In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should always launch outside the U.S. first, noting that shifting regulatory landscapes—especially in Europe—have made the U.S. a more attractive primary entry point for many.
The conversation pivots to the technical and strategic nuances of "same device, different claims." Mike explains that if a device maintains the same design but utilizes different labeling or indications for use across borders, it is technically a different device in the eyes of regulators. This creates significant complexity for Quality Management Systems and post-market surveillance, particularly concerning reporting requirements for Class III (PMA) devices.
Finally, the duo explores the "trap of equivalency," where companies mistakenly assume that a CE Mark or other international approval guarantees a smooth path through the FDA. From differing consensus standards to the strategic use of OUS (Outside US) clinical data, the episode provides a roadmap for global players to synchronize their regulatory and reimbursement strategies early in the development lifecycle.
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Think of Label Expansion like a smartphone software update. The hardware (the phone) stays the same, but the update allows the phone to do something it couldn't do before—like a new photography mode. In MedTech, if you have a stent approved for use in the leg (the "old label") and you want to use that same stent in the heart, you apply for a "label expansion." You aren't changing the device; you're just proving it’s safe and effective for a new job.
"If you’re marketing the same device—same design, same materials—but the labeling and claims are different in the EU versus the US, then technically, it is not the same device." - Mike Drues
"The regulatory logic is agnostic of the scenario. Whether it's a label expansion or a 'species expansion' from a dog to a human, the underlying logic remains the same." - Mike Drues
We want to hear from you! Did this episode change your mind about your international launch strategy? Do you have a "culture shock" story from bringing a device to the US? Send your thoughts, reviews, or topic suggestions to podcast@greenlight.guru. We read every email and love providing personalized responses to our listeners.
This episode is brought to you by Greenlight Guru. Navigating international waters requires a robust foundation. Greenlight Guru’s Quality Management Software (QMS) helps you maintain a "single source of truth" for your design history files and labeling, while their Electronic Data Capture (EDC) solution streamlines the collection of the clinical data you'll need to satisfy both the FDA and international regulators. Whether you are managing post-market surveillance for a PMA or running a multi-center global trial, Greenlight Guru has you covered.
Etienne Nichols: Hey, everybody. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols, and today we're going to be talking about the culture shock that can, I guess it could stink. A MedTech company, really, if you think about it, when they're trying to cross the pond from international waters. Whether you're a scrappy startup or a global player, bringing a device to the US Is never just a copy paste from what you've done in the past.
So, whether, even if you have a device in Europe or Asia, there's a lot of things that are different when it comes to the US, joining us to navigate this is Mike Drues, president of Vascular Sciences.
Mike is a regulatory expert. He's, he's.
Well, the intro that I really need for him is too long to give here. But if you're not familiar with Mike, then maybe you need to come to a few more of our podcasts and webinars.
But, Mike, how are you doing today?
Mike Drues: I'm very well, thank you, Etienne. And thank you for asking. And thank you for those very kind words. I appreciate that.
Etienne Nichols: Kind of choked on the intro, but. No, it's good to have you. It's good to have you here. And I'm excited to talk about this international topic.
I don't know how do you want to jump in? Do you want to talk about some of the biggest mistakes maybe that you see international medical device companies coming when they're trying to bring medical device to…
Mike Drues: the US Yeah, Etienne and I would be very happy, as always, to do that. And once again, thank you to you and your audience for the opportunity to have this very important discussion before getting into the specific mistakes.
And by the way, I've identified what I think are the top seven biggest or most common mistakes. But in the spirit of David Letterman and the top 10 list, this is not going to be an exhaustive or comprehensive list, though maybe between you and your audience, we can come up with a couple of others to add.
But anyway, before discussing the specific ones, I wanted to point out that we are making at least three assumptions when we ask that question. What are the top, biggest or most uncommon mistakes?
Just as a reminder, good engineers will always state their assumptions before identifying the solutions.
I'm not sure, Etienne. And if they still teach that in engineering school, they did a long time ago when I was in school.
As a matter of fact, real quick story, I had one of my graduate students admit to me that they used ChatGPT to help them solve a problem. And I pointed out that they did not state their assumptions, and they said to me, well, Jet ChatGPT did not tell me what assumptions that they made.
So, you're laughing. I know you appreciate my not-so-subtle use of humor, but it is becoming a bit of a scary world.
In any event, assumption number one is that we're assuming that there is that the best strategy is to bring the device onto the market first outside the United States, in Europe or Japan or Canada, and then bring it in onto the market here in the United States.
Well, as you know, Etienne, and that used to be a very common practice today, it's not nearly so simple of a decision and that's a topic of a completely different discussion which you and I have had before.
