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How do you feel about pre-market approval (PMA) for Class III medical devices?

Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death.

Embrace the PMA concept as a way to bring novel and unique devices to the market. Mike Drues of Vascular Sciences and I explore the topic of PMA. Lives depend on it!

 

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Some of the highlights of the show include:

  • Efforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to get devices on the market sooner for customers.

  • Class III medical devices are often those that are life-sustaining, and making them safe is critical.

  • Questions to consider: What is safety? How safe is safe? How much testing is enough?

  • FDA has an initiative to promote innovation and for companies to bring products to market in the United States.

  • Industry statistics show that reporting issues may not be done or delayed when there are problems and malfunctions with devices; deadlines may be extended.

  • When you learn of problems with a device, you have a professional and ethical obligation to investigate and resolve them. Don’t just put a Band-Aid on it!

  • Finding a new PMA pathway: One way for novel devices and one way for me-too devices

  • Take a risk-based approach to regulations and value predicates.

 

Links:

Debunking Pre-market Approval Myths

510(k) Clearances

PMA Approvals

Medical Device Reporting

De Novo

 

Quotes:

“There are a lot of reasons why people and companies are very reluctant to consider developing a Class III OMA device.” - Mike

“I think it’s a risky proposition to start out with the most risky devices.” - Mike

“FDA has an initiative right now to promote innovation and for companies to bring products to market first in the United States.” - Jon


Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: I'm curious. What are your thoughts around premarket approval for Class III medical devices? Is this a good thing? Is this a bad thing? If your product fits within that classification requiring a PMA, is that something you're excited about? If you're like most, I would guess the answer to that is probably no. You're probably not excited about that. You might even look at that as a kiss of death for that new product that you're trying to develop. But what if you didn't have to look at it that way? What if you can embrace the concepts and the ideas around PMA as a way to bring a novel, unique device to market? I would encourage you to listen to this episode of the Global Medical Device Podcast where Mike Drues from Vascular Sciences, and I explore the PMA topic in a little bit more depth.

Jon Speer: Hello, and welcome to the Global Medical Device Podcast. This is your host, the Founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer, and today I have my good friend from Vascular Sciences, Mike Drues. Mike, welcome to the Global Medical Device Podcast.

Mike Drues: Thanks, Jon, always a pleasure to speak with you and your audience.

Jon Speer: Yeah, likewise. Recently, you and I just dove into this topic of PMA, premarket approval. Largely, surprisingly, there's not a ton out there for companies on this particular topic. And actually, when we spoke the last time, I think we debunked some of the common myths on the PMA topic. I remember it used to be, people perceived PMA, and they may still even today, they think that their device is Class III and it's gonna require the PMA path. It was like a kiss of death, and I think you did a really good job of explaining why that may not be the case. And I know there's a little bit more that we can jump into today on the 510(k). I think there are some things that we can get into, some of the things that are new and different, and maybe throw out some ideas. So what do you think? Can we explore this topic a little bit more today?

Mike Drues: I think that would be wonderful, Jon. I think, regrettably, you're exactly right. There are a lot of reasons why people and companies are very reluctant to consider developing a Class III PMA device, some of which we talked about last time. But on the flip side, there are some ways that are being discussed to make it a little bit more attractive for companies to do this, and one of them is to reduce the clinical data, the clinical burden requirements. For example, there's one proposal, and I'll throw it out there, Jon, and I'd love to hear your thoughts on it, but there's one proposal out there that's been floated to basically let companies market a Class III device in the US if the EU has already approved it with little or no clinical data from here in the United States. Of course, the advantage would be to get devices out onto the market sooner for the benefit of US customers with less testing and including less clinical data. And then the compromise, of course, would be to use postmarket surveillance or postmarket clinical data to figure out after the fact if these devices are safe enough.

Mike Drues: I'm just curious, Jon. Keeping in mind that we're tal1king about the Class III universe, which by definition is often life-sustaining or life-supporting devices, often devices that involve more complex technologies than Class II, 510(k), or De Novo devices, as well as devices that are intended to diagnose or treat much more complicated pathophysiological conditions, do you think this is a good idea, Jon?

