Demystifying the De Novo Process

How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations?

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner.

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Some highlights of this episode include:

• In the medical device industry, De Novo refers to something new and innovative.  When you have an idea that has not been done before and is not substantially equivalent, then the De Novo pathway may be the right choice.

• The De Novo process is not as commonly used as the 510(k) pathway. The rate of innovation compared to incrementals tends to not be as often.

• Rob describes the pros and cons of the De Novo pathway. Some people think it requires extra work and higher submission fees, but it’s an opportunity to work with the FDA to create and regulate a new product category that may be copied.

• The De Novo pathway takes longer to review than 510(k) submissions due to risk management activities. It’s worth it to be the first innovative leader in the field.

• Think, prepare, and plan for different scenarios and conflicting messages when choosing a pathway to avoid pitfalls, such as analysis paralysis.

• Don’t compromise core technology and features when making a product/device. Focus on quality without sacrificing compliance to improve quality of life.

• Work together and collaborate to understand the client’s needs and amount of key information to give to the FDA to provide meaningful and quality feedback.

Links:

FDA - De Novo Classification Request

FDA - Medical Device Overview

FDA - Q-Submission Program Guidance

FDA - 510(k) Submission

FDA - Premarket Approval (PMA)

FDA - Case for Quality

Rob MacCuspie on LinkedIn

Proxima CRO

True Quality 2022

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable quotes from rob maccuspie:

“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.”

“The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.”

“The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.”

“Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.”

“Don’t be afraid of the De Novo process. It’s actually a really great tool.”

Transcript

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.

Etienne Nichols: Hey, everyone. Today, we're going to be talking about the De Novo process and how you navigate that when you decide to go that way. The person we're talking with that about today is Rob MacCuspie. He's the Manager of Regulatory Affairs at Proxima Clinical Research, where he oversees high quality regulatory submissions to the FDA, other regulatory agencies as well, including Q- Sub requests, 510( k) submissions, De Novo classification requests, pre- market approval applications, breakthrough device designation applications, IDE/ IND applications. He's done it all. He has a lot of knowledge in this area, and he's very passionate about getting products to market in a safe and effective as well as efficient way. So I think you can learn a lot from this episode, so stay tuned for the rest. Hey, everyone. Welcome back to the Global Medical Device Podcast. This is Etienne Nichols, your co- host for the podcast. Well, today I'm actually the host. We don't have Jon Speer with us today. He's off saving the world in a different way, but with me today, I'm really excited to have Rob MacCuspie from Proxima Clinical Research. Rob has a lot of background in regulatory affairs and helping companies bring devices to market. I'll let you speak to your experience. You'd probably do a better job than I can, Rob, go ahead.

Rob MacCuspie: Yeah, thanks Etienne, and really excited to be here. Yeah, so I have an interesting career path. I started out as a PhD bench chemist in the national lab system at NIST and got the idea of science and business at that intersection. Got to do a brief stint in academia at a startup university, and then transitioned into industry and was in the natural products space and helping companies launch their first Class II medical devices, getting to do product education, product development, Director of Labs. So got experience with quality management systems and the importance there and building things. And then got a chance to go to a couple of startups and help them launch some products, and really got that itch and been here at Proxima Clinical Research for over a year now, as the Regulatory Affairs Manager. Coming up on a year, actually. And it's going by quick, and just loving it, because I get to help lots of folks and lots of interesting technologies, and get to use the Greenlight Guru to help folks improve their quality management system as part of that. So it's really a fun space, and glad to be here.

Etienne Nichols: Awesome. Well, I'm excited to get to talk to you today. The topic that we kind of have on the docket is De Novo. So one of the courses that I had, I try to approach this with a beginner's mindset. I might have certain assumptions in my mind, but I'll try to put those out. What does De Novo even mean to the medical device world?

Rob MacCuspie: Yeah. I don't know about the actual translation of the word, but to me it just means something new and something innovative. So I like to think of it as okay, if you've got this new idea and you sketched it out on the whiteboard, so we've figured out now it's not going to be a Class III medical device. It's not going to require a PMA, because it's not that high risk to safety, but we've looked around and it's really innovative. So we're trying to go maybe see if the 510( k) pathway's an options. Is there a substantial equivalent predicate device? But we just really can't find anything that's really substantially equivalent. This is just so new, so innovative, so cool, there's nothing else like that out there. So to me, that's when the De Novo pathway might be the right choice for bringing this to market.

