How to Make De Novo a Viable Option for your Medical Device

Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo? Think again. Who cares about de novo? We do! Today’s guest is “Dr. De Novo “(a.k.a. Mike Drues of Vascular Sciences), who describes how to make de novo a viable option for your medical device. 

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Some of the highlights of the show include:

• For years, use of de novo was rare; fewer than five devices were brought to market. MDUFA stats state FDA received 56 de novos in 2018; 18 in 2019.
• Congress deserves credit for changing the law to make de novos more attractive to companies. De novo nuances became less problematic and challenging.
• Mike’s public prediction in 2012 came true. De novo pathway has increased in importance, popularity, and usage; but still pale in comparison to 510(k).
• De novo is advantageous option for medical device technology, especially mobile medical apps, imaging, and in-vitro diagnostics (IVDs).
• Rather than focusing on options from a regulatory pathway, analyze and account for who at the agency will be the recipient due to their de novo experience.
• 510(k) vs. De Novo: Is device new and novel? Or, similar in technology and labeling to another device on the market?
• De Novo: Applicable for lower than Class III medical devices; 510(k) requires substantial equivalence and risk; de novo only needs risk mitigation strategy.
• FDA’s review time of de novo submissions average six to eight months, while 510(k) submissions take three to four months.

Links:

De Novo Pathway: Explaining the Process for Medical Device Companies

Advanced Strategies and Tactics for Using the De Novo Pathway

Guest Editorial: The de novo pathway – strategies and tactics to use and avoid

Secrets Of The De Novo Pathway, Part 1: Why Aren't More Device Makers Using It?

Secrets Of The De Novo Pathway, Part 2: Is De Novo Right For Your Device?

FDA De Novo Program

FDA Premarket Notification 510(k)

MedTech True Quality Stories Podcast

Drug Industry Association (DIA)

Medical Device User Fee Amendments (MDUFA)

Mike Drues

Greenlight Guru

Episode Quotes by Mike drues:

“For the first decade or so of the de novo’s life, it was used very infrequently. That is obviously changing." 

“We have to give Congress credit. They changed the law to make de novos much more attractive to companies.”

“Any monkey can see a trend...where were all these people five years ago predicting the trend, before that data was observable?”

“The numbers of the de novo, although they are higher, they still pale in comparison to the 510(k).”

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: Yeah, I know you're thinking De Novo, who cares? It's a kiss of death for your product. It's not something that's really a realistic thing to consider as a regulatory pathway so yeah, I know you're not gonna listen to this because it's all about De Novo but you should because De Novo might be the best option for your medical device. I've got Dr. De Novo on this episode of The Global Medical Device Podcast, so tune in to listen who Dr. De Novo is and get some tips and pointers on how this might be a viable path for your medical device. Hello and welcome to The Global Medical Device Podcast, this is your Host, Founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. We talked a lot about regulatory, regulatory strategy, different types of submission, we put a lot of emphasis on 510(k) s in recent content and podcast episodes, and there's certainly been a ton that has come out from FDA about that, but there's another submission that we've talked a little bit about here and there, but I think one is very important and I think will be gaining in importance in the rest of this year and years to follow. And that is the De Novo pathway, so who better to talk about De Novo and its benefits than Mike Drues from Vascular Sciences. So Mike, welcome to The Global Medical Device Podcast.

Mike Drues: Well, thank you Jon. As always it's a pleasure to speak with you and your audience.

Jon Speer: So, I remember back in the day Mike, it wasn't that long ago, but it was a few years ago where you... If you identify that De Novo was kind of the pathway for your device, I remember that almost like a kiss of death for what you were doing. Do you remember those days?

Mike Drues: I do Jon. Thank you for reminding me that I'm getting older. Yes, you're exactly right. For the first decade or so of the De Novo's life, it was used very infrequently. In fact, on average, less than five medical devices were brought to the market each year under the De Novo and that is obviously changing as we speak, but in many ways it could be considered the kiss of death at that time.

