[Music] 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 hey everyone today we're going to be talking about the denovo process and how you navigate that when you decide to go that way and the person we're talking with that about out today is Rob mcus he's the manager of Regulatory Affairs at Proxima clinical research where he oversees highquality regulatory submissions to the FDA other Regulatory Agencies as well um including Q sub requests 510k submissions denova classification requests premarket approval applications breakthrough device designation applications ID indd applications he's kind of done it all um 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 etan Nichols your co-host for the podcast well today I'm actually the the host we don't have John spear with us today he's off saving the world in a different way so 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 probably do a better job than I can rob go ahead yeah thanks etn and really excited to be here yeah so I kind of have a 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 uh space and helping companies launch their first class two 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 helped 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 are coming up on a year actually and uh it's going by quick I'm just loving it because we get to help lots of folks and lots of interesting Technologies and get to use uh green like G to help folks improve their quality management system as part of that so it's really a fun space I'm glad to be here awesome well I'm excited to get to talk to you today the topic that we kind of have on the the docket is uh denovo so one of the questions that I had you know if I I'm just I try to approach this kind of with a beginner's mindset I might have certain assumptions in my mind but I'll try to put those out what does denovo even mean to the medical device world yeah so I don't know about the actual translation of the word but to me it just means something new and something Innovative and so I like to think of it as okay if if you've got this new idea and you know you sketched it out on the Whiteboard so we've figured out now it's not going to be a class three medical device it's not going to require PMA because it's not that high risk to safety um but we've looked around and you know it's really Innovative so we're trying to go maybe see if the 510k pathways and options is there 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 and so to me that's when the denovo pathway might be the right choice for bringing this to Market how often does that actually come to fruition in your mind I mean 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 is it truly vetted where it truly is a denovo product yeah so there's there's a couple ways people can arrive at the decision you can kind of do the analysis for yourself and try to like go straight to the denovo submission pathway or sometimes people may try to do a pre-submission meeting and and get the opinions of FDA sometimes they might go the 510k pathway and FDA just says nope it's not substantial equivalent you have to go to noo 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 denovo but it's actually not nearly as common as the 510k pathway when we do our searches for substantial equ CR devices you could use used something that was a denova at one point in time so we searched the denovo approval database we searched the 510k database and there's a lot more predicates there to look at so it's it's not used as often I mean a lot of um submissions people are maybe expanding an existing technology or you know coming up with a new different way to do the same indication so it might be suitable for the 510k pathway so you know just the rate of innovation compared to incremental seems to be you know not quite as often but uh it's it's a fun opportunity when you get to work on those projects yeah okay do you have some examples of uh or or maybe what are some examples of devices that I might be familiar with that that word denovo I don't know that I have a ton of examples off the top of my head but typically what I think of is you know is this something that is really truly Innovative it's almost like you know somebody's making a brand new left-handed widget right and it's never been created before so it's just something that is really really Innovative so you know 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 have been going through the denovo pathway had that been there back when yeah yeah if it was coming to market today right if it was something that new and Innovative you know that's that's when we would look at the denovo I can see some pros and cons of doing that but I'm curious what your take is is so you know if I'm blazing a trail you know 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 you know knowing you're a lower risk device maybe you don't have to do a class three submission but how does that work what's the pros and cons of going the denova route yeah so a lot of people look at the cons first and say oh well I feel like I'm gonna have to do all of this extra work and you know there's a higher submission fee and so they get really hung up on you know some of those cons but to me the real opportunity with the denovo 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 me2 device or or copy this new innovation right if if it's that disruptive people are going to want to do it and so when when the FDA is reviewing a denovo 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 and so in some ways it's an opportunity to try to set the bar for Market entry if you will you know obviously FDA is making those determinations but with the special controls that a denovo submission selects it's really guiding FDA to really think about hey everybody should be looking at these types of things then as an innovator right 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 right yeah yeah so is that kind of something that they do maybe they'll go above and beyond just to to increase that barrier to entry or well so I mean obviously you don't want to go too far above and beyond needlessly right so there's always that balance of you know like the least burdensome perspective of course so you want to always try to keep that in mind but but it really is an opportunity to kind of you know be strategic and think about okay you know in a 510k pathway you know maybe other devices didn't have this particular test that we feel as innovators should have been there you know maybe it wasn't common in the in the type of setting or maybe it's just really not needed in that type of setting you know but we would like to see that in this space that gives you the chance to say well know 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 gives you the opportunity to say look we really want to make sure that this whole Space is held to a really high standard and so obviously that protects the consumers you know the users the patients but it's also an opportunity to try to you know really build and strengthen the field that makes a lot of sense I guess in my mind when I think about denovo I would assume it's a tough submission because you are sort of Blazing that trail is that accurate and and if so what what makes it tough to me the tough part can be you have to help the FDA become familiar with this new technology right they want to understand you know how are they going to need to approach this so that it fits into the regulations and 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 you know and there's usually a lot of questions that arise along the way about well you know 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 you know that these three end points are sufficient we wouldn't need a fourth one in a in a study for example and so it's it's a great time to have those conversations and get the Buy in at an early stage in the design process and