:33)

    Well, it depends on the business model. think what we've done is charge for using the time-lapse devices, for using the algorithms that predict outcomes. And we've had some criticism. I've had some criticism from some colleagues, scientific colleagues, because of course, ideally, we don't want to be taking more money off our patients. We want to give them the best, most cost-effective treatment, the lowest possible price.

     

    but these devices are expensive. made investment, big financial investment and R &D investment in them. So we have to charge a fee to use it. So we can get the return on that investment through the patient fees.

     

    Griffin Jones (30:14)

    Tell me about the time savings and tell me about, I had Dr. Schenkman on the podcast a month ago, asked her the same question she said must have, and she had referenced a paper that I hadn't seen from UCSF of something like they think that they're saving the equivalent of one embryologist time per day. Anecdotally, what are you observing with regard to

     

    saving embryologists time or reducing their workload.

     

    Prof. Alison Campbell (30:46)

    Well, I would say that if you used a time lapse device, in the typical way, let's say without any algorithms automation, just a manual annotation, which is how we all started using it. Then it will actually take you more time than not having it. So it increases the time required because.

     

    You're looking at the embryos every day and you're annotating using the software that comes with the device. And on average, it will take two minutes per embryo and most patients, let's say, have eight to 10 embryos. So it'll take you 20 minutes, whereas typically with standard practice, no time lapse, you may just make one or two quick observations and it may not take as long as that. But more recently, we've had the introduction of automated annotation.

     

    So the software is analyzing the development of the embryo, the morphokinetics, and generating that data, which is clearly taking much less time. So our own system, it takes two seconds. So we've gone from 20 minutes to two seconds. And that we invested, it cost us about a million. And we've talked about this before, Griffin, but that million pounds was

     

    Really well spent, I would say, because we've got a singing and dancing system that's saving six months of embryology time across our network.

     

    Griffin Jones (32:10)

    Christine, you've got partners. Your REI partner is Dr. Rhonda Zwingerman, and then you've got business partners, Tanner and Zach to Bay Street, entrepreneur, finance, business guys. Besides being really good guys who listen to their teams, why did they go for your

     

    Christine S Yeh (32:20)

    Thank

     

    Griffin Jones (32:30)

    proposal when you said, really want embryoscopes in Vancouver. Why did they go along?

     

    Christine S Yeh (32:35)

    mean, this is extremely multifaceted and we're only going to scratch the surface of it. One is the standardization across laboratories. Alison already mentioned it. She has vast experience with running a network. It's much more difficult to run laboratories when their procedures are extremely different. That goes down to the equipment that's being used. The protocols for using a time lapse incubator versus a bench top or a boxed incubator are very different.

     

    from, as Mina mentioned, the dishes that you use and how you prepare those, as well as the daily observations and how you have to work with that, as well as how you have to work with other equipment in your laboratory and what gets used at what time. So there's the standardization aspect. There's the aspect of us wanting to standardize the use of AI for assisted embryo evaluations.

     

    One thing that we're evaluating, as Alison mentioned, is potentially taking out day three observations, which then would correlate to saving a lot of embryologist time, because that's one full day of observations that are not going to have to be done. Being able to use assisted calling helps to reduce that time. We do use assisted calling in our laboratory in Toronto, and it works extremely well. It's very beneficial for the patients. We also believe, myself and Alla put

     

    Dr. Zwingerman in here as well, that the time lapse incubator is a phenomenal incubator for the embryos and where we don't have a large study showing that there is an increase in pregnancy rate due to the undisturbed culture, we do believe that there is an incremental benefit to our patients because of that. And to be able to expand that over to our new laboratory in Vancouver is necessary.

     

    Additionally, with the embryo scope itself, the space savings in the laboratory is very helpful with growth of the laboratory and because you can fit so many samples in a smaller incubator. So it fits 15 patient samples in there, 16 samples each dish. So to maximize the space or the usage of square foot in the laboratory,

     

    This for us was the most beneficial time-lapse incubator to have.