Which region or which country should you go to first, whether it's the US or somewhere else. And one other thing I wanted to point out along those lines is, excuse me, if you make a mistake in one country, don't make the same mistake in other countries.
And I see this happen more frequently than some people might like to admit. I know obviously Etienne, and you know a lot about CAPAs.
Well, if you make a mistake in one country, maybe issue a CAPA in part to prevent the same mistake from happening when you make your 510(k) or PMA submission in the next country.
Just something to think about.
The second assumption is that we're talking about international medical device companies, well named for me, one company that's not international after all, nearly all medical device companies today, there are a few exceptions, but nearly all of them, they should consider themselves to be international companies because they want to market their device in, you know, ideally the entire world.
So don't limit yourself to thinking in terms of, you know, a US company or an EU company or what have you. If you have plans to market your device in multiple regions in the world, then you should think of yourself as a international company. And the third assumption that I'll make, and then Etienne and I'll pause and give you an opportunity to chime in, is if you're marketing the quote, unquote, same device in different countries, but your labeling is different in different countries.
And what I mean here, Etienne, by labeling is the high-level labeling, specifically the claims, then you are not marketing the same device in different countries.
Let me say that one more time. If you're marketing the quote, unquote Same device, in other words, same design, same materials, same mechanism of action and so on and so on.
But the labeling, i.e. the claims are different in the EU versus US versus Canada versus Wherever, then technically it's not the same device. And one other thing that I'll point out on the quality side because I'm trying to balance off these problems, both regulatory as well as quality.
If you have device, a device, device that has different labeling or claims in different regions, then as you can appreciate, Etienne this can make your quality management system much more complicated and much more confusing.
Just as a quick example, the post market surveillance requirements for PMA devices, Class III devices here in the United States are different than they are for Class II, 510(k) or De Novo. In other words, if you're making a PMA submission here in the United States and you've already got ostensibly the same device on the market, say in the EU if though if you have had problems related reported to you in the EU, you are required to include those problems as part of your PMA application to the FDA. Now that is not a requirement in the 510(k) or the De Novo world. Perhaps it should be in my opinion, probably should be, but it is definitely in the PMA world.
So before continuing on to the individual problems, I just want to give you a chance to either make some comments or ask some questions about our underlying assumptions first.
Etienne Nichols: Yeah, so the first assumption that it's better to go to another. So just kind of see if I can go my memory here that, that it's better to start outside the US I might take issue with that as an assumption because I can see a company maybe just better just because out of convenience or starting where they are now, they're, they're approaching regulatory strategy. I'm not sure exactly what their reasoning was, but I guess I'm just kind of starting at point zero. But there, but I see where you come from that there was an assumption of some sort, for some reason it was better.
That makes sense.
Mike Drues: Well, let me just make a clarification and I apologize if I would didn't explain this properly but the way that our question number one is written is we already have a device on the market somewhere else outside the United States.
And therefore, the underlining assumption is that for whatever reasons, as you just pointed out, yeah we, you know, our best strategy was to bring it onto the market somewhere else first.
Remember Etienne, and this is in part not just a regulatory exercise, it's an engineering exercise in being careful to identify our assumptions.
Etienne Nichols: Yeah, okay. I Think. I think you've proven that assumption in my mind. I think I'm good with that.
The international versus global is an interesting one, so I'm going to stretch my brain and get outside my realm of knowledge here. But international and global being international, where a company works with a company across borders or has things that crosses borders, whereas a global company, where they actually have operations in other countries.
So, what you're suggesting is a company should start to think of themselves more as a, a company that is going to work across borders. So, the pure international sense.
Mike Drues: Well, that's an interesting comment, Etienne. And to be honest with you, I didn't really think about distinguishing between international versus global for the purposes of today's discussion. What I would suggest is let's not focus too much on semantics.
What I had in mind was if you have a company, let's say, that develops a device in the.
And then that same company wants to bring it onto the market here in the United States. That's the scenario that I was sort of assuming.
But your point is well taken. If the EU company wants to, you know, license it to somebody else, maybe already in the US that's fine as well.
But I'd rather just, you know.
Etienne Nichols: Yeah.
Mike Drues: Stick to the, to the more important problems rather than the semantics.
Etienne Nichols: No, to your point, most likely you are going to be starting to consider yourself across borders. So, and, and selling in all these different regions, at least at some, on some level. So, I, I totally agree.
I think that's, I'm, I'm with you on those assumptions.
Mike Drues: Okay, terrific.
Etienne Nichols: So, if we were to look at these, I mean, you mentioned several different things.
Maybe we can go through those one by one, just maybe take out and take out some of the top biggest or most common mistakes.
