What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).

Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device.

 

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Some of the highlights of the show include:

  • BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. 
  • BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.
  • STeP is for medical devices and device-led combination products that improve the safety of currently available treatments or diagnostics that target an underlying disease or condition less serious than those eligible for BDP.
  • FDA hones in on the indication statement for breakthrough devices. A general indication statement of intended use that is not indication specific is more likely along the lines of STeP, then it is a breakthrough device.
  • BDP designation and STeP need to be their own usually distinct q-submissions. It’s a 60-day period between submission and final designation or denial. At day 30, most get a request for more information.
  • Some of the drawbacks of the BDP and STeP process include engagement and interactions with the FDA that do not go as expected. 
  • Consider reimbursement early on because it’s important. The Centers for Medicare and Medicaid Services (CMS) has paused the Medicare Coverage of Innovative Technology (MCIT) reimbursement for BDP designation.

 

Links:

Isabella Schmitt

Proxima CRO

Breakthrough Device Designation Reimbursement

FDA - BDP

FDA - STeP

STeP Guidance Document

510(k) Premarket Notification

Premarket Approval (PMA)

De Novo Classification Request

Q-Submission Guidance

European Union Medical Device Regulation (EU MDR)

Emergency Use Authorization (EUA)

Centers for Medicare and Medicaid Services (CMS)

Medicare Coverage of Innovative Technology (MCIT)

Medical Device User Fee and Modernization Act (MDUFMA)

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable Quotes from Isabella Schmitt:

“When you have more of a general indication statement, it’s more of an intended use and not really indication specific, that’s probably more along the lines of STeP than it is a breakthrough device.”

“FDA really hones in on the indication statement for a lot of breakthrough devices.”

“Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.”

“The FDA’s bar can get a little bit higher for your clearance or approval because you’re focusing on specific language...and you’re basically making claims that need to be proven.”


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.

Jon Speer: Welcome to the Global Medical Device podcast, powered by Greenlight Guru. This is your host and founder and Greenlight guru Jon Speer, and on this episode of the Global Medical Device podcast, I catch up with Isabella Schmitt. Isabella is the director of regulatory affairs for Proxima CRO. You can check out more for Proxima CRO by visiting their website: proximacro.com, very easy. On this episode, Isabella talks some in depth about breakthrough device designation as well the Safer Technology program. Both are programs from the FDA. Talks a little bit about the differences and the similarities between the two and the potential benefits of pursuing these as options. Enjoy this episode of the Global Medical Device podcast. Hello, and welcome to the Global Medical Device podcast, now with video. We're trying a new tool out, so bear with us. Hopefully we get through this episode with little or no technical glitches. Joining me today is Isabella Schmitt. Isabella is the director of regulatory affairs for Proxima CRO. Isabella, welcome back.

Isabella Schmitt: Hello, I'm a familiar voice but probably not face although I've been on a couple of your summits, so I guess I'm sort of familiar.

Jon Speer: Well, I'm going to remind people, if you're listening to us wherever you've been listening to the Global Medical Device podcast, that's fine, but if you want to get the whole video element to it, check it out. We're on YouTube. We'll be posting links on LinkedIn and the usual channel, so do check that out. But, Isabella, I guess, in your role at Proxima and as a director of regulatory affairs, you deal a lot with different types of submissions. There's a couple programs that, I don't know maybe they're not popular, but I think they're interesting. One is the breakthrough device designation program, and the other is the STeP program. For listeners of the Global Medical Device podcast we've talked a little bit about those things before, but regardless, can you maybe give folks a little bit of an overview of what a BDD is and what the STeP program is as well?