     

    Griffin Jones (34:52)

    That topic of scale makes me think of everything that David Sable has been talking about, everything that patient advocates have been talking about, that we are a field of medicine that has a cure for people. I'm paraphrasing Joshua Abrams, who might be paraphrasing someone else, but putting it in these terms has lasered my focus of that we have a cure for a disease that strikes people in the prime of their lives, but we don't have a delivery mechanism that

     

    Christine S Yeh (35:03)

    and

     

    Griffin Jones (35:21)

    delivers that to patients at the level of population health and I look at the investment coming in and I look at the the companies growing I look at the political climates and I don't see the status quo as acceptable for For much longer. I we are seeing people demand much broader access to IVF I believe that they will get it both through the markets and through legislation

     

    It sounds like that the standardization provided by time lapse is a big ingredient. Can you tell me about any of this is for any of the three of you, why this is so important for scale?

     

    Prof. Alison Campbell (36:00)

    I think it's all about the data for me. If things are standardized, you can be more confident in the data that's being generated. And so we don't have all the answers. And one of the main reasons that we went for time-lapse was to get a better understanding of how the embryo develops and to help us collect data in order to make some more informed decisions. yeah, I think that for me is the main thing.

     

    So it's scalability in order to generate the data, in order to plow it back in to continuous improvement.

     

    Dr. Mina Alikani (36:31)

    I think that's a very important point that Alison just made. I mean, we live in an information age and big data and more and more of our decisions are data driven. And so it only makes sense that we would do the same in the embryology laboratory and push

     

    for data, more and more data and the analysis of the data, which will eventually actually help those who may not have contributed the same amount of data to this analysis. We want others to benefit from the data that Alison collects and so meticulously

     

    Christine S Yeh (37:14)

    Mm-hmm. Mm-hmm.

     

    Dr. Mina Alikani (37:22)

    A great example is actually the paper on checking fertilization and how many laboratories may be doing this one hour later than they should be checking fertilization, therefore ending up with these, you know, unfertilized embryos.

     

    which is a complete misnomer and it's a misinterpretation of what has actually happened. So we are benefiting, the community at large is benefiting from all the data that were collected in Alison's laboratories and were in turn analyzed and the conclusion was made that is relevant to

     

    Griffin Jones (38:09)

    that is relevant

     

    to everybody, all practitioners in the field. And that's very, very important. And I think that this discussion with the people who hold the purse about cost and benefit, you it really has to shift. It has to shift from a focus on pure...

     

    Dr. Mina Alikani (38:11)

    everybody, all practitioners in the field. And that's very, very important. And I think that this discussion with the people who hold the Paris and about cost and benefit, you it really has to shift. It has to shift from a focus on pure,

     

    what's the profit in it? And are we getting

     

    amazing increases in pregnancy rate in to what is it we are achieving here? And is that important to the program as an individual program, but also to the field and to all the patients as a whole? You know, and the answer to that is yes, it is to the benefit of the general population of

     

    patients as well as clinics that are doing IVF. So the more data we have, the more power we have to make the right changes, to choose the right direction. So I don't subscribe to this very narrow

     

    interpretation of what these add-ons, which I don't use. I don't use that terminology. I'm just using it as to illustrate my point. This very narrow ideology that if time-lapse microscopy has not been shown to lead to major increases or significant increases in pregnancy rates,

     

    Griffin Jones (39:41)

    not been shown to lead to major increases or significant increases in pregnancy rates,

     

    Dr. Mina Alikani (39:49)

    then it's an add on it's unnecessary. I just don't subscribe to that vision and that idea.

     

    Griffin Jones (39:49)

    then it's an add-on, it's unnecessary. I just don't subscribe to that vision and that idea.

     

    Christine S Yeh (39:56)

    Mm-hmm.

     

    Dr. Mina Alikani (39:57)

    know, IVF has improved since the 1980s and I don't think there's anyone except for perhaps one person who will remain unnamed. There's agreement that IVF

     

    Dr. Mina Alikani (40:17)

    has improved incredibly over the past four decades or so. And these improvements have been incremental and due in large part to the changes and innovations in the lab. And so we have to look at time-lapse and other tools in that specific context, rather than saying, well, does it improve pregnancy rate? What? It doesn't? No, we're not interested. It's an add-on. It gets a red light. It gets an orange light or, know, I just don't see it that way.

