premarket_approval_pathway

When developing a new medical device, do you try to figure out the fastest and simplest way to get your product to market?

As a product developer, do you explore a regulatory path? Or, are you afraid that may kill your idea?

Mike Drues, president of Vascular Sciences, is with us today to do some premarket approval (PMA) myth busting and describes why a PMA path may not be as scary as you think.

 

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Some of the highlights of the show include:

● PMAs are reserved for the highest risk devices (Class III and life-supporting).

● Utilize the patient-centered approach because assumptions are often made about risks and invasive vs. non-invasive devices.

● Can you use a predicate to show substantial equivalence for a PMA device? From a regulatory perspective, there is no concept of substantial equivalence.

● Use the MAUDE database and identify any precedence that has been set to gather knowledge about devices you are developing.

● You have a story to tell. Be able to explain your product, position, and why your product is good for the patient.

● All PMAs require clinical data. False! The vast majority of PMAs do require clinical data, but some PMAs do not require such data.

● What are the pros and cons of a PMA vs. a 510(k)? Most opt for a 510(k).

● Class III devices can do a PMA, or other options, including the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP).

 

Links:

FDA’s PMA

FDA’s Device Development Process

EU Classification Guidance Flowchart (refer to section 4.1)

Understanding the Many Connotations of Risk in Medical Device Development

FDA’s MAUDE

Greenlight Guru Quality Management Software

Humanitarian Device Exemption

Product Development Protocol

 

Quotes by Jon Speer and Mike Drues:

A lot of companies shy away from that (PMA) path because of the time and dollars, but that may not always make good sense.” - Jon Speer

From an engineering perspective...I do think, that as a general rule, Class III devices are much more interesting, and often times, much more important.” - Mike Drues

From a strict theoretical regulatory textbook perspective, there’s no concept of substantial equivalence in the PMA world. Yet, from a regulatory logic perspective, I use substantial equivalence all the time in the PMA world. ” - Mike Drues

 

transcription: 

Recorded Intro: Welcome to the Global Medical Device podcast. Where today's brightest minds in the medial 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         You know, I've worked in the medical device industry for a long time and I can tell you for much of that time, when developing a new medical device, I wanted to try and figure out the simplest, fastest, most streamline way to get my product to market through regulatory challenges and things of that nature. And it seems like product developer, I was more keen or more interested in trying to figure out, could I go to class one path? Is there a way to get my product there? Or could I do this through a 510(K) and it always seemed like I was exploring a regulatory pathway and I came across the PMA Class 3 indication, that a lot of times that that might've been a kiss of death. That it might've been a reason to kill an idea, and that's crazy, isn't it? Or is it I'm not sure.

                        Maybe the PMA path is not as scary as we might think. And on this episode of the global medical device podcast, Mike Drues, from Vascular Sciences, he does a little bit of myth busting of some things that we might've previously thought would've been reasons to not pursue a PMA. So you should listen to this episode of the Global Medical Device podcast to learn about some of those myths and ways that the PMA path may not be as scary as you might think.

Jon Speer:        Hello, and welcome to the Global Medical Device podcast, this is your host and founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer.

Jon Speer:        And we have a topic today that we're gonna discuss. That frankly, we haven't spent that much time talking about it, it seems like in the med divide world, one of the topics when it comes totally regulatory, seems to dominate as the 510(K) topic. And maybe justifiably so. But we haven't really spent that much time talking to you about PMA Class 3, that that means and that sort of thing. So good news, I've got my good friend and a familiar voice on the Global Medical Device podcast. Mike Drues from Vascular Sciences.

Jon Speer:        Mike, welcome.

Mike Drues:     Thank you Jon, I'm looking forward to our conversation today.