Jon Speer: But you know, to... Well, someone's credit I guess, I'll give credit to FDA 'cause I think they had a huge part in it, but it seems like the tide has turned quite a bit, it's like some of the nuances and the gotchas that were a part and parcel with the De Novo pathway, they don't seem to be as problematic or challenging for companies. Would you, I guess, agree with that sentiment?

Mike Drues: To a certain extent, Jon. Let's go back in history just a tiny bit. So as I said, the first decade or so after the De Novo was created, it was used less than five times per year. We cannot really give, to be fair, FDA credit. We have to give Congress credit because back in 2011 and '12 they changed the law to make De Novos much more attractive to companies. And as a matter of fact Jon, not to toot my own horn, but back in 2012, I was invited to give a presentation at the drug industry association, the DIA Annual Meeting, and at that time I predicted publicly that based on those changes, that it would become a much more popular pathway to market. Over the last five or so years, that is exactly what's happened. So I kind of find it interesting on a personal note, how so many people are talking about it now, you know, in an increase in its popularity. Well, quite frankly, any monkey can see a trend after there's... In this case, five data points, but where were all these people five years ago when I think the trend before that data was observable.

Jon Speer: Alright well, let's give people kind of an update on... I mean, it still pales in comparison to something like a 510(k) as far as the volume but if you look at the baseline of... Let's say five per year about a decade ago, where are we sitting at today? How many De Novos like in 2018? And... I don't know if there are 2019 numbers but how much more popular is the De Novo pathway today?

Mike Drues: Well, it is increasing. First of all, your point about the comparison to the 510(k) is well taken, the numbers of the De Novo although they are higher, they're still pale in comparison to the 510(k). So just some statistics for you Jon, and I don't carry these statistics around in my head, I actually look these up in the most recent MDUFA report through February of this year. There were 56 De Novos that were received by the FDA in the calendar year 2018, and thus far this year, in 2019, there have been 80... I'm sorry, there have been 18 received. So given that we're actually on trend at the moment to have more De Novos in 2019 than we did the 56 in 2018. Of those 56 that were granted last year, Jon, I'm sorry, that were submitted that were received through the FDA, 44 of them were granted. Now, one of the most common questions I get from companies is what's the average success rate for De Novos. It's very difficult to calculate that because some of those De Novos that were granted in 2018 were actually submitted in 2017 or maybe even in 2016.

Mike Drues: So it's very difficult to come up with an accurate success rate. 44 of them as I said, we're granted, the others were still pending, a decision has not been made yet. Some cases they were withdrawn. In a few cases, the FDA declined the De Novo and in some cases, the company decided to switch to a 510(k) or sometimes even a PMA, if they didn't make the case that it's less than class III. What's interesting to know Jon, about those statistics is you really have to go beyond just those MDUFA statistics, is what parts of the agency are seeing more or less De Novos, and it's an interesting statistic about 27%, almost a third of De Novos that were received last year by the FDA were specifically for In Vitro Diagnostics or IVDs. And again, not to toot my own horn Jon, but in the webinar that I did for Greenlight about a year ago on the De Novo, one of the things that I said was the De Novo is a very attractive option for medical device technology companies across the board, but the three that I highlighted were mobile medical apps, imaging and IVDs, and that's exactly what's happening here.

Mike Drues: And the reason why I bring that up, Jon, is because one of the many things that I take into account into my calculus in developing my regulatory strategy is how much, if I'm gonna do a De Novo for example, how much the De Novo experience does that particular group at the agency have? For example, as I mentioned IVDs, there's a lot of experience with the De Novo, other areas of FDA not so much. And so, for example, if I have a platform technology, if I have a device that could be used for many different applications, one of the many factors that I take into account is which part of the FDA, do I wanna bring it to first. Cardiology, gastroenterology, neurology, urology, and so on. Because not all of them have the same De Novo experience. So if I take it to a group that has more De Novo experience first, it's going to make it easier to bring it to another group later on that has less De Novo experience because I wouldn't quite do it this way Jon. But when I go into the second group, I can kinda start out by saying, "Well we've already had this conversation with your friends up the hall, and this other group. And so why are we having this conversation with you? I don't know about you Jon but I'm not sure how many regulatory consultants take that kind of account into their calculus for developing their regulatory strategy.

