What do manufacturers need to know about the Safer Technologies Program (STeP) for Medical Devices from FDA? How is STeP different from similar programs, like the Breakthrough Devices Program? Which devices are eligible?

In this episode of the Global Medical Device Podcast, host Jon Speer and his guest Mike Drues from Vascular Sciences offer answers to these questions and educate listeners on this new, voluntary program, helping manufacturers with eligible devices leverage STeP for easier, faster entrance into the US marketplace.

 

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Some highlights of this episode include:

  • STeP intended to make medical devices and combination devices eligible through the Breakthrough Devices Program (BDP). However, STeP offers improvements in safety, not necessarily in efficacy.   
  • What if you have devices that include both safety and efficacy improvements? STeP and BDP are mutually exclusive and not pathways to market. Neither are done in lieu of a 510(k) or De Novo, but in addition to those regulatory pathways. 
  • The BDP is limited to life-threatening and irreversibly debilitating diseases, injuries, and conditions. The STeP is limited to less severe diseases.
  • Criteria to show improvement in safety include an increase in the benefit/risk ratio for known serious adverse events, a decrease in known failure mode of the device, reductions in user-related errors/hazards, or make intervention using another device more safely.
  • The mechanics of applying for a STeP or BDP are ‘substantially equivalent.’ Yet, you can’t commingle or combine a STeP or BDP pre-submission with a traditional pre-submission. FDA has made the pre-sub process inherently inefficient. 
  • Any devices given a STeP or BDP designation are treated by the FDA as a priority. However, if you get a BDP or STeP designation, your regulatory burden  is not reduced.

 

Links:

Mike Drues on LinkedIn

Vascular Sciences

Safer Technologies Program (STeP) for Medical Devices

STeP for Medical Devices Guidance

Breakthrough Devices Program (BDP)

Premarket Notification 510(k)

De Novo Classification Request

Premarket Approval (PMA)

Global Medical Device Podcast — Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes by Mike Drues:

“There were a number of devices that I took and some other folks took to the FDA under the BDP, the Breakthrough Designation Program. But the improvement of these devices was more on the safety side as opposed to the efficacy side.”

“The way FDA set these two programs up, they are mutually exclusive. If you get a BDP, you cannot get a STeP. If you get a STeP, you cannot get a BDP.”

“The BDP is limited to life-threatening and irreversibly debilitating diseases, injuries, and conditions. I’m fine with that. But on the STeP side, it’s limited to less severe diseases.”

“If you get a BDP or a STeP designation, that is not a reduction in your regulatory burden. In other words, that does not mean that you have to do less testing, less bench top, less clinical, whatever it is.”


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: All right. Welcome to the Global Medical Device podcast. As you've noticed, we're doing this now on video as well, but don't worry if you're listening to it wherever you listen to podcasts, you'll still get the audio version. But on this episode of the Global Medical Device podcast, Mike Drues from Vascular Sciences joins me. We talk about the new, I guess, STeP from FDA. I say new, even though it was introduced back in late 2019, due to pandemic and all those things that we have been dealing with since 2020, kind of went on the back burner. But it sounds like this is getting some momentum, recent guidance was finalized, but anyway, enjoy this episode of the Global Medical Device podcast. Hello and welcome to the Global Medical Device podcast. This is your host and founder at Greenlight Guru, Jon Speer, and joining me today is Mike Drues with Vascular Sciences. So Mike, welcome.

Mike Drues: Thank you, Jon. Nice to speak with you today and nice to see you today. crosstalk a little different for us.

Jon Speer: Nice to see you too. For folks who are listening, that's cool, but if you want to see Mike Drues and Jon Speer on video, we are offering this as a video option for you as well, so something new that we're doing with the Global Medical Device podcast, so anyway...

Mike Drues: But don't feel obligated to watch the video. I've been told that I have a face for radio.