Isabella Schmitt: Sure. I will say BDD is pretty popular. STeP, not so much, because it's so new. BDD's, I call them BDD's, sorry, breakthrough device designation, my acronyms, I'm throwing them out there already. Breakthrough device designations are designations for medical devices that treat or diagnose life threatening or irreversibly de habilitating conditions, and they essentially have an improvement over the current standard of care in some form or fashion. They may be a completely new technology, so there is no really comparison device or drug to treat or diagnose this condition, or they could be a modification of an existing technology. Ultimately, they show or have the potential to show that they're more effective than current technologies out these. There is a component to breakthrough device designation that does include that they're more safe, which is basically, I'm going to shift to safer technology program in a second, is basically the crux of the Safer Technology Program. With breakthrough device designation companies apply. If they treat a life threatening or diagnose a life threatening or irreversibly de habilitating condition. Then they usually get feedback within 60 days from FDA, and they have the ability to engage in different types of interactions with the FDA than normal products do, so non breakthrough device products. This can just facilitate more collaboration and more interactive discussion with FDA, or it's supposed to at least. Priority review for the final pre- market submission, things of that nature. Also companies, it's great for marketing and fundraising, especially to say, " Hey, I have a breakthrough device, and it's been designated as such by FDA." On the other hand, STeP is a newer program. There was a draft guidance out a couple years back, but the final guidance was released. It's for products that are not life- threatening or irreversibly de habilitating, or not products that treat those types of diseases. It still offers some sort of safety benefit to the current technologies that are out there. It's really more focused on safety and kind of eliminating the need to have a life- threatening or irreversibly de habilitating condition that you're diagnosing or treating.

Jon Speer: Okay, that's a great overview. One of the things that I think, well I know I've heard, that I think is confusing for some folks is they think, oh I got breakthrough device designation. They almost describe it as if that is a specific type of FDA submission. I was like, " No, no, no, that's not exactly the case." You're still going to have to go, depending on your classification, you're still going to have to go through the 510( k) or PMA or what have you. This is just, to your point, I think you said this, this just gives you a little bit of priority when you're in the queue. crosstalk

Isabella Schmitt: Gives you a leg up.

Jon Speer: Yeah, it gives you a leg up. What are some scenarios where a company may be choosing one or the other. Can you choose both, I mean. I guess, talk about some examples. I know you can't share always intimate details, but if you have some generalities that you can share, that would be helpful, I think.

Isabella Schmitt: I have seen since the STeP final guidance came out that in some of these breakthrough device interactions that I've had with FDA they'll either be on the fence about a product being breakthrough device, or they think it's not, and they'll start suggesting STeP. Sometimes they suggest it and it makes sense, and other times, I'm like, it doesn't make sense. This is a life- threatening condition. The situations that you would look at are really primarily focused on the indication, right, so is this a life- threatening or irreversibly de habilitating condition, or is it more acute of an issue, right. If it's an acute issue, you're more likely to fall into STeP. If it's long- term, life- threatening, more likely breakthrough device. When you're thinking about this, when you have more of like a general indication statement, like it's more of like an intended use and not really indication specific, that's probably more along the lines of STeP than it is breakthrough device because FDA really hones in on the indication statement for a lot of breakthrough devices. Usually one of the last steps when you're about to get designated is that there's some negotiation about the language, patient population, the indication in that breakthrough device designation. They're really specific about the indication whereas I've seen general use devices, and there have been general use devices that have got breakthrough device designation that maybe now that they have the STeP program, they probably would have been more appropriate for STeP. But, typically, I've seen them now referring them more to the STeP program than the breakthrough device program. You can go for both. You can go for breakthrough device first, say, and then the FDA says, " Nah, I don't think you're really a breakthrough device. Maybe you should do STeP." Then, you can apply to STeP. I mean, it's not like you get told no for breakthrough device and then that's it. You don't have the option to do STeP. Or, even if you get told no the first time for breakthrough device, you can always reapply if it's something like, " Oh, we really need to see more evidence." The more evidence part is kind of the sticking point for specific types of products because it can be a little bit confusing because FDA says, " Hey, we just need a reasonable expectation," but that terminology is very vague, and so what do they mean by that.

