In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee
revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.
Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.
The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product's lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US’s stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.
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Think of bioequivalence like buying a generic medication versus a brand-name one. If you know the ingredients (materials) and the way they are manufactured (processes) are identical to a device that has already been proven safe on the market, you shouldn't have to re-run expensive, time-consuming tests. In MedTech, this means showing that your "New Device B" is biologically the same as your "Proven Device A" because they use the same grade of titanium and the same sterilization method.
"The testing that we developed back in the 50s and 60s actually doesn't really work the best with some of these complex devices... we've been moving the standard away from what we call checkboxing." - Thor Rollins
"I only say that expensive tests always impact innovation. We don't want to over-test, but we want to do the right tests." - Thor Rollins
We want to hear from you! How is your team preparing for the 2025 revision of ISO 10993-1? Are you concerned about the lifecycle evaluation requirements? Send your thoughts, questions, or topic suggestions to podcast@greenlight.guru. We read every email and love providing personalized responses to our community.
This episode is brought to you by Greenlight Guru. As the industry shifts toward a risk-based approach as seen in ISO 10993-1:2025, having a centralized source of truth is vital. Greenlight Guru's QMS (Quality Management System) allows you to integrate risk management directly into your design process, while their EDC (Electronic Data Capture) solution helps you gather the clinical evidence needed to prove long-term safety. When your risk assessments and clinical data live in the same ecosystem, "state of the art" compliance becomes a standard, not a struggle.
Etienne Nichols: Everyone, welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. And today I want to talk about 10993-1.
More than just a list of tests, but a way to prove your device is safe for human contact based on risk, materials and real use. And it's being revised now.
It has been revised. We'll talk a little bit about its history. But to do that today I'm joined with, joined by Thor Rollins from Nelson Lab Stores, the convener for the committee revising ISO1993-1.
So, I wanted to go straight to the source and talk about what's changing, why it's changing, how to keep your team from wasting months on the wrong evidence, any practical thoughts that we, that you might have.
As I mentioned, he is the leader at a leader at Nelson Labs, the convener of the committee revising ISO1993-1, which is the global standard that shapes how medical devices play, plan and justify biological evaluation and biocompatibility.
So, I know I probably missed some different things there in that intro, Thor, but how are you doing today?
Thor Rollins: Doing great and thank you for having me. It's always great to talk to you and, and I love talking about biocomp. So, I'm happy to be on talking about the standard and hopefully not making too many people upset at me and, and the work that we've done recently.
So.
Etienne Nichols: Well, I mean, you know, I mean in the medical device industry people are going to be upset about one thing or another, but I think the goal, I hopefully we all have the goal to make safe and effective devices to improve the quality of life.
I know that is your goal. It's one of your goals. Anyway, I want this to be, but I also want to start maybe let's start with a brief background and how we got to where we are today and maybe where we're moving forward.
Thor Rollins: Yeah. So, 2018, we came out with the previous version of 1093, part one. And actually, if you look through the history of part one,
we've been slowly moving the standard away from what we call checkboxing. Right. Just doing the tests that are required for a device and more into a risk-based approach. So, there's a couple reasons why we've been doing that.
One we think it's better science. But also, two, the devices are becoming more complicated. You know, they used to just be metal and hard plastics and there wasn't a whole lot of other type of devices besides those.
And so, testing those were pretty standard. But nowadays our devices are really complex. We have coatings, we have, you know, biomaterials, we have degradable devices. You know, we're getting into nanomaterials.
And so, the testing that we developed back in the, well, not we, I'm not that old but back in the 50s and 60s actually doesn't really work the best with some of these devices.
And so, and we can't write an overall standard to accompany or accompany all of these types of devices.
So, we, we've been moving more into a risk-based approach.
And so, 2018 was a step forward into more of a risk-based approach. But honestly the more the standard tries to do risk based, the more the companies and regulatory bodies are still just wanting that checkbox.