Jon Speer: Amanda, my better half, she always rolls her eyes whenever I do podcasts. She's like," Oh, oh. There he goes with his podcast voice again." Apparently there's a difference. I don't know. I don't pick up on it. But anyway, Mike, I thought today we could dive into this program from FDA known as this Safer Technologies Program or the STeP program. So maybe a good place to start as we usually do is, what is the STeP and why was it created?

Mike Drues: Yeah. Great question, Jon. As always, thanks very much for the opportunity to talk to you and our audience about a relatively new and potentially very important subject that everybody in our industry should know about and that is the Safer Technologies Program or STeP. This was a program that was created, actually, back in 2019. That's when the original draft guidance came out. As you might remember, Jon, you and I did a podcast on this topic back in October of 2019. One of the things that I'm proud of, just to go off on a little bit of a tangent here, Jon, in many of our conversations, you and I are among the first to talk about a lot of things, regulatory and quality related unlike a lot of other people out there that talk about things months and years after the fact. So as I often say," If you're following in somebody else's footsteps, there's one thing I can guarantee and that is you'll never go anywhere new." So this discussion is an update to that discussion from almost a year and a half ago. Why are we updating it? Very simple, because shortly after FDA announced the draft guidance for the STeP program, as I said back in 2019, COVID hit and everything basically went on hold. It wasn't until just last month in January, in fact, where this particular guidance was finalized. So for the last year and a half, any of my customers that were possibly considering the STeP, I said," Well, it's probably better to put that on hold because the program hasn't really started yet." But now that the guidance has been finalized we're hundred percent good to go. As we'll talk about any device that fits the qualifications for the STeP, we should definitely consider submitting it to the FDA even right now. Another question that sometimes people ask, Jon, is," Why was it created?" Well, this is another thing that I'm a little bit personally proud of because I had a small hand in creating this. There were a number of devices that I took and some other folks took to the FDA under the BDP, the Breakthrough Designation Program, which you and I have talked about before as well. But the improvement of these devices was more on the safety side as opposed to the efficacy side. The FDA said," Gee, this is great. We definitely need to have some sort of a priority here, but it doesn't fit the BDP criteria." So the STeP was essentially created to address those devices as we'll talk more about in a moment, Jon, that basically offer an improvement of safety, not necessarily an improvement in efficacy. That's one of the fundamental differences between the two programs. Does that make sense, Jon?

Jon Speer: It does. I want to get into some of the nuances and the specifics here in a few moments. I think sometimes with both BDP and now, maybe even STeP, I think what a lot of people might hear is that this is a new regulatory pathway. There's a correlation for sure, but I want to understand that a little bit better and share that with the audience.

Mike Drues: Great question, Jon. Somebody, in fact, just asked me this very similar question yesterday. Neither the BDP nor the STeP are a pathway to market; that is, we don't do a STeP or a BDP in lieu of a 510(k) or Denovo or a PMA or HDE, we do it in addition to. So it's not a pathway to market. If you're bringing your device onto the market, say, as a 510(k) or as a PMA, you can do a STeP or not. You can do a BDP or not, but you still have to do the 510(k) the PMA in order to get it out to the market. Does that make sense?

Jon Speer: It totally does, and I think that's where a lot of the confusion lies with folks is that they hear about BDP and STeP and they're like," Oh, well this is a pathway that's similar to, but different than the 510(k) or the Denovo," but to your point crosstalk additive not inaudible from one another.