Jon Speer: Yeah, I mean, you hit on a couple things. The priority access, I think, is a benefit. Sounds like, to me, oh I've got breakthrough device designation. That sounds like, wow that's cool, right. STeP doesn't sound as cool, but again I think it's still a great thing to pursue if applicable because of that priority status. Can I just look at and say, " Oh, I have this cool device. Here are the criteria. Oh, I'm breakthrough," or do I have to go through FDA? How does that all work?

Isabella Schmitt: One thing on your point about the kind of terminology there, like STeP is not really like glowy marketing words, but I have had companies that I've talked to that I'm like, " I really don't think you're breakthrough device." But, their primary marketing focus, even in sales focus, is about being safer than the current technology out there. Having the STeP designation can be beneficial for them because that's really their selling point, right. You're basically saying, " Hey, I've been designated the safer technology." Even though the word isn't as fun, it's still, can be good marketing for certain companies.

Jon Speer: Can I say that? Can I say, " Oh, our product is safer than product xyz?"

Isabella Schmitt: Not officially. You can say that you have the STeP designation, I mean, you can if ultimately in your marketing submission you prove that with the evidence, and you do a comparison, and that's what the data shows. But, you can say, when you're marketing post submission, and you've proven that, you can say that you were designated that, and you have STeP designation.

Jon Speer: You might be a little generic, right? You might say, " Oh, well, FDA designated us as a safer technology from what's existing." I mean, you don't have to necessarily name somebody, but you can at least make that claim, I suppose, right?

Isabella Schmitt: Yeah, and then another interesting thing about STeP is that for breakthrough device designation you have to do it prior to your pre- market submission. With STeP, you can do it at the same time or even after your pre- market submission, or prior. I think they prefer prior, well, I say that. The intention is to have some of it get done prior because they want you to engage and have the more collaborative discussion. I'm hesitant about whether they really want that or not because I think a lot of time with FDA, some of the policy folks and the review teams are not in exact alignment. This is really arduous for the review teams. Things like inaudible discussions, they're not used to engaging in those types of things. You're making them respond in a 15 day or a week time frame that they usually have 60 days to respond to you, and sometimes that can make the discussion challenging with certain divisions who are not familiar with that process. So that's an important thing to know.

Jon Speer: Again, though, I can't as a company say I'm this or I'm that. I still need that authorization or confirmation from FDA. This is yes we agree you are breakthrough, or yes we agree you are STeP, at some point in that journey, right?

Isabella Schmitt: Yeah, so you usually file that through a q- sub, or you don't usually, you always file that through a q- sub.

Jon Speer: Okay

Isabella Schmitt: It's not, so a long time ago breakthrough device designations, they would allow you to file them as part of a pre- sub, and so you'd be able to get other feedback and also get the breakthrough designation kind of in one fell swoop. Now, they don't allow that anymore. It's a separate submission for both breakthrough device and STeP, and you only get feedback on whether you're breakthrough device or STeP. What I will say is that if you do file it with additional questions, and you get designated, then they'll kind of auto put that in their queue rather than you having to file a new submission, but you're still in that 60 day waiting clock. They won't answer those questions in the same moment. And so, breakthrough device designation and STeP need to be their own usually distinct q- subs, and it's a 60 day period between submission and final designation or denial. At day 30, you get some additional requests for information. I would say, that happens 100 percent of the time. I've never had it happen where it doesn't. I mean, there are probably situations if you've engaged them a bunch beforehand through pre- subs before filing breakthrough device designation, it may happen within the 30 days, but usually they ask for additional requests for information. And, it can be something as simple as, " Hey, what do you mean by this in your indication statement? We would suggest you change it to this." Or it can be, " Hey, we don't understand your evidence." At that 30 day mark, you can kind of get a feel for how it's going to fall. Usually what I do, when I get that feedback, I obviously discuss it with the companies, right, but I also try to discuss it with FDA to make sure that we understand what they're asking us for and that we're responding appropriately to what they're asking, so that our response to that additional request for information really touches upon the points that they want to see and that we're framing it in the right way. Sometimes if they're asking for things like more evidence, like they want clinical trial data, you can't thoroughly...