And maybe there's an assumption there that people are going to make mistakes, but I think that's actually a pretty safe assumption to make. What do, what do you think those would be?
Starting with whichever one you think is the first.
Mike Drues: Okay, so first of all, just as a reminder, one of the assumptions that we're making is that the device is already on the market somewhere on earth and it's not on the market here in the United States yet.
So, with that reminder, and because it's on the market somewhere, it probably already has a CE mark and now we're going to go for a 510(k) or De Novo or something like that, that should we assume, Etienne, that what we did to obtain the CE mark will suffice for the US clearance or approval.
What do you think?
Etienne Nichols: No, I think that would be a trap of equivalency. I don't think so.
And I wanted to mention one thing that I thought of. I forgot about when you were talking about the exact equivalent device, but different claims.
I was actually thinking of the analogy of the screwdriver and the paint can opener, which maybe they're one in the same, but if you claim differently, then they may have different requirements.
Mike Drues: So anyway, that's a beautiful and a very simple example. I love that. Maybe I'll have to use that one myself. Or maybe I did use that one in the past, I don't remember.
But anyway, I agree with you. Many people do unfortunately make this assumption that whatever I did to get my CE mark will suffice for getting my 510(k) or PMA or whatever it is.
And actually, I saw that a lot during COVID A lot of people made the assumption that whatever I did for my EUA, my emergency use authorization would be sufficient to get my 510(k) or De Novo or whatever it is.
The short answer to both of those is absolutely not.
So officially or theoretically, having some sort of previous approval like a CE mark will not officially buy you any brownie points with the FDA.
However, that's the official, that's the tech theoretical answer.
Inefficiently, it might get you some brownie points. Now, I have to be a little careful what I say here because I do work as a consultant for the agency as well as for companies.
I have had some reviewers, not many, but some reviewers sort of express to me the opinion that if the device is already on the market elsewhere, that if it's gone through the EU system or the Japanese system or the Canadian system or whatever it is, then they might not have to take a quite as, you know, critical look at it, if you will, because it's already passed, you know, somebody else's sniff test. Now this gets us into all the issues of global harmonization and everything else, but indirectly there could be some, or unofficially there could be some benefit, certainly more direct benefits of having a device on the market is you already have clinical data in most likely the form of what we call real world evidence, or RWE.
And I love to include that real world evidence as part of my U.S. submission.
And you and I, maybe even going back to your predecessor, John Sperry, you know, we did a number of discussions on real world evidence and specifically including real world evidence in, in a US submission, typically real world evidence here in the United States, the connotation is limited to the US but as I pointed out in one of my first podcasts on that topic, it doesn't say anywhere US Real world evidence. It's real world evidence.
It's not real US evidence.
So, if you have a device on the market in the EU or Canada or wherever, one of the first things that I would be looking at is can I use some of that real estate data? I'm not talking about, you know, artificially contrived clinical trial, you know, RCT data, but real world evidence or real world data.
And by the way, those are two different things as part of my US submission.
Just one or two other things I would point out is just as a reminder that oftentimes outside the US problems or complaints, as I mentioned, are required in a PMA submission.
And the reason why I'm repeating that is because I consider that tremendously in my product liability experience when I work as, you know, frequently as an expert witness in medical device product liability cases and a company tries to claim that they haven't seen this problem before, one of my first questions I'm going to ask is, well, have you not seen that problem before only in the United States, or have you seen it in other parts of the world?
And if they say, well, we've never seen it in the US we've seen it in other places, but in the US we're not, because it's a 510(k), for example, we're not required to report that to the FDA.
The jury and the judge could care less.
You don't have to have a JD from Harvard after your name to hear, ka ching, ka ching, ka ching.
And finally, you know, just to reiterate one last thing, and then we can move on to the next one. Unless you have specific questions. Etienne and I mentioned the possibility of using real world evidence from outside the US as part of a US submission.
You know, when you think about it, this is nothing more than a riff on a label expansion. The traditional approach or the traditional thinking of a label expansion is we have a device on the market for x, and we want to add another use or another indication, you know, for why.
But if we have on the device onto the market in the EU and we want to add Japan or we want to add the US or anywhere else, how is that any different than a label expansion?
It's just another riff on a label expansion. And the reason why I get kind of frustrated with a lot of regulatory folks is they're very, I don't mean this to be critical, but they're very myopic. Thinkers and they don't think, well, what other possibilities for label expansion, or as I've talked about before, what I call a species expansion, getting a device on the market for a dog and then getting it onto the market for a human being.
This is what I call a species expansion. Once again, it's a riff on a label expansion. But if you understand, as I've talked about many times before, Etienne, and the regulatory logic, the logic is agnostic of all of the different scenarios that I just described.