It's easy, right? I mean it's just easy to check box testing.
So, some of the people on the ISIL committee kind of got a little bit frustrated with the slow progression into risk-based biocompatibility and they wanted to really align this standard with the risk-based standard which is 14971.
So, what they did is they basically wrote a new standard, and they put it under a kind of a new work item proposal. But how they did it required it to be very fast timeline.
So, they wrote this new standard to the committee for comments, and we basically spent a year and a half to two years going back and forth on this standard which in this, in the standard world is very quick.
That, that usually takes a lot longer to have a brand-new standard.
And we all now in November, we now have the new 2025 version which is completely different. Some, some really there's a lot of differences and there's webinars all out there talking about them, but just high level some of the big differences.
The risk estimation. So, part of 14971 you need to estimate your risk of a medical device.
Well now in this part, in the new 2025 version of part one, you have to do some type of risk estimation from a biocompatibility perspective, which is not something we've done officially.
I think everything we do is kind of risk estimation, but we haven't really given an official way to do that.
We also have life cycle which is a big issue in this new standard. So, it used to be you did biocomp at time zero that represented the device throughout its life cycle.
But in this new standard, you have to evaluate the differences in biocompatibility throughout a product's life cycle.
So, for a single use device, that's easy, that's, you know, brand new device and then end of shelf life and just evaluating what could happen during the shelf life. But then we have devices that are reprocessed.
And to me that's going to be the big potential issue here because we've never really evaluated what happens to a device during its reprocessing.
Or there's a lot of those devices that never actually determine when the end of the life cycle is. They just use it until it breaks and they throw it away.
And no one's really evaluated right before it breaks is it different in biocompatibility.
So that's something we brought into this standard that's unique.
Etienne Nichols: I think that's, you know. Okay, you mentioned the controversy and I can imagine there's probably some controversy because I'm seeing maybe some dollar signs come up. I can, as a manufacturing engineer, I can look back in my past and remember when I did some testing with, it was bleach testing and autoclave testing for the World Health Organization standard.
I don't know if it's 49 cycles or whatever the case, whatever it was, those devices looked very different at the end than they did before. And they were, I think they were aluminum devices with a, either an anodized or something else. But I mean, it was, they were different devices. So, I can understand where you're coming from a safety and effective perspective.
Thor Rollins: Yeah. And, and to your point, it's like it's so hard from, from people on this standard because our main goal, like you said, is to have safe medical devices on the market. And I hear all the time, well, my device isn't causing people to come sick.
Right.
That's a relative term. So, you might not get what we call acute systemic toxicity, which is very quick reactions, even irritation or sensitization.
But things we care about are things like chronic toxicity or even carcinogenicity. And like, no one is looking at people who have a specific cancer going through their lifespan and saying, oh, all these guys got this implant 20 years ago.
Maybe that's the. Yeah, we're not doing that. Maybe with AI, something similar would do that.
But so, for, for us, what we're trying to do, since no, we can't really do that today, is trying to do on the front end. And to your point, like, if you subject a device to Enzymatic cleaners for like 200 cycles.
You can't tell me that polymer is not different.
Right. So, like, does it. Is it still safe? Like, maybe those are things that we have to evaluate. And this standard is now calling it out where before we never really did.
Etienne Nichols: Yeah. Okay, so what else has changed? What else do companies really, when I'm thinking about this, I don't know, I guess it sounds like it's a philosophical change. And any other things you could point to as far as that are big philosophical changes?
Thor Rollins: Yeah, the other one that's kind of aligned to 14971, that it could be a big change or maybe not. I guess it depends on how it's regulated.
We've added the concept of foreseeable misuse.
Right.
So, this is something in 14971. And companies do this already, but a lot of times they may not think about it as a biocompatibility perspective. I'll give you an example real fast.
So, you know, biocomp is all about how the device is used for how long it's used and where in the body is it used. So those are like the inputs that we put in to evaluate the risk.