Jon Speer: Well, it is an interesting idea; let me put in that category first. I know a lot of people struggle with, "Why are there different pathways for regulatory clearance?" You know what, it would be nice if I could do one submission to a regulatory body and for that to be recognized in other parts of the world. And I think there's some credence to that argument, especially today, especially with the work that's been done on the Medical Device Single Audit Program for quality management systems for companies. I think the FDA is gung-ho and very much behind that program and endorsing that very strongly these days.

Jon Speer: It's an interesting idea, and I know, historically though, that hasn't meant a whole heck of a lot. So, what would have to change from a regulatory perspective, from a regulatory agency perspective in order for that to be okay? It seems like there would have to be one submission to address the needs of all markets, more like an MDSAP but more on the submission side.

Mike Drues: Well, it's an interesting metaphor. It's an interesting comparison, Jon, to the MDSAP program. There is some similarity. I think, from a regulatory perspective, this idea of allowing Class III devices onto the market quicker based on an EU approval is a little bit backasswards when you think about it because if we're gonna use this model for anything, maybe we should start out with the lower-risk devices, maybe 510(k) devices that are already on the market in the EU with, say, a CE mark, allow them to get quicker onto the market here in the United States. And to a certain extent, this is already being done. You and I talked recently about the alternative 510(k) that Dr. Gottlieb, the Commissioner of FDA, started touting back in December. Whether it's truly an alternative or not, I'll leave that to the audience to decide.

Mike Drues: Let me put it this way, I think it's a risky proposition to start out with the most risky devices to allow them onto the market here in the United States. All of us, we have to remember, Jon, that the FDA has a difficult job to do and what we're really talking about here are some very fundamental questions like, what is safety? How safe is safe? How much testing is enough? And it just seems to me that doing this with Class III, with PMA devices, it's an interesting idea, but it's also a bit of a risky proposition.

Jon Speer: No, that's a really good point. And you raised the real value might be in the lower class devices. That might make a lot more sense for, as you stated, the obvious reasons. And it'll also be I think very interesting to see what happens in Europe these next couple of years. For all intents and purposes, everything that I've read and heard and learned about the new EU MDR, it's gonna be quite the mess for device [chuckle] companies. But, FDA has an initiative right now to promote innovation and for companies to bring products to market first in the United States and just the forces of political nature and regulatory nature in Europe just might drive that FDA initiative to become a reality. So, that'll be interesting to see.

Mike Drues: Well, you're right, Jon. And although some people might not want to believe it. There are a tremendous amount of politics between our side of the pond and the EU side of the pond, including who gets devices first. Obviously, we want devices to get out to the market as quickly as we can, but on the other hand, we also wanna make sure that we get only the devices that we really want on the market, the ones that are safe and effective and not the others.

Mike Drues: So, there's another change that people have been talking about in the PMA world when it comes to postmarket reporting requirements, especially when there are problems with devices, like for example, device malfunctions. As you and your audience probably know, Jon, the current regulation requires medical device companies to report malfunctions within 30 days of them occurring. But based on your experience, Jon, do you think that is reality? Do you think that happens most of the time?

Jon Speer: I'm gonna say no. And I've got a few anecdotal experiences from companies that I worked with over time. And the people who hear about the issue from a company, they're often, not always, but a lot of times it might be field, sales, resources or just field service people or what have you, and it seems like there is a big disconnect from people, from a company learning about events and that information getting back to the headquarters if you will, and to the right people to do something about that. And my experience has also been that by the time somebody hears about it, the event was certainly several days prior, if not sometimes a couple weeks. It's almost mentioned as, "Oh, by the way, this thing happened the other day." And it doesn't seem like that's taken as serious as it should.