Etienne Nichols: Yeah, interesting. Okay, well, let's talk about the second. I know we have. Yeah, there's a lot of room to cover here. So, what's the second mistake international companies
Mike Drues: Make to number two, again, in no particular order, I run into a lot of people that will make the assumption that the outside the US, the OUS standards that they followed to get their CE mark or whatever are or will be the same standards that are required or recognized here in the United States.
And the shorter answer is absolutely not. At least not necessarily.
This could be a topic of a podcast discussion in and of itself, but my quick advice would be One of the webinars that I did in the past for Greenlight, Etienne, was doing regulatory due diligence.
And one of the many FDA databases that I covered in that webinar is CDRH's recognized consensus standards database.
So, what I would suggest before making your US submission, you visit that recognized consensus standards database, which is on FDA’s website, and check the standards to look to first of all, make sure that the standard that you followed already for the EU CE mark, for example, is recognized by the FDA and not just the standard is recognized.
Make sure that the version or the date of that standard is recognized by the FDA. Because I've seen a lot of companies make the mistake, Etienne, in that FDA always recognizes the most current version of a standard, and that's not always the case.
As a matter of fact, because I'm a consultant for FDA myself occasionally, not often, but occasionally, I will recommend to the FDA that they not recognize the most current version of standard because there's something in there that I am concerned about or that I don't particularly like.
So don't just assume that because you're following what you think is the current standard recognized by the E.U. for example, necessarily means that the E.U. s will do the same.
If you're going to follow some standards differently, I strongly recommend bringing this to the FDA in advance.
That is in the form of a pre submission meeting or a pre sub, which you and I have talked about many, many times.
And finally, if you're doing something truly new or novel, like a de novo, for example, where there are no recognize standards yet, and you might be using some new or what I like to call proprietary standards or special controls, definitely bring that to the FDA in advance of your submission as well.
So, this is the second or another mistake that I see a lot of companies make when it comes to making assumptions about standards.
Etienne Nichols: I think that's a good one, And I think 10993-1 is a good example of that, where the US is not currently recognized, or at least last I checked, in the last couple weeks, the most recent one.
So, I'm sure there's lots of different examples like that.
Okay, what's number three?
Mike Drues: So, another mistake that international companies make is they do not consider what I like to call international regulatory strategy, or they do not consider international regulatory strategy soon enough in the development process.
So, before we get into this a little bit more, Etienne and I've done podcasts and webinars for Greenlight on international regulatory strategy. Do you have a sort of a working definition, a simple definition?
When I use the phrase international regulatory strategy, what does that mean to you?
Etienne Nichols: To me, I just see it as the strategy of where will we take this device and how will we take it there? That's purely and simple for me, I suppose. But I'm sure there's a lot more complexity that should go into it.
But that's, that's the, the crux of what I would be after.
Mike Drues: Well, that's certainly part of it. You know, one of the questions, perhaps even the first question when entertaining a discussion on international regulatory strategy is what we sort of alluded to a few minutes ago, and that's where do you go first?
But once you decide where to go first or second or third, that's not your international regulatory strategy. Because think about it this way. I've seen it happen many times where a company gets a device onto the market, say again in the European Union, and then comes to the US and finds out that the us, the FDA, wants some bit of information that the EU didn't want for whatever reason, and now they want to do a whole. They have to do a whole new test again, in some cases a whole new clinical trial again to collect that additional information.
Can you say ka ching, ka ching, ka ching.
So, my recommendation on international regulatory strategy is two steps.
First of all, identify the first few companies that you want to bring your device onto the market. Please don't tell me you want to bring your device onto all 170 countries there are in the world at the same time, that just ain't going to happen.
But identify 2, 3, 4, 5, some reasonable number and then calculate the lowest common denominator. In other words, pool all the regulatory requirements to make sure that by the time you do all of your testing, this is benchtop testing, computational testing, maybe animal testing, clinical testing, whatever kind of testing to make sure that you meet all of the requirements for those three or four or five countries.
Because the last thing that you want to happen is to forget something or not recognize something. And now you have to do all that testing all over again. In other words, find the lowest common denominator.
And one last thing, Etienne, and on this one is on reimbursement. We'll talk about reimbursement a little more in a few minutes. But when you identify the regulatory requirements, don't just identify the regulatory requirements.
It's probably a good idea to identify the reimbursement requirements as well.
Because as we'll discuss more and more, when we do testing, especially clinical trials, we're not just doing it for regulatory purposes or FDA purposes, we're doing it for reimbursement or health economic or CMS purposes either.
So that's the next mistake that I think a lot of companies make.