Mike Drues: One other minor point along those lines, Jon, the way FDA set these two programs up, and I'm not sure, to be honest, if I agree with this or not, but the way they set these two programs up is that they are mutually exclusive. In other words, if you get a BDP, you cannot get a STeP. If you get a STeP, you cannot get a BDP. As I said, I'm not sure if I like that or not, because I have devices that I'm working on, Jon, where there's not only an improvement of safety, but also, of efficacy. So I don't know. The jury is out on that one. I think that's a relatively minor point, but that's another difference between the two programs. Fundamentally, the biggest difference between these two programs I see are twofold. First of all, as I said a moment ago, the STeP program is primarily focusing on devices that increase the safety of a device, not necessarily efficacy; where the BDP, the emphasis is on improvement of efficacy, not necessarily safety. That's difference number one and I have no problem with that. I'm I'm in full agreement with that one. Difference number two, I have a little bit of a philosophical difference with my friends at FDA because the BDP is limited to life- threatening and irreversibly debilitating diseases, injuries and conditions, and I'm fine with that. But on the STeP side, it's limited to less severe diseases, right? So hypothetically speaking, Jon, and I have already a couple of devices that are in this category, what if we have a device that improves the safety, not the efficacy, but the safety, of a life- threatening or irreversibly debilitating disease, injury or condition? By literal interpretation of the guidance as it stands now, that would not be eligible for a STeP designation. I think that's an oversight. I think that part of the guidance is poorly written and don't be surprised, Jon, if that's not fixed, hopefully, sometime in the coming months or years, but I think that's a bit of a problem. Does that make sense?

Jon Speer: Well, maybe I think maybe to help clarify, it might make sense to get into more of the criteria for when STeP applies to something that I'm working on. Maybe that'll help clarify any confusion that might be on that particular area.

Mike Drues: Yeah, absolutely. So let me give you some examples of the criteria that we have to show in order to show an improvement in safety. We have to show, for example, and this is in the STeP guidance, which we can provide a link to as part of the podcast, we have to show that there's an increase in the benefit- risk ratio, specifically, in the known serious adverse events. So this is for devices that are already on the market or similar devices that are already on the market where we can show that there's a reduction in the serious adverse events or SAEs. That's one way we can do it. Another way that we can do it is to show a decrease in the known failure mode of the device, reductions in user- related errors or hazards. Finally, if we make the intervention using another device more safer, and this is where it gets really interesting, Jon, because notice that the words they're using in the guidance are intervention. They're not saying that it's necessarily another device. So there's three possible scenarios here, based on my interpretation of this guidance. Scenario number one is, we have a improvement in safety of a given device that we're working on. Scenario number two is, our device is used in conjunction with another device and our device leads to an improvement in the safety of the other device. Then finally, scenario number three is, if our device is used in a surgical procedure, because remember, Jon, in the guidance, it says,'intervention.' It doesn't say,'device.' If our device is used in a surgical procedure and we improve the safety of the surgical procedure, that would also potentially be applicable to the STeP program. So those are three different scenarios that I can envision. Perhaps there's even more, Jon, that you might think of. Whether FDA, intentionally thought of those different scenarios or not? I don't know, but as we've talked about before, Jon, regulation is all about the interpretation of words and our ability to defend our interpretation. I can interpret those words in the guidance, specifically, intervention, making an intervention safer in many different ways as I just illustrated there. Does that make sense, Jon? I can give you a specific example if you want.

Jon Speer: Yeah. Specific examples probably would be extremely helpful because I'm just thinking, as you talk about those different scenarios, safety as the first scenario, using with another device, improve the safety of that other device or the third scenario, being an intervention in a surgical procedure to improve the safety of those things. I guess what's rattling around in my head is that burden of proof. How does one demonstrate that? Maybe your example can help illustrate how one might be able to go about demonstrating crosstalk