Mike Drues: Well, regrettably Jon, your personal, your anecdotal experience is actually reflective of the entire industry. Let me share with you some industry statistics that, quite frankly, are pretty humbling, are pretty sobering, at least to me. As I said a moment ago, the current regulation requires that medical device malfunctions be reported within 30 days. However, the reality is just simply not the case. When we look at 2016, which is the most current statistics that I have, there were over 300,000 cases of overdue adverse events reports. In other words, device malfunctions that were not reported to the FDA during that initial 30-day window, which is clearly what the regulation requires. More than 300,000. So we're not talking about one or two examples, and some of them from some of the largest medical device companies on Earth. I don't know about you, Jon, but I think that's totally inexcusable and we need to do better.

Jon Speer: What do you think the underlying issue is or the root cause of this? Do you have anything you wanna speculate on?

Mike Drues: Well, that's a good point, Jon. I just think, although the statistics are indeed humbling, I do think we have to be careful about over-generalizing. I'm sure in some of those situations, some of those 300,000 cases, some of them were legitimate. In other words, maybe the company was undergoing an investigation to determine what we as engineers would call the root cause of the problem before reporting it. But regrettably, Jon, I think most of the time, either it was delayed by simple bureaucracy or paperwork. Perhaps in some cases, people didn't know they were supposed to report within 30 days. I think there can be a number of different reasons. But overall, I think that statistic is pretty humbling. So as a result of this, FDA has proposed to make it a little bit less burdensome for companies to do it, and they've created what's called a Retrospective Summary Reporting Program for these late filers.

Mike Drues: It's like we filed our income taxes here in the United States not long ago. It's like an extension for late filers. In other words, if you can't file your income taxes by the due date of April 15th, you could put in an extension. However, the IRS puts a caveat on that, it's an extension to file, it's not an extension to pay. You still have to pay by April 15th, and then you can file your taxes within a few months after that. I think the FDA could propose a similar model. This is an extension to do something about the problem if you have not determined yet what the underlying root cause is, but I don't think it should be an extension to report. I think we should still have to report those problems within that 30-day window.

Jon Speer: Yeah.

Mike Drues: So for example, there were 75,000 reports of malfunctions of a single brand of drug pump, a type of an infusion pump, that basically led to FDA allowing a manufacturer to combine all of those into a single summary. So, 75,000 reports into a single summary. What do you think of that, Jon? Is that a good idea?

Speaker 1: Well, [chuckle] I don't know all the details. My knee-jerk response is no, I don't think that's a good idea because 75,000 different incidents, how in the world could you bundle those into a single report? The other thing that my initial reaction is, it sounds like this pump has a big problem if there's 75,000 incidents. It sounds like there's a significant issue with this thing. I don't know, some red flags raised when you pitch in that particular example. It seems like the company was given a pretty easy path and almost like this wasn't taken very seriously, from this company's perspective.

Speaker 1: Well, I think the points that you just make, Jon, are very valid. I, as you very well know and as your audience knows, I try to take a commonsensical approach to regulation in everything that we do and we talk about, including what we're talking about here. So to me, it doesn't bother me if we combine even as many as 75,000 instances into a single summary if, and this is the big caveat, if they're all related to the same problem. In other words, if they are all indeed caused by the very same or very very similar problem, then to issue 75,000 reports that are exactly the same as one another, not only would that be overkill, but that would just bring the system to a grinding halt. So if we're sure that all of these reports are very, very similar; in other words, they have the same root cause, then I don't have a problem with it. If, on the other hand, that there are 75,000 different causes of this problem, then I don't know that it's necessarily appropriate to include them all in a summary unless all of them are still, although they're different, they might be very low criticality, they might be very easy to fix, that kind of thing. So again, I think we have to use common sense. We have to use what attorneys call "The Reasonable Test" here.

