Episode 333

#333: Exploring Breakthrough Device Designation


In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain.

Learn about the benefits and scrutiny of the breakthrough designation, hear examples that emphasize the need for precise data and quality in the application process, and listen as we explain the planning and considerations for success, and how innovation can thrive within regulation.

Some of the highlights of this episode include:

  1. The changes in CMS reimbursement, and how breakthrough devices no longer guarantee automatic CMS reimbursement.
  2. Planning for FDA Submission, and how to align with FDA timelines.
  3. Competitive Landscape - how achieving breakthrough is still possible, even if competitors have it.
  4. Whether or not it's worth pursuing Breakthrough Designation.
  5. The benefits of Breakthrough Designation Benefits (such as FDA priority review and potential marketing buzz).


"Say you are a direct competitor with someone else, and they got breakthrough but they're not on the market yet... You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative - even if they're miles ahead of you."

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Ellie Reynolds: Say you are a direct competitor with someone else. They got breakthrough. They're not on the market yet though. You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative. Even if they're miles ahead of you. They're in clinical study. You just got it out of your animal study.

Etienne Nichols: Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Are you tired of having to look in so many places to find the information you need as a medical device professional? Are you looking to level up your career, your device, or just your day to day performance on the job? Greenlight Guru Academy was started with you in mind. Our goal is to bring you online learning on all the topics that are impactful for medical device companies. The Academy represents years of experience helping companies get their devices on the market and keep them there.

Etienne Nichols: I can't tell you how many times.

I remember that correctly, in:

Etienne Nichols: We hope you enjoy this episode. Hey, everyone. Welcome back to the Global medical device podcast. My name is Etcha Nichols. I am the host for today's episode. Today we're going to talk about something that we may have talked about on the podcast before, but I personally have not. So I'm excited to talk about and that is the Breakthrough Device designation. And with me to talk about this is Ellie Reynolds, the Associate Director for Quality Assurance and Regulatory Affairs at Proxima Clinical Research. So Ellie, glad to have you on the show. How are you doing today?

Ellie Reynolds: Happy to be here. I'm excited to talk about this. We have startups coming to us left and right. Everyone thinks their breakthrough. I think it's a harder path to get down than most might imagine, but there's some serious benefits to the program that these novel technologies can really benefit from.

Etienne Nichols: That's fantastic, and I'm glad you said you're happy to be here because poor Ellie, she was subjected to kind of a barrage of questions before we hit record. So thank you for putting up with my curiosity, and I'm excited to talk about this today. So I don't know exactly where you would want to start. My mind when I think, okay, where do I want to start? I typically think, okay, what's the history of this Breakthrough Device designation or where's it come from, something like that. Can you tell us a little bit about where it used to be and maybe where it is now and we can look at some of the things that we need to be applying today?

device side of things around:

Etienne Nichols: Interesting. Okay, so there's a lot to unpack there. So I really appreciate you going through that. So maybe if we built the perimeter around or built the scope of this conversation, what classes of device does this apply to and how would you determine whether or not maybe you are potential for a breakthrough designation.

Ellie Reynolds: So it applies to any device that has to go through a marketing submission. If you're exempt, it's not going to apply to you. It technically applies to anything. 510k de novo PMA. However, there is some sort of juxtaposition of calling yourself a breakthrough technology, but then claiming substantial equivalent. It's possible, but holding both of those in your mind is a little bit hard to make both arguments. So that's a fair warning. There are 510K devices that are breakthrough, but they're a little bit opposing arguments whether you qualify for breakthrough designation. There are two main criteria, the first one being that the device provides a more effective treatment or diagnosis for a life threatening or irreversibly debilitating disease. The second one is in a slew of four different sub criteria that you technically only have to meet one of them, they kind of overlap and it's usually worth making the argument for more than one. Those four being it represents a breakthrough technology, that there's no approved or cleared alternative, that the device offers significant advantages over any approved or cleared alternative, and that the availability is in the best interest of patients, the first criteria being the biggest one. The second criteria and the subparts are a little more subjective. But ultimately, if you think your device is a good candidate for those and meeting those qualifications, then you submit a key sub asking FDA to grant the designation.

Etienne Nichols: Okay, so that would be the, I guess the first step. I would look at my device and determine whether or not I am more effective or life saving, some of the things that you mentioned. And then that is the next step is just to do a Q sub or is there more of a formal document that I would look at or to do that gap analysis?