Jon Speer:        Yeah, and I know you're a regulatory strategist and expert for all sorts of things and you and I have talked a lot about 510(K)s in the past and we've talked a little bit more of the de novos as well. But we were commenting the other day that we really haven't spent any time talking about PMSs and what that means. My history in the medical device industry, it seems like a lot of companies shy away from that path because of the time and dollars and that sort of thing. But that might not always make good sense. So maybe today, we can talk a little bit about strategic advice for PMAs, is this a good thing? Is this a bad thing? What do you think?

Mike Drues:     I think that's a great idea, John. You mentioned that I was a regulatory strategist and that is in fact what I spend a lot of my time doing. But first and foremost, I'm a biomedical engineer, that's what my PhD is in, that's what my background is in. And from an engineering perspective, this is not a criticism of Class 1 or Class 2 devices, but I do think there's a general rule Class 3 are much more interesting, and often times, that they're much more important. In the sense that they're often life supporting of life sustaining devices.

Jon Speer:        Yeah, so why don't we start there. Because I suspect that's there's probably a lot of misconceptions or maybe not a real thorough understanding of what a PMA is. So maybe providing an over view of what is a PMA and getting into some of the depth of that, that might be helpful.

Mike Drues:     Okay, I do think that's a great place to start, Jonn. So first and foremost, when it comes to the overall medical device universe, we are talking about a fairly small piece of the pie. In other words, only about five to 10% of medical devices are Class 3 devices. The vast majority of them are Class 2 or Class 1 devices. And this is exactly why we've spent so much time in the past talking about 510(K)s and de novos and more importantly, that's where most of the industry is focused.

Mike Drues:     So in terms of a PMA, PMAs are obviously reserved for the highest risk devices. Class 3 devices, often times, life supporting devices. Some of these devices may be invasive. Some of these devices may be permanent implants, but it's important for our audience to remember, Jon, there are a ton of exceptions.

Mike Drues:     For example, in orthopedics, there are an awful lot of permanent implants that we use in orthopedics that are 510(K)-able. That do not require a PMA. Whether or not an implant should require a PMA or not, that would perhaps be a topic of a different discussion.

Jon Speer:        Yeah.

Mike Drues:     But, that's the simple reality. And one other thing I thought I would mention, Jon, in terms of the invasiveness, I se a lot of people make the assumption that if a device is not invasive, then it's necessarily low risk. And that's just simply not the case.

Mike Drues:     There are anum of examples of medical devices that do not go inside of a patient's body, do not come in contact with the patient, and some cases are not even used in the same room or even in the same building as the patient. And yet, they are Class 3 devices requiring a PMA. There are many examples, my favorite would be Invitro diagnostic or IVD for cancer. Right? So an IVD for cancer does not committee ein contact with the patient, it's not even used in the same room or as I said, sometimes in the same building. And yet, that device in Class 3. Why? Because of risk and specifically the type of risk I'm talking about here is probability of providing the wrong information. Having a patient that they do not have cancer, when In fact they do, a false negative. Or telling the patient they have cancer when in fact they don't, a false positive.

Mike Drues:     And one last thing I'll say about the assumption that so many people make, that non-invasive devices are low risk. This was actually reflected for many, many years in the EU classification guidance flow chart. If you look at that flow chart, and perhaps we can provide it as a link to the podcast, it says, "Is the device non-invasive? If it's not invasive, it's automatically low risk." And that's just simply not the case.

Jon Speer:        Yeah, I agree. And the cancer IVD is a good example and I think there are countless others. But you think about the outcomes, the purpose of the device is to do something, right? And if we're presenting results to a patient that are wrong, well that could prevent them from getting treatment, or they could be getting treatments that they don't need. And cancer is certainly one of those things where if you tell a patient that they have cancer and they don't, and they start going through a whole chemotherapy regime, talk about ... that's not good. Totally makes sense.

Mike Drues:     Program the other side of that, Jon, which is even worse. Telling the patient that they don't have cancer, when in fact they do.

Jon Speer:        Yeah, for sure.