Mike Drues: Well, in terms of the burden of proof, Jon, that's a very interesting question. The STeP program is still relatively new and I've got a couple of devices that we're putting through the STeP now. But the best way I can answer that question about the burden of proof is on the BDP side, right? So on the BDP side, we're required to show, and I always get the verbiage here wrong, so I want to just refer to the guidance, the sponsor needs to demonstrate that the device has a reasonable expectation, that the device could provide for a more effective diagnosis or treatment relative to the current standard of care in the United States. So basically, what we have to show for the BDP, and now similarly for the STeP, is that the device has a reasonable expectation that it could provide in the case of the BDP and improvement of efficacy or in the case of the STeP and improvement of safety. Exactly how much data that you need to show that there's a reasonable expectation that it could work? Well, this is when consultants like us get in, because this is the argument that you have to make. But let me give a real simple example, an actual medical device example for our audience, Jon. Maybe this'll help with the understanding. So my favorite example for something for the STeP would be a syringe, right? We all know, for example, how big of a problem needle stick injuries are associated with syringes, or other harms that can result from using a hypodermic needle, right? So what if a company came out with an idea to improve the safety of this syringe, for example, by reducing the likelihood of having a needle stick injury? There is no change in the efficacy. At the end of the day, Jon, you're going to be injecting the same drug into the patient, so there's no change in efficacy. So this would clearly not be eligible for the BDP, but if we can show that it has a reasonable expectation to improve the safety, for example, when user errors, which is a needle stick injury, that would be eligible for a potential STeP designation. Taking that just one STeP further, Jon, what about a pre- filled syringe? Well, this gets into combination products and here's the interesting irony, Jon. The STeP program is eligible, not just for medical devices, but device- led combination products. So if you have a combination product that the primary mode of action is a device, then it would be eligible for the STeP program. \ On the other hand, if you have a drug device combination product, it is not eligible for the STeP program. The reason why I mentioned that pre- filled syringe is because pre- filled syringes are primarily regulated as drugs, not medical devices. So here's the thing, Jon, a plain old empty syringe would be eligible for STeP; a pre- filled syringe or a pre- school preloaded syringe would not.

Jon Speer: Gotcha.

Mike Drues: An interesting little hiccup in the regulatory world, Jon, perhaps will fix that someday. By the way, for the benefit of our audience. I just found out that I'm going to be doing a webinar later this year for Greenlight specifically on combination products, an area that I've been working in for more than 20 years. So for those in our audience that are interested in that particular topic, stay tuned.

Jon Speer: Absolutely. Did you hear the news? That's right, Greenlight Guru, we're at it again. This time we're launching the Greenlight Guru Academy. The Greenlight Guru Academy aims to be the worldwide leader in online education for medical device quality, regulatory and product development professionals. Hi, I'm Jon Speer, the founder at Greenlight Guru and I'm really excited about this announcement and launching the Greenlight Guru Academy. The first course offerings we're going to provide to you for free include things around design controls, risk management and regulatory submissions. If you are a current Greenlight Guru Medical Device Success platform user, we're going to provide content and information, tips, pointers and best practices on using the software platform. So I hope you enjoy the content and the Greenlight Guru Academy and be on the lookout because we're going to continue to roll out additional courses here very soon. Folks, I want to remind you I'm talking with Mike Drues. Mike is the president of Vascular Sciences, a familiar voice, and soon- to- be familiar face on the Greenlight Guru Global Medical Device podcast. We talk about a lot of things regulatory related. I'll tell you, I've said it before and I'll say it again," He's the guy you want your corner when it comes to creative regulatory strategy." No, that's not an oxymoron. Those words were used together on purpose. crosstalk One of the other things I want you all to be aware of is Greenlight Guru, we're here to help too. We have the only Medical Device Success platform on the market today designed specifically and only for the medical device industry to help you through design and development, risk, change management, and all of your quality events, caps complaints, things of that nature. If you'd like to learn more about the Greenlight Guru Success platform, go to www.greenlight.guru, and we'd be thrilled to have a conversation with you to better understand your needs and requirements. All right. So Mike, let's dive back in. I guess, talk a little bit about the mechanics or applying for STeP. I guess as I'm thinking about it, it seems like it's sort of kind of like a pre- sub, but I don't know if that's a good analogy or not, but I guess talk a little bit about some of the mechanics.