Etienne Nichols: Yeah, that's, that's a really good, a lot of different avenues to think about when you're talking about those things. So that we've covered what, four or where are we at now?
Mike Drues: We've covered three. I think the next one is the fourth.
Etienne Nichols: Okay. Yeah, let's jump in.
Mike Drues: Okay, so the next one, once again, in no particular order, is labeling. I mentioned labeling a little bit before and you and I have had many discussions on labeling. I see a lot of medical device companies, when they make that transition from outside the US to inside the US that the labeling in their CE mark, for example, will be or should be the same as it will be in their 510(k) here in the United States. In other words, the labeling between the CE mark and the 510(k) should be the same or substantially equivalent, pun, definitely intended.
First of all, what I'm talking about here, Etienne, when I'm talking about labeling, is I'm talking primarily about the high-level labeling, not that low level labeling. So, I'm talking about primarily the intended use and the indications for use.
You have no obligation, the manufacturer, I should say, has no obligation to come to the FDA with the same labeling as they do in their CE mark in Canada or Japan or whatever.
Because remember, as I said earlier, it's a completely different device.
So, in a sense you're starting from scratch, kind of like you would in the de novo world.
You can follow the same labeling; you can make the same claims as you do elsewhere. You can make different claims. And this is going to depend on what the regulatory burden is to support those claims in the different jurisdictions.
For example, it could be much easier to support one claim in the EU and at the same time much more difficult to support the same claim here in the United States or vice versa.
That street definitely runs in in two directions, and this can lead to a lot of problems and a lot of confusions as you can imagine that in because international companies that are marketing their devices outside the US they're probably advertising their device claims from their CE mark on the Internet and social media and so on.
Well, as you know, Etienne the injury, the Internet does not have boundaries, certainly not geographic boundaries.
So, what happens? Not so hypothetically speaking, if a patient here in the United States wants to use a device that is that indication is approved in the EU but not in the US and goes to their doctor and says, hey, I want you to use this device in this case, but it's not approved here in the United States.
Right.
So, unless we're talking about, you know, having a model like China, you know, where we're going to have, you know, all kinds of censorship. This is why oftentimes when you go to a manufacturer's website,
one of the first questions it'll ask you is, are you in the United States or outside the US And I teach a whole three-day course on post market surveillance and complaint handling.
So, if people have questions on how to handle these challenges, please feel free to contact me. But this is another mistake I see that companies make when they try to bring a device onto the market here in the United States.
As a matter of fact, just one thing.
I had a reviewer ask me in the same scenario where we had this device already. The company already had the device on the market somewhere. I think it was Canada maybe, and they were bringing the device onto the market here in the US and one of the claims that we were going to make here in the US.
I’m sorry, one of the claims that we made in Canada was not a claim that the company wanted to make here in the US at least not right away because the regulatory burden was going to be too high in the United States.
So, I had an FDA reviewer ask me, well, your device, you know, Health Canada bought off on this with this particular claim, I don't see how you, sorry, I don't see that particular claim included in your US Submission. How are you going to handle that problem?
That was a very interesting question and I defaulted. You know, the short answer is, well, here in the United States that would be considered off label use.
However, it is anticipated off label use because it's, the claim is officially listed in some other part of the country and in this particular case it's not like in a different hemisphere, it's just north of our border.
So, a lot of interesting little, you know, nuances, you know, in these, in these questions.
Etienne Nichols: Interesting, yeah. Anticipated off label use, huh? Okay, we've covered four. We're at five. Yeah. What's next?
Mike Drues: Question number five.
Why do so many companies do the same or very, very similar clinical trials both inside the United States as well as outside the United States? In other words, there are exceptions, which I'll talk about in a moment, but isn't this very much like reinvent the wheel, in other words? And I'll throw this out to you as a question first, Eden, and then I'll throw in my two bits.
If I establish the safety and efficacy of my device in one country, must I do the same thing in a different country? Establish the same, the safety and efficacy and let's assume for the sake of discussion that the device is the same.
The indications, the labeling is the same. In other words, let's try to make this as much of an apples-to-apples comparison as we can.
So once again to repeat the question, if, if my company does a clinical trial to establish the safety and efficacy of a device, again, pick a, pick a country, say in Japan and then we want to bring the same device onto the market with the same claims here in the United States.
Must I do a clinical trial here in the US well, I don't.
Etienne Nichols: So, I don't believe you must from a regulatory line, CFR perspective.
But my, and my, my, my gut tells me that they're going to tell you, you're, you have homogeneous clinical data and if your trials were done entirely in one region outside the US.
The FDA is probably going to say they don't reflect the diversity of the American patient base. That's my expectation.
