When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.
Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today’s conversation to learn how to approach a 510(k) submission if your predicate had a recall, how to develop products that are safer and more effective, and the importance of tracing the genealogy of your predicate.
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Some of the highlights of this episode include:
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What happens when the predicate that you’d like to use for your 510(k) has undergone a Class 1 recall
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The risk management element of using a predicate that’s undergone a Class 1 recall
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The statistics about recall predicates used in 510(k)s
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How the way the 510(k) is used has changed since it was first created
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Why the descendants of a predicate with a Class 1 recall are so much more likely to also undergo a recall
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Solving the problem of a predicate that’s been through multiple recalls
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Considering competitor’s products or other products similar to the one yours is based on
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What post-market surveillance should entail
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The direct and indirect economic impact of a Class 1 recall
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Changes that may happen with the FDA in the future
Links:
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
Ultimate Guide to Postmarket Surveillance of Medical Devices
Memorable quotes from Mike Drues:
“I can tell you that of the total number of devices that come onto the market, less than 5% are Class 3s.”
“When the 510(k) was created half a century ago, it was intended to be an exception, not the rule.”
“I do not advocate these simple-minded solutions like no 510(k) should allow to use a predicate that’s undergone a recall.”
“Unfortunately, good news does not sell. Bad news sells.”
Transcript:
Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. Today with me is Mike Dreus, a familiar voice on the podcast. I'm excited to get to talk with him. We've, we've been discussing a few different things. The 510(k) program is something we were thinking about discussing today. But first, how are you doing today, Mike?
Mike Drues: I'm well, thank you, Elian, for asking.
Etienne Nichols: I'm excited to, to talk to you about this today. So, you have some specific scenarios I know you wanted to talk about with the 510 program?
Um, I'll, I'll just go ahead and give the floor to you and see, you know, see what those scenarios are, first of all.
Mike Drues: Well, thanks, Etienne. And as always, I appreciate the opportunity to, to have this discussion with you and your audience today. And we're going to talk about one of my favorite subjects, near and dear to my heart, as well as to most of the medical device industry here in the United States, and that is the 510.
It is clearly the workhorse of the medical device industry here, but it is also the most controversial pathway to market. And we'll talk about one of the big reasons why.
But to kick us off, Etienne, and let's start out with a not so hypothetical scenario. And the reason why I say not so hypothetical is because this is something that companies run into all the time.
So, let's say that you want to bring your new medical device onto the market here in the United States under the 510.
In fact, as I said, it is the workhorse of the industry. There are more than 3,000 devices that get 510 clearance per year here in the United States.
And the 510 in essence means that we have to show that our device is substantially equivalent or basically the same as another device already on the market. We call that the predicate.
So, you want to bring your device onto the market using the 510, but you find out that the predicate that you want to use has in fact undergone a Class I recall.
Let me say that one more time. The predicate that you would like to use for your 510 has undergone a Class I recall. And for those that are not real familiar with recalls, Class I recalls are the most severe type of recalls.
What that means essentially is there is a reasonable probability.
That's what the regulation says a reasonable probability that the use of that recalled device will cause serious adverse events, serious adverse health consequences, or death to the patient.
So, the question to you, Etienne, is fairly simple. You want to bring your device onto the market under the 510(k), you've identified this predicate, but you found out in doing your homework that it underwent a Class I recall.
The question is, should you be allowed to do that? Is that kosher? What are your thoughts?
Etienne Nichols: It's a good question. So, and I might just say one thing too. If you're substantially equivalent.
Yeah, I mean, that's essentially what we're talking about with 5, 10k here, substantial equivalent. Is it kosher to use something that is to release a product that is based on something that could potentially have killed somebody?
I mean, there's a risk management element that has to take place there. At face value, I want to say no, it doesn't sound kosher. Obviously, there's more facets that you have to get into with each situation.
Mike Drues: Well, that's a great response, Etienne, and thank you for allowing me to put you a little bit on the spot. I appreciate the fact that you don't think that that should be kosher.
And again, I.
Let me just clarify for our broader, broader audience. I don't mean kosher in the religious sense of the word, obviously. So, I don't want to, you know, get any nasty emails about that.