Mike Drues: Yeah. Great question, Jon. So the mechanics of the STeP are sort of, kind of like, to use your phrase, the mechanics of the BDP program. As a matter of fact, I would say that the mechanics of the two programs to use a regulatory pun, Jon, are substantially equivalent to one another. The process is very similar. If you understand the mechanics of the BDP, just scratch off BDP and insert the acronym STeP and you'll be all set. Basically, what we do is we put together a STeP pre- sub, just like we would put together a BDP pre- sub. Now, one of the way FDA is set up, both the BDP and the STeP program, which I strongly disagree with, is that you cannot combine, or as I like to say, co- mingle, a BDP pre- sub or a STeP pre- sub with a traditional pre- sub. In other words, with a BDP or a STeP pre sub, you only have one meeting objective and that is," Have we demonstrated that we met the BDP criteria or alternatively, in the STeP, have we demonstrated that we met the STeP criteria?" This is a topic of a bit of a tangent, Jon. I think the FDA has made the process inherently inefficient by having to do the STeP or the BDP pre- sub, and then immediately follow that by a traditional pre- sub. I see no way why these things could not have been combined into one, but again, that's just my opinion, Jon, throwing it out there for whatever it's worth. So we include all of that information, our device description, most importantly, the information to show FDA how we do provide, or we could provide, an improvement of safety, as I talked about before, those three or four different criteria. We submit it to the FDA according to the guidance within 60 days, FDA intends to make their decision. Please notice they're parsing their words very carefully, Jon. Nothing gets out of the FDA without being vetted by 500 lawyers first, right? So they're not saying they're going to make their decision within 60 days; they say they intend to. But to be fair, on the BDP side, and now on the STeP side, usually those timelines, even with COVID, are being adhered to. So within 60 days, they're going to make their decision as to whether you qualify for the STeP. At a high level, that's the mechanical process. Once you do get the STeP decision, then the company can decide following up with their traditional pre- setup or what have you. But at a high- level job, that's the mechanics of the process. Does that make sense?

Jon Speer: Yeah, it does. The question that's just lingering in the back of my mind right now, and I guess I'll bring it out to the forefront is, so what? What's the big idea? What's the big deal? Why is this an advantage for me as a company to consider a STeP for my device? What's the big deal/

Mike Drues: That's a good question, Jon. To be honest with you, we don't completely know yet and here's why I say that. So just like the BDP program, any devices that get a STeP designation will be treated as a priority at the FDA. I want to make this next point crystal clear, Jon, because a lot of people, they misunderstand. If you get a BDP or a STeP designation, that is not a reduction in your regulatory burden. In other words, that does not mean that you have to do less testing, less benchtop, less clinical, whatever it is. It simply means that you go through the FDA process in a more efficient way. So the way I like to describe the BDP and now the STeP program, Jon, is imagine you're in the grocery store standing at the deli counter, and everybody has taken a number waiting to get served. Then all of a sudden, somebody comes in wearing a big red hat and they go to the front of the line and they're served first. Getting a BDP or now getting a STeP is kind of like wearing a big red hat. You go to the front of the line, but it is not a reduction in the regulatory burden. When it comes to the non- regulatory benefits, I think Jon, some of your audience knows I have nine devices currently in the BDP program. A couple of those devices we got into the program, the company could care less about the regulatory benefits. They were interested in the non- regulatory benefits, for example, on the reimbursement side. CMS originally automatically reimbursed for two years for BDP devices; now they're reimbursing for four years for BDP devices, automatically. We don't know, at least I haven't seen anything yet, and maybe you or your audience can correct me, Jon, I haven't seen anything yet coming out of CMS about STeP designated devices, whether they're going to get automatic reimbursement or not. I suspect because FDA, at least currently, is limiting STeP devices essentially to improvements of existing devices. If the existing device is getting reimbursed, then the new safer version of that device will probably also get reimbursed. But what if we expand, as I suggested earlier, Jon, the STeP to truly new devices? There might not be reimbursement for it. Another non- regulatory benefit of the BDP is for small and startup companies to be able to go to their potential investors and say," Hey, it's not just us that think our device is the greatest thing since sliced bread. The USFDA said that it's the greatest thing since sliced bread because they gave us a BDP." Or perhaps in this case, a STeP. Although, to be honest, Jon, BDPs because they're a breakthrough, they tend to be a little bit more glitzy, I think. If you have a device that offers an improvement of safety, sometimes, unless you're a real biomedical engineering geek or a regulatory geek, like I happen to be involved, getting excited about an improvement of safety, it's not like we were doing something that we couldn't do before; rather, we're doing something that we've been doing before, but we're doing it in a safer way. Kind of like a seatbelt on a car job, right? It's not going to make the car go down the road any faster or more efficiently. It's going to make your experience in that car safer should you get into an accident. But how many people get excited about a new design of a safety belt in a car, right? Probably not many.