Mike Drues:     You and I have talked about risk many times. I would invite the audience, I was fortunate enough to do a webinar for Greenlight last year I think, on my particular approach to risk. So if anybody is interested in that specifically, we can provide a pointer to that as well.

Jon Speer:        Yeah, and I think that ... not to go to much on a tangent, but think that the whole concept of risk has been a bit, we'll say maligned or abused or misused, and the webinar that Mike mentions is really a good synopsis. He has the bucket approach and I guess I'll leave that as a teaser and ...

Mike Drues:     It is a different approach, it's not the ISO or the FDA, it is a different approach.

Jon Speer:        But it's a good methodology because ... you've probably heard me say this a time or two, but we make medical devices and we're trying to improve the quality of life, we're trying to save lives and all those sorts of things. So, let's have the patient centered approach when it comes to risk. So anyway, that's all I'll say about that. I'll step off the soap box now.

Jon Speer:        The notion, as I mentioned on the times that we spent a fair amount of time talking about 510(K)s and that's kind of the work horse in FDA med devices, that 510(K). And of course, the 510(K), the premise is that we're demonstrating substantial equivalence to a predicant device., what is a predicant device substantial equivalence, does that have any bearing or does it make any sense from a PMA standpoint?

Mike Drues:     It's a great question Jon. So another of the very common questions that I get in the PMA universe is, can I use a predicant to show substantial equivalence for a PMA device? Now, technically speaking, from a regulatory perspective, there is no concept of substantial equivalence, you can't just simply show that our device is basically the same as the other guy's device. Therefore, end of discussion. But, I use the concept of substantial equivalence, the regulatory logic if you will, of substantial equivalence in the pA world all the time.

Mike Drues:     And there are two general areas where I use this. First, in terms of testing, and second, in terms of risk. So, in terms of testing, one of the first things that I do when I'm working on a PMA as an engineer myself, I will look at what kind of testing that other companies have done for similar PMA Class 3 devices. And I will use that as a starting point, and then when I go into the FDA, I'll say here's our new device, but oh by the way, it's similar. I won't say substantially equivalent, I'll say it's similar to these other PMA devices. Heres the testing matrix that the other companies used. So I'm going to use that as a starting point. That's how I use the concept of substantial equivalence in terms of testing.

Mike Drues:     I do exactly the same thing in terms of risk. In other words, if there are other products out there ... and by the way, I'm not limiting myself here to just the United States, I'm truly taking a global view. So I'll look at other products on the market, for example, that are PMA devices here in the U.S. and I'll look at their risk mitigation strategy and if they're using methods to mitigate risk of their technology, I'll use that as a starting point for my PMA as well.

Mike Drues:     So again, from a strick theoretical regulatory textbook perspective, there's no concept of substantial equivalence in the PMA world. Yet, from a regulatory logic perspective, I use substantial equivalence all the time in the PMA world.

Jon Speer:        And I think that's really an important point. You're trying to figure out what else is ... at least me as an engineer, I guess let me preface it by saying that when I am, as an engineer, product development engineer designing and developing a product, one of the things that I try to know or learn as quickly as I can is what else is similar to what I'm doing? And not hat I'm trying to do a me-too per se, but I wanna know if there's any sort of precedence that has been set with technology or a product or some sort of device ion the space that I'm working. 'Cause that's knowledge that I can gather and lean and learn from.

Jon Speer:        Sometimes I can learn from the things that others have done that were good. And other times, I might be able to learn from things that maybe weren't so good. Maybe it's a risk factor again. But a good example is if I'm developing a Class 3 PMA product and there are other products that are in that space that may already be in the market. One example is I could go to the mod database from FDA and I can see what kind of problems they're having and I can make sure as an approved engineer that I'm making sure that I'm addressing those risks scenarios into the design and development into my particular product.

Mike Drues:     Well, I agree 100% Jon, with that you just said with one very small modification.

Jon Speer:        Sure.

Mike Drues:     I would not say I could do things like going to the mod database, I would say, "I do do those things going to the mod database."