But here's the.
Etienne Nichols: I wanted to ask one thing. So, you mentioned 3,000 devices, and I know that is that that's a lot more devices for the Class II, 510(k) pathway.
But let's just do another quick number for comparison for Class III, just round numbers. What in comparison would you say are Class IIIs?
Mike Drues: Well, I can tell you that of the total number of devices that come onto the market, less than 5% are Class IIIs, either PMAs or in even more remote instances, HD humanitarian device exemptions.
So, I can't give you the specific number off the top of my head, but less than 5%, clearly the vast majority are Class II, 510(k) or some DE novo. But anyway, coming back to the original question of is it kosher?
Should you be allowed to use a device as a predicate that in fact has undergone a Class I recall?
The textbook answer is that, yes, that is kosher. In other words, current regulations do permit manufacturers to use medical devices subject to a Class I recall. As I said, that's the most serious designation, indicating a high probability of adverse health consequences or death.
That regulation does allow for the use of such a predicate.
Should the regulation allow for it or should it not?
I'll leave that as a rhetorical question temporarily. But that's a discussion that I want to to dig into here further.
Now, taking that one step further, Etienne, and I think it's important not to overgeneralize.
Medical devices can experience problems and as a result undergo recalls for lots of different reasons.
Some of the more common reasons include things like design issues, things like manufacturing issues, sometimes user or usability issues, material issues. There's a litany of reasons.
So, when we talk about, for example, some people that think that we should ban, that we should not allow predicates to be used that are in fact undergoing a recall, I think that's putting a thumbtack in with a sledgehammer. I think that's way overkill.
Clearly it should make sense to everybody in our audience. I think that if the predicate device has undergone a recall that's designed, related, and your device is based on that same design, then I would like to think that it does not take an MD or a PhD or an RAC after somebody's name to appreciate the G.
Maybe it's not a great idea to compare the design of our device to the design of this other device, when in fact, oh, by the way, there are known problems with this other device.
On the other hand, if the recall was caused by a manufacturing issue, and let's say, hypothetically speaking, that your device is being manufactured using a different method than their device, or you've instituted measures to prevent those manufacturing problems in your manufacturing methods, then I have absolutely no problem using such a device as a predicate.
So, we have to be a little careful about overgeneralizing as we continue to peel back this onion and does that make sense?
Etienne Nichols: 100%. And you know, it makes me think of two sides of design and development. So, the one side obviously is what regulatory pathway are you going to take? What's the quickest way to market, however you want to look at that.
But on the other side, and I've heard you say this before, when it comes to medical devices, the engineering should never be overlooked. There's the true engineering. We don't just do engineering because regulations require us to do that. So, there's kind of a marrying of those two sides of the coin here.
But I, but I would be curious to hear more about maybe the statistics about the recalled predicates used in 510s.
You, you mentioned that they can be used on or a 510(k) may be based on a, a, a device that has undergone a Class I recall.
What are some of the statistics around that? How often does that happen?
Mike Drues: Yeah, great question, Etienne. And, and it actually happens more frequently than some people might like to think.
By the way, the topic of today's podcast is sort of based on two studies that were published just a couple of months ago in January of this year in the Journal of the American Medical Association, JAMA, which is a fairly prestigious medical journal.
And we can certainly provide the references along with the podcast information on the website. But here are some statistics from those two publications.
About 11% of the 35,000 medical devices that were cleared by the FDA under the 510 between the years 2003 and 2018, about 11% of them underwent a high-risk Class I or a moderate risk Class II medical device recall.
So about 11% of all 510s. We're talking a sample size of more than 35,000, so that's a pretty good sample size.
Underwent either a Class I or a Class II recall. Getting a little bit more focused to your question about predicates.
Of those 35,000, a little over 4,000 of them.
Of the recalled products, about 6% cited predicates that were also subject to at least one recall.
So again, I know I'm going through some numbers here. Let me say that one more time.
Of the 4,000 recalled devices, about 6% of them cited predicates that were in fact the subject of their own recall. So, in other words, there were known problems to the predicate device even before the new 510 was cleared.