     

    Christine S Yeh (40:56)

    Mm.

     

    Griffin Jones (41:07)

    for embryoscopes for eligible labs and they'd have to check who's eligible. Well, I'll put some info in the show notes, but provided that a lab is eligible, VitroLife will give them the embryoscopes, install them, If labs are eligible for that,One, should they take advantage of that? And if the answer to that is yes, how should they take advantage of those four months?

     

    Prof. Alison Campbell (41:33)

    I would say always take advantage of a nice piece of kit being offered to your lab. It's a privilege to have time-lapse in the laboratory. It's a privilege to watch the embryos developing. yeah, I think the advice would be geek out, read the papers, talk to experts, use it properly, collect the data.

     

    Prof. Alison Campbell (41:58)

    Show your patients their beautiful embryos developing and yeah, embrace it. Why not?

     

    Griffin Jones (42:04)

    Mina and Christine, would you give people any tips of try to learn this or try to obtain this information or try to test this workflow or anything that what tips would you give to someone during that four month period?

     

    Dr. Mina Alikani (42:21)

    You know, I think that bringing time-lapse technologies into the lab is not trivial at all. It's nerve-wracking, at least it was for me. And I always show these stages of dealing with incorporating the technology. You at first you have sticker shock and then...

     

    You are euphoric that it's there and then you are pulling your hair out because you're seeing things that you've never seen before in embryos and you're saying something is wrong here, what's happening and you need therapy and all of that. And then you pass that stage and you go into this, wow, what a tool. And I went through all of those stages and I suspect that other people will too. And if you can get help avoiding some of the more unpleasant aspects of that integration, then I think you should. If the company is offering to help you establish the technology

     

    Christine S Yeh (43:14)

    Mm-hmm.

     

    Dr. Mina Alikani (43:25)

    in your laboratory and integrate it in the right way,I would go for it. The more help you get, the easier it becomes. It's not easy. Don't expect it to be easy, but it does get there. And the more help you have before you get really involved with patient material, the better it will be.

     

    Christine S Yeh (43:31)

    Mm.

     

    Griffin Jones (43:35)

    You get the easier it becomes. It's not easy. Don't expect it to be easy. But it does get there. And the more help you have before you get really involved, the patient is the better it

     

    People always seem to say embryoscope like Q-tip. Like we don't say cotton swab, we say Q-tip. And I there are other time lapse incubators out there.

     

    Christine S Yeh (43:53)

    Thank you.

     

    Griffin Jones (44:02)

    they might be pretty good, but it seems like there's a general preference towards embryoscope. For those of you that use embryoscope, why embryoscope as opposed to a different incubator? What was it that you were dealing with that you've preferred embryoscope for?

     

    Prof. Alison Campbell (44:28)

    Well, we chose Embryoscope really because it was the only one available at the time. And once you've got one system in, it's especially across a network and you've got your protocols and you've got the data collection and it's all working seamlessly. It's quite hard to change. Saying that, we do have GERI time-lapse incubators from Junaea as well now, because we've acquired clinics that have had them or we've decided to evaluate.

     

    Prof. Alison Campbell (44:53)

    We look at both systems and they're similar but they're also different. And the main difference I would say is the humidification in the jerry whereas the embryoscope is a dry incubator. So I don't think there's much between them. It's great that there is competition and that we do have choices and there are others also available.

     

    Griffin Jones (45:09)

    that there is competition and that we do have choices.

     

    Christine S Yeh (45:13)

    well, to your Q tip question. One, I think embryoscope is one of the first ones out there. So it caught on. Also, they hit the name very well, embryo scope, a microscope for embryos. I think it kind of tells exactly what a time lapse does in more layman's terms. So I think that is very catchy and easy to use.

     

    in regards to our decision to use the embryo scope or to go with the embryo scope, a lot of it went down to one, the reliability of the incubators. think the Jerry also has a very reliable incubator. It's very good, very sound. think Miri as well has a time-lapse incubator. But for us, it was the square footage and how many patients we could fit into a small area. We built a laboratory in a city. We're building a new one in a new city.