Jon Speer: Well, I don't know. Do you remember the airbag craze of a few years ago? How many airbags does a standard car have in it now? They're all over the freaking place. So crosstalk I don't know, but yeah.

Mike Drues: There you go. Thank you for correcting my metaphor, Jon, because if you can make an improvement to safety of a car by introducing an airbag, rather than, say, a stronger cloth belt, that might be enough to get people excited.

Jon Speer: Well, the marketers are having a hey- day with it on the automotive side, so maybe a med device marketers pursuing some STeP, maybe there's an opportunity there. But in all seriousness, though, I think it is an important program because we are making medical devices and we want those devices to be as safe as they possibly can be. If you come across some sort of opportunity to make it safer or to augment another product or procedure and improve the safety of those cases as well, it's a worthwhile thing to consider. I like the idea of the getting in line and getting a priority pass, so to speak, to get in line maybe ahead of some of the other more traditional paths. But I also think it's important for people to hear, you don't just get to say,"I'm BDP," or," I'm STeP," you have to get the endorsement from FDA. I don't know if endorsement's the right word, but blessing from FDA's maybe a better word.

Mike Drues: You have to be accepted into the program, right? So you have to be awarded a BDP designation or you have to be awarded a STeP designation. As we've talked about before, it's not in lieu of a 510(k) or something else; it's an addition to.

Jon Speer: Right.

Mike Drues: Not to be critical, Jon, I agree 100% with what you just said. We obviously want to design devices to be safe and hopefully, this newly finalized STeP program will create yet another incentive for companies to do exactly that. However, Jon, I get a little nervous when I hear people use phrases like the one that you just did. We want to make our devices as safe as we possibly can. Well, with all due respect, what the heck does that mean? crosstalk Please name for me any device. crosstalk What's that?

Jon Speer: It's I said it's like motherhood and apple pie. It's just-

Mike Drues: Yeah, exactly. Please name for me any device that couldn't be designed to be safer in some way if we wanted to. So I agree with your sentiments 110% or more, no question about it. But on the other hand, we have to have a realistic expectations. For example, when I read in the mission statements, and this is a little off topic, but when I read in the mission statements of some of the largest medical device companies on earth, they say something like," We want to make our devices as safe as we can." Yet, with all due respect, are people just drinking that Kool- Aid? It's just not realistic.

Jon Speer: Correct me if I'm wrong, but as we've been talking about this, I was like," Oh, okay." You and I have talked a lot, both on the Global Medical Device podcast and just when we have a chance to catch up about 510(k) and how it's really just some companies that are pursuing that. It's me too, and that's fine, if that makes sense for your product. It seems like the STeP could be an opportunity for me to, maybe still follow that me too path, but to bring something new to the conversation, so to speak, being able to effectively market that," My product is safer than this other product because I have this STeP designation and a 510(k)." Am I thinking about this in the right path here or the right mindset?

Mike Drues: Well, Jon, I don't know if you did this on purpose or not, but you remind me, what you're talking about now, of one of my all- time, favorite medical device videos that I use in many of my device regulatory training course. That is your infamous 510(k) and Ketchup and Mustard video.

Jon Speer: Right.

Mike Drues: One of the points that you just made is something that I've been talking about for years, how can a device be basically the same, i. e., substantially equivalent and better at the same time? Well, now you're asking similar questions, how can something be basically the same and safer at the same time? So maybe, Jon, you need to update that Ketchup and Mustard video to include this STeP.

Jon Speer: Maybe. Maybe that's a whole different podcast for us to dive into, we can get the condiments out and we could talk about which ones are Denovo versus PMA. I'll log that. Maybe crosstalk about that later.