Well, you might determine that a device is going to be used in the lungs, for example. In fact, I have a real lively scenario on this that I talked to a customer last year about.
They have a very small scope that they use in the lungs. And it's a great technology, very clear picture, very, very small.
Well, that's the intended use of that device is to look through the lungs. But if doctors can start using this really small flexible endoscope to see really clearly, they may start looking at other applications to use this with, like vascular, for example, or others.
And so, they could start using it and things that you did not intend that does now increase its biocompatibility risks.
So, as a company, like where do we become or whether companies become responsible for foreseeable misuse. Right. Is it something you've contraindicated like do not use in this population of people, but you know, doctors, are, are you now responsible or is the doctor like. There's a lot of vagueness there. But from a biocompatibility perspective, if it's starting to be used in a population that you do not intend, we want to look at the risks of that population or in the part of the body you do not intend, we want to look at that risk.
And so that's how the standard is written. But once again, I'm not sure how it's going to be enforced right now.
Etienne Nichols: Yeah. In my lateral thinking, I guess I start to think a little bit about predetermined change control plans or the PCCPs. I mean it seems like at the very beginning if you don't have any intention to go into that additional indication for use, maybe this feels like a waste.
Or if you're purely looking at economically now, if you're looking at it from a more holistic viewpoint, from a moral standpoint, okay, we're going to make sure nobody's getting hurt and that's the way to look at it.
But at the same time, you could take that additional approach and say, okay, I'm gathering some more information. This could potentially help me in the future if you have some sort of like PCCP.
I don't know if it's just a thought.
Thor Rollins: Yeah, no, I, that's something that was brought up those VCCPs. And it's like maybe right now you don't intend but you're opening up a whole nother business opportunity. Right. With a different type of use.
But I think what people are scared about is that Pandora box. Like maybe our foreseeable misuse is going to be different from an FDA's foreseeable misuse and how you're going to predict that.
Right. So, I think there's obviously we're coming from a risk-based approach and for patient safety and there are a lot of companies and I'm not nobody who works with you guys I'm sure because all your companies are very, you know, very good and upright.
But I know there's companies out there that will say do not use more for than 28 days.
And they know that doctors will. Yeah, but they do that, so they don't have to do the testing for long term contact. And so, there are times where I understand where the foreseeable issue comes in.
And by the way, this is an FDA kind of addition to the, to the standard.
So there, there are things that I know that, why they're trying to protect some of those things. I'm sure the FDA seen it that way, but it doesn't like there's going to be a potential impact on a lot of different devices that I'm worried about.
Etienne Nichols: Yeah, that's a really good, I think that's a really good example to use that, that, that 28-day mark because I can totally see that being a temptation to companies.
Any other things that this revision may have be helping or at least prevent some of the better, the worst things that are, that could potentially happen.
Thor Rollins: Yeah. So, for some of the help thing, some of the things that I'm actually proud of that we were able to put in, there's a couple of indications about biological equivalence.
So, one of my pet peeves is a testing lab and one of the things that I'm continually trying to enforce to my customers is that I've tested the same stainless steel, the same titanium’s, the same new seal, silicones, whatever, over and over and over again. And, and so like I know that they're safe, right. They're not automatically become sensitizers. Like titanium is not going to automatically become a sensitizer. The FDA, which I agree with, will say they're less worried about those materials and more about processes that could be left behind.
Right. Like detergents or other things.
But that, that should be a way for us to evaluate that in a risk-based approach where we can really understand the possible residuals and then understand when testing is needed and when it's not.
The concept of bioequivalence is. Well, like there are a lot of companies who have very similar devices already on the market that are processed very similar ways. Just might be a change of shape or a change in dimensions or whatever.
Like, can't we use that information to help us evaluate the risk of the other product? Like, and we do. Nelson has done this forever, but there's not been a standard way to suggest it. So, we now have this bioequivalence kind of concept where this is equivalent from its biological impact to another device on the market.