Jon Speer: You know it's... I don't know why it wasn't obvious to me before, but my goodness Mike that is definitely in the category of a pro tip. I think so often, we get caught up or focused on the options from a regulatory pathway, we don't go a layer or two deeper to really analyze who at the agency is going to be the recipient of this. And it's very insightful. It's an excellent tip that folks should consider and factor in whenever they're figuring out options and pathways and different ways to work with the agency. That's a... This was a fantastic pro tip thanks for sharing that. But it is interesting I mean, what is it that... I'll ask you speculate a little bit or maybe you know, but what is it that you think about medical device apps and IVDs that make it a little bit more prone to the De Novo side of things?

Mike Drues: Well, that's a good question, Jon. So when it comes to mobile medical apps, and imaging and IVDs, I think there are a lot of advantages of the De Novo across the board in terms of starting out with a blank slate when it comes to the labeling. Not having to show substantial equivalence. In those three technology areas, those are some very significant advantages. Again, I know, for the purposes of this particular discussion Jon we're somewhat limited on time, but I would point the audience to the webinar that I did for Greenlight a year or so ago where I go into these in much more detail.

Jon Speer: Alright, and maybe it bears mentioned at least briefly without getting super deep. Some people, I shouldn't assume, but some people might be hearing about De Novo for the first time, and may not know what it is and why it matters and sort of thing. So maybe take a moment or two and give a high level overview of what De Novo is, that might be helpful for these folks.

Mike Drues: It's a great question, Jon, and thanks for the opportunity to talk about what I call De Novo 101. So here's my De Novo 101. First and foremost, the De Novo is appropriate for medical devices that are less than class III. So any medical device that's class two or below is applicable for a De Novo. It's also applicable for a 510(k). Because both the De Novo and the 510(k) are for less than class III devices. Okay, so that's question number one. Can you show that this is not a class III device. Question number two gets into 510(k) versus De Novo. And this is a conversation that I have with a lot of companies that decide whether they go to 510(k) route or the De Novo route. The simple answer is, is there another device out there on the market, that's very similar to our device, what we call a predicate device? And when I say similar, what I mean is in terms of the technology as well as the labeling.

Mike Drues: So if there's a device out there that is very similar to ours, in terms of the technology and the labeling, then that might be a push towards the 510(k) side. On the other hand, if you're working on a device that it is truly newer novel, in other words a device that's not similar to something out there in terms of technology or labeling that's gonna be approached to the De Novo. Because one of the big advantages of the De Novo is you don't have to show a substantial equivalence. One of the things that you brought up in your recent column on the De Novo Jon, is that many people think that the 510(k) is the simplest pathway to market for medical devices, but in many ways the De Novo is even simpler than the 510(k). And here's why; because the 510(k) comes down to two things, substantial equivalence as well as risk. In other words, quite frankly, I don't care if you filled out all the forms properly, if you've dotted all your Is and crossed all your Ts. Unless you have a rock solid, substantial equivalence argument and a bullet proof risk mitigation strategy, your 510(k), is simply not going to be successful. Certainly not first time out of the box. But in the De Novo world, it's actually simpler. Because in the De Novo world, there is no substantial equivalence. If there was, you would be in the 510(k).