Etienne Nichols: How often does that actually come to fruition in your mind? I mean, and maybe I should ask a question before I ask that question, which is what does the process actually look like for a person who has that idea? How often is it truly vetted, where it truly is a De Novo product?

Rob MacCuspie: Yeah. So there's a couple of ways people can arrive at the decision. You can do the analysis for yourself and try to go straight to the De Novo submission pathway or sometimes, people may try to do a pre- submission meeting and get the opinions of FDA. Sometimes they might go the 510(k) pathway and FDA just says, " Nope, it's not substantially equivalent. You have to go De Novo." That happens pretty rarely now. In history, that was the only way you could enter it. So it's a little more efficient to go straight to De Novo, but it's actually not nearly as common as the 510(k) pathway. When we do our searches for substantially equivalent predicate devices, you could use something that was a De Novo at one point in time. So we searched the De Novo approval database. We searched the 510( k) database and there's a lot more predicates there to look at. So it's not used as often. I mean, a lot of submissions, people are maybe expanding an existing technology or coming up with a new different way to do the same indication, so it might be suitable for the 510( k) pathway. So just the rate of innovation compared to incremental seems to be not quite as often, but it's a fun opportunity when you get to work on those projects.

Etienne Nichols: Yeah. Okay. Do you have some examples of, or maybe what are some examples of devices that I might be familiar with that were De Novo?

Rob MacCuspie: Well, so I don't know that I have a ton of examples off the top of my head, but typically what I think of, is this something that is really truly innovative? It's almost like somebody's making a brand new left- handed widget, and it's never been created before. So it's just something that is really, really innovative. So if you think about the insulin pump community, there's a lot of insulin pumps that are out there, but the very first insulin pump that came on the market when that was just a brand new technology, nobody else had ever had, that would've been going through the De Novo pathway, had that been there back when. If it was coming to market today, if it was something that new and innovative, that's when we would look at the De Novo.

Etienne Nichols: I can see some pros and cons of doing that but I'm curious what your take is. So if I'm blazing a trail, there's a lot of work to be done, I would assume. And maybe we can get into what that extra work would be. You did mention knowing you're a lower risk device, so maybe you don't have to do a Class III submission, but how does that work? What's the pros and cons of going the De Novo route?

Rob MacCuspie: Yes. A lot of people look at the cons first and say, " Oh, well, I feel like I'm going to have to do all of this extra work. And there's a higher submission fee." So they get really hung up on some of those cons. But to me, the real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category. And you're going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future. So inevitably, there's going to be folks trying to have a me too device or copy this new innovation. If it's that disruptive, people are going to want to do it. So when the FDA's reviewing a De Novo application, they're thinking about well, for the next product that comes along, what are the types of testing that we're going to want to see to make sure the next product is safe and effective, just like this one? So in some ways, it's an opportunity to try to set the bar for market entry, if you will. Obviously, FDA's making those determinations, but with the special controls that a De Novo submission selects, it's really guiding FDA to really think about hey, everybody should be looking at these types of things. And as an innovator, typically folks know what that type of testing is for their product. So they're going to know, " Okay, hey, look, to convince ourselves this was working before we wanted to go to market, this is what we were doing." So of course we want everybody else to be doing at least that much.

Etienne Nichols: Yeah, yeah. So is that something that they do? Maybe they'll go above and beyond just to increase that barrier to entry, or?

Rob MacCuspie: Well, so I mean, obviously you don't want to go too far above and beyond needlessly. So there's always that balance of the burdensome perspective, of course. So you want to always try to keep that in mind, but it really is an opportunity to be strategic and think about, okay, in a 510(k) pathway, maybe other devices didn't have this particular test that we feel as innovators should've been there. Maybe it wasn't common in the type of setting or maybe it's just really not needed in that type of setting. But we would like to see that in this space. That gives you the chance to say, " Well, we were going above and beyond. We'd like to see all the competition do that," where the FDA may have been able to be convinced one way or the other, it gives you the opportunity to say, " Look, we really want to make sure that this whole space is held to a really high standard." So obviously that protects the consumers, the users, the patients, but it's also an opportunity to try to really build and strengthen the field.

Etienne Nichols: Yeah. That makes a lot of sense. I guess in my mind, when I think about De Novo, I would assume it's a tough submission because you are blazing that trail. Is that accurate? And if so, what makes it tough?