The conclusion here, of course, is that recalls have raised concerns that substantial equivalents may be a poor marker. I would say a surrogate biomarker, to use a little regulatory jargon, a poor marker of safety and efficacy.
Now, that's one of the big conclusions of not just these studies, but a number of articles that have been published along these lines over the many years that the 510 has been controversial, which is essentially since it was created in 1976.
Let me just tick through a couple more statistics, Etienne, and then happy to let you chime in.
There were 156 510(k)s that underwent a Class I recall fairly recently. Between 2017 and 2021, about 44%, or almost a half of them, used a predicate that also underwent a Class I recall.
Which means to me that not only has this been going on for a while, it seems to be happening more and more frequently in the last half dozen or so years.
These two JAMA studies that I mentioned a moment ago are just the latest in a string of concerns about the 510 that in fact go back, well, more than a decade. I would argue go back a half a century to when the 510(k) was created in 1976.
In addition to that, there have been a number of very high-profile examples of medical device that have caused problems, like for example, the pelvic mesh fiasco and the Meadow on Meadow hip implant fiasco, both of which I've been involved with. You may remember Etienne, a little over a decade ago, back in 2011, the Institute of Medicine, the IOM, came out with their famous or their infamous report and recommendation to the FDA that basically said that the FDA should throw the entire 510(k) out the window.
I have said publicly many, many times that I never agreed with that recommendation. I think that would be truly throwing the baby out with the bathwater.
But one of the reasons is if we did throw the 510 out, what would we have left? The de novo and the PMA, essentially. So, we would be treating all new medical devices as either a de novo or a PMA.
That doesn't make any sense to me.
And finally, in 2018, FDA did announce plans to strengthen and modernize the 510.
But quite frankly, that really has not gone anywhere in the last five or six years. And in my opinion, that's not something that should come from the FDA. That's something that's really a matter of healthcare policy.
That's really something that needs to come from Congress.
And the last thing that I just want to mention very quickly, Etienne, and then I'm happy to let you chime in with questions or comments.
Just want to remind everybody of what my friend Dr. David Kessler said.
Former FDA commissioner. He was actually the commissioner of the FDA for most of the decade of the 90s. And one of my former bosses at the FDA, he likes to point out that when the 510 was created by Congress in 1976, it was, it was intended to be the exception rather than the rule. Let me say that one more time because I think this might be a bit surprising for a lot of the audience.
The former FDA commissioner said that when the 510 was created a half a century ago, it was intended to be the exception rather than the rule.
Now Fast forward to 2023. A half a century later, that trend has become reversed. It's become the rule rather than the exception.
And this is a direct quote from Dr. Kessler. He mentioned this in the Bleeding Edge video, among other places. He said the vast majority of medical devices today regrettably are regulated under this framework, meaning the 510(k).
Now I think it's unfortunate that Dr. Kessler is saying this after he left the FDA. What was he saying while he was still at the FDA? But that's a topic of a different discussion, nonetheless.
That's a little bit of the backstory here to not just simply talk about the recall situation, but to give the broader context as well.
So again, I went through an awful lot there.
What are your thoughts so far?
Etienne Nichols: Well, the first thing that comes to mind is the fact that you said the risk of a Class I recall was 6.4 times higher for descendants that use predicates.
That's, that's incredible. If the descendant was a, went through a Class I recall, that's, that's really a huge number. And I'm curious if you have any specifics as to why that might be the case. I mean, is it, is it truly people are just copying like, for like design?
Are they, are they neglecting the, their own risk management? What are the specifics behind that, that in your mind?
Mike Drues: Well, it's a great question and again, thank you for the opportunity to continue to peel this onion back layer by layer because there's, there's a lot to unpack here. And I love what you said about, I'm paraphrasing what you said a moment ago, that the manufacturer copied the design or copied in some way.
In the 510(k) world, when companies say what's the simplest, the easiest, the quickest, the cheapest way that I can get my device onto the market.
My regulatory advice to them is very simple.
Make your device as close as you possibly can to a predicate to an existing device.
Now from a regulatory perspective, that is the correct response. But as you can appreciate, Etienne, and from a biomedical engineering perspective, and first and foremost that's my background, biomedical engineering, that makes my blood pressure go up when I have to give companies that advice.