and really understand what fda's thinking will be about are there additional concerns that they may have that were unanticipated right so that's always the benefit of a prub whether you're going the 510k pathway or the denovo pathway um but it really is also a chance for after to learn and get familiar with the technology and the device you know maybe maybe this is so new they're they're not familiar with it because they haven't seen anything like it yet you know they're experts in their field and in their domain so they'll be able to grasp it quickly but you want to make sure that that's being articulated well so you know the Pres submission meeting is really a great opportunity to work together with FDA and make that process easy easier versus I know some folks like to just go straight to a submission you know maybe it sounds appealing as a faster pathway but sometimes you can get in there and find out oh they were you know thinking something a little differently than what we did and now we've got you know we've gotta kind of backtrack a little bit so yeah if they don't fully understand yeah that makes a lot of sense if they if they don't even fully understand the device um I was talking to someone earlier today and they they have started to recommend sending a device with with uh to the FDA so they can hold it look at it I don't know if that's something you've seen or or experienced but I I haven't personally seen um clients requesting that strategy yet we've started to see folks with videos you know kind of doing that approach you know where you kind of get a chance to look at it and see it you know maybe an operation or something like that if it's particularly complex so yeah that's an interesting idea you know give them a give 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 yeah yeah go yeah maybe those days will return I don't know well when I think about kind of what you're describing one of the questions that pops up into mind is does it take longer to do a denovo 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 than maybe a 510k yeah that's a great question so the the review clock is longer for denovo the regulations are 120 days but there's a with MFA 4 there's a negotiation for 150 day clock so and that's a review clock that will pause as we all know when the FDA asks for additional information so for all practical purposes it could take you know up to a year in some cases you know depending on how long it takes to gather that data how many rounds of back and forth um again that's where the preset meeting can come in maybe and and help reduce a little bit of that time on the on the back end um make that process go a little bit smoother so it does take a little bit longer um because again the fda's perspective when they created the 510k pathway was you know this is something we're familiar with we've seen products in this space before so we kind of 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 denovo 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 and 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 um in the process C but you know to me it's also uh it's it's worth it to to have that Mark of you know being really Innovative in the field yeah being the leader being the first that's 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 to even do that well okay so personally I'm not sure I believe you it is it is humanly possible to plan for every single scenario so I grew up in Florida and so there you deal with hurricanes from time to time so one year we had done all the preparations you had all the bottled water the batteries you know we're watching the storm go over our house 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 like hearing a fire alarm going off and I've got these conflicting messages of like okay wait a minute you know supposed to stay inside so like 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 like I cautiously was kind of like poking my head outside and this was after the winds were so high the fire trucks weren't even supposed to be like responding but I saw a fire track outside and the guys in the truck were just like waving me back inside like go back in you're fine like get back in I'm like okay thanks oh wow had not thought that through what was I going to do right so I I so there you know I forget which general it was forgive me but you know the plan is nothing the planning is everything right so you 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 you know okay these are the types of scenarios and then there's always going to be that unanticipated curveball 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 yeah yeah I love that I mean I love that quote by the way too that's really cool um so okay well maybe we'll look at it a different way because I agree you know it's hard to 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 have otherwise if that if you just kind of take a realistic approach a risk-based approach but still realistic so that said what would you say and maybe maybe specific with denovo what are some pitfalls that you see some companies getting into or could get into yeah I think one of the pitfalls it's it's kind of universal Beyond denovo um but it can really come out um I've I've gotten stuck myself in this like analysis paralysis mindset of like oh my gosh I've got to have a perfect thing the first time and no errors no push back no questions and everything's going to go perfectly and you know that's just not reality right right I mean there's there's going to be something right you're gonna you know Miss a comment somewhere or something right like so like it but at the end of the day going through the process you know it's 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 you know maybe we utilize the Pres submission Pathway to try to get some you know 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 like a version two product in the future you know hey maybe our version two product which is more perfect if you will than the denovo that we're submitting now our V1 is the predicate for rp2 because we've you know it's pretty similar we're just adding a new feature or something you know so 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 like okay well maybe I can break this into stages and get like this is my first Milestone and this is you know phase one tier one a product one and then we'll go into phase two you we'll let the R&D team continue to innovate and develop right and they can make all these new cool things and they can finish that for v2 while we're getting the V1 pushed through you know a lot of times the the desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop you know that can really slow down the time to Market in that desire to get there and so sometimes it's better to get something out there that helps and then get the the full benefit out there a little bit later but it's always a case-by case basis too you know you don't want to compromise on that core technology and those core features that really make it special yeah I like what you're saying and it's um it makes me think of the case for Quality you know sometimes companies get focused on just pure compliance and forget really I mean they're building they they should be building a quality device that um you know a certain amount of Elegance a certain amount of uh you know Excellence um obviously without sacrificing compliance um so yeah the other thing I'd say is if you could if we could just shift our mindset a little bit because I mentioned earlier if I'm if I'm first in the market can I can I add a few extra features or make you know raise the expectations raise the bar to increase that barrier to entry rather get getting out of that that 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 um getting out of the mindset of just just blocking my competitors instead thinking okay what's the best advice I can give