Rob MacCuspie: So to me, the tough part can be you have to help the FDA become familiar with this new technology. They want to understand how are they going to need to approach this so that it fits into the regulations? So a lot of times, we recommend doing a pre- submission meeting with the FDA, so they have a chance to get familiar with the device. They'll get a chance to see the description, the intended use, and there's usually a lot of questions that arise along the way about, " Well, we think this might be sufficient, but we're just not 100% sure if FDA thinks this is a large enough sample size for our study," or that these three endpoints are sufficient. We wouldn't need a fourth one in a study, for example. So it's a great time to have those conversations and get the buy- in at an early stage in the design process and really understand what FDA's thinking will be about, or there additional concerns that they may have that were unanticipated. So that's always the benefit of a pre- sub, where they go on the 510(k) pathway or the De Novo pathway. But it really is also a chance for the FDA to learn and get familiar with the technology and the device. Maybe this is so new, they're not familiar with it because they haven't seen anything like it yet. They're experts in their field and in their domains, so they'll be able to grasp it quickly, but you want to make sure that's being articulated well. So the pre- submission meeting is really a great opportunity to work together with FDA and make that process easier versus I know some folks like to just go straight to a submission. Maybe it sounds appealing as a faster pathway, but sometimes you can get in there and find out, " Oh, they were thinking something a little differently than what we did and now we've got to backtrack a little bit," so.

Etienne Nichols: Yeah, if they don't fully understand. That makes a lot of sense. If they don't even fully understand the device. I was talking to someone earlier today and they had started to recommend sending a device to the FDA, so they can hold it, look at it. I don't know if that's something you've seen or experienced, but...

Rob MacCuspie: I haven't personally seen clients requesting that strategy yet. We've started to see folks with videos, doing that approach where you get a chance to look at it and see it, maybe an operation or something like that if it's particularly complex. So yeah, that's an interesting idea. Give them a little show and tell, I mean, I guess that's something maybe people did back in the days when we traveled on site for those meetings too.

Etienne Nichols: Yeah, yeah, yeah. Maybe those days will return. I don't know. When I think about what you're describing, one of the questions that pops into mind is does it take longer to do a De Novo? It feels like maybe there's a certain amount of risk management activities that need to take place to do it right, but does it take longer than maybe a 510( k)?

Rob MacCuspie: Yeah. That's a great question. So the review clock is longer for a De Novo. The regulations are 120 days, but there's a... With MDUFA IV, there's a negotiation for 150- day clock. And that's a review clock that'll pause, as we all know, when the FDA asks for additional information. So for all practical purposes, it could take up to a year in some cases depending on how long it takes to gather that data, how many rounds of back and forth. Again, that's where the precep meeting can come in maybe, and help reduce a little bit of that time on the back end, make that process go a little bit smoother. So it does take a little bit longer because again, the FDA's perspective when they created the 510( k) pathway was this is something we're familiar with. We've seen products in this space before. So we generally understand what we're going to ask for in the safety and efficacy. And we just have to look at does that meet the requirements, versus De Novo is okay, let's make sure we've got the requirements set for that next round of review for when this becomes a predicate device in the future. So that requires a little bit of extra time and care and attention for them to do. So yeah, it does take a little bit longer in the process, but to me, it's worth it to have that mark of being really innovative in the field.

Etienne Nichols: Yeah. Being the leader, being the first, that's super cool. I imagine as a regulatory affairs professional, you're probably hit with a lot of different scenarios and you have to plan for every scenario. How do you go about doing that? Is it possible to even do that?

Rob MacCuspie: Well, okay, so personally, I'm not sure I believe it is humanly possible to plan for every single scenario. So I grew up in Florida, so there you deal with hurricanes from time to time. So one year, we had done all the preparation, we had all the bottled water, the batteries. We were watching the storm go over our house, or our apartment complex. And apparently the wind was driving the water so hard, it triggered one of the fire alarms in the hallway. So it's the middle of a hurricane and I'm hearing a fire alarm going off, and I've got these conflicting messages of, " Okay, wait a minute. I'm supposed to stay inside, so a tree doesn't fly by and hit me, or something. But the building's on fire and it's not safe to stay inside." So, okay. I had not thought this scenario through. What do I do here? So I cautiously was poking my head outside. And this was after the winds were so high, the fire trucks weren't even supposed to be responding, but I saw a firetruck outside and the guys in the truck were just waving me back inside, like, " Go back in. You're fine. Get back in." I'm like, " Okay, thanks."