Because we've essentially created incentives for companies to, in academia we would call that plagiarize.
And so, when you copy somebody, you're copying their good things, you're also copying their not so good things. So, it stands to reason, coming back to the recall question, if the predicate device was recalled, especially if it was a design related recall and your device is based on, is predicated on that design, you are probably copying their problems, their mistakes as well.
But let's take this a little bit further. About the 6.4 times higher likelihood of problems. Because I think anybody with Quite frankly an IQ of more than 5, that should not be a surprise.
Out of Those more than 35,510s that I mentioned a moment ago, as I said, about 11% of them were recalled. Here's a couple of other interesting numbers.
These the average 510 uses 2.6 predicates.
2.6 predicates. That was a surprise even to me.
My advice to companies is if you can use a single predicate, although I will never be adverse to using more than one predicate if I have to, we could use and I've did a webinar for Greenlight a few years ago on Substantial Equivalence, one of my most popular webinars where we go into this in more detail.
I will use the primary reference predicate strategy. I will use the multiple predicate strategy. I will even use in extreme cases the split predicate strategy, even though that is very, very controversial.
But you don't have to use only a single predicate. And yet, and this was a surprise to me, looking at more than 35,510(k)s, the average number of predicates on were 2.6.
And the mean age of those predicates on the low end was three and a half years and on the high end was about seven and a half years.
Which kind of begs the question, if you remember maybe a year or two ago, there was a lot of chatter about this so-called ten year predicate rule. Basically, there was an idea where to try to prevent a problem we call predicate creep, that 510s should only be allowed to use a predicate that was less than 10 years old.
Well, these statistics show that the vast majority of 510s already do in fact use a predicate that's less than 10 years old. So, in my opinion the 5 year 10, sorry, the 10-year predicate rule is totally is a dumb idea. It's not going to solve any kind of a problem.
And finally, in terms of the number of devices that are cited with recalls, 4.3 devices cited predicates with a single recall.
About 1% of devices cited predicates with two recalls.
And most interesting to me is almost 1% of devices now again 1% of 35,000. That's a big number.
Almost 1% cited predicates with three or more recalls to it.
The conclusion of this study, and it's in my opinion it's a statement of the obvious.
The JAMA studies concluded that of the more than 35,510s that were cleared in that period of time between 2003 and 2018.
They demonstrated the obvious to me that is the more recalls that your predicate experiences, the more likely you're going to have problems yourself. Unless you, and this is the very, very big caveat Etienne, unless you do your homework in advance.
And that's what I'd like to drill into as we continue. But thoughts or comments on anything that.
Etienne Nichols: No, I'd love to keep going because what makes really stands out in my mind, like you said, just the specific issues with using a predicate that has gone through multiple recalls. Okay, well how do we solve this? You mentioned not throwing the baby out with the bathwater.
So how do. How would you like in a perfect world, Mike Dreus has the wand. How, how would you parse through some of these things? Because I can see a few different pathways forward that might make sense.
But of course, you know, regulatory, you're not going to change it overnight. But I'm curious what your thoughts are on this.
Mike Drues: Well, first of all, let me be crystal clear.
I do not advocate this simple-minded solution like no 510(k) should allow to use a predicate that was undergone a recall. In fact, not only is that a bad idea because it doesn't solve the problem, it's also a bad idea because it doesn't take into account the law of unintended consequences.
In other words, that's going to preclude me from using my professional judgment to choose the best predicate. So here is my what you're calling my ideal world.
It's escalated. It's quite simple.
When you use a device as a predicate, do your homework first.
It's as simple as that. Do your homework first. So, what do I mean by doing your homework?
Look at the history of that predicate. And by the way, don't just look at the history of that particular predicate or the two and a half on average predicates that go into a 510, but look at the history of similar devices as well. There are almost always other devices that we could use as a predicate. So, look at the history of those devices and look at the predicates of your predicate.
In other words, what problems did the predicate of your predicate experience and what problems did the predicate of your predicate of your predicate experience? And so on and so on.
This is in my opinion the best solution to the whole predicate creepy problem.