We should be able to use that to justify reduced testing or no testing. Right. So that's something that's in this standard. The concept of the Zen in the standard right now.
And I'm excited about that. And the thing I'm most excited about is this standard actually removes one of our animal testing, which is the first time we've officially like in a, in there's been kind of this in vitro irritation that's, that's been part of part 23 now, but not recognized by the FDA.
This one I think we're going to get recognition in. It's got; it's the removal of material mediated pyrogenicity.
And there were some good studies done.
The labs like us and other labs gave a bunch of our leachable data to, to a company or to a group of individuals and they, they showed that there were no pyrogens found in our leachable data. Like there's no such, really, there's no such thing as material pyrogens. On medical devices.
So, we were able to remove it from the standard as a requirement. So going forward, that test is only required if you're using device materials that have never been used in a medical device before.
So that's good news too.
Etienne Nichols: Yeah, that is really exciting to hear. And I mean I love the equivalence idea. I've seen. Well, I've heard a little bit about this in I guess lateral industries, for example, packaging where you take apart, you make put all the worst-case scenarios or, or, and, and just do some drop testing with that so then you can leverage some of that data.
And I think that's fantastic that that's being applied to biocompatibility. I don't think I would have really thought of exactly how to do that, which is why we have you guys at the helm there.
So that's, that's exciting.
Thor Rollins: Yeah, it's something like I said that we've done in the past, we've done, we call them monster devices, but like you said, kind of trying to do a worst case and then also do bioequivalence.
But there was no standard way to do it. So, we try to put some of our philosophies in a standard to get that as, as a tool for people to use.
Etienne Nichols: Yeah, that's very cool. So, what's driving the revision now? I know, I don't know how far away we are from a future revision, but.
Thor Rollins: Yeah. So, I'm going to kind of talk really quickly about two major things. One is the global acceptance of this and, and then what we're doing and kind of what. How the acceptance of it went.
So just real fast, so this got up for committee draft voting like three or four times and every single time the draft was up for voting within the standard committee, US has voted no.
So, the US voted no every single time it went up for a vote, even at the very end moving it to what we call an F disc, which is the final draft international standard. Basically, when all the science is done and there can be no more changes.
The US voted was the only country, I think Denmark might have also voted NO for that one. But basically, US has voted no every time.
The reasoning behind why the US voted no wasn't because the direction of the standard we felt was bad, it was that we felt like, at least me personally, I'm mostly speaking about by vote, but all of the US people voted no.
Is that these changes, like all these things we talked about are in the standard, but we don't give guidance on how to do them. Like we talked about foreseeable misuse, we talked about risk estimation, even end of life.
We say you have to do these things, but then we don't give honestly good guidance on how to do it. So, we're going to leave every single company out there with their own way to evaluate those endpoints.
And I just didn't think that was fair. I thought that if we were going to require these assessments that we should also give them guidance on how to do so.
But regardless, the standard is now published. And so, what we're doing is we're actually having six projects that are being done right now within the standard group.
And these standards, these projects are addressing the things I just talked about and a couple others.
But basically, we're putting together technical specifications where we're going to put out separate documents on how to look at risk estimation, how to look at foreseeable misuse, how to look at end of life, and these other ones.
And then once we get those published, we're going to do a new work item proposal to revise the standard again and then we're going to put those in the standard as an actual appendix to the standard.
So that's the plan. We have two of these working groups or these project groups working right now and we're going to be meeting in October in Tokyo, hopefully moving those forward to a publication. So, I'm hoping the next two to three years we'll be able to get. That's ambitious, but I'm pushing two to three years that we'll get these projects done and then we can start redoing the part one again, hopefully this time with more, more guidance in it.
Etienne Nichols: Okay, now that makes sense. I think that clarifies a lot, at least in my mind. It makes me think; I guess of we talk about ISO 14971. There's the ISO 24971, which is the guidance on the application of 14971.