Ellie Reynolds: Yeah, there's FDA guidance about it that outlines what the submission needs to entail the different considerations they're thinking about with regards to each of the criteria. But it is just a document that you submit to FDA, making your claim of how you meet both of these criteria, which ones you think you fall under. You describe the device, obviously, and what your plan marketing submission is, any history that you may have with FDA. But the core is we think that we treat a life threatening or irreversibly debilitating disease. Making the case that your indication does fall under, that some of them are more obvious cases than others, but there's always an argument to be made there and then that your device provides a more effective treatment or diagnosis in accomplishing that. So those are the main arguments that you tee yourself up to making to FDA. And then they will usually at 30 days, request information from you if there's any clarification they need, if they need more information on data that you're presenting. And then within 60 days, they will give you an answer. Whether they designate you or whether they do not. They will provide feedback in that letter if they don't designate you. So if it's something like, we don't agree that your indication is life threatening, you're a little bit dead in the water on that one. It's hard to make a case if they just fundamentally don't agree with that. But if they agree on that aspect and the data you've presented doesn't make a compelling argument at this point, they have some other concerns. You can always submit later. So it's something that you can submit multiple times if it's really something that you're interested in pursuing.

Etienne Nichols: Okay, so no doesn't necessarily mean no. It may mean more you need more information. Is that accurate?

Ellie Reynolds: Yeah, it can definitely mean not at this time. They require what the guidance says is reasonable expectation of technical and clinical success. Again, that's a little hand wavy. It depends on the review team of where that bar is actually set. And so say you have some robust early bench data. You only have some animal data and reviewed teams not convinced on the translating to humans. Maybe you have some early first in human data coming down the line. You can submit once you have that. So it just kind of depends where you fall on the spectrum as to whether submitting again would make sense. If you're gung ho on submitting, say, your five, ten K, it may not be worth it to pursue again if that's where your timeline aligns. So it's definitely an option to submit technically as many times as you want. So definitely diminishing returns as you get closer and closer to your submission date.

Etienne Nichols: Okay. And I don't know if this is something that's in your wheelhouse, but is there a cost associated with that early on?

Ellie Reynolds: No cost.

Etienne Nichols: Okay.

Ellie Reynolds: Yeah, no cost to submit. No cost to take use of any of the benefits that the designation gets you. Obviously, if you're paying a consultant firm to submit it for you, there's cost for that. But to actually interact with FDA on this is free to the sponsor.

Etienne Nichols: Okay, so that phrase reasonable expectation of clinical and technical success that you mentioned. So that suggests to me that when you submit is really going to matter because like you said in your timeline, you're going to have to have probably a working prototype, maybe started your first Inhuman or something along those lines. So I guess it falls down to the benefit or the comparison of if I'm going to do that 510K or de novo versus this breakthrough designation. Part of what is going to determine which pathway I take is the timing. So how much time can I save? And this is getting to be a very rambly question. I am sorry. I don't mean to set it up so long, but how much time does it save and what are the real benefits there and maybe we could talk about if there are other benefits besides just time.

Ellie Reynolds: Yeah. So FDA is not going to give you a specific number of days that they will review your five point, um, they don't have anything like that. They say priority review, technically yours may get slaughtered at the top of the stack when it finally comes in. Ultimately, though, that's up to it. Depends on the resources that the review team has at the time. So it's not going to guarantee that, say, your 510K review happens any faster. However, if you do get granted Breakthrough, say, just prior to your clinical study, and you really need to discuss finalizing all the elements for your IDE, you can do that still through a traditional pre sub. As if you would, if you didn't have Breakthrough designation. Discuss those plans with your review team before you move forward to that submission. If you have Breakthrough, though, you are afforded something called Sprint Discussions, where you can talk about one topic over a series of interactions. So say you really are trying to nail down your efficacy endpoints, and there's a lot of negotiation on that and how it plays into your sample side. You can have a very pointed discussion with FDA over the span of maybe 45 days, rather than tossing that in a presub and then waiting the 65 70 days, however long it takes them to schedule your meeting to get those answers. So if you make use of the benefits that the designation allows for, then you can expedite those timelines in getting FDA's feedback of getting their review of your elements. But ultimately, once you submit your marketing submission, they're only tied to the medufa timelines. So the standard ones that everyone would face, they just make their best efforts to give you that priority review, and you may have built a relationship with your review team and have more insight on how the review is going. If you already have Breakthrough and have interacted with them a bunch.