     

    Real estate is expensive and you don't have a lot of it. So we don't have the space to grow in the laboratory, or we don't have infinite space in a laboratory and overheads are already very expensive. So if we're able to fit 15 patients in a, what is it about 18 inch by 18 inch area on a bench top versus something that's one and a half times that size for the same amount of patients for us, that was the cost per square footage.

     

    Griffin Jones (46:27)

    How important is it to be able to have quality control and do quality control in one chamber for 15 dishes as opposed to having multiple different chambers?

     

    Dr. Mina Alikani (46:37)

    Yeah, I think the engineering and design of this particular time-lapse incubator are really quite impressive. that's maybe partly the reason for the name embryoscope being used.

     

    Griffin Jones (46:46)

    really surprised.

     

    Dr. Mina Alikani (46:56)

    as a sort of generic for this type of incubation systems. They were also the first, if you don't count Eva, which was a very different concept, although it sort of the same, it was the same idea, but it wasn't an independent incubator. So they were the first.

     

    Griffin Jones (47:11)

    So they were the first.

     

    Dr. Mina Alikani (47:21)

    And very often this happens that name then becomes generic. In terms of quality control, think yes, there is an advantage to having a larger number of patients in the same incubator so that you're focused on that one incubator to QC rather than 10 different incubators to QC. But I am not sure if I see that necessarily as an advantage, at least in the context of regulations in the United States. I think our problem is that those regulations are actually outdated.

     

    Griffin Jones (48:09)

    think our problem is that those regulations are actually outdated. You know, we have in the embryos scope a system that is monitoring continuously all the conditions within the incubator. Yet, we are obliged to use external instruments that may not be...

     

    Dr. Mina Alikani (48:18)

    in the embryo scope, a system that is monitoring continuously all the conditions within the incubator. Yet we are obliged to use external instruments that may not be, may

     

    or may not be as accurate as the instrument itself, you know, to double check to see that those values

     

    Griffin Jones (48:38)

    And then you're going to have an actual instrument itself to double check to see that those values

     

    Christine S Yeh (48:41)

    Thank

     

    Griffin Jones (48:47)

    are within range. So the Ambioscope is such a sensitive piece of equipment and also in my experience, very, stable. So on this little thing.

     

    Dr. Mina Alikani (48:47)

    are within range. So, you know, the embryo scope is such a sensitive piece of equipment and also, in my experience, very, very stable. So all this fiddling, you know, trying

     

    to measure this and measure that external to the incubator itself may actually be not only superfluous, but

     

    It may backfire at some point. So I think there are issues, you know, the other issues that, okay, you're collecting all of the data, all the data are being collected by the instrument itself, but very often there is no connection to your EMR. you have information, enormous amounts of information.

     

    Dr. Mina Alikani (49:40)

    that are being collected separately and you have to still go into your EMR and enter data by hand on development of the embryos. So there are issues like that that need to be resolved and in some cases may have been already resolved. yeah, QC.

     

    is an important aspect and I think that because of the stability of this system and because it continuously records the conditions of the incubator, that is helpful.

     

    Griffin Jones (50:09)

    report each individual edition.

     

    For any or all of you, what should people consider about time lapse incubation that I haven't asked you about?

     

    Prof. Alison Campbell (50:25)

    I think we haven't talked about how you use it and how you would choose the embryos and how you can be confident that you're doing that correctly, especially if we're thinking if we've got new potential new users listening, it could be quite daunting. Do they just because it isn't it could be just plug and play. But if it is plug and play and that plug and play provides you with an automated assessment and

     

    grading or score for each embryo, then how do you know that you can trust it? And that's quite a daunting prospect for new users. So the advice would be to validate in-house as with anything else. You can say, OK, the machine says this is the best. You either agree or not. But record when you agree, when you don't agree, what you do if you don't agree. And try and then tally up all the numbers and see.