Mike Drues: So the De Novo comes down to one and only one thing. Risk mitigation strategy. And here's the example that I like to share with people when I talk about the De Novo Jon. Think about a band aid. Today band aids are ubiquitous. But back in the day, there were no band-aids. So if we were bringing the very first band aid on to the market, what would be its default classification? We would have no choice, it would be set at class III. And when you think about it, that makes sense because it doesn't have any history. So we set the risk bar as high as we possibly can. But it shouldn't take an MD or a PhD or an RAC after somebody's name to appreciate that, "Gee, it doesn't make sense to treat a band-aid like an artificial heart for no other reason than it's new." So when it comes to the De Novo, the simplest way I can explain it, it comes down to one thing Jon, risk mitigation strategy. We have to go into the FDA, and to be able to argue with a straight phase and that it doesn't, here's our band-aid. It's brand new, there's nothing like it on the market, but it doesn't make sense to treat our band-aid as an artificial heart. Instead it should be class two and here's why or a class one, and here's why. So that's sort of the De Novo 101, does that make sense, Jon?

Jon Speer: It totally does, it totally does. And folks, this is not trying to diminish what a De Novo is and the details, there's a lot of nuances in these details and Mike has written about, talked about, he mentioned the webinar that he did with Greenlight a bit ago. So we'll provide a whole bunch of information for you all and the text that accompanies this podcast on the De Novo do you can dive much much deeper than that. But yeah the context makes sense. And folks I wanna remind you all, I'm talking with Mike Drues. Mike is the president of vascular sciences and today we're talking about De Novo and some of the benefits of this particular path from a regulatory perspective. And while I got your attention on brief interruption. Did you know that Greenlight Guru that we launched a brand new podcast? Yep, that's right.

Jon Speer: You'll have to go check out MedTech True Quality Stories wherever you're listening to this podcast, a Global Medical Device podcast, you'll be able to find MedTech True Quality Stories. So to go to iTunes, or Sound Cloud or any other place that you're consuming podcasts, check it out. It's fantastic. We're talking with CEOs and medical device professionals working with companies and bringing new products to market, and they're sharing some of their challenges and what's worked, what hasn't worked, and it's really fascinating. So be sure to check it out and share that with your friends as well. Alright, so Mike, let's get back to De Novo. I don't know if this is fair or not, but it does seem like whenever you talk about De Novo or whenever I hear about De Novo anyway, it's almost like there's always a comparison between De Novo and 510(k). I mean is that fair to always have this two topics sort of bundled together in the same conversation?

Mike Drues: Well, I do think in many ways, it is a fair comparison, Jon. Because they're sort of opposite sides of the same coin. In other words, both the 510(k) and De Novo as I just explained are appropriate for class two medical devices or lower. So it does make sense to compare them. And in that sense Jon, one of the most common questions that I get when I talk to companies about the 510(k) versus the De Novo decision is what's the typical review time or the average review time? And by the way Jon, I hate when people ask me that question, because...

Jon Speer: Oh I know.

Mike Drues: Because it's so variable. But let me just share some statistics with you and your audience. And I did a little fact checking, because some of this statistics are a little different than what some people in the press will have people believe. So right now, according to the most recent MDUFA statistics, the average review time for De Novos across the board is about 183 days. Now, that's the total time to the decision. In other words, that includes both the FDA time as well as the company's time. So about 183 days. Now putting that in comparison, those statistics have remained fairly constant, over the last five years. In other words in 2013, about five years ago, the average review time was about 260 days and over the last five years, the numbers have fluctuated a little bit, but largely we're talking between six months and eight and a half months. In spite of what the politicians will have us believe, there's really been only a decrease in De Novo review time over the last five years of about two months. Is that significant? Well, in my opinion, if I'm gonna be brutally honest here, Jon, it's really not significant at all.