Mike Drues: That's certainly a possibility. And you're, you're, I would say probably about 80% of the way there. Let me see if I can help you get to, you know, to the, to the finish line.
So, the short answer is we in fact can, can combine clinical data that is, we can use OUS clinical data as part of a US Submission. As a matter of fact, FDA has put out a couple of guidances specifically on how to do that in a small number of cases.
I have actually used 100% OUS or outside the US clinical data as part in order to support a US submission. That's still even in 26, 2026. That's still very much the exception rather than the rule.
But it can be done with three important caveats.
Three important caveats. One is Statistics 101, or what I like to call common sense, is we have to be able to show that we have the same patients.
In other words, if there are genomic differences in people from different parts of the world or if there are environmental differences. I worked on one device several years ago where the safety and efficacy of the device was affected by sun exposure and in some regions, you got more sun exposure in other regions that you don't.
So, your sample size, sorry, your sample has to be reflective of the population.
If you can show that the patients that you tested your device on in the EU or Japan are representative of the patients here in the United States, then not a problem.
You can do that.
Now, let's not just talk about the patients, let's talk about the users.
We have to be able to show that the user of the device, whether it's a physician or a nurse or the patient or whoever it is the user of the device would use the device in the EU, say, is the same as they would in the United States.
Once again, it's the transferability of the data. We have to do an apples-to-apples comparison.
The sample, in this case the doctors or the patients have to be representative of the population. The population here being the United States.
Remember, the burden of all of this is on the company to prove this to the FDA.
It's not on the, the burden is not on the FDA.
So, the default, I would say, is to assume you're probably going to need some clinical data from the FDA from the US, but I would not necessarily make that assumption flat out.
Once again, if you can show that the patients here are reflective of outside the US and you can show that the users are reflective outside the US then you will likely be okay.
Now, pragmatically speaking, I worked on several devices where I think we could have made good arguments on both of those things.
However, the company decided it's going to be too much time and work and effort to make those arguments. Therefore, let's just do maybe a smaller trial here in the US and do what I call a micro trial, where the function of the trial is not to show safety and efficacy of your device, but the function of the micro trial is just to show that your results here in the US are reflective of what they are in the EU or Japan. And I've used that strategy successfully many times.
And then one other thing that I would point out is on the reimbursement side, remember, there's a litany of reasons why a company might do a clinical trial.
Regulatory or FDA is only one of them.
Health economics or reimbursement is another.
Clinical adoption is a third, and so on. So, I see a lot of companies, they make the assumption that if they did a clinical trial for their device and they have it listed in, say, their PMA or their de novo or whatever it is, then they must do a clinical trial. And that's absolutely not the case because you don't know why they did a clinical trial.
And that's a topic of a whole other podcast.
And so, bottom line, don't just assume that if your competitor did a clinical trial, they did it for regulatory reason reasons.
Maybe they did it for regulatory reasons. Maybe they did it for some completely other reasons.
Etienne Nichols: Makes sense. Okay, so it's not completely against the rules. It's a little bit difficult.
Mike Drues: It's a little bit difficult. But as you know, clinical trials can be very time consuming.
Etienne Nichols: Oh, man. Very expensive.
Mike Drues: Yeah, so, but, but, but, but. Thank you for making that comment, because I want to make this point very, very strong.
I don't want our audience to misunderstand what I'm saying here. I'm not advocating. I'm not looking for an excuse to take shortcuts. I'm not looking for an excuse not to do a clinical trial.
On the contrary, I will oftentimes ask a company or recommend a company to do testing, including a clinical trial, even when FDA or EU does not want it.
Etienne Nichols: Why?
Mike Drues: Because I think as a biomedical engineer, it's the right thing to do.
What I'm saying here is if I do a clinical trial and I'm not going to learn anything new than I got from the clinical trial I did before.
Etienne Nichols: Yeah, absolutely. Makes total sense. Okay, we have one more question, I think. Or one more. That was seven.
Mike Drues: That was six.
Etienne Nichols: I'm so bad accounting today.
Mike Drues: That's okay. Two more. The last two are pretty quick.
Etienne Nichols: No, yeah, that's great. Let's jump to the last or to the seventh, at least.
Mike Drues: All right, so the next question is.
Oh, I think we talked about this one already, maybe. And that is companies they don't consider international regulatory strategy, or they don't consider it soon enough. So yeah, so you're right.
We are on the last, the seventh question.
This is on the quality side. Style companies will assume that the quality requirements are the same in the other parts of the world as they are here in the United States.
Now I know, especially as you mentioned earlier with the advent of the new QMSR that's going into effect and so on, that there is more harmonization, if you will, but there are some still very, very significant differences.