Jon Speer: Might be to early, right.

Isabella Schmitt: Right, and then you would have to go back and refile, but a lot of times it's just how you respond to them. Having that discussion, in many cases, can help determine whether or not you end up ultimately getting it because you need them to understand your perspective and you to understand theirs. That's not a requirement, and they don't have to meet with you, and you don't have to meet with them after you get that additional request for information, but it usually helps a whole lot.

Jon Speer: Yeah, for sure, any time that you have, at least in my experience, that you have an opportunity to engage and interact with your FDA reviewer or review team, especially if they're asking for something, rather than you go off and think, " Oh I know what that means. I'm going to go do this," and you go do it, and you come back, and like, nope, that's not really what they meant. Do you have that opportunity to get clarification and have a live conversation? I always find that beneficial. I'm, generally speaking, a huge fan of pre- subs or q- submissions, but can I tell you my wish list on that topic?

Isabella Schmitt: Yeah.

Jon Speer: When you do a pre- sub, you have to indicate, oh this is for a 510( k) or oh this is, or for a breakthrough device or a STeP, or PMA or what have you, or an ID. Why can't we just check all the possible boxes and have that part of the conversation? I just don't understand that, but like oh I'm a pre- sub, I think I want to learn more about this. Here's my case for BDD. Here's my case for STeP. Why can't I just do that all in one pre- sub? But, that's a rhetorical question I suppose. Neither you nor I can answer that.

Isabella Schmitt: They will give you some indication in pre- subs as to what they would like to see if you engage with them beforehand. They won't tell you, " Yes, you're a breakthrough device designation," because they haven't seen your full argument, right, in that pre- sub. But, if you have some evidence, and you say, " Hey, we're thinking about filing a breakthrough device designation. Do you think that this evidence that we have would be sufficient to support that?" They'll give you some answer. Usually not a very distinct answer, and they won't tell you, " Hey, we really want to see 40 patients."

Jon Speer: And, it's not binding.

Isabella Schmitt: And it's not binding, right. For the ones, even when you file a breakthrough device designation, and you have that subsequent conversation with them, and if it's about evidence, and you ask them, " Okay, you want to see more evidence. What are you really looking for? Say, clinical evidence. You want to see 10 patients? 20 patients? How many? What do we need to give you?" It's kind of an arbitrary number that they come up with. It's just like what do they feel is good in their gut. They don't have a full rationale for it, and so that can be challenging with some of these submissions. On the front end, because you're like, " Okay, is this evidence enough, or is it not?" I think a lot of it has to do with how you frame the argument. I've talked to companies who are much further along than companies that I've worked with that have been designated, and it has a lot to do with how they explain their device and how they put together their argument because I think more than a lot of other documents, these are really thesis statements, right, and you're developing an argument around this rather than just giving them a bunch of information, which is, I mean, you develop an argument around all of the submissions to a degree. But, this is really an argument that you're putting forth, and you're trying to say, " Hey, we need this thesis statement that we're a breakthrough device or a STeP device."

Jon Speer: Sure, sure. So, we're going to take a quick break. I want to remind you all that I am talking with Isabella Schmitt with, she's the director of regulatory affairs with Proxima CRO. We are talking about breakthrough device designation and the safer technology program from FDA, and we'll get back to that here in a moment. But, Isabella, while we're taking a short break, let folks know a little bit more about Proxima CRO and the types of products and services that you help with.

Isabella Schmitt: Sure, I'm used to giving this pitch now. I do it all the time. So, Proxima is a full contract, full contract, I keep saying that, full service contract research organization. Basically we do regulatory quality and clinical consulting, so that means we can help you with early regulatory strategy. We can engage with FDA, pull together submissions, set up quality systems for you, manage quality systems for you, do audits. Then, we can, on the clinical side, do clinical development, so generate protocols, statistics, what are your end points need to be. Then, we do full clinical trial execution as well. That involves study startups, selecting sites, monitoring the data, setting up the electronic data capture systems, and then closing out those sites and writing the final report. Really, from start to finish, everything except bench and animal testing we can do.