Mike Drues: Because... And some companies are probably not gonna like to hear this, but a lot of the companies that I see out there, including some of the ones that I work with, they waste so much time. It takes them so long to a seemingly simple thing that a reduction of two months over five years from the FDA is not a very significant reduction in my book. But nonetheless, the review times are going down a little bit. So most importantly for when it comes to planning purposes, here's what I say to companies, "If you're gonna submit a De Novo figure on average, about six to eight and a half months for a decision. From the time that you make the submission to the actual decision. Now putting that in comparison to a 510(k). I also looked up the most recent statistics for the 510(k). The average total review time for 510(k) across the board and keep in mind Jon as you well know, and 510(k) universe is a very broad universe, is about 105 days. So bottom line, for a 510(k), we're talking averages across the board. And figure about three to four months for a De Novo, figure about six to eight months.

Mike Drues: So a De Novo is, give or take, a few months longer than a 510(k). Why? Well when you think about it, Jon, this makes total sense. Because as I said earlier, a De Novo is for new and novel products. Products where there is not a comparable me-too out there already. So it does make sense that it's going to take a little longer for FDA to review that submission because we don't have anything to directly compare it to. In addition, a new product code is created, new regulation is created in some cases, new special controls are created. So all of that takes a bit of time. But nonetheless I don't think a couple extra months of a De Novo review should be a negative thing when it comes to a company making a decision of 510(k) versus De Novo.

Mike Drues: On the contrary, Jon, there are some very significant advantages of the De Novo, especially when it comes to competitive regulatory strategy that will make those few months, just payout in comparison. And one other thing that I wanna just remind our audience in the 510(k) universe is that although the average time to decision for a 510(k) right now is sitting at about 105 days, please keep in mind that 70% of 510(k) submissions are being sent back by the FDA to the company with an additional information request. I think that's totally embarrassing, as an industry. And you and I had talked about this before, Jon. 70% of these submissions are basically being marked 'Incomplete' for whatever reasons. I think that's just, quite frankly embarrassing. And then the last thing that I mentioned...

Jon Speer: I mean, it's alarming. Hang on... I wanna hang on that for a moment 'cause it's kind of alarming because that number hasn't really improved in a... Well, I think ever is probably the actual word but... It's like the quality of our submissions, at least on the 510(k) world don't seem to be trending in the right direction. And you and I have talked about this in the past, on a previous episode of the Global Medical Device podcast. Most of the times, the reasons for the additional information, they're almost always 100% in control of the company. So this is inexcusable, really.

Mike Drues: Regrettably, Jon, I could not agree with you more. As I said publicly many times, our... And by the way, I take no pride in saying this about our industry, but our industry has devolved, not evolved, but devolved to the point where we are essentially treating the FDA as our elementary school teacher. In other words, "Here's my homework assignment, will you please mark this up and give it back?" And I'm sorry, Jon, maybe I'm getting a little old but that's not the way this game is supposed to be played. So, as you and I have also talked about before, we can greatly hedge our bets by avoiding an additional information request or some other kind of a problem, by communicating with the agency in advance of the submission, whether it's with a pre-submission meeting or something else. And as you know, Jon, the popularity of the Pre-Sub program has increased over the last several years; as a matter of fact, there were over 2700 Pre-Sub requests...

Jon Speer: Wow.

Mike Drues: Just last year. Not hell, but over 2700 Pre-Sub requests.

Jon Speer: Wow.

Mike Drues: And simply put, Jon, and this is a topic of another discussion and I did a webinar for Greenlight on this as well, but the Pre-Sub can be the company's best friend, it can also be the company's worst nightmare. Most Pre-Subs in my opinion, Jon, are not successful. The question is, "What is a successful Pre-Sub?" My definition of a successful Pre-Sub is when everybody walks out of the room agreeing with me, by that criteria, Jon...

Mike Drues: Most Pre-Subs are not successful. But fortunately for me, because I do... I do quite frankly know what I'm doing when it comes to putting together the biology and the engineering, and the regulatory all in one, you can have a successful Pre-Sub, and you can really minimize the delays and so on later on. So my best advice, and people that listen to us before, you've heard me talk about this many times, talk to the agency in advance. But the last thing I'll remind everybody of, Jon, is remember my regulatory mantra, and that is, "Tell, don't ask. Lead, don't follow." Please don't go to the FDA with a Pre-Sub, and basically ask the FDA, "What do we do?" That's not their job to tell you what to do. [chuckle] That's our job.