Do your homework. Look for problems, look for recalls. Use Post market surveillance, use whatever tools, tips and tricks that you, that you have. And I have lots of suggestions. I give companies all the time.
This, by the way, for those in our audience that work in the Class III university, and you asked about Class III devices a moment ago. This should be no surprise to them whatsoever because what I'm describing here is a Class III PMA requirement for all PMAs.
You have to go through this analysis. But for, for Class II devices, for 510s and also for De Novos, there is no regulatory requirement to do that. Perhaps there should be.
I would not be adverse to that, but I would like to think that if we're going to call ourselves medical device professionals, and I use that word professional very, very purposely, very, very seriously, I would like to think that we would not need a requirement like that.
So, this is required for all PMA devices. It's not required for 510s if you're using your own device as a predicate. In other words, if the predicate device is from your own company, then this should be very, very easy for you to do because you're going to have, I hope, access to all of the history, all of the information, the complaint handling and yada, yada, yada. On the other hand, if you're using a predicate from a competing company, they're not going to be keen on, you know, if you call them up and say, hey, can you tell me the history of your device? But that said, it might require a little homework, but it's not impossible to do.
You know, there's a lot of very valuable information out there that is publicly available.
The CIA, I remember, said many times the most valuable intelligence they get is from publicly available sources. In other words, they'll look at, for example, the background in a picture and see something that nobody else has seen before or something like that.
So don't overlook what is out there publicly. So first and foremost, do your homework.
If you don't find any problems with your predicate, then terrific. But ask yourself the question, are you sure?
You know, the late great Carl Sagan said the absence of evidence is not evidence of absence. So just because you didn't find a problem with your predicate or similar devices, doesn't necessarily mean that there isn't one.
If you do your homework and you do find problems with your predicates, that's not necessarily a deal breaker. Although some people think that it should be a deal breaker. But that, in my opinion, should not be a deal breaker. The next question is, find out why did those problems happen?
Like I said, if it was a design related issue, I'm sorry, if it was a manufacturing related issue and your device is manufactured using a different method and that problem can't happen to you, then fine, put that into your documentation and you're done.
If it's something that could happen to your device, then what kind of measures can you institute to mitigate the risks and the resulting harms that would result from that problem?
All of those things, in my opinion go into the attributes of what I call a medical device professional. A professional knows to do all those things anyway.
Banning devices with problems, i.e. devices under recall, as I said, in my opinion, is overkill. It's, it's truly throwing the baby out with the bathwater like the ten-year predicate rule.
And so, my solution to you asked. In my ideal world, Etienne, my solution is to a treat people like professionals.
In other words, let them make decisions based on their experience, their recommendations. That's part one. But part two, hold them accountable for their actions and their decisions. In other words, if it turns out that they bring their device onto the market using a predicate that underwent a recall and they didn't know about it or they didn't institute measures to mitigate the chances of problems from happening and so on, in my opinion, Etienne, and maybe this might sound a little harsh to some people that is not acting as a medical device professional. In fact, that is, you know, making a mistake or maybe flat-out negligence.
And people like that should be held accountable. Let me just remind everybody that in addition to providing regulatory and quality consulting for companies, I also work as a product liability expert witness in cases like these.
And let me tell you, it makes my job very easy if I can identify a problem and I've been involved in many cases like this that led to very large judgments.
If I can identify a known problem in the past that that have happened to a predicate or a competing device or a similar device that the company either didn't know about, or they knew about but didn't sufficiently mitigate.
Doesn't take a JD after somebody's name, Etienne into to hear ka-ching, ka-ching, ka-ching.
Etienne Nichols: Yeah. And what you're saying makes a hundred. I mean, I'm 100% behind what you're saying because it feels relatively obvious. If you reverse engineer someone's design, you are inherently taking some of the issues with that.
And so, you have to be able to analyze that design, determine whether or not those things are going to result in failures in the field. Another thing that's interesting to me about the 510(k) process is the predicate had a predicate potentially.
And so, you do need to do your due diligence, look at the friends of your friends, kind of a, kind of a concept because those people are going to influence you in this sense. You know that previous design that you may not be looking at may be influencing your design.