And once again, this is a topic of a whole different discussion. But I'll just point out maybe one for illustrative purposes, you know, even long before these new regulations are going into effect, that in the EU the post market surveillance requirements have increased quite a bit over what they were, much more in many ways than they are in the United States.
And here's a question to you because I know obviously Greenlight does a lot of work in this area. Why do you think that the EU has increased their post market surveillance requirements for medical devices almost across the board?
Etienne Nichols: Well, I guess in my mind I go to the current events of some of the different things that happened, like with the silicone non-medical use grade. But I'm sure there's other things as well that have contributed to that.
Mike Drues: Yeah, well, again, I don't mean to put you on the spot, but you're exactly correct that it gives me no pleasure to say this about my industry. But if we're honest and I could share with you tons of statistics to support my regulatory assertion here, we as an industry have done a lousy job of post market surveillance across the board.
An absolutely hideous job, including in the Class III universe. So, think about it this way, Etienne.
If we as an industry, and again, I know I'm stereotyping here because there are plenty of companies out there that do a terrific job with post market surveillance, but there are those companies that don't.
So, if we as an industry did a good job at doing post market surveillance, do you think the EU or other entities would have to increase their requirements?
Absolutely not. No, absolutely not. The simplest way to put this is the better we do our jobs,
the less regulation we will need and we will have.
But that straight runs in two directions. The worse we do our jobs, and believe me, from my product liability experience, I see some companies of the people in them doing some of the most boneheaded things. And boneheaded is putting it politely, the worse we do our jobs, the more regulation that we're going to have.
It's as simple as that.
Etienne Nichols: And you mentioned the post market surveillance. So many more companies now are coming out with AI and at least they're claiming some AI parts of their devices. And if those are going to be, if that's the case, it's going to be even more and more proactive requirements, I believe, because you know, with algorithm drift and different things like that, it's going to be a proactive approach is necessary with some of those devices.
Mike Drues: Well, that's exactly right. And taking it just a half a step further when it comes to post market surveillance, you know that what we've done in the past, what I call passive post market surveillance events, waiting people to report problems to you is no longer sufficient. And now what we're looking for more and more is active post market surveillance actually going out and looking for problems which, let's be honest,
Etienne, and most companies do not like to do.
Etienne Nichols: That's not very revenue generating.
Mike Drues: That's exactly right. And the reason why, quite frankly, is because of, and once again, this is a topic of a whole different discussion, the underreporting of problems. By Some estimates, only 3 to 5% of adverse events involving medical devices, 3 to 5% are reported to manufacturers or to regulators. 3 to 5%.
Well, if we spin that statistic the other way, that means if I don't embarrass myself with the arithmetic, what's that? 95 to 97% of problems are not reported.
As the late great Carl Sagan used to say, the absence of evidence is not evidence of absence.
When I'm sitting on the FDA side of the table, I cannot tell you. If I or somebody else asked the company about a potential problem and they say, well, we don't have evidence of that problem, therefore it's not happening.
I just use that as an opportunity to pounce.
I was not in China this morning to see it, but I'm pretty sure that the sun came up in China. This.
I don't have data to support it, I don't have evidence, but I'm pretty sure that it happened.
The absence of evidence is not evidence of absence.
Etienne Nichols: Yeah, that's one of my favorite quotes. That's a good one.
What else is, what other things?
Are there any other things that are maybe didn't make the top seven, but in your mind.
Mike Drues: So, at this point, you know, as I said at the beginning, these are the seven or so that I kind of came up with. As I thought about this.
It's certainly not meant to be a comprehensive or exhaustive list.
Etienne Nichols: Let me ask something then, because two things came to my mind when I thought about this. One was the EMDR has the PRRC, the person required for regulatory compliance.
Obviously, the FDA does not have a PRRC requirement, but I can see the logistical issue across the ocean. So, I'm curious what you think about remote management trying to handle the US market using, you know, a mailbox or leaving everything to a distributor and any thoughts there from a regulatory standpoint?
Mike Drues: So, as always, Etienne, and I'm going to be brutally honest in the things that I think about and the concerns that I have about our industry, and believe me, there are many, that is not even on my list.
Etienne Nichols: Okay.
Mike Drues: And me, that is once again, a matter of semantics.
You know, one could easily argue that we do have already a PRRC here in the United States. It's who is who. Who ultimately signs off on the 510(k) or De Novo or whatever it is.
What, you know, usually its senior management in the form of the DP of, you know, regulatory or whatever it is.
Whether you want to call it as a.
Oh, shoot, what is it? What is the.
When we market devices in other countries, we have to have what I call a boots on the ground presence.
Yeah, I forget what we call that at the moment.