Etienne Nichols: Oh, wow.

Rob MacCuspie: I had not thought that through, what was I going to do? So I forget which general it was, forgive me, but the plan is nothing, the planning's everything. So you try to prepare for as much as you can anticipate, and then just be ready to respond as best as you can because you've thought it through and you have all of these, okay, these are the types of scenarios. And then there's always going to be that unanticipated curve ball that comes at some point and you're just like, " All right, let's roll with it. This is what we got and we'll get through it."

Etienne Nichols: Yeah. I love that. I mean, I love that quote by the way, too. That's really cool. So, okay. Well, maybe we'll look at it a different way, because I agree. And I think some medical device companies think they're planning for every scenario and as a result, maybe it takes longer than it would've otherwise, if you just take a realistic approach, a risk- based approach, but still realistic. So that said, what would you say, and maybe specific with De Novo, what are some pitfalls that you see some companies getting into or could get into?

Rob MacCuspie: Yeah, I think one of the pitfalls, it's universal beyond De Novo, but it can really come out. I've gotten stuck myself in this analysis paralysis mindset of like, " Oh my gosh, I've got to have a perfect thing the first time and no errors, no pushback, no questions and everything's going to go perfectly." And that's just not reality. I mean, there's going to be something. You're going to miss a comma somewhere or something. But at the end of the day, going through the process, it's about saying, " All right, this is everything that we've thought of, this is everything we've anticipated. We're really confident in this." And maybe there's some questions, maybe we utilize the pre- submission pathway to try to get some ideas, but we're going to go with this is version one, and we're going to try to get that out there. We know there's opportunities for a version two product in the future. Hey, maybe our version two product, which is more perfect if you will, than the De Novo that we're submitting now, our V1 is the predicate for our V2, because it's pretty similar. We're just adding a new feature or something. So this idea of getting locked into it's got to be perfect, it's got to have everything in it versus like you were describing, having that risk- based approach of okay, well, maybe I can break this into stages and get like, this is my first milestone. And this is phase one, tier one of product one. And then we'll go into phase two. We'll let the R&D team continue to innovate and develop. And they can make all these new cool things and they can finish that for V2 while we're getting the V1 pushed through. A lot of times, the desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market in that desire to get there. So sometimes, it's better to get something out there that helps and then get the full benefit out there a little bit later. But it's always a case by case basis too. You don't want to compromise on that core technology and those core features that really make it special.

Etienne Nichols: Yeah. I like what you're saying. And it makes me think of the case for quality. Sometimes companies get focused on just pure compliance and forget really, I mean, they should be building a quality device that a certain amount of elegance, a certain amount of excellence obviously without sacrificing compliance. So yeah, the other thing I'd say is if we could just shift our mindset a little bit, because I mentioned earlier, if I'm first in the market, can I add a few extra features or raise the expectations, raise the bar to increase that barrier to entry, rather getting out of that marketing mindset, I suppose? I don't know if that's the right... Sorry for those of you who are marketing who are listening, but getting out of the mindset of just blocking my competitors. And instead thinking okay, what's the best advice I can give right now for the customer to improve their quality of life? I like what you're saying. That makes sense.

Rob MacCuspie: Yeah. I mean, I think for a lot of us in this industry, we went into it because we want to help people in some way. So the idea of being able to help some people sooner and get that better tool out there and then make an even better tool the next day when we come back, that's going to keep us coming back and keep us helping others. So I think that's really a great mindset to shift into looking into that. So yeah.

Etienne Nichols: There's something else you mentioned. And that was the communication with the FDA and in speaking with the context of pitfalls, potential pitfalls that companies could get into, what are some thoughts around there as far as the communication goes with FDA?