Another thing that made me think of is the post market surveillance. You may be looking only at the adverse events related to your product, but what about your competitor’s products or similar products that your technology is based on and wonder if you have any thoughts on that as well.
Mike Drues: I have a lot of thoughts on that Etienne, and I give recommendations to companies all the time. I actually teach a two-day short course on post market surveillance and complaint handling.
I think, and again this might sound harsh to some people, but I think only doing post market surveillance on your device and your device alone is at the very least not being a medical device professional and at most possibly incompetence.
Again, it defies common sense. It devise logic if you're bringing your device onto the market under the 510. And the logic of the 510 is very simple.
If my device is.
Sorry, let me start again.
If my device is basically the same as or substantially equivalent to another device and that other device is already on the market, it's assumed to be safe and effective. Therefore, my device is assumed to be safe and effective. In other words, if A equals B and B equals C, then A equals C.
That's the logic of the 510. I'm not suggesting that I agree with it or not, but that's the logic.
It works most of the time. It does not work all of the time.
And this is exactly why over a decade ago the Institute of Medicine said to the FDA that you should throw out the entire 510(k), which as I said earlier is overkill in my opinion.
But not to look at post market surveillance of other devices when they're similar to yours, to me just doesn't make any sense. It is a requirement in the PMA world, It's not a requirement in the 510 world, it's not in the regulation, it's not in the QSR on the quality side, but it is a recommendation that I give to virtually all of the companies that I work with when we get to that point.
Etienne Nichols: So, you gave some advice for companies who may be going through the predicate process or the 510 process, looking at their predicates looking at the history, looking at the predicates, predicates, even post market surveillance of existing things that may not be your predicate, those all make sense. But if this is still happening for the last several years and some people aren't listening because this isn't necessarily new.
So, I want, and you know, I, I hate to say it because we should be focused on the patient safety. We should be focusing on improving the lives, improving the quality of life for those we're, we're building these devices for. But if nothing else, people need to think about the economic value.
A Class I recall is not a cheap situation to go through either. Your, your business, that's a, that's a big deal as well. Something to think about.
Mike Drues: I don't, and not just, I think that's a good point, Etienne. And not just the, what I would call the direct economic impact, but the indirect economic impact. Usually recalls, especially a Class I recall, the most severe, that's going to generate a lot of press, not necessarily positive press either.
So, you're going to be in sort of damage control mode. I can also.
Now, I have to be really, really careful what I say here because as you and most of our audience know, I also work as a consultant for the FDA.
When I see a company come in with a submission and I know or I find out when I do my own due diligence, that the company has, let's just say, a series of recalls, more recalls than I might expect in a situation like that.
I'm probably going to give them, I'm probably not going to give them the benefit of the doubt. In other words, I'm probably going to look at them and, you know, scrutinize them more closely, if you will, than another company that's been in business for a long time that has just a few relatively minor problems along the road and so on.
Now, to be fair, how many, if any, you know, other FDA reviewers take this into their calculus, I have no idea, but it's one of the many factors that I, that I take into account.
So, the simple reality is it's not just the direct economic impact of the recall that we have to take into account, but all the other things. And obviously the economics of a product liability lawsuit is off the charts.
Etienne Nichols: I think in every industry, this is something that every industry, it's human nature really. You need to look at the full picture. You can look at just what's on the paper.
But a company's history matters. It really does. And the other thing that I was going to Mention is around post market surveillance.
You know, the medical device industry is a unique industry, but we have a lot to learn from other industries.
I would never want to denigrate or, you know, speak poorly of the medical device industry because I think there's a lot of things other industries could learn from the medical device industry. But this is one area.
What other product or industry ignores their competition? You know, they, they, they pay attention to the ecosystem that they're in because their competitor is likely in the same ecosystem and they will likely will be impacted if another product is going through something.
So, it's something that we could learn from, I think, from other companies as well.
Mike Drues: Well, your point is very well taken. I appreciate the sentiment, Etienne, but on the other hand, I don't want to paint an overly negative picture here. I don't want to paint with an overly broad brush.