Thor Rollins: I don't.
Etienne Nichols: It sounds like maybe it's being combined a little bit differently, but that's. That sounds cool.
Thor Rollins: Similar concepts. Yeah, we'll come up with technical specifications to support part one. In fact, the names of these are like risk estimation in context of 1093, part one. Right. So, like our main goal is to eventually have all these documents feed into the standard as part of the standard.
But we. It's a lot easier for us to get a couple of these TSS published and instead of redoing the whole standard.
Etienne Nichols: Yeah, that makes, that makes total sense. Well, that being said, okay, I'm. I would assume there are certain aspects that you would say, well this part of the standard that came out last year, you know, this is where people are really going to get tripped up.
This is the part I care about the most. Any advice that you can give right now, obviously the guidance is going to come a little bit later, but anything you can give right now.
Thor Rollins: Yeah. So, I think what we're seeing, so the interesting thing in the industry is maybe I'll lead in with one of the points to is acceptance of this standard. So MHRA, which is the UK's government body, they came out and said they'd be open to having a two-year kind of buy in or grace period for this standard.
The FDA has not recognized it because we all know how long sometimes it takes the FDA to recognize the standard. They've been getting guidance from the industry on what the industry would like them to do as far as recognition goes, either partial or no recognition.
I would be scared if it was no if they didn't recognize it at all because that would be a tough spot to be in. I, I hope there's some partial recognition of the standard.
But what we're seeing as far as from us as Nelson, what we're seeing as being requirements right now is all from notified bodies.
So notified bodies under MDR are considering this standard state of the art.
And so, we're actually seeing today, in the last couple of weeks feedback pushback from notified bodies saying you need to do your biocomp assessments per -1 to 20, 25.
And the things that we're seeing the most kind of pushback on are the ones I mentioned. So, they're like hey, your life cycle like, like why aren't you evaluating over the life cycle of your dominical device?
And customers are like well how do I do that? And they're like I don't know, you, you do it right.
So, what we've been doing, asking or having our customers do is just some simple chemistry, especially if it's a, like if it's a metal device you can justify in a single use medical metal device like an implant.
That's easy because a piece of titanium sitting on a shelf probably not going to change over five years.
A polymer though, you would want to do some chemistry on an accelerated aged sample to compare. So you're looking at things like thermal dynamics like DSC or molecular weight like GPC or FTIR, things like that that you can compare kind of like new device versus accelerated age device and see if you've had significant changes in any of Those areas that might think that you've changed the polymer enough that you might want to do more evaluation for biocompatibility.
It's the other devices that degrade over time that I'm more worried about and, and reprocessed devices that like, they don't right now, they don't do a lot of repeat studies to show the end of life of these.
And so those are the ones I think we're going to get mostly hooked up on. I mean those chemistry tests I mentioned are relatively inexpensive and quick. So, I think we could do that relatively easily.
I am interested to see what kind of impact it will have from the reprocessing side of things. Just to see what they're going to have to do to come up with a.
Like after 200 cycles is where I'm going to evaluate the biocompatibility of my device.
So, I think that's what I see as a big hiccup.
Etienne Nichols: Do you think there's going to be a change in the reprocessing process or the type of materials that we choose as a result of this standard?
Thor Rollins: I think that's a possibility.
So, here's my thought on that.
I think most people pick good materials already. I'm not throwing anybody on the.
But no one's really evaluating those changes from a safety perspective after knowing 200 cycles like I mentioned.
Etienne Nichols: Right.
Thor Rollins: So, I could see the possibility of some materials after being exposed to that much detergent or, or heat cycles starting to leach things that we don't want them to leach. In that case we'd have to look for a substitute.
Right. And so, it could, and ultimately it could lead to safer, should lead to safer medical devices when that's needed. And we've seen that all the time, like the introduction of extractables and leachables that we started talking about ENL back in like 2005 or 6 in this ISO standards.