Jon Speer: Awesome, awesome work, and folks you can learn a lot more about all the services from Proxima clinical research by visiting their website: proximacro. com, and that's p- r- o- x- i-m- a- c- r-c- o. com. Speaking of the topic today, you probably already knew this, Isabella, you probably were involved in it, but there's a really great content article on breakthrough device designation that is on the Proxima website, so we'll include that link in the show notes that accompany. While we're taking this break. I want to remind you all about Greenlight Guru, the only medical device success platform on the market today. It's designed specifically and only for medical device companies by actual medical device professionals within the platform that all work close to help you better manage your design and development activities, document and record management, as well as post market surveillance, which is a big deal, obviously, always has been, but it's a specially big deal these days with the emergence of EUMDR, putting so much more emphasis on this. We posed to help you manage all of your quality events, all of these workflows and activities within the Greenlight platform. They're interconnected; they're linked. We have also included recently some AI and machine learning aspects of this to help make your change process a little bit more thorough, holistic, and robust, as well as give you a picture of all of the connections within your quality ecosystem, so it's pretty cool stuff. Check it out: www.greenlight.guru to learn more. All right, so let's get back to the conversation on breakthrough and STeP. It sounds, there's some nuances, there's process, there's engagement or involvement with FDA. You're going to have a pre- sub and that sort of thing. Sounds pretty good for products that fit within those designations. There's probably some drawbacks to this too. It can't all be roses, right?

Isabella Schmitt: Yeah, so I think some of the drawbacks of it are, I kind of alluded to it earlier. I think it depends on the division that you're engaging with and how familiar they are with the program, and so sometimes the engagements don't go the way that they were intended and can actually lead to a little bit more frustration. You obviously can get back on the same page with FDA, acknowledging, hey, this is first part discussion, for example, " Hey, we're responding in rapid time frame." The things that I would caution companies are when engaging in the interactions that are associated with this program, as a first thing are make sure that you understand your review team's experience with breakthrough devices and STeP devices to figure out which engagements will work the best with them and kind of managing their expectations as well. I think a lot of these teams don't engage in these types of discussions, and so there is a bit of education on their side about how the process will work. Otherwise, it can be a little bit frustrating. As a bigger picture thing, sometimes when you have a breakthrough device or a STeP device, the FDA's bar can get a little bit higher for your clearance or approval because you're focusing on specific language things, like I said, in the indication statement, and you're making, basically making claims that need to be proven.

Jon Speer: Corroborated, right, yeah.

Isabella Schmitt: That can make the overall review process a little bit more challenging because they're looking at it through a different lens, and if you're saying, " Hey, I'm a brand new novel technology," I mean, I don't know that this is associated with specifically being breakthrough device or specifically being STeP, but any new technology that's out there, FDA doesn't really have past precedent to rely on, so it eliminates some of the ease of the review for them, and so it does take a little bit more time even though you have priority review for them to review it because they have to understand certain details that they don't really understand. Again, that's that sort of education process that you have to get with them. Depending on the FDA review team, that can either be an easy process or a more challenging one depending on the personalities within that team, right. I think, like I said, it's not because you're STeP or because you're breakthrough device, but, I think, going out there and saying that can put that different lens on it, and sometimes that can be challenging. That's not always the case. I mean, by any means, but it is a possibility.

Jon Speer: Well, and I think it's something to be aware of. I mean, if I'm new to this, pursuing breakthrough or STeP, I want somebody who's in my corner who's been through that before, even if that person isn't, or entity or firm, is not necessarily FDA facing, I want them to provide some coaching and guidance, and that's one of the things that you and the team at Proxima does. I'm kind of putting you on the spot a little bit. Are there some offices or device categories that you think are better suited to this than others? Are there certain examples that come to mind?

Isabella Schmitt: I'll say the ones that I think are good, and I won't go to the ones that I think are challenging.

Jon Speer: Okay, that's fine.