Jon Speer:        Touche.

Mike Drues:     As a matter of fact, not because it's required or FDA tells me to do, but because it's the right thing to do. I wanna demonstrate, first and foremost, to my friends at the FDA that I do know what the heck I'm doing. I'm not just simply checking off boxes on a form and I'm learning ... to paraphrase what you just said, other people's mistakes. And this happens very frequently, especially in the PMA world. And one other piece of strategy advice I would give, John, fortunately for me, a good chunk of my business is bringing products to the FDA that are truly new and novel, not just simply me toos. But, from the FDA's perspective, they are obviously very nervous when it comes to things that are new or novel. For the obvious reasons, there's no history and so on.

Mike Drues:     So, when I go to the FDA in those situations, I say here's my new device, there's nothing out there that's like it. On the other hand, then what I do is I decouple, or break down the technology into individual components and I try to find similarities to other devices that are already out there. In other words, I say on one hand this is a new device, but on the other hand, it's really not new, it's just a combination of a bunch of old things that we're putting together perhaps for the first time.

Mike Drues:     From a regulatory strategy perspective, John, that makes that pill much easier for FDA to swallow.

Jon Speer:        You know, it's really terrific advice, Mike, because a lot of regulatory professionals, and even product developers for that matter, I think we get, I don't know what the right word is, but, I think sometimes we forget that we're story tellers. I don't mean we're making things up, I mean that ...

Mike Drues:     Hopefully not.

Jon Speer:        It's like if I go to the movie, or read a book, why am I doing that? Because I think it's gonna be a good story, I think it's gonna be something that's fascinating and exciting and exhilarating. Well, we, as product developers, as regulatory professionals, we have that same sort of opportunity, and one might even argue responsibility regarding our product. So, we have a story to tell and sometimes we get kind of mired in the minutia of the engineering tests for this and the analysis for that, which, don't mishear me, are very, very important, but let's make sure we can explain our product, our position and why this is good for the patient. Again, I keep coming back to that.

Jon Speer:        I think that's really important.

Mike Drues:     Once again, John, I love your metaphor as storyteller, because when I go to the FDA, and as you know I'm down there very frequently, at least once a month, sometimes more. I tell a story, that's exactly what I do, I tell a story.

Mike Drues:     It should be nonfiction by the way, it shouldn't be fiction.

Jon Speer:        For sure.

Mike Drues:     But I tell a story. I'll give you a quick example, one of the very first things that I love to do in my presentations, I do this a lot at pre subs for example. Before getting into the engineering, before getting into the biology, before getting into the regulation, I start out, I like to put what I call a clinical face on the problem.

Mike Drues:     In other words, I will literally show on the screen, a picture of a patient or sometimes a video of a patient and I'll say, meet Mary Smith. Before using our device, Mary Smith was not able to do x, y and z. As a result of using our device, she is now able to do x, y and z.

Mike Drues:     Some people accuse me of pulling on people's emotional purse strings. I think there's a lot...that is exactly what I'm doing but on the other hand I'm reminding people that we're not just talking about the biology or engineering or regulation here. We're talking about people's lives.

Jon Speer:        Yeah.

Mike Drues:     And especially in the class 3PMA world, where these are often life supporting or life sustaining products. I think that's something that all of us need to remember.

Jon Speer:        Totally with you there. The more we can humanize what we're doing, it serves a purpose. We're trying to save lives, we're trying to support life. I think that's a really, really key point. And the story telling I think is something that all of us as medical device professionals can do a better of job of telling nonfiction stories about our products and processes.

Jon Speer:        Kind of related to the Mary Smith example, you talked about look at Mary and this is the way her life was before our product and this is after our product. Which kind of leads me to the next question.

Jon Speer:        The conventional wisdom that I think a lot of us are conditioned with is that all PMAs require clinical data. Is that true?

