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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)
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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.