And then it came out and became a pretty big impact in the industry.
We've seen devices, we've had plenty of devices that we've had to pull off the market or customers had to pull off the market because ENL showed things that the regular animal testing didn't.
And so, we were putting patients at risk unknowingly.
I think that's a possibility here for.
Etienne Nichols: Sure, with the bio equivalence or that concept. I would guess that there, it's probably going to be a way to help customers pick those materials a little bit better in the future than maybe they are currently.
What are your thoughts there?
Thor Rollins: So, I talk to My customers all the time. With this new standard coming out we should, all the big customers should start their own internal databases. Right? Like their own databases of materials and processes that those materials have been subject to and the biocompatibility results.
And you know, I would totally foresee, I, I feel like sometimes I just am so pessimistic about the standard. Like you're going to have to do all this other stuff and testing but like I, I would see an offset where after a while we have good databases on these materials and processes that companies can use as bioequivalence concept and, and maybe not test all their new devices that they're making. Right. And maybe it offsets. Maybe you're doing testing more on these reprocessed ends of life kind of stuff or foreseeable misuse, but you're doing less testing on normal, just regular medical devices.
Well, time will tell but that's the hope here. I don't, I only said that costs like expensive tests always impact innovation. Right. And venture capitalists and things like that. And that's where our true engine is in medical devices. So, we don't want to over test, but we want to do the right tests.
Etienne Nichols: Yeah, it does feel like it might be a short-term challenge to get through but potentially that will become the new normal and we'll have those databases to draw from hopefully.
So yeah, any, any advice on, I mean it's, it's, it makes sense building those databases internally especially the bigger, bigger players as they, you know, accumulate all of their data, they're going to make better decisions. But what about the little guys who won't have access to what Stryker and Abbott and J and J are doing.
Any thoughts there?
Thor Rollins: Yeah, you're right. So, this would definitely help the bigger guys with big experience and experts in house and things like that for the midsize and small companies.
I, I'll say it again, you really need to have the best relationships with the right people.
There are opportunities for these guys, for the small guys to use the same concepts. They just have to partner with the right people who have experience and knowledge to do so.
And you know there's a lot, there's a lot of so called biocomp experts out there and, and there are some that are really good. So, it's not a broad brush at all, but in the past with checkboxing almost anybody could be a consultant or an expert because it was following a chart.
I think now you're going to want to make sure you're partnering with the person who kind of knows what to do.
In fact, that's another change we did in the standard is specifically notified bodies were getting kind of fed up with the subpar like biological evaluation plans and risk assessments. And so, they put in a lot more requirements for the people who write those.
And so, there's going to be a lot more pressure on the people who are making assessments to make sure they have the right background education experience to make these conclusions.
Because it is a risk-based approach today or going to be.
So, I think for the small guys, like they need to just make sure they have the right partners. You know, I've seen companies, so many companies burned by doing the wrong tests or taking the wrong approaches or having the wrong information and then having to repeat the whole thing. And that's, that's tough.
So yeah, that would be my suggestion.
Etienne Nichols: Well, you mentioned the risk-based approach a couple times. And when I think of that phrase a lot of, I mean on the one hand we talk about oh, the increase testing, the additional burden and so on.
But a risk-based approach inherently has with it you focus on the risky side of things and the less risky things, maybe there's less work to do. Are there any areas where this is actually lighten the load?
Thor Rollins: Yeah. And then this goes back to partnering.
So, I get kind of frustrated when I hear people talk about all the FDA just wants testing or the notified bodies just want testing. If you're going to ask the FDA up front, what do you want us to do?
Which I would never recommend.
They're, they're going to give you the list of tests, right? They're going to give you everything.
So yes, the FDA wants you to do testing. Yes, the notified bodies want you to test. It's the easiest way for them to approve a device.
But we don't do that. Like when we write a biological evaluation plan, we go through this risk-based approach. And if you're using titanium, if you're using stainless steel, that's 316L and the processes are like we actually recommend like most of our projects try to get out of testing.