Etienne Nichols: Yeah.
Mike Drues: Not an independent reviewer, but I'll think about it in a.
Look, I'm not saying that this is a bad idea.
At the end of the day, the buck has to stop somewhere. Somebody has to be responsible, but what we call that person.
And more importantly, and of course, this could never happen to my friends that work in large companies, the people in senior management who sign off on the bottom line on the regulatory side or on the quality side. Of course, Etienne, we know that all of the senior management folks know in nauseating detail what's going on inside the company.
Not just what's written on the paper, but how things are actually being done.
And I hope everybody appreciates my not-so-subtle use of humor here. Because what's the point of having some senior management folks sign off on something if they don't really know what's going on down in the trenches where.
Where people like me live.
Etienne Nichols: Yeah, one other thing is that I wanted to mention was cybersecurity.
Feels like the FDA has an increased scope of cybersecurity, maybe more so than what, some other ISO standards. So, I don't know if you wanted to touch on that, but that's.
That's the only other thing I could think of.
Mike Drues: Sure. Well, okay, so let's talk about cyber security for. For just a second.
And once again, I've done, I think, a couple of podcasts with cyber. And one of the first things that I said, I have no problem. Problem with FDA being concerned about cybersecurity when it can directly impact the safety and efficacy of a device.
So, I don't know if you remember, there was.
Oh, my gosh, what was the name of the fictional TV show? This was like, from 10 years ago, where somebody hacked into the vice president of the United States pacemaker and actually caused the vice president to have partisan attack.
Etienne Nichols: Yeah, well, there was actually one movie, core, I think, where they had everybody with a pacemaker that happened to.
Mike Drues: Fair enough.
So, in those kinds of situations, obviously, cyber security for the FDA is a concern and should be a concern. And quite frankly, anybody that doesn't understand that shouldn't be in this business.
However, other aspects of cyber security, when it comes to things like identity theft or, you know, stuff that does not. Not directly impact safety and efficacy, in my opinion, FDA has no business being concerned about that. Now, I'm not suggesting that the company should not be concerned. Of course they should be, but it's not the FDA, because FDA's primary mission is to make sure that in this case, the medical devices that we use are safe, reasonably safe, and effective when it comes to something like identity theft. I don't know, maybe you can think of a situation, but I can't. How can identity theft, you know, impact the safety of a device? I don't. I don't know. It's possible, but. But anyway, when it comes to cyber, if it can affect the safety and efficacy of the device, then absolutely FDA should be concerned about it as well as the company as well.
Etienne Nichols: Yeah.
Great. Well, I appreciate it. Now, I think this has covered a lot of ground for companies that are bringing a medical device to the US if you are out there and you're planning to do this, definitely send us some questions.
We'd love to hear what your thoughts are on this episode. If you have any additional questions, what's your biggest concern?
Mike Drues: And I just have one last quick thought here to kind of wrap this up from absolutely my side, Etienne and I've shared over the years many of my regulatory mantras. Probably my most known regulatory mantra, as you've heard me say many times, is tell, don't ask, lead, don't follow when it comes to the FDA. Well, another of my regulatory mantras that I don't talk about so much is if the regulation makes sense, we shouldn't need it.
If the regulation doesn't make sense, we shouldn't have it. Let me say it one more time. If the regulation makes sense, we shouldn't need it. And if the regulation doesn't make sense, we shouldn't have it.
I used to teach medical school back in the day, and one of the adages I used to share with my med students was the surgery went perfectly, but the patient died anyway.
Well, the regulatory equivalent of that is we followed the regulation perfectly. We did all the EU or Japan or FDA or whoever asked us to do, and yet the patient died anyway.
A lot of the things that we talked about today, Etienne, and things that we've talked about in other discussions as well, meet that mantra. If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it. And the last question that I'll throw back to you, you, Etienne, and if you want to take this as a rhetorical, it's okay.
If we applied that same standard, as I just described it, to our current regulation, that is the regulation that we have today, do you think we would end up with having more or less regulation than we have today?
Etienne Nichols: I would think we'd have less, yeah. Yeah.
Mike Drues: And maybe it's not such a bad world.
Etienne Nichols: Yeah.
Mike Drues: The solution to most problems is not creating more regulation, but you. Not my opinion.
Etienne Nichols: Yeah. More understanding.
Mike Drues: A regulatory consultant. One would think that's a bit hypocritical, but I think it's not. Yeah.
Etienne Nichols: Well, thank you, Mike. Really appreciate it. Always appreciate you sharing your wisdom. Those of you out there listening, let us know what you think and really appreciate you taking the time to listen to this episode.
We will let you get back to the rest of your day, but until then, take care.
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