We have to be a little careful, as I said earlier, about overgeneralizing. So, there are already a lot of companies in our industry that are doing all of the things that I'm suggesting and in some cases more than what I'm suggesting.
And I think that's terrific.
But unfortunately, good news does not sell, bad news sells. And so, we're talking about, you know, some number of companies and the people in them that are not going above and beyond, you know, what, what is required.
Etienne Nichols: And I do have a question about that because like you said, 2018, there was a guidance put out by the FDA about this.
I wonder if you, being as connected as you are to the industry, do you see any change in the future happening with the FDA? I know it's all spec.
Mike Drues: Well, it's a great question, and I'm often reminded of the French philosopher, I can't remember his name, who said, the more things change, the more they remain the same.
So, I hear a lot of talk, a lot of chatter about change.
But let's be honest, at the end of the day, how much of this really changes?
It's kind of like; I've used this metaphor and other examples before.
It's kind of like our industry you can think of as a heavily loaded freight train barreling down the tracks. It's 60 miles an hour, very difficult to get it to change direction without causing a derailment.
On the other hand, some people would argue that, gee, maybe a derailment is exactly what we need in order to get people to wake up and pay attention.
I don't want to go so far as to cause a derailment. That's really not my intent here. But what I try to do in having discussions like this and in other venues as well is get, get, you know, two of the wheels up in the air just to kind of scare people a little bit. Just kind of wake them up and say, hey, if we don't do something, you know, maybe the train will derail.
So let me be crystal clear. I think all of these problems are fixable, solvable problems.
I don't think solution is to throw away the 510. I don't think the solution is to ban recalled devices to prevent them from being used as predicates. I don't think that the 10-year predicate rule is, is a solution.
I think those are perhaps good thoughts for discussion, but I think what we need is more people having open, honest discussions about not just the things that we as an industry do well, but more importantly the things that we as an industry don't do so well and figure out ways to, to make them better.
Maybe it's me, Etienne, and maybe I'm, you know, naive, maybe I just fell off the turnip truck yesterday, but I do believe there are solutions to all of these problems.
Etienne Nichols: Yeah. And I, I really appreciate that you try.
However dark things go, whatever statistics we pull up, I, I really do appreciate the fact that you pull, try to pull a positive takeaway because that really, there is a positive takeaway.
Honestly here. If you look at those numbers, okay, 6.4 times more likely to go through a Class I recall if your predicate went through a Class I re recall. Well, that's for me as a manufacturer, okay, I have an easy fix.
I, I, I could look at the, the history of my predicate and maybe I can avoid that particular, you know, situation.
So those are a lot of good takeaways. I mean, there's a, there's a silver lining for every dark cloud, honestly. Of course, there's always a dark cloud for every silver lining.
Mike Drues: That's.
Etienne Nichols: Any other thoughts that you have on this subject? I mean, I, I appreciate you taking the time to, to discuss this today.
Mike Drues: Yeah.
Again, thanks for the opportunity to have this very important discussion. Just, just a few highlights to, to kind of reflect and summarize, you know, what we've talked about in the, in the last half an hour.
So, the 510(k) is what I would call a pretty good program. It's not a perfect program.
And in my opinion, anybody that says it's perfect, including some of the very large industry organizations that, that represent, you know, the medical device industry, I think is just naive, if not, you know, Worse, it's definitely not a perfect program.
We have to acknowledge the simple reality, as I've shared with you in the statistics and as you pointed out, that there are a lot of 510 devices that have been subject to recalls, including Class I recalls that in fact use as their predicate a device with a history of known problems, with a history of recalls. So, the question is, what do we do about it? And I've tried to offer some very, very specific, tangible suggestions, like, for example, doing your homework and like, for example, making sure that any of the problems that have happened in the past cannot happen to you or do as much as you can to mitigate the chances of that happening to you.
It should be no surprise to any of us that devices do have a substantially higher risk of a subsequent recall when the device that they're based on has also undergone recalls.
So, you know, do we need safer, sorry, stronger safeguards to prevent problematic predicates from being used in the future to ensure patient safety?
That's what some people believe.
That's what the conclusion of these two particular articles basically say.