Jon Speer: Yeah.

Mike Drues: Anyway, back to the De Novo.

Jon Speer: With respect to de novo, I mean there's still... You and I have talked a fair amount about Pre-Subs in the past, but there's a lot of value in a Pre-Sub for a de novo, can you maybe speak to that just a little bit?

Mike Drues: Absolutely correct. Let's take this up a notch or two. So, when I go to the FDA with a de novo as a Pre-Sub, I say, "Here's my device, this is the way that it works, this is our labeling and so on, we're gonna bring it on to the market as a de novo. But before I tell you why I'm bringing it onto the market as a de novo, let me first tell you why I'm not bringing it onto the market as a 510(k)." In other words, I want to take away every possible opportunity that I have for FDA to disagree with me. And by the way, Jon, that street now runs in two directions, because as you and I have also talked about the 510(k) is under a tremendous amount of controversy and it has today. So, when I go to the FDA and I did this just a couple of weeks ago with a Pre-Sub; if I go to the FDA with a device as a 510(k), I say, "Here's my device, this is what it does, this is how it works, this is our labeling and so on, we're gonna bring it onto the market as a 510(k). Before I tell you why we're gonna do it as a 510(k) let me also... Let me first tell you why I'm not doing it as a de novo." So once again, when I play this game, Jon, and this is a Poker game to be, in every sense of the word, I wanna take away every possible opportunity that I can for FDA to disagree with me.

Jon Speer: Yeah, I mean, that's sound advice. And folks, you've heard me say this about Mike, before I was thinking I should start calling him Dr. De Novo, but that would be limiting, he...

[laughter]

Jon Speer: In all seriousness. Mike is a pro at this, and I don't know how his real poker game is, but his regulatory poker game is fantastic. He makes it to the final table, and he usually leaves the table with the tallest stack of chips. So...

Mike Drues: Well, thank you for saying that, Jon. And by the way, one or two other things to add.

Jon Speer: Yeah.

Mike Drues: Speaking of controversy of the 510(k) as you and I have talked about many times before, it's actually become much more difficult for me to sell a 510(k) at the FDA today; and conversely much easier today to sell the De Novo...

Jon Speer: Wow.

Mike Drues: At the FDA. And so I try to use those political winds to my advantage. And here's an interesting question to you, Jon. So the popularity, the number of de novos as we talked about has increased over the last several years. There's no question about it. But can we conclude that because we have more De Novos being granted today that we have more new and novel medical devices coming onto the market as opposed to 510(k) me-toos, do you think we can make that conclusion based on that data, Jon?

Jon Speer: This feels like a trap question. I was like, "Well, Mike does this to me on the spot." My knee-jerk response is, no, you can't make that conclusion. So I'm gonna stick with that, I'm not gonna dive into the trap any further.

Mike Drues: Well, as you did get the correct answer Jon, but let me explain why I'm bringing this up. Because a lot of the politicians are saying that because of the increase in the de novos, that we have more new and novel devices. And simply put, that's a conclusion that the data simply does not support. In other words, it's possible that we have more new and novel devices, but it is also possible that because of the controversies around the 510(k) as I mentioned a moment ago, 510(k)'s are now becoming more difficult to sell at the agency, and therefore FDA is pushing more in the de novo direction. I'll give you a recent example Jon, and I have to be a little careful what I say because this is a device still under development. We brought a device to the FDA just a few months ago as a 510(k), and my opinion as a professional biomedical engineer, this was a very strong, very legitimate 510(k). FDA did identify a couple of new risks that were in our particular device, that were not present in the predicate device. And as an engineer, I have to stipulate that, yes, they are correct. Those were new risks, but in my opinion, they were trivial risks. It's kind of like the old expression, "You couldn't put an eye out with that."