Mike Drues:     Yeah. This is exactly what a lot of people think. Unfortunately, those people are totally wrong. This is sometimes what FDA thinks. Unfortunately, they're totally wrong.

Mike Drues:     The vast majority of PMA's do require clinical data, there's no question about it. But, notice I'm saying the vast majority, I'm not saying all. Some PMAs, granted not many, but some PMAs do not require clinical data. Since the audience is so familiar with the 510K, let's do quick compare and contrast to the 510K. The vast majority of 510K's do not require clinical data. But again, notice I'm saying the vast majority. Some, and that number is rapidly growing, 510K's do require clinical data.

Mike Drues:     The question becomes, how do we know for a device whether it's a PMA, a 510K or De Novo or what have you, how do we know whether or not that device requires clinical data and if so, how much?

Mike Drues:     Well, this is not an answer that we should find in the regulation. This is an answer based on how well established the technology is, in other words, if it's been around for a very long time. What the pathophysiology is, what the risks are and so on. In other words, there's a lot of factors that go into the question of whether or not a device needs clinical data or not.

Mike Drues:     The regulation should not be one of them. Even if the FDA says you need to do a clinical trial, that doesn't necessarily mean that you need to do a clinical trial. As we've talked about before, John, FDA can ask us to do anything they want. But, that doesn't necessarily mean that we have to do it. If we can push back and say, look this technology is so well established there's no new information that we would get, then we can easily push back and make that argument.

Mike Drues:     One other thing that I would mention on the clinical data requirements, John, and that is a lot of people see this as a binary decision. It's either you have to do a clinical trial or not. I think the better question to ask is how much clinical data do we need? In other words, if we can show, for example, that our technology is well established, that the risks are understood, that the disease is understood, then we might be able to ... I hate to even phrase it this way, but we can get away with, or justify, doing a much smaller clinical trial than if the technology was brand new or the risks were not understood or that type of thing.

Mike Drues:     I'll give a perfect example. Bare-metal coronary stents, never mind even drug-eluting stents, but just a bare-metal coronary stent - was the level of difficulty to get the first bare-metal coronary stent onto the market almost 28 years ago the same as it is today? Absolutely not, because today the mechanism of action is much better understood, the risks are much better understood. Will we need to do a clinic trial? Of course, but we might be able to get away with a trial of maybe a few tens of patients as opposed to a few hundred patients. There's a big difference there.

Mike Drues:     In my opinion, John, the question of whether or not we need clinical data should not be answered by the regulation, it should be answered by the biology and engineering.

Jon Speer:        For sure. Folks, talking with Mike Drues from the Vascular Sciences today and we're talking about strategic advice for PMA manufacturers. Just wanted to remind all you guys, we're going through this green light guru, we have an EQMS software platform that's been designed by medical device professionals, specifically for the medical device industry. Why does that matter for PMA product? Well, there are certainly things you need to be doing during the design and development process such as your design and development activities - design controls, risk management - those are all the proof, the evidence that we're designing products that are safe and effective to meet indications for use. Doesn't matter, in my opinion, what your class of product is, whether it's a class 1, class 2 or a class 3 PMA. Design controls are foundational for telling your story that your product is safe and effective.

Jon Speer:        Mike, let's start to talk about some pros and cons or advantages and disadvantages of a PMA versus a 510K. I assume there are some, what are your thoughts?

Mike Drues:     Yeah, I think let's start out with a premise John. And that is, given a choice if a company has a choice between going for a 510K versus a PMA, I think you and I and probably most of our audience would agree, that 99.999% of the time they're going to opt for the 510K.

Mike Drues:     But, there are some significant advantages to a PMA, especially when it comes to what I call competitive regulatory strategy. I'll give you a quick example. Let's say that we're coming out with a new device, that we're in the kind of gray area, we're sort of between class 2 and class 3, it could go either way.

Mike Drues:     It would be very tempting to bring this to the FDA as a class 2 as a 510K, or perhaps as a De Novo, and that would make our job easier, but who else's job would it make easier? Our competition.