Rob MacCuspie: So one of the things that we see is sometimes there's a reluctance to want to provide all the information to the FDA, especially in a pre- submission meeting, because they're like, " We're still innovating our product. We haven't reached design freeze yet, but we want some feedback and we're worried it's going to impact our De Novo application if we tell them we're going to do something and then change our minds later, or we don't want to give them information because we don't know what the answer is yet. So there's a little bit of just trying to understand what are the client's needs there, what's the information you're trying to seek and how much information can you give FDA as background and context so that they will truly be able to give you the meaningful feedback you're looking for. Right? If you don't give them a sufficient like protocol for testing for your VNV plan, if you haven't gotten there yet and why this is an important aspect for the safety efficacy of the product and why you feel this is a sufficient approach, why you feel this is a valid statistical sampling plan or whatever those aspects are that you're looking to get the feedback on, you want to give them as much background as you can. Not to say that you want to flood them with information. They're humans too. They're under tight deadlines like we are. So you want to make it so that it's an efficient presentation, but you want to have all that key information there so you get that quality feedback you're looking for versus if there's not enough information there for the FDA to make a decision, a lot of times they'll come back and say that and say, "Look, we just don't understand enough about your device especially if it's new to offer any feedback at this time. So we'd like to see more about X, Y, and Z before we can answer your question." So now you got to go through another round, which can add to timelines sometimes unnecessarily. So that's I would say one of the bigger pitfalls that we've seen along the way.

Etienne Nichols: Yeah. I could see it. It's hard to trust sometimes, especially when it's a government authority, I suppose. I don't know, but I see the mindset there. Yeah.

Rob MacCuspie: But that trust is an interesting thing, because I've seen with quality folks and quality teams that sometimes people don't even trust the quality team in house and it almost becomes like an adversarial relationship. Like, " I'm worried they're out to get me." Don't get me wrong, I've seen occasional quality teams that have a gotcha mentality. But really, most of the quality folks I've seen that really do well are inspiring the team to say, " Look, we're here to help. We're here to work together." And the quality systems in a lot of ways, if it wasn't written down, it never happened. So we're just trying to document all the great things that you were doing anyway, so that when somebody comes and knocks on the door and says, " Well, how do you know this is the greatest product ever?"" Well, yeah, here's everything that we've got to show you this is what we thought about. This is why we included these design features. This is how we tested it to make sure it was working. This is how we know we're making it the same way every single time to make sure every customer gets the one that's working as it should, as it was designed." All of the great things that I see in companies every day wanting to go and do, it's almost like you get to brag about all the great work that everybody else is doing if it's going well. So shifting into that mindset doesn't happen overnight. It's easy to sit here and say, " Yeah, this is a great aspirational goal," especially when sometimes quality has to come back and say, " There's just not enough data yet. Design team, we got to go back and tweak this or fix that." That's sometimes the bearer of bad news. It's hard to hear that, but ultimately that's going to protect everybody in the long run and help hit those goals that everyone's set out in the project with in the beginning. So it's like a journal article peer review process. You've always got the reviewer one that loves the article, just a champion. Then you got the reviewer three that's really poking holes in the argument. But then you're like, " Oh, man, darn that reviewer three," but then you know what? My paper's stronger for it. And now that it's published and I can't change it, I'm glad a few years later that they made me put that in there.

Etienne Nichols: Yeah. It hurts in the moment, but oh, long term, it's so good. Yeah.

Rob MacCuspie: Yeah, absolutely.

Etienne Nichols: I had one guy in my career, he told me, " Quality, you can look at them as police or you can look them as a partner and you should look at them as a partner." So especially manufacturing teams, they struggle sometimes with that because they just validate it to their equipment. But then yeah, you're absolutely right. Okay. If we go back to De Novo for just a minute, let's say we know we want to do that process. We know we're a novel device and there's no predicate out there. What are some things we need to start doing earlier, as far as between that decision and the actual submission, what should we be doing and getting together and getting ready?

Rob MacCuspie: Yeah. To me, it's a very similar process for any submission. You're going to be wanting to again, get the quality management system in place, get the design history file going the user needs, design inputs and outputs, the VNV testing. You're going to want to be looking at what are the special controls that we're going to want to put in place for this. How does that map to the intended use? So there's going to be a lot of time and thought into what are those special controls, so what's the testing that we're going to need to do? The De Novo package is going to have the obligatory sections, like your regulatory history, some background about the device, the device description. You're going to want to make sure that when you get to that point where you're now starting to do the labeling and the manuals and things like that, you've got all of those components compiled and ready to go. So to me, it's the summary and the compilation of everything that goes into the process. So to me, if you've got a good product development process, it's going to lead to getting everything that you need. So you can start on that De Novo packet then just start filling things in as they come in, so that it's not as overwhelming. And then you're ready to go right at the last minute when everyone's excited and it's like, " Okay, can we turn it in?"