Mike Drues: So they were new risks. Now, in the past, and when I say in the past Jon, I'm talking about just with... More than just say two years ago. That would have never raised an eyebrow at the FDA. But now FDA is taking a much more literal interpretation of the risk regulation when it comes to the 510(k). And I think, Jon, you and I perhaps have talked about this a little bit in the past, and I happen to be a subject matter expert for FDA in a couple of different areas. One of them being risk, but suffice it to say, the risk regulation for the 510(k) has not changed since the 510(k) was created in 1976. But what has changed, and what is changing is the interpretation of that regulation. So, in that particular case that I described a moment ago, the FDA is pushing back on the company very hard that... Not be because of substantial equivalence, but because of risk. This device does... I think does create the new risk which again I won't stipulate, but I would also comment that they're trivial risks, and as a result, this device should be a de novo. Now, in the past, I am 100% confident that we would have been able to get that device onto the market as a 510(k).

Mike Drues: As a matter of fact, there were so many examples that I gave to the FDA from the imaging world, Jon. And, you asked about imaging earlier. So we brought MRI machines onto the market using CT as a predicate. Now, it should not take a PhD in biomedical engineering or an expert in risk to appreciate that gee, maybe there are some differences when it comes to risk for MR versus CT.

Jon Speer: Yeah. That's right.

Mike Drues: And so, in the past, that was a no brainer. But in... Currently, things are changing, so the regulation has not changed, at least not yet. There are some proposed changes, but nothing has gone into effect. But what has changed and what is changing, is people's interpretation of that regulation. As I've said before Jon, regulation is all about the interpretation of words, and our ability to defend our interpretations.

Jon Speer: Yeah. Absolutely. And I... I know we can go back in time, and I know you might have first brought this to the world's attention back in 2012-2013 about the de novo pathway, but I recall some time last year, maybe it was a couple of years ago during some of our conversations. This was in... Beginning so to speak, of the flurry of all the '510(k)' changes that were coming from the agency. I don't remember if we talked about it actually on the podcast or just in one of our conversations but we talked about it. Is this... Is this almost a movement to almost drive or push the de novo as a more preferred pathway? So, we could speculate on that a little bit, but you said something a minute ago that I wanna kinda of dive into just a bit and use as sort of the wrap up for our podcast today. You said something about there are some competitive advantages of a de novo over a 510(k), would you care to elaborate on that a little bit as we wrap up the conversation today?

Mike Drues: Absolutely Jon. Happy to do so. And again, thanks for the opportunity to do just that. So, look, we can say a lot of things about the 510(k), but at the end of the day, it comes down to one thing. We have to show for a 510(k), that our device is basically the same, I.e. Substantially equivalent to another device already out there on the market in terms of both technology as well as in terms of labeling. In some cases that's easy, in other cases it's not. But in the de novo, we don't have that limitation. In the de novo world when it comes to labeling... Let's just focus on the labeling for a second Jon. When it comes to labeling, we start out with a blank slate, a blank canvas, and we can literally paint onto that canvas anything that we want. We can make any claim that we want as long as we can support it.

Mike Drues: One of the things that differentiates my approach to this game Jon compared to some of the others, is, I refuse to be the regulatory police. I refuse to tell companies what they cannot do. If a company says we wanna make the claim that our new device regrows missing limbs and cures cancer, I say, "By all means go for it, as long as you can prove. As long as you can prove it." So let me use a specific example to illustrate what I call competitive regulatory strategy. A few years ago, a company came to me, they had a sterilization device. It was kind of like an auto plate. And they told me that they were gonna bring this on to the market as a 510(k). And I said, "Okay, fine. Tell me a little more about your technology." Well, it turns out that they were able to achieve the same level of sterilization as the other devices out there but at a significantly lower temperature point. And I said to them, "Okay, you couldn't do this as a 510(k), there would be nothing wrong with that, but what would you have accomplished?" Nothing. Because now, why should anybody use your particular device when they could use one of the other 50 or so other devices that are like that. And so instead of doing the 510(k), they did a de novo, and we incorporated this low-temperature claim in our high-level labeling. And what did that buy us, Jon?