Mike Drues:     If we're working in a large medical device company, which is nothing more than code speak for having a lot of time and a lot of resources, and our competition are a bunch of start ups and small and VC funded companies, it might be advantageous to us to set the bar higher. To go to the FDA and argue that this is a class 3 PMA, and by the way it's much easier for me to sell a class 3 device at the FDA than a class 2 because we're already at the top of the pyramid, there's nowhere to go from up.

Mike Drues:     The advantage is, although it might make our job a little bit harder, it's also gonna make our competitors job harder to follow in our footsteps. And, I guarantee, John, 'cause I've seen this happen many times, if the competition finds out that the folks that are a little bit ahead of them have set the bar at the PMA level, that's gonna cause them to immediately reevaluate their technology strategy as well as perhaps their regulatory strategy. It might even cause them to close their doors and go out of business today.

Mike Drues:     That's just one of many examples of what I call competitive regulatory strategy. Using regulation as a tactical weapon to your advantage.

Jon Speer:        Yeah, and I think that's important. I always like in a PMA, in some respects, and I think you and I have talked a little bit about this even from a De Novo standpoint, is med device industry is often very keen to things like intellectual property and patents and things like that and while a PMA is not a patent, per se, it is, in some respects, a way to strengthen your position from an IP standpoint as well.

Mike Drues:     It certainly is, and the way I like to describe it John, it's certainly not a barrier to entry like a patent would provide. But, it can provide at least a speed bump in the road.

Jon Speer:        Let me throw a twist in on this. The fees for a PMA, well unless it's your first, the fees for a PMA are substantially more than a 510K, and if I'm a start up company, and I'm putting you on the spot here. I know you'll handle this as you always do, with good regulatory strategy.

Jon Speer:        Let's say I'm a start up, or an early stage company with a finite amount of capital, I can get a 510K for a few thousand dollars really, and the PMA might be a lot more time consuming, a lot more costly, it's gonna take more work and that sort of thing. Is that true?

Mike Drues:     Well, in terms of the user fees, John, regrettably you are exactly correct. The user fees for PMA's are much larger. For 510K's we're talking, give or take, five to ten thousand dollars [inaudible 00:26:30] depending on the company size.

Mike Drues:     In the PMA universe, we're talking 77,000 to a little over 300,000 once again depending on the company size. As you mentioned, though, it's important for people to understand, especially in smaller start up companies that your first PMA is free. So that is an incentive that Congress created for more medical device companies, especially small companies, to consider doing this.

Mike Drues:     I understand that user fees can be a significant cost, however, we have to be honest here. Compared to the cost of the overall development process, maybe that user fee is not as significant as it might seem to some people.

Mike Drues:     The reality of it is, that is the cost of doing business and so we have to factor that into our business calculus. But, more importantly, John, another question that I get, and this is an underlying assumption that many people in our industry make, and that is comparing the PMA to the 510K.

Mike Drues:     A lot of people think that the testing requirements for the PMA are higher, that the amount of time is longer, that the risk is higher, all those kinds of things. In general, that's true, but when you think about it, it should be that way because we're talking about devices that are often life supporting or life sustaining. We're talking often about devices that are technologically more complex than 510(k) devices, so it does make sense, but here's how my approach differs from so many other people in this industry. In my opinion, as a professional biomedical engineer, the amount of testing, the amount of clinical data and so on, should absolutely not be a function of the regulatory pathway. In other words, it should be a function [ge-M-A 00:28:26] versus 510(k) versus [denogle 00:28:28]. Those things are nothing more than the package that we put this information in when we send it to the FDA. What should go into the calculus to determine the testing requirements, the clinical data burden, and so in is the technology. How well established is it? Is it the risk? The pathophysiology of the disease and so on. That is independent of the regulatory pathway.