And so, to your point, I, that's why I'm thinking about making sure you partner with the right person because if not you will end up just doing a ton of tests because that's the easiest way to get a like feel good about things.
Etienne Nichols: Yeah, I just think, you know what I when I hear phrases like risk-based approach, look at both sides, the difficult side, but also the way it helps you, I mean benefit risk analysis, think about the benefit. We don't always think about benefits, you know, and really accentuate them.
Thor Rollins: And I just had one that.
To your point, a lot of people don't think the FDA cares about that, but they. They definitely do. We just had a device that we got through the FDA in December where they had some testing issues.
The material itself was very difficult to test.
And so, we had this great discussion with the FDA. They brought in experts who knew testing. They understood the difficulties that the lab would have on testing it.
They saw the benefit to the patient versus the risks that they have in the testing. And that's what the FDA kind of went through with. So, to your point, the FDA actually, all these regulatory bodies actually are pretty good partners when you. You have the right conversations. Yeah, I think they get frustrated when you don't have the right conversations and they kind of just put up a wall.
Right. So, you want to work as a partnership with them. For sure.
Etienne Nichols: Yeah. So, let. Okay, I want to. Just one more question and then if you have any additional things that you think are worth talking about, I'd love to hear whatever you have to say.
If I'm talking to three different companies and company A is just now starting to think about a prototype and getting funding. They're very early stage. And you have another one, hey, we are almost on the market.
And then a third company, we've been on the market for a while.
How does this impact. Or do you have a piece of advice for each one of these companies individually as it pertains to the standard?
Thor Rollins: Yeah, this is actually a great. And I've given this advice a couple of times just recently.
So, it kind of depends on your strategy for regulatory pathway. Like I mentioned, the FDA has not recognized part 25 yet, or year 25, part 1, and I probably will probably a good year or so out until maybe the end of this year is the earliest. I would assume that they would recognize it. Maybe I'll be wrong there, but.
Or partially recognize it.
So, if you're a new company and. Or any of those three companies. Well, the first two for sure. The ones that are just starting and the one that is about to, you know, put the submission in.
If you're just going to the US first, you could follow 2018.
You could start to think about 2025 and maybe some of the aspects. But honestly, you're going to be held more to the 2018 requirements through the FDA. They may choose to bring some of the things they care most about in this new version out to you.
But most of the time what we're seeing is 2018 is still working.
If you're going to go to Europe, even in that company who's about to submit and maybe done all their testing under the 2018 version, you want someone to do a gap analysis under the 2025. Because like I said, we've had probably three or four in the last couple weeks that have went to notify bodies who come back and said, hey, where's your, your 2025 evaluation? You did. Everything's a 2018 state of the art now. So, it kind of depends on, on your first two criteria there, your two examples, your regulatory strategy and where you're going to go.
For the person who already has a device on the market, we specifically put in this because there's a lot of heartburn about MDR, we specifically put in the standard that this does not apply to devices already on the market.
So, if you're. There's no like grandfathering, there's no, you have to do this.
But if you make a change to your device at all that requires a new submission to like a 510k or to a regulatory, then you'd fall back into that first scenario where if it's to the FDA, you're probably fine for right now.
But if you're going to Europe and have a change, then you're going to have to do a gap analysis to 2025.
Etienne Nichols: Yeah. Okay, that makes sense. Well, cool. I appreciate you following through and on each one of those companies and it's a little bit slightly different for each one.
They look at life through a little bit different lens.
Any other piece of advice or things that you think are worth thinking about.
Thor Rollins: So, to me, I think ultimately, I think a lot of people get scared, especially when we start talking about some of these new concepts.
I think they get scared and there might be some hesitation.
I really want to say that to your good point, that the whole concept of this standard was to help companies get their device on the market easier. Right. Get away from some of these animal tests that like make no sense.
Right. Like, and really do what's needed for the risk of the medical device.