Mike Drues: And so, as a result of all of this, as a result of so many companies not turning in their reports on time, what FDA is proposing is to extend the deadline from 30 days to 60 days if the malfunctions don't result in death or serious injury. Again, I don't necessarily have a problem with that, but let's keep in mind, Jon, that hindsight is always 20/20. How do we know if a problem didn't result in death or serious injury until we investigate it? I think the problem here, Jon, is it reminds me of one of the local high schools near where I live where not enough kids were passing the graduation test. So what did they do? They lowered the bar, they lowered the passing score so that more kids would pass. I think in a certain extent what FDA is doing here is they're saying, "Okay, not enough companies are doing it within 30 days, therefore, let's lower the bar and let's give them more time." Like everything, there's advantages and disadvantages. On the upside, they would give it more time for companies to complete these investigations in order to avoid reporting these events that don't meet the threshold for reporting, and this would create a lower regulatory burden on manufacturers, it would improve FDA surveillance of device safety.

Mike Drues: These are all certainly admirable goals, but we have to use some common sense. Most importantly, and this is, I think, the most important thing for our audience to remember, Jon, is when we do learn of problems with a device, we have an obligation. Never mind regulatory, never mind quality, never mind whatever you wanna call it, a professional obligation, an ethical obligation to investigate and to try to find out as quickly as we can the severity of the problem, what led to the problem, and most importantly what can be done to try to avoid having it happen in the future.

Jon Speer: Yeah, it does feel like a Band-Aid is being applied with this proposal. It doesn't really feel like it's addressing the real issue. And I know there was some communication, I can't remember where I read it, I think I spoke about it. I don't know if it was on a podcast, but just talking one day that there's some program that FDA has discussed as well, about having some bundling efforts to have a frequent review of adverse events and product performance of things in the field. I think it was the program that suggested it was something about doing a quarterly report, or something like that. Do you recall the details of that?

Mike Drues: Yeah, you're right, Jon. As a result of everything that we've been talking about in the last few minutes, FDA is actually considering expanding this program and allowing companies to bundle similar complications into summaries instead of submitting them either once every month or once every two months to be able to submit them quarterly. I actually think that that's got some advantages, but that would be for a summary only that we would have to put a number of caveats on that, a number of limitations like for example, for non-life-threatening, non-fatal kinds of problems. I think, and this might generate a tiny bit more paperwork for companies, but I think that reporting the problems within a shorter period of time, perhaps 30 days as is currently required, and then following that up with a quarterly or annual summary report. That would be actually a good idea because that would help us see the forest through the trees. And there's a lot of precedent for this from the quality world, Jon, as you certainly know.

Mike Drues: When it comes to complaints and CAPAs and so on, one of the things that I've always encouraged companies is not to look at your complaints or your CAPAs just simply individually, as many companies do, but periodically, whether it's once a quarter, once every six months, once a year. Periodically look at all of the complaints and the CAPAs to try to see if there are relationships between them that you might not see if you consider them only individually. I think applying that same sort of logic to the PMA world, and specifically to reporting adverse events, could have some benefits. Do you think that has some advantages, Jon?

Jon Speer: Yeah, I like the idea a great deal. It's similar in respects, at least in the methodology, at least when I think about it, to what companies should be doing already and that's a management review. Even as I let the words escape my mouth, I know a lot of companies, when they do management review, they do the bare minimum, they do it annually, and they treat it a lot like a check box because they're obligated to do that. But if you take the intent behind management review seriously, in my opinion, my advice would be to do that more frequently throughout the year. I think quarterly is a good frequency. And I think if you looked at, when we're talking about PMA devices, especially, I think, if you look at the highest risk, the products that are saving and sustaining lives and doing some sort of quarterly report or quarterly review. I don't think that's egregious. I think that should be what we're doing anyway to manage our business. We are trying to save lives here, so we should not look at that as a burden, we should look at that as this is being proactive. I agree.