Mike Drues:     The reason why this is so important is because regrettably, John, and perhaps you've seen this as well, there are a number of medical device companies, including a few of the largest medical device companies on Earth that have, as a matter of business policy, decided that they will not pursue a device that is a class 3PMA because of this underlining assumption that PMAs are inherently more work. I just don't see it that way. More importantly, I think that's really holding us back.

Jon Speer:        Yeah. Let me summarize a few things that I think are very key points that Mike has, in my opinion, he shared some things that can debunk some of the reasons why we don't go down the PMA path. One of the first things he debunked was not all PMAs require clinical data. Sometimes people look at, "If I have to go down the PMA path, I have to do this long, expensive clinical study." That is not necessarily true. That's conventional wisdom number one that's debunked.

Mike Drues:     John, if I could just interrupt, just real quickly, I'm sorry, but that reminds me, in debunking that number one, as you just mentioned, if we're doing a device that's 510(k)-able but we're going to do a clinical trial anyway, then what I often suggest to the company is, "If we're going to do a 510(k) with clinical, then why not just do a PMA?" There's not a big difference between a 510(k) with a clinical trial and a PMA. Yes, there are more manufacturing requirements, more post market surveillance requirements, but other than that, that's just paperwork. There's not a huge difference.

Jon Speer:        Yeah, and those other requirements from a PMA standpoint, guess what folks? It's called your quality management system. Guess what? It's something you're going to have to do anyway, so it's not like it's necessarily extra, above and beyond work that you wouldn't have to do for a class 1 or a class 2 device.

Jon Speer:        Here's the other thing that Mike has helped us uncover and debunk. If this is your first PMA, the user fee excuse as far as the cost is concerned, that goes away because your first PMA is free. There's another compelling reason to consider PMA as a path. Really interesting. As Mike also just mentioned, is by and large, it might not be substantially more work, but it might, from a product positioning standpoint, give you a better edge in the marketplace with your product, too. Definitely some things to consider.

Jon Speer:        If a device is class 3, does that de facto mean, without a doubt, we always do a PMA?

Mike Drues:     Great question, John, and the short is answer absolutely not. If we're working in the class 3 universe, the PMA is one option, and it's of course the most common option, but other options would include the Humanitarian Device Exemption, or HDE, as well as the Product Development Protocol, or PDP. I know we're getting a little short on time, so I won't get into those in detail, but suffice it to say, those are often less regulatorily burdensome than a traditional PMA, and as a result, I love to use both the HDE and in some cases the PDP as a label expansion.

Mike Drues:     In other words, simply put, most medical products, we have to show that the product is safe and effective, but remember, I'm saying most, I'm not saying all. Average regulatory professionals know the rules, but the best ones know the exceptions. The HDE is an exception to that. We do not have to show efficacy for an HDE. Instead, we have to show what we call probable benefit. What's the difference between efficacy and probable benefit? We don't have time to get into a detailed discussion of that, but the simplest way I can explain it is it's efficacy at a lower statistical power, in other words, efficacy with fewer patients. Simply put, we can get an HDE device onto the market with much less data than a PMA, and as a result, we can then go back to the FDA later as a label expansion to go after a bigger market.

Mike Drues:     This is a strategy that I've used a number of times. This is a strategy that some other companies have used, but the short answer to your question, John, is if you're working in the class 3 universe, a PMA is certainly one option, and there are several different subtypes of PMAs, but it's not the only option. A good regulatory professional needs to understand all of the different options that they have, not just the common ones, not just the vanilla flavored ones, but all of the different options and the advantages and disadvantages of each, because quite frankly, if you don't know what all your options are, how can you decide what's the best path for you in that particular situation? In other words, how can you do your job?

Jon Speer:        Yeah, good points. Alright, let's wrap up today's conversation on strategic advice for PMA with maybe one last myth. I guess we'll determine if this is a myth that you can debunk or not. Sometimes, if I were to think ... I'm a company. I decide I'm going to go down this PMA path. I'm going to do all the things that I need to do, but one last hang up for me might be, if I do all the work with a PMA product, did I just pave the path for somebody else to come in behind me and go to market via a 510(k).