I would like to think that we would not need regulation like that if we act as medical device professionals. And again, I'm using that word professional not loosely. On the contrary, I'm using it very, very specifically and seriously, kind of like a surgeon.
You know, if you needed surgery, you would have the expectation that a surgeon knows what he or she is doing. And not only do they know, should they know what he, what he or she is doing in quote, unquote, normal situations, but in the situations where they, something unexpected happens, you would expect them to have the knowledge, the experience, the intellect to be able to, you know, to act responsibly as well. I hold the same standard to medical device professionals as well.
So, I would like to think that we would not need regulation for that.
But regrettably, Etienne, I didn't fall off the turnip truck yesterday. There are people out there that either out of naivete or simply ignorance, they don't know those things. So if we are going to create more regulation, and believe me, as a regulatory consultant myself, you people might think, well, gee, you must be a big fan of regulation and created more regulation.
On the contrary, I think we have, you know, way too much regulation and most of it is a bunch of you know what.
But, but maybe if we do need to create new regulation, let's at least have a discussion on what is the most effective way to do it in the real world, not in the theoretical world, but in the real world. So those are some of my final thoughts. What do you think Etienne? Would you add to that list and then we can wrap this up?
Etienne Nichols: Yeah, the top-down approach of, you know, changing things, providing regulation to stop or start the industry in these different ways.
I almost look at it as a barrier to entry for medical devices to a certain degree. I mean you're right, that's not my preference a regulation but like you said, unfortunately it is necessary. But a bottom-up approach is the only way to truly change the industry where you are changing the people you're working with and changing the mindset, shifting them more towards a true quality approach, for example. So, I, I suppose it could be, the argument could be made that both are needed. My preference would be to change the company, to change the, the atmosphere that you personally are in.
Because at the end of the day really, you know, we talk about government, we talk about companies, those are ideas ultimately, we're talking with, with people. And if you don't, if you can't convince them of approaching things with, with safety and performance at the end of, you know, at the end the, the patient safety with the goal in mind, then it's not really going to work anyway. They're going to find another way to break the system. So.
Mike Drues: Could not agree more. And just to wrap this up, Etienne, and with one very last story, please.
And I've shared this with, with our audience in the past, so some people may have heard it.
Probably the single most common question that I get from medical device companies across the board. I get it every week, in some cases every day. They come to me, and they say, Mike, you work with lots of different medical device companies.
You also work as a consultant for the FDA.
If we came to the FDA with our new medical device, what do you think FDA would want to see in terms of benchtop testing, animal testing, clinical testing, blah, blah, blah. And I say, you know what, I understand that's an important question and I understand why you're asking me this question.
But let's think about this from a totally different perspective. Let's remove FDA completely from the equation. Let's pretend for the moment that FDA did not exist.
Sooner or later a family member, a friend, maybe even yourself will be on the receiving end of your medical device when that day occurs. What would you, Etienne, and what would me, Mike, what would you know we need to see in terms of evidence, safety, efficacy, performance, blah blah, blah, to put our own stamp of endorsement, approval to say that this is okay to be used in my neighbor in my spouse, in my child, in my case, my seven year old grandson.
And then, and only then can we go to the FDA and have an intelligent conversation as to what is really necessary to do here, whether something is required or not.
Quite frankly, I could care less what makes sense.
Now again, I don't want to be overly flippant because I get emails from people. Oh, how could you say regulation doesn't? No, no, that's not my.
But if the regulation makes sense, then do it.
If the regulation doesn't make sense and we do it anyway, and we all agree that it doesn't make sense and we do it anyway, is that a problem with the system or is that a problem with us?
Something to think about.
Etienne Nichols: Yeah, really appreciate it Mike. The three takeaways. If I were to kind of sum them up. The one the more recall predicates the more recalls a predicate goes through, the more likely a recall is in your future.
So, I suppose that's the number one for me.
Number two when you use a device as a predicate, you need to do your homework first. I really appreciate those takeaways. Look at the history, look at the friend of a friend, your predicate of your predicates.
And then the third thing would be keep an eye on the competition. If I were to sum this up. But really appreciate you coming on the podcast today, Mike, and I hope you all enjoy the rest of your day.
Thanks so much.
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