Mike Drues: Well, I could not agree with you more, Jon. And I would like to think that we would not need regulation to remind companies to do these kinds of things, that they would do them because it is the right thing to do. But unfortunately, I guess not everybody looks at it that way. And just one last thing I would say on this topic. Again, we have to apply a little reasonableness here. I don't like regulation that's universal, that's absolute. In other words, I don't like regulation that says I have to report things every 30 days or every 90 days or once a year. I think we need to be able to use our own judgement. So for example, if we're working on a device that uses well-established technology, in other words, the technology's been around for a very long time, maybe there are multiple companies and multiple devices that have been using this technology for a long time, if the risks are well-understood, if the disease is well-understood then I have no problem reporting those problems in a less-frequent fashion. On the other hand, if you're using a device that uses technology that's very new and novel, and not well-established, there's not a lot of history on it, then I think we have to make more of an effort to monitor and to report things because it is simply new. To me as an engineer, Jon, that's simply common sense.

Jon Speer: No, I agree, and...

Mike Drues: So I think...

Jon Speer: Yeah, I was just gonna offer that, and this might be a tangent for today's conversation so we can table it if need be, but as we've been talking about this, it seems like FDA has the pre-submission program for a vehicle for companies to be able to collaborate and communicate with FDA, prior to any sort of 510(k) or PMA. And it seems like that model might have some opportunity for a collaboration with FDA and with companies in more of a postmarket fashion as well, like maybe a post-submission [chuckle] I don't know, it's just an idea of just a way to be able to communicate those types of things with FDA.

Mike Drues: Well, you know Jon, I think that's a wonderful idea. And to be honest, I'm a little envious, I'm a little jealous because that's not something that I thought of myself. But we have, obviously, a lot of pre-subs that we do today. You and I have talked about these many times. As you and your audience know, I spend an awful lot of my time doing pre-subs with companies. But maybe we need a post-sub version of a meeting to be able to address some of these kinds of concerns, as well. I think that would be an interesting discussion.

Jon Speer: Alright, so noodle that one and we'll explore that maybe downstream.

Mike Drues: I would love to.

Jon Speer: There was a thing that, you sent me an email recently and I don't think there was a lot of substance in the email, it might have just been the subject line, but it was something around finding a new PMA pathway for non-me-toos, and it was intriguing. And I think that's actually what sparked the whole idea of you and I spending a little bit time talking about PMA. So, what did you mean by that?

Mike Drues: Thanks, Jon, for bringing that up. Everything that we've talked about thus far, have been new ideas that are being talked about in a variety of circles. This last idea that you brought up, creating a separate pathway for Class III devices or devices that are truly new or novel, that's a microseism. That's something that I have been thinking about over the last year or so. And here's the idea. A lot of people think there are not a lot of me-toos in the PMA world. A 510(k), by definition, is a me-too. And in the Class II and Class I universe, the way we separate the me-toos versus the devices that are truly novel, is the me-toos can get on to the market with a 510(k), and devices that are truly new or novel, they get on to the market under the De Novo.

Mike Drues: In the Class III universe, we make no distinction. There are a ton of me-too devices in the Class III universe. I could give you a number of examples, but let's just take one of my favorites, the bare-metal coronary stent. Never mind even the drug-eluting stent, just the bare-metal coronary stent. I did a search on this recently. There are over 500 bare-metal coronary stent PMAs that have come through the FDA over the last 20 years or so, that we've had coronary stents. Over 500. The vast majority of them are what I would consider, as a biomedical engineer, as nothing more than me-toos. Yes, they have several differences in their design, maybe the shape of the hypotube is slightly different, maybe the bend of the wire is slightly different. But listen, at the end of the day, their mechanism of action is exactly the same, they're doing what they're doing in the body exactly the same way as the others.

Mike Drues: So, in order to help differentiate the truly new and novels from the me-toos, maybe we need a De Novo like pathway for the Class III universe so that FDA could apply more resources to those truly new and novel class III devices, and perhaps less resources if you're coming to the market with a device that, even though it's Class III, even though it's PMA, even though it's life-supporting or life-sustaining, it's still basically a copy of what's already out there. I think if it makes sense to have a De Novo pathway for Class I and II devices, it probably makes sense to at least have a discussion about the merits of having a similar pathway in the Class III universe. That's sort of the logic, that's sort of the thinking of it, Jon. I'm just throwing it out as a topic of discussion. Maybe there are advantages, maybe there are disadvantages, but at least something for people to talk about and for people to think about. And I also think that as an industry, we have an obligation not to wait for FDA to tell us, to give us options. We should not be led like sheep, we should be able to be a shepherd, and we should go to the FDA, if there is consensus in the industry, and say, "Hey, we need a De Novo-like pathway for Class III devices. Let's sit down and have a conversation as to what that might look like."