Mike Drues:     It's a great question, John. It's another very common question that I get from people, and that is, "Once I bring my device onto the market as a PMA, can somebody else follow in my footsteps using a 510(k)?" The textbook answer is no, because we're talking about class 3 devices, and 99.999% of the regulatory professionals out there would also probably say no, but I'm not interested in what the majority thinks. I'm not interested in just being average, because remember, I said average regulatory professionals know the rules; the best ones know the exceptions. It is possible to bring the same device onto the market as a 510(k) after somebody else has done it as a PMA, and I'll give you a possible scenario.

Mike Drues:     I mentioned the bare metal stent earlier. Sometimes people ask me, "There's already a ton of bare metal stents on the market. Can I bring a new bare metal stent to the market as a 510(k) rather than the PMA?" The short answer is no, but there's a possibility. If the indication for your bare metal stent is coronary atherosclerosis, then there's no chance that you're going to do this as a 510(k). You must do it as a PMA. However, if you can somehow come up with a different indication, a different reason for putting a bare metal stent in a coronary artery for something other than atherosclerosis, for example, for vasospasm, it is possible to go to the FDA and argue that, because the indication here is vasospasm, that the risk is lower to justify putting it in the class 2 bucket, and as a result, we can do it as a 510(k) or perhaps as a de novo.

Mike Drues:     Bottom line, most people think that once a device is a PMA, it will always be a PMA. That's often true, but it's not always true.

Jon Speer:        This has been enlightening for me. I hope all of you listening have found a nugget or two or five that you can take back to your companies. Should really, frankly, reconsider this as a path. This is not gloom and doom, as historically many companies think. I know companies think, "It's class 3 PMA. It's like the kiss of the death to my company." That's not true. We just debunked some of that head trash on this topic. Go back, reevaluate, and I would encourage you, if you have questions about this topic, you should reach out to Mike Drues from vascular sciences and use his knowledge, his experience, his way to navigate these regulatory waters to your advantage as well.

Jon Speer:        Mike, thank you so much for being a guest on this topic. I know there's a lot more that we can cover on this PMA topic. What do you think about maybe having another podcast here soon, and maybe we can explore what's new in the PMA world as a kind of a followup to this?

Mike Drues:     I think that would be a wonderful idea, John. I would love to talk about what's new in the PMA world. There are some suggestions being floated around. Some of them, I think, have some advantages. Some of them quite frankly have some concerns to me, and then I also have a proposal that I've floated myself for creating a version of the PMA that's specifically for [non-me-too 00:38:30] products, in other words, a de novo for class 3 devices, if you will.

Jon Speer:        Interesting.

Mike Drues:     I would love to be able to talk about that in a future discussion.

Jon Speer:        Alright. Folks, we'll get that on the books here soon. In your quest for greatness in the medical device industry, we need to make sure that we're focusing on what's good for patient, of course, but part of that is also making sure that we have a solid holiday management system and infrastructure in place to make our lives, frankly, easier as medical device professionals. I'm not saying we're cutting corners, but certainly, if you're of that mindset and you're looking at your processes and your procedures, and you're dreading filing out a certain form, and it's overly burdensome, and it takes extra time and effort, maybe there's a better way. Maybe there's a simpler path.

Jon Speer:        Maybe we can help you at Greenlight Guru. Reach out to us, www.greenlight.guru. Take a little bit of time to learn how we are changing the mindset of the medical device industry when it comes to your quality management system. Learn how we're shifting that mindset from being a checkbox, compliance-focused person to becoming a true quality professional. If that's at all interesting to you, then we should talk.

Jon Speer:        Once again, this is John Spear, your host, founder, and VP of quality in regulatory at Greenlight Guru, and you have been listening to the Global Medical Device Podcast.

 


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