Isabella Schmitt: The ones that have been good interactions are typically the cardiovascular division cert review teams, so things like heart failure products where it's kind of obviously very life- threatening, and so they do see quite a few of those breakthrough devices. They just have a bit more experience with the program. The in vitro diagnostics division pre- COVID, and even during COVID to a degree, has been really easy to work with through the submission process. They, just as a tangent kind of on the in vitro diagnostic division, so they are no longer accepting pre- subs for the rest of this year.

Jon Speer: I mean, as we're recording this there's still a lot of this year to go.

Isabella Schmitt: That's what I said. I was like, the whole year?

Jon Speer: Okay.

Isabella Schmitt: They sent out an email notice and said that they weren't receiving any more pre- subs this year at all. They will accept q- subs for breakthrough devices designations. They will do their pre- market review, and they are still accepting COVID products. The issue is the EUA's. They just still have extensive backlog.

Jon Speer: That makes sense.

Isabella Schmitt: That's actually affecting other divisions too. So they will accept q-subs or breakthrough devices, and they will engage with breakthrough device products, at least right now. That division has been easy to work with even, for breakthrough devices, even during COVID times because they are still willing to engage and get feedback on those. I really like working with them. Their neuro division, different culture, but they have been pretty good to work with as well.

Jon Speer: Cool. All right, that's good news. There's a lot of products that fit into those buckets. I guess I'm also curious, I get breakthrough or STeP, I get my products cleared or approved, whichever's applicable and appropriate, something that we've talked a little bit on the Greenlight Guru Global Medical Device podcast in the past is this topic of reimbursement. I think it's one of those topics that probably doesn't get as much emphasis or awareness as it should because that's really important especially in the United States the way the payer system works. Are you finding that there's any challenges or any issues with respect to reimbursement for something that has breakthrough or STeP?

Isabella Schmitt: No challenges specifically. The article that you alluded to earlier, for breakthrough device designation there was a rule proposed that any breakthrough device would get CMS reimbursement. And then there was a paper written by, I think a bunch of physicians that were essentially saying, " Hey, what? These haven't been reviewed as normal for reimbursement claims, and there's a lot of these. Are we sure we want to do this?" And so it was put on hold for a little bit longer of a review period, and I think in the next few weeks, they should, unless they extend it again, have a decision on that whether or not that auto type of reimbursement happens for these breakthrough devices. So that was a big opportunity for a lot of the breakthrough devices, and it did have a lot of companies more interested in getting breakthrough device designation because that's huge for them, right?

Jon Speer: Right.

Isabella Schmitt: STeP doesn't have that offering, and so it doesn't have that potential appeal. I guess, I'm not a reimbursement expert. I wish I was a little bit more, but on the front of reimbursement, I will say, CMS payers and FDA don't often have the same evidence goals in mind, and so meeting both of those goals is often challenging, and it's a situation that you should try to navigate on the front end instead of the back end because if you can at least check some of the boxes for payers and CMS and all of that, within trials that you may need to conduct for regulatory approval, you should, but you also don't want to add too much burden to the regulatory, clearance, or approval side of things if it's not necessary, and then it's going to be crosstalk that milestone. They have parallel review programs. I've not worked in a parallel review program yet.

Jon Speer: I think it's only happened like three times ever. It's not utilized that much, which kind of blows my mind. It seems like that would be, and I know there's probably certain criteria that one has to meet even to qualify, but man I wish that program would grow some legs because I think that would be huge.

Isabella Schmitt: Yeah, I've heard positive things about it actually. Of course, positive things mostly from reimbursement people, so maybe it is helpful for them and maybe not so much on the regulatory side of things. They're two different entities with two different goals, and I think...

Jon Speer: They don't necessarily talk. I mean, they're not butting heads, but they don't fight at all, they never cross, and barely do they interact because it's just two different branches.

Isabella Schmitt: Yeah, and even if you don't do parallel review, in many cases you can request payers be present for discussions. Obviously that depends on their schedule and all of that. I think considering reimbursement early on is always beneficial. How are you going to get paid ultimately once you get out there is pretty important.