Etienne Nichols: Yeah. No, that makes sense. Are there any changes or maybe differences when it comes to the actual clinical side, the actual validation and so forth?

Rob MacCuspie: So in some cases, the FDA may want to see larger patient populations that they may want to see larger in terms of numbers and maybe larger in terms of representative groups. Maybe there's a special subpopulation for the particular indication that they want to see a little bit more data on. So sometimes that can impact things, maybe take a little bit longer to complete the trial. So we've seen some cases like that, but in terms of a well- designed clinical trial, it's going to be required. Sometimes with 510( k) s, you don't necessarily need that clinical trial. So that's going to be a key difference there depending on the risk level, but a lot of the devices that we've seen as De Novos come in at a Class II, so they're getting into that risk level where a clinical trial really makes sense, especially with something new to go in there with.

Etienne Nichols: Okay. I know we focused on the FDA because De Novo's specific. What are some equivalent things? If I have a novel device in the US, maybe it's a globally novel device. What are your thoughts there? Do you have any knowledge to share when it comes to other regulatory spaces?

Rob MacCuspie: Yeah. I mean, with the CE mark, to me, I'm just familiar with devices having to go through the Notified Body Process to get that CE mark. So again, it's a case by case basis and the notified bodies are going to be reviewing that everything that needs to be in that dossier if you will is there and is complete, so in that case again, it might be requiring a little bit more burden of evidence, just like the FDA wants to see a little bit more burden of evidence. So I think in that sense, there's probably going to be a similar increase in terms of the lift that's required there.

Etienne Nichols: Yeah. But basically, everything you've told me so far though almost feels like companies shouldn't be afraid to be innovative... not necessarily innovative. I don't think anyone's necessarily afraid of that, but don't be afraid of the De Novo process maybe. Is that accurate?

Rob MacCuspie: Yeah. I mean, I guess if I've got one message that I hope folks walk away with is yeah, don't be afraid of the De Novo process. Actually, it's a really great tool and the idea is that you really want to look at... We were talking about earlier, what's going to be the best device that we can make for the patients that solves this need in the clinical workflow, that's going to really improve the patient outcomes? So what's the best way we can leverage our really cool technologies and innovations and bring those to market? So thinking about that first and then saying, " Okay, is 510( k) the best strategy? Is De Novo the best strategy? Is PMA the best strategy?" Because maybe in order to really help the patient populations, it might be just that higher risk level and PMA might be appropriate. So you don't want to water down that innovation just to go an easier regulatory burden pathway and then lose some of that power and that potential opportunity. So to me, I really want to encourage people to think about what's the reason for being in the first place? Why did we set out on this journey? And then, okay, how is that going to fit into the regulatory pathways that are out there and how can we navigate that in the most efficient path possible?

Etienne Nichols: Yeah. Okay. You mentioned something about the PMA that made me curious. I don't know that we covered this necessarily. Suppose we go down the De Novo pathway, with a certain amount of risk management activities already completed, but we get to a certain point, we realize the risk profile's actually much higher than we expected. How does that look? Does it revert to a PMA? What are the processes there?

Rob MacCuspie: Yeah. So I've seen that go a couple different ways with folks that are innovating in that space. So in some cases, you have a choice of like, it's within your control to say, okay, to maybe oversimplify this, " There's a cancer patient population we could help with this." So the cancer patient population puts us in Class III almost right away, because of how we're helping. Okay, well, maybe there's a different indication where we can still use our core technology, but it's a lower risk population. So maybe what we'll do is we'll launch two versions of our product. First one might go the De Novo pathway, and we can get to market faster and get some revenue and help that population. And then the second one might be the PMA patient pathway for the cancer population, so we'll have two versions of products and then obviously there'll be the additional burdens for the testing for that second product and the higher risk pathway. Sometimes though, that's not really possible. Maybe what you're describing is a case where okay, we're doing some investigation, we do some discovery and it really is now Class III, because there's just these additional considerations that put it into a little bit higher risk category. So in those cases, people do have to make a choice of, " Okay, do we want to pivot and go down the PMA pathway with this particular product, or do we want to maybe see if there's something else that we want to do that would be maybe a different innovation or different application that would be a different regulatory pathway, maybe something different altogether?" So those are the kinds of conversations I see folks tending to have when they go to that pathway, if it's like, okay, well, this really is just going to be one shift that moves us in that direction. But there might be some ways in some cases where you can identify that early on and try to do some investigation and figure out is there anything we can do in that case and try to recognize that as early as possible.