Mike Drues: So, I'm curious to see your thoughts on this De Novo like pathway for a Class III product, Jon. Do you think there would be advantages? Do you think there would be disadvantages? What are your thoughts?

Jon Speer: Yeah, every time I talk to you, Mike, about regulatory topics, I usually leave the conversation with one or two things, sometimes more that I learn. And one of the things I've learned in previous conversations with you on this topic of regulatory is that there... I don't wanna say loopholes, that's not the right, real word, because that sounds like we're not doing something appropriate. But there are certain areas of the regulations that are a little bit gray to begin with, and as you were speaking about the de-novo opportunity for Class III, the question popped into my head, couldn't we do that now? Is there anything that prevents us from doing a Class III device via De Novo? Or is it cut and dry for a lot of our Class III devices? Does it say, "Thou shalt do a PMA"?

Mike Drues: Well, that's a good question, Jon. There are very, very few regulatory absolutes. There are few areas in all of regulatory or quality that are black and white. What you just mentioned, Jon, is one of them. Regrettably, the De Novo is limited to Class III. I'm sorry, let me say that again. Regrettably, De Novo's are limited to Class II or lower devices. Under the current regulation, you could not bring a Class III device onto the market under a De Novo, at least for the same indication. If you wanted to get into some very sophisticated regulatory strategy, there are examples where one device used one way is a class III PMA. Whereas, the exact same device used in a separate way is a Class II De Novo, or perhaps even a 510(k). But the short answer to your question, Jon, is, in general, you could not use a De Novo as it stands now for a Class III device. Now, obviously, Congress could change that and add a version of the De Novo, perhaps as I'm suggesting, for Class III devices, but under current regulation that could not be done.

Jon Speer: Yeah, alright, well, and anytime you throw Congress in the mix, that's [chuckle] certainly a wild card for sure. But it is an interesting idea. Let me pull some of the layers apart of the idea, get maybe a little bit deeper. So, it's the Mike Drues' idea of a Class III De Novo, what would that look like? Would it be ostensibly different from a PMA today? Or, have you vetted the idea a little bit further to think about if somebody said, "Hey, Mike, I need you to make this new program, the Class III De Novo." Have you put some more thought into what that might look like?

Mike Drues: Well, that's an interesting question, Jon. And to be honest with you, I haven't given it an awful lot of thought as to the details of what it would look. I don't think the requirements for this De Novo like pathway for Class IIIs would be significantly different than the PMA for the same reason that when you look at what the De Novo requirements are for a Class II compared to a 510(k), they're really not any different. One of the things, and we've talked about this before, Jon, one of the things that differentiates my approach to this business as opposed to so many others is, I'm a huge fan of doing what makes sense. In other words, to me, I think all of the testing that we should be doing, whether it's bench-top, animal, clinical, what have you, all of that should be predicated on the biology and on the engineering, not on the regulatory pathway. So we should not have additional regulatory requirements for a De Novo just because it's a De Novo, they should be based on the biology and the engineering. So in general, Jon, I would take the same approach here. I would say that we should not have additional requirements for this De Novo like pathway for Class IIIs just because it's new or novel.