So even though it is scary, any new regulation that changes and has such a price tag as biocompatibility does, and timelines too is scary. I get that. But like, really step back and talk to somebody who has the experience in this. You know, there's lots of good consultants out there.
There's a lot of good laboratories out there that have people on these standard committees.
Have. Have us take a look at your project.
I bet you'd come away feeling more comfortable.
Knowledge is power. So, I would definitely suggest that because it, it's not as scary as it sometimes feel. And we can be dramatic too, right? I mean, we like to talk about all the things, but we still don't. We still haven't seen how these are going to be regulated either. So maybe there's not a whole lot of strict regulations in some of these concepts too.
Etienne Nichols: Yeah, well, and I'll just kind of reiterate the point you made with making those strategic partnerships with people who have seen a wide breadth of experience and seeing all the different things in the market across different companies.
Just going back to my own experience as a mechanical engineer doing different types of testing and product development.
It pays to have someone who knows a thing or two. I can remember. I shouldn't, probably shouldn't say some of the things, but like a pig study, an adhesive study that we learned actually doesn't even apply to a human skin. So, I mean, had we known, that could have saved a whole lot of time, you know, so.
Thor Rollins: A lot of time and a whole lot of money. I tell people all the time. So, I've been 25 years is how long I've been doing biocompatibility and working in the laboratory space.
People ask me all the time, what's my, like, key to success or the thing that I would tell people to focus on. And as they're starting the career for me, it's always network. It's like, especially in this industry, like, people in this industry generally are great people who want to help.
And so, get, get networks, like, network with people and then you'll have someone that you're like, you know what? I know a guy or I know a gal, right? Like, let me reach out to that person.
And I've always had just the best experiences with people in this industry. So, to your point, like, if you're new to this industry or if you've been in the industry for 20 years, you can always strengthen that network and, and get, get that, you know, group of people that you support your.
That support you.
Etienne Nichols: Yeah, that's great. And I think that's great advice no matter what level you are. So really appreciate that. Really appreciate the conversation and your willingness to talk about this standard.
Thor Rollins: Thank you.
Etienne Nichols: Excited to see the guidance as it comes out. Guidances are personally my favorite thing to read because. Oh, how to apply it. That's, that's what we all want to know. So really appreciate all the work you're doing and where can people find you?
I know people see you every now and then in events. You got anything coming up or any place you want to people direct people to.
Thor Rollins: Yeah, so just one, two things on that. So, we're. Because I'm the convener, I'm going to try to update as much as possible.
So, there's a, there's a Nelson Academy that we put all our web or our digital content, it's free that you can go to. Also, you can always link with me on LinkedIn.
I'm trying to update my LinkedIn with updates on what's happening. So, you can always keep up to date there.
Then also you can always reach out to Nelson Labs. In fact, the good thing about having the name Thor is there's not that many Thor Rollins in the world. So, if you just type in Thor Rollins, you'll probably see me.
So, my next conference I'll be speaking at is actually over in Germany. There's a. And you can see that on my LinkedIn. So, they asked me to come over and actually talk about the part one and, and actually a couple of people from the standard committee that are working on these projects will also be talking about their projects over there.
So that's in March in Berlin.
And then. So, but I'm. Like you said, I'm usually at every conference and trade show or whatever. So just, just look me up and I'll, I'll be happy to talk to anybody.
Etienne Nichols: Okay. And if, and if you are nervous out there to start a conversation with Thor about biocompatibility cause you're intimidated to ask him about books because he's got great book recommendations too, different genres. So very recommend.
Thor Rollins: I love, I love to read and I love to talk about biocomp. So please, you'll never make me mad by coming up and asking me a question.
Etienne Nichols: So awesome. Well, thank you so much. Really appreciate it. Those who've been listening, thank you so much for listening. Hope this has been helpful and we will see you all next time.
Everybody take care.
Thor Rollins: Thank you.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you.
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