Mike Drues: Well, one of the things that results from a successful De Novo. It creates a predicate that your competitors can use to get their new device onto the market as a 510(k). But, you see, we can make it more difficult for them to do that if we, as I just described, include this technology claim, this low-temperature claim in our high-level labeling. Why? Because, now nobody else can use our device as a predicate unless and until they meet our technology. And oh, by the way, if we own the IP on that technology, that ain't gonna happen any time soon. So this is one of many examples of what I call, competitive regulatory strategy, Jon. A very sophisticated way of using regulation to your advantage. A way that, in my opinion, most people don't even think about. What do you think about that idea Jon?

Jon Speer: I love it. It goes back to that head trash or moment in time that I started with this conversation that, it used to be a kiss of death, and I think that that head trash, that baggage is still probably lingering throughout the industry. I think, to your point that you offered a little bit ago, that even though the review time is theoretically longer, if you look at the averages by maybe a couple of months, there's such a... A much greater upside from a De Novo path. And I love the idea. I love the thoughts, the advantages, the, just figuring out how this could be used to your benefit rather than to your detriment.

Mike Drues: Well, I agree with you 100%, Jon. Like everything, there's advantages and disadvantages, in the conversation that you and I have been having today, it's very illustrative, it's very similar to the conversations that I have with companies every single week. When we talk about... Assuming that our device is class II or lower, what are the advantages and disadvantages of the 510(k)? What are the advantages and disadvantages of The De Novo?

Mike Drues: And one last thing that I'll mention quickly Jon before we wrap this up, we have to make that decision, not just from a regulatory perspective, but we also have to take into account reimbursement and product liability and other things as well. You can't make these regulatory strategy decisions in a back shop. What good is it after all to get a product onto the market, that is get it through the FDA, via De Novo or some other pathway, only to come to find that nobody can use it 'cause nobody can get paid for it 'cause CMS won't reimburse for it? What good is it to get a device onto the market under the De Novo or any other pathway only to come to find that it causes harm to people, and you as a manufacturer gets sued, and you didn't take into account your product liability when it comes to the strategy as well? So, this is a complex game Jon, but one of the first steps is to separate the different pieces of the puzzle, try to understand them individually, and then put them all together to make something that looks like a coherent big picture.

Jon Speer: Absolutely. So, folks, I am gonna use Doctor De Novo. [chuckle] He does other things more, above and beyond De Novos, but he's got a track record that's impeccable and a success rate that is... Frankly should be the bar for the rest of those dealing with regulatory submissions. Of course, as soon as you all start to reach the bar set by Mike Drues, they'll figure out a way to exceed that. But, in all seriousness, Mike Drues, Vascular Scientist, he is the best when it comes to creative, and really... I think creative is a good word here. I wanted to make sure It wasn't a misappropriation, but a creative regulatory strategy that makes sense to help companies maximize the value of the products that they're bringing to market.

Jon Speer: As always, I wanna thank Mike and his insights on these topics. It's truly helping the industry. I mean, I get comments all the time from many of you who listen about how you're enjoying these conversations. Certainly, if there's topics that you would like Mike and I to dive into further, shoot us a note, we'd be happy to dive into any type of regulatory topic that you're curious about. This is the highlight of my day. I get to have these conversations, this is why I get to have probably the best job in the world because I get to talk about these things with pros like Mike Drues. So, as always folks, this is the founder and host of the Global Medical Device podcast and VP of Quality and Regulatory at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device podcast.

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