Jon Speer: For sure.

Isabella Schmitt: The breakthrough device designation had potential for an easy answer, but it hasn't...

Jon Speer: Maybe the easy answer will still become the reality, so it's, you know.

Isabella Schmitt: Yeah.

Jon Speer: Well, one other thought that I have before we start to wrap things up, I know you mentioned a little bit, or hinted at it a little bit, breakthrough has been around for a bit. STeP actually, I think, actually was first authored in a draft guidance. Don't quote me on this, but something like 2019, I think most of 2020 we didn't see anything, and then I think the final guidance was issued January 2021- ish.

Isabella Schmitt: That's what I think too, but I'm not sure.

Jon Speer: Close or thereabouts, but for all intents and purposes, the STeP has become active just in 2021, so it's still a very new program. I know EUA's and all sorts of things and some branches and divisions are not accepting q- subs, and there's been delays on others. Do you see that there's still a pretty significant jam and backlog in reviews of pre- subs or 510( k)'s in inaudible, or are we seeing that free up at all. What's the state of things right now?

Isabella Schmitt: For breakthrough devices and STeP, well, for breakthrough devices. STeP, not so much, but breakthrough devices, they have been hitting their timelines. Q- subs have been, and when I say q- subs I'm not meaning breakthrough device, I'm meaning pre- subs basically, have been hit or miss, and it's really hard to tell whether or not you're going to get through. Like I said, IVD, they basically made it clear, hey don't send us a pre- sub. We're not going to respond to you. But other divisions, it's been challenging to know whether or not the timeline is going to be met, whether they're going to accept it or not. Sometimes they do, and you get through, and then you find out on the back end that they're super busy, and it takes a little bit longer for them to meet the normal timeline for the meeting. Sometimes they send an email saying, " Hey, we closed your pre- sub, and that's it for you. We're not responding to this. You can resubmit. It might take us 120 days to respond to you." Which is kind of a weird thing.

Jon Speer: Yeah.

Isabella Schmitt: Seriously, you just resubmit, and then you get put on the clock. Why can't I just get put on the clock now? So I asked them. And they said, " Yeah, resubmit, and we'll put you on the clock." So we did that, and it has worked.

Jon Speer: And exactly the same thing. You didn't change anything about what you...

Isabella Schmitt: Nope, same submission. It's weird, but yeah it works. What I've seen has been that divisions that are more impacted are the ones that have some propensity for diagnostic tendencies in general because what FDA seems to be doing is pulling folks who have diagnostic background and experience to help with the IBD overload for the EUA's.

Jon Speer: Oh wow.

Isabella Schmitt: The IBD division is very, very backed up. What I've seen FDA do is call it COVID deployment, so when your reviewer gets pulled into EUA review, they get put on COVID deployment, and it's more challenging for them and more challenging for companies, but it doesn't happen, with IVD, I'd say 100% of the time now, for sure, but even before it was, " Hey, we have a delay." With other divisions it's been hit or miss. With 510(k)'s, DENOVOS, PMA type products. PMA's not really so much, but 510( k)'s primarily, in the IVD division, they were backlogged for months and months beyond their MDUFA timeline. I think they're going by queue when you submitted it to re initiate the review of those products. I have had a couple that did finally get put under review.

Jon Speer: On that point, I haven't kept up with the current statistics on EUA's, but once upon a time, it was something like, there had been like 5, 000 EUA's submitted. I'm sure it's way more than that now. To put it in context, I think, on a normal year from an FDA perspective there's roughly around five or six thousand give or take, 510( k)'s that are submitted. Granted an EUA probably not as detailed as complex as a 510( k) submission, but ramifications are, and the majority of those EUA's have been IVD type products, so that makes perfect sense. I mean, they're getting way more of a load than a normal year within that division, so it's kind of crazy.