Etienne Nichols: Yeah. Okay. That makes sense. And when you're doing that, do the design controls... I guess I'm curious about when you need to have that determination made. Throughout your design controls process, is it early? Is it just user needs inputs? Maybe when you have the VMV plan put together. Any recommendations?

Rob MacCuspie: Yeah. So we see a lot of folks doing that regulatory assessment work at the very early stages, sometimes-

Etienne Nichols: Oh, wow.

Rob MacCuspie: ...even before they've established their quality management system. So in some senses, you almost can't have that conversation too early. I know everyone feels that their domain, you can't have that conversation too early, but we used to use a stage gate process at one of the places I worked. So having those initial early, really high level conversations with everybody in the room to make sure that it's like, okay, marketing wants to make this claim. Well, that's going to push it into Class III. But the core technology, if we make this claim, pushes it into Class II. Having those conversations up front, " Well, we just can't make any money off of this unless we go to Class III route." Okay, well, hey, finance folks, do we have enough runway to get there? For the Class III, do we want to do it? Having those conversations early on can lead to better outcomes in the long run? Again, you can't anticipate everything, back to what we were talking about earlier. You're not going to have it all done, but with that risk mindset approach of okay, we've got some uncertainties here, but we're comfortable with the level of uncertainty and the level of risk we're taking, yeah, we think it's worth going out and doing some of that R& D work now. We think it's worth doing a little bit more digging on the regulatory front to make sure we can really confirm this pathway. We think it's true, it's going to happen. So having those conversations early can really de- risk it in the long run.

Etienne Nichols: Yeah. It sounds like you're mitigating a lot of business risk by treating it like a system, having all these inputs from the different departments, the cross- functional team, even finance and marketing. Absolutely, I love that approach. It just mitigates your business risk considerably, sounds like, so.

Rob MacCuspie: Yeah. Well, I mean, that's the strength of a good team, right?

Etienne Nichols: Right. Absolutely. Well, very cool. How can people find you and learn more about what you're doing?

Rob MacCuspie: Yeah. ProximaCRO.com is a great place to start. We've got a lot of information there. We've got different blog posts and different content and some videos, little explainer videos that are nice, short, and sweet summaries of different things and concepts. So great place to start if you're looking for more information, whether it be about De Novos or any of the other categories and areas that we help with. I'm available on LinkedIn as well. Find me at Rob MacCuspie, there's not a lot of MacCuspies in the world apparently. So it should be pretty easy to find me and you can link to it from my bio page on the Proxima website as well. So those are some good ways to get ahold of me.

Etienne Nichols: We'll put links in the show notes as well, so that people can find you and reach out directly and get ahold of you as well. Any last thoughts that you want to leave with the audience? Recommendations, suggestions, advice, anything?

Rob MacCuspie: Yeah, I think just coming back to what we were talking about earlier, the De Novo process can sound scary. There can be maybe some preconceived notions and some scary stereotypes of, " Oh my gosh, it's impossible to go this pathway," but it really is an opportunity to really showcase and get something new to market and set the standard for the industry with this new innovation, and really help establish and work with the FDA to make sure that everything in that space is going to be of the standard that you would hope as an innovator. That way, it helps protect the brand of the company and the idea and the innovation itself, because you wouldn't want to copycat/ me too, having any issues that tarnish the brand. So the De Novo process is really a great way for folks that are in that innovative space to really in a way, almost get recognized for being a true innovator and really differentiate what they're doing out there. So really want to encourage people to think about why it is they're doing what they're doing and pick the best pathway for it. And maybe De Novo is it, and maybe there's another pathway too.

Etienne Nichols: Awesome. I love that. And I'll start spreading the word myself. It's not as scary as maybe it sounds initially. That's great to hear and I love you breaking it down so simply. Well, I want to especially thank you for being on the podcast and thank our listeners for listening. You all have been listening to the Global Medical Device Podcast powered by Greenlight Guru. So if you're interested in a medical success platform that is specifically designed and built for medical device professionals, look over at Greenlight. guru, check out the website and get more information there. Thanks, everybody. Let you get back to your day. See you later.

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