Mike Drues: But on the other hand, when you think about it, it's common sense if you're bringing a device onto the market, regardless of the classification, regardless if it's Class III or II or even I. If it is using new or novel technology, by definition, the testing requirements should be more robust, should be more comprehensive, maybe even more aggressive because the technology is new or novel as opposed to devices that you use technologies that have been around for a long time. I mentioned the bare-metal coronary stent a moment ago, Jon, let me use that again as an example. A lot of people think that all PMAs for a similar device require the similar amount of depth of testing, in other words, the same regulatory burden. It's simply not the case. When you look at the first experimental coronary stents, and I've been in this game for a long time, Jon, I was involved in some of the very first stents, we had to do a heck of a lot more testing, bench-top, animal and clinical testing for the Class III PMA coronary stents.

Mike Drues: Then, fast forward to 20 years later to today, the stents coming on to the market today, comparatively speaking, are undergoing less testing than the ones 20 years ago. Why? Because that technology is relatively well-established and relatively well-understood. So, I think that, quite frankly, this De Novo like pathway for a Class III device, and I also think that just to avoid confusion, we probably should not call it a De Novo, we should call it something else, but I think this De Novo-like pathway for Class III devices, I think we could take the same or a similar approach. Not necessarily having more rigorous regulatory requirements, but at the very least, calling it something else which would allow FDA to separate it from all of the me-too's that are out there and be able to, as I said earlier, devote more resources to reviewing those products, and granted, there are not that many of them, as opposed to the vast majority of PMAs that are me-too's.

Jon Speer: Yeah, really, what you're pointing out is using a risk-based approach from a regulatory review perspective, giving FDA, I guess, rationale or justification to basically spend more resources on things that are truly unique and novel, and I guess the more unknown, theoretically, would be higher risk only because there's more unknown about that. So, those are the type of submissions that FDA might deploy more resources. And I guess, that's a really great point to wrap up our conversation today. There's quite a few lessons that those listening could apply and use to move forward, and I think risk is a big one.

Mike Drues: Well, once again Jon, I think you're spot-on correct. And I must say, I'm also very envious, very jealous because you put that better than I ever could. We're taking a risk-based approach, something that all of us are familiar with at least on paper, but what people, ironic as it might sound, are not really used to thinking of, is taking a risk-based approach to regulation. That is regrettably a bit of a novel concept, but maybe it's something that might catch on.

Jon Speer: Yeah, I hope so. I think interestingly, regulatory agencies, I wish this weren't the case, but they've been driving and pushing industry to apply risk-based approaches within their quality system and product development documentation. The reason I said regrettably is, I would like to think that we as companies, designing, developing, and manufacturing medical devices, would already be using that logic rather than waiting for regulators to come to us with the rules, so to speak, and we've talked a lot about that. But there are probably a few other lessons, at least things that I've picked up as we've talked about this PMA topic. Things like predicates, does that have any value in a PMA conversation?

Mike Drues: Well, again, as we talked about in the first part of our previous podcast, Jon, although in a regulatory sense, a predicate in the PMA world doesn't have a lot of value in a substantial equivalent sense of the word. I use predicates all the time in the PMA world in terms of risk mitigation, and in terms of testing methodology. So to me, predicates have a tremendous amount of value in the PMA world.

Jon Speer: Yeah, and you mentioned a classic example with bare-metal coronary stents. Obviously, there are... Well, would you say 500 PMAs over the past 20 years? So, there are a lot of predicates that are there from a PMA standpoint as it stands today. What are some of the other things that you would advise companies on this topic?

Mike Drues: I think to wrap this up, Jon, we've covered a lot, not just in this particular podcast on the PMAs, but the previous one as well. I would leave the audience with just a couple of pieces of general advice. First, if you're working in the PMA or Class III universe, just like any medical device, don't wait until your actual submission for the first time to share this with the FDA. Go to the FDA in advance in the form of a pre-submission meeting. You and I have talked about this many times in the past, Jon, and present to them your device, here's what it does, here's how it works, here's our regulatory strategy, here's the testing that we're doing, here are the clinical trials that we're doing, or not, and here are all the reasons why. And make sure you get a meeting of the minds, make sure that everybody's on the same page, or pulling in the same direction, whatever metaphor you wanna use. Quite frankly, I don't really care, but make sure everybody is in sync so that that will greatly mitigate your risk of problems or delays later on. That's piece of advice number one.