Isabella Schmitt: I mean, this is a whole topic in and of itself, but the EUA's started off pretty lean and like, oh yeah. I mean they started off doing those notifications, right. And they were like, " You just need to notify us." And then they were like, " Whoa, this is not going so well." So then everything had to go through the authorization process. They've started reviewing them almost like a 510( k).

Jon Speer: Wow, I think it's good, I mean, it's hard to go back in time to those earlier ones, but early days there was some crazy statistic too about how many morning letters were being issued for EUA type products, and I was like, " Oh, crap, what is gong on."

Isabella Schmitt: Yeah.

Jon Speer: Anyway, so hopefully here soon things get back to normal not just in our everyday world but also from a regulatory world because there's lots of cool products and technologies that, and it's justifiable, it makes sense, but they're just kind of sitting there waiting on the sidelines, so hopefully things start to open up. I know FDA is, they do a great service, and I think they're underappreciated a lot of times. I think especially in time that we've been through in the past year or so that, just in seeing the response, I noticed that the agency had been frankly very encouraging as a medical device professional, and I think there's some things that, some practices that started to occur because they had to in a pandemic situation that, some of those I'd like to see stick around. You and I have talked about some of the clinical side of things and remote monitoring and things of that nature. I think there's a lot of things. At some point it might be good to say, " All right, let's pull this in, and let's grab this. Here let's sort of revamp the normal everyday operating process and borrow some of the things that we learned." Any other final thoughts before we call today a wrap?

Isabella Schmitt: I have two, two final thoughts. One is on the point that you just made about the changing environment, and some of those things seem to be positive like remote monitoring and whatnot. One thing, FDA has been in remote virtual environment themselves, so all meetings have been teleconferences. Sometimes they turn on their video, but it's kind of up to their discretion. I did reach out to a reviewer recently because I had a client who wanted an in person meeting, and they said that they're still on indefinite virtual existence. It is, I wonder if they're going to move to just doing teleconferences. I mean, I'd hope not, but you never know and not doing those in person meetings anymore because they can knock them out much faster. The second thing was on the breakthrough device designation and the STeP front of things. One important thing to know, and I've had companies ask me this, is how can they find out what other companies have been designated, and FDA does not make that publicly available. It is confidential information, and so it's up to the discretion of a company to share that information. Really the way to go about finding this is to look for press releases...

Jon Speer: And usually companies are, they're screaming, "Oh, we got breakthrough," so you'll find it.

Isabella Schmitt: Although I will say I've had a couple companies who wanted to keep it a secret and fly under the radar for a while.

Jon Speer: That makes sense.

Isabella Schmitt: But, a lot of times, you will find lots of them although I haven't found very many for STeP designation, and I think that's because it's so new.

Jon Speer: I think it's new, right?

Isabella Schmitt: Yeah, so if you want to do STeP designation you might be a trailblazer out there, rank really high on SEO for now.

Jon Speer: Yeah, that's a good point. All right. Terrific, well, Isabella, as always, thank you. I appreciate, I always learn a nugget or two about things regulatory. I've been out of practice and haven't actually worked on breakthrough devices or STeP, at least from a hands on approach. I know Greenlight has a few customers that have products in those, at least the breakthrough side of things, and I know Proxima is doing great work on that, so thank you so much as always. Again, Isabella Schmitt with Proxima CRO. Check their website out: proximacro. com. Once again, this is Jon Speer, founder and host, founder of Greenlight Guru, host of Global Medical Device podcast, something like that.

Isabella Schmitt: Same thing.

Jon Speer: Same thing, yeah. If you're watching this episode, of course we always appreciate the thumbs up when you like those things, and be sure to subscribe. Click that giant red button, and there's also, YouTube has this little bell that when you click it, you can get notified of when new episodes are live, so those are all great things to be a part of and aware of, the ways you know when we're having a new episode, so check that out. I guess for now, thank you for listening and watching and always appreciate the opportunity to catch up with some peers in the industry, so thank you to Isabella. Until next time, you have been listening to the Global Medical Device Podcast.


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