     

    if it's better than you and if you can embrace it wholeheartedly and use it, trust it completely to do the choice for you because that is quite a leap of faith, I would say for new users, especially if you're relying on an algorithm or a system that you've not built yourself and you don't really know how it's been built. So ask questions and yeah, take it and enjoy it. Enjoy the ride.

     

    Christine S Yeh (51:31)

    Thank

     

    Dr. Mina Alikani (51:41)

    I would say that, like I said before, it's not easy. And like Alison said, it's not quite plug and play. You need to invest the time and energy and you need to collect the data and look at how, decide how.

     

    you're going to be selecting embryos if you don't have the automated version, which I'm not sure if in the US that embryo selection feature is available yet. So, you may not have that. And if it costs additional dollars for that, people may shy away from it. it is...

     

    Griffin Jones (52:06)

    with version which I'm not sure if in the US that NBO selection features is available yet. So, you do not have that. And if it costs additional dollars for that.

     

    Dr. Mina Alikani (52:26)

    You need to work it out. And I think Alison said it very nicely that you need to think about how you're going to validate it. You need to know how you're going to use it. You need your own protocols. It is not a, from lab to lab, it may be different. We still have not really found algorithms that are universally

     

    applicable and so it takes work. You have to expect to work a little bit before you feel comfortable and confident about using the system for embryo selection.

     

    Griffin Jones (53:05)

    using the system for embryos

     

    Christine S Yeh (53:07)

    I'll just add in here to sum my opinion up. think the embryo scope and time-lapse incubators are a phenomenal tool to be able to elevate a lot of embryology labs. Is it essential at this time for all embryology labs to have it? No, I think the laboratories that don't have time-lapse also have great fertilization and pregnancy rates. And like we've mentioned before,

     

    is a time-lapse incubator going to make that jump up exponentially? Not at this time, but every incremental bit helps. And I think to move forward into kind of the next frontier of IVF, the time-lapse incubator is going to be essential and it's going to be necessary to be able to seamlessly integrate AI assisted calling or assistance in the laboratory in a very smooth and trouble-free

     

    Griffin Jones (53:44)

    I to move forward into kind of the next frontier of IVF, the time-lapse incubator is going to be essential and is going to be necessary to be able to seamlessly integrate AI assisted calling or assistance in the laboratory in a very smooth and troubled

     

    Christine S Yeh (54:04)

    free manner that's not gonna take a lot of time to do that

     

    Griffin Jones (54:04)

    free manner that's not going to take a lot of time.

     

    Christine S Yeh (54:07)

    and a lot of embryology time. I think the information that we're gathering, like Mina had mentioned before, is bleeding into all laboratories and just the standard of care that we're able to give our patients and to be able to move the standard of time to pregnancy to decrease that. We're learning a ton of information from these laboratories that are able to collect this data and are able to share it. So I think...

     

    time lapse incubators are essential to our field. I think that they're going to become more more important. And I urge the vendors to help develop payment plans for laboratories who might not be able to make that one time payment to make it possible to get it into their laboratories. Initiatives to be able to support research with AI being, or not AI, maybe AI, but with time lapse incubators to support or offset the cost.

     

    of the incubator can be essential to get that integrated kind of into the laboratory. But if you can make that payment plan, so it's a year or two years, build it into the cost of supplies.

     

    get more creative with the ability to get those machines into the laboratories. I think it's going to benefit everybody.

     

    So just got to work together.

     

    Griffin Jones (55:19)

    Alison Campbell, you're becoming one of my favorite people in the field as we get to know each other more. Mina Alikani, we will someday. You will be one of my favorites too, and I am honored to have all three of you. Thank you for coming on the Inside Reproductive Health Podcast.

     

    Dr. Mina Alikani (55:39)

    Thank you very much.

     

    Prof. Alison Campbell (55:40)

    Thank you.

     

    Christine S Yeh (55:41)

    It's been such a pleasure, Alison and Mina feel honored to be able to be on this podcast with the two of you and Griffin. It's always a pleasure. So thank you so much.

CARE Fertility
LinkedIn

Twig Fertility
LinkedIn

Prof. Alison Campbell
LinkedIn

Ms. Christine Sykas Yeh
LinkedIn

Dr. Mina Alikani
LinkedIn