Mike Drues: And piece of advice number two, when it comes to the more risky devices, the Class III devices, we should not shy away from them because many people think that because it's a Class III PMA, it's gonna be more time, more work and so on. Those things are often true, but when you think about it, it's supposed to be true because these are devices that are oftentimes life sustaining, or life supporting. These are often devices that involve more complicated technologies than Class II or Class I devices. These are often devices that are involved in treating much more complex diseases, much more intricate pathophysiologies, oftentimes with co-morbidities. These are challenges. But on the other hand, these are challenges that we should not shy away from. On the contrary, for me, as a regulatory professional as well as a professional biomedical engineer, I welcome the opportunity to work on devices like that. I think we need more of them, not less.

Jon Speer: Yeah. And folks, for me, every time I do these podcasts, I leave with something that I've learned and a fresh perspective. And as Mike and I wrap up this conversation on PMAs, from the first time that we talked about it till today, I'm gonna have to confess, Mike, I might have been one of those people that looked at PMA as a kiss of death [chuckle] at one point down in my career because you just perceive that that was gonna be longer, more expensive, a lot of burden on a company, but I agree with you. The reason that I enjoy being an engineer is not to design and develop a me-too product. I'm a smart person. I wanna solve a problem in a unique way. And I'll wrap this up with an example that I worked on.

Jon Speer: It was a Class II device, but it still drove me crazy a few years ago, and looking back, I might have advised a different path, but a person contacted me and they had a pump device. And I won't go into the specifics, but basically, they were distributing a pump of a different manufacturer and they were making okay revenue and they were helping patients and that sort of thing. But he's like, "I wanna make my own device. I wanna put my name on it." And one day, this person called me into his office and he opened, literally had the pump device that he was distributing open, and he's like, "I can make exactly this. Let's do that." And that's more or less what he did. And looking back, I was like, was that the best approach? And I would definitely argue now, no, it was not the best approach because just opening somebody else's product or just looking at somebody else's product and saying, "I want that, but I wanna do it slightly different." That reduces what you're doing to a commodity status. You didn't use your own brain, your own thought, you didn't understand ways to make that product better to raise the bar, so to speak. And I think we have a responsibility as medical device professionals to raise the bar, to try to improve the human experience through our devices that we're bringing to market. Yeah, go ahead, Mike.

Mike Drues: Well, once again, Jon, I could not agree with you more. One of the things I think I started out with in the beginning of our first podcast on this topic is the statistic that 90-95% of the medical devices that come to market here in the United States are Class II and Class I devices, and only 5-10% devices are Class III devices, either PMA or HDE, or something similar. I think that's unfortunate. I think that we need more efforts going on in the Class III universe. But on the other hand, I have to acknowledge the reality. I did not just fall off the turnip truck yesterday. For a small company or a startup to be going to investors, to NGOs, or VCs, I can tell you, and it pains me as an engineer to say this, Jon, but if you tell a potential investor that your new device is probably a Class III PMA, that is often the end of the discussion, the end of the conversation. Don't let the door hit you on the way out.

Jon Speer: Yeah.

Mike Drues: And that is a reality, but there are ways that we can overcome it. And I work with companies all the time to make this palatable to all size. Not to get too philosophical here, but we do have to consider the greater good as well, not just the business.

Jon Speer: Yeah. And Mike, I'm gonna let that be the last word for today. I wanna thank once again Mike Drues, President of Vascular Sciences for being my guest on the Global Medical Device Podcast. And I would encourage you to reach out to Mike if you have questions on regulatory strategy. And if you'd like to do a little bit more on your quality management system, you like to learn about a quality management system that is designed for the medical device industry by medical device professionals to streamline your work flows, for design controls risk, as well as all the post-market activities, things like CAPAs and complaints, then I would encourage you to reach out to us at Greenlight Guru. Just simply go to www.greenlight.guru to learn more. And that's a wrap up of today's episode of the Global Medical Device Podcast.


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