Mike Drues: In all seriousness for those in our audience who are not familiar with, I think that video that I was alluding to from Jon, Jon, you did that what? More than 10 years ago, I'm sure.

Jon Speer: Oh my God.

Mike Drues: It's one of the best videos. It's very short. It's only a couple of minutes, but it's one of the best videos on the 510(k) insubstantial equivalents. Notice Jon, I didn't say that it was better than mine, but I said, it's one of the best-

Jon Speer: One of the best, yeah. I heard you. You chose your words carefully too, but you didn't have to go through 500 attorneys to do so.

Mike Drues: As any good regulatory professional would do.

Jon Speer: All right, Mike, this has been helpful. Any other important tips, pointers, advice regarding the STeP program before we wrap things up today?

Mike Drues: Yeah, no. So I think this is a program that medical device companies should definitely be aware of. If you're developing a device that doesn't necessarily make an improvement on the efficacy side, but does improve safety that, by definition, the STeP should be considered. By the way, Jon, as an aside and again, not to be critical of my many friends at FDA, but I do know a number of FDA folks do listen to these discussions. What they do with that information, that's a different topic, but I personally think that it is not necessary to have a separate BDP and a STeP program. I think they could have, and perhaps, maybe someday will be, combined into one. But for anybody working on a device that offers a potential improvement in safety and at the same time, doesn't necessarily address a irreversibly debilitating or serious disease, injury or condition, the STeP is definitely something to consider.

Jon Speer: Sure.

Mike Drues: So if anybody has any questions on how that might apply to their device or if that applies to their device, by all means, reach out to Jon, reach out to myself, we'd be happy to help.

Jon Speer: Yeah, absolutely. Mike, I know you said earlier in the conversation today that this program was sort of on hiatus for most of 2020, and now starting to pick up a little bit of steam, maybe, with the finalization of the guidance. Sounds like you've got a couple of things that are in the queue at some stage going through this. So maybe after you get a little bit more experience and maybe some data to share, we can revisit this and maybe a few other topics related to STeP and BDP and that sort of thing, maybe do a deeper dive to compare and contrast. But let's let you get some of that experience, get some data and then we can share what you discover after getting a couple of those data points. Is that okay?

Mike Drues: I would be very happy to do that, Jon. Obviously, the numbers of devices that are getting BDP designation since it was created about three years ago, is on the increase. Although, some people might argue that there's too many BDP devices, that FDA has allowed some devices to get the BDP designation and when you look at it, it's like," Well, gee, why the heck is this a breakthrough?" But on the other hand, I would love nothing more than to see a growing number of devices get STeP designation as well. I think both of those programs are good incentives. They're not perfect. They need some adjustments, just like the 510(k). It's not perfect. It needs some adjustments, but I think both the BDP as well as the STeP, overall, are very positive steps in the right direction to encourage companies to bring devices out to the market that either are improvements of efficacy or improvements of safety or hopefully, improvements in both.

Jon Speer: Absolutely. Mike, thank you so much. Ladies and gentlemen, Mike Drues at Vascular Sciences. We've been talking about the STeP program. Again, if you have any regulatory conversations or topics of discussion, Mike Drues from Vascular Sciences, he's your guy. I would encourage you to reach out to him. You can find numerous conversations that he and I have had on the Global Medical Device podcast, on webinars from Greenlight Guru, as well as many other sources. He's a very prolific writer and publishes content and podcasts and all sorts of things, so he's pretty easy to find. If you can't find him, just send me a note and I'll be happy to make a connection. As always, as I mentioned, Greenlight Guru, we're here to help you as well. We have the only Medical Device Success platform on the market today designed, actually, for medical device companies by actual medical device professionals. So check it out, www.greenlight.guru to learn more. As always thank you for being loyal listeners and now, maybe even watchers of the Global Medical Device podcast. As always, this is your host and founder, Jon Speer, and you have been listening to the Global Medical Device podcast.


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

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The Global Medical Device Podcast powered by Greenlight Guru is 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.

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