Etienne Nichols: Okay. Yeah, I like that. It sounds like you have a few more touch points, so that does sound like a benefit as well. I don't know if you have an example. I don't want to put you on the spot necessarily, feel free to pass on this, but can you give me an example of something that meets this more effective treatment or diagnosis for a life saving device? Just to give me something concrete to think? Because I'm thinking, okay, every device I have, it's a medical device is going to save the world, and this is more effective than what's out there. But can you give me kind of an example of this? Makes sense, this not really any thought?

Ellie Reynolds: Yeah. Without disclosing too many details, I would say something that's really transforming how the patient proceeds through the care pathway. If it's allowing for earlier detection, if it's taking, for example, repeated surgeries off the table. So maybe there's an indication that starts in childhood the current standard of care. They have to come back multiple times, undergo really invasive surgeries. If there's something instead that they can use that then eliminates that need for repeated surgeries, that's really more effective treatment. You're reducing the burden to the healthcare system, you're reducing the burden to the patient. You're reducing the risks associated with that. So that's something that is a very obvious change. If you're taking, for example, the treatment or diagnosis outside of the hospital and allowing patients to do that at home or to do it earlier on in the pathway that has the potential depending what you're diagnosing, obviously you can diagnose things that are not life threatening at home, but if you're allowing that treatment to take place and sort of give the patients the autonomy back of being able to perform that on their own schedule or just give them some more independence, that is also something that would stand a chance for Breakthrough designation.

Etienne Nichols: Okay, that makes sense. Yeah, I can definitely see the benefits there. Then when you talk through some of those examples, one of the things that came to me while you're talking though, too, was we typically focus on the timeline. Is expedition the word. I'm looking for expediting of the timeline. That being said, I see sometimes somebody maybe advertising, whether to investors or whoever else, if they're post market to the commercialization, we receive Breakthrough designation and just kind of like something that sounds great. Is that something you've seen as well, that you could potentially use it in your marketing strategy just to really get a little bit more buzz?

Ellie Reynolds: That's a little out of no that's a lot of times if people come because they want to be able to say it to investors and for the sake of marketing, which is definitely a benefit, I think that might be over time, and this is just my opinion, FDA, I think, has gotten a little bit harder on granting breakthrough designation. I think it was easier to get earlier on in the program. They gave them out more frequently, I think, with a lower bar of evidence than what is expected now. And so part of that may be that it kind of just became this buzzy, trendy buzword in the community of We're Breakthrough. We're Breakthrough and several devices, many devices are worthy of receiving that designation. But I do think FDA might be cracking down a little bit just on how many they gave out in the early years and making sure that people that make it to this designation are truly worthy of receiving it and have the evidence to show it as.

Etienne Nichols: I don't. Are you able to speculate on what exactly they're cracking down on? Are they looking for a larger population that will see the benefit? What are the things that they might be looking at specifically?

Ellie Reynolds: I think it's stricter on that clinical and technical success in theory, they accept literature, bent animal, human data, the whole slew of it. In practice, I would say it's generally expected. You have something animal with an obvious translation to human, if not really human. I think the bar is just increasing, and you can see it in the number of designations that FDA has granted in the past years. They do publish that data. I just think what they're framing as worthy at the stage of development for breakthrough designation, that bar is what's increasing the criteria. Two elements. Again, those are more subjective. I think those are true regardless of the stage of development. It's just the trusting that the device can actually manifest the benefits and the more effective treatment or diagnosis. I think there's just more, not skepticism per se, but just expectation of a little more robust data around that and really making sure that the benefit you're claiming is true and attributable to your device.

Etienne Nichols: Okay? Yeah, I guess I could know. Maybe I have an idea that I haven't really proven. I'm going to go say, hey, this is going to be a breakthrough. I can see them saying, yeah, let's hold off on this guy. Show me some more evidence that makes sense. Well, okay, so let's just say I've gone through the FDA guidance. I've decided that this does make sense for me. It's not just a buzword for me, although I'm probably going to leverage that in my marketing. But I truly think this is the case. What are some challenges or unique things that I need to do? I know you talked about them a little bit, but maybe as I go through this process, are there any things that companies need to be thinking about as they go through that's going to be a little bit different? I don't know if it's harder is the right word, but what's unique?

Ellie Reynolds: Yeah, it's making sure that the data you have is telling that story of really how your device is achieving whatever indication more effectively, really making sure that your data, in order, that it's clean, that you're not doing just like you're not putting your early feasibility stuff out there. That's just like no comparator arm. Or I would say you don't want to put sloppy data out there just because you're early doesn't give an excuse for it to be not thought out. So I would say that's very important is telling the clarity of your story going forward. And then I think also the timing of your submission. Again, you want to benefit from the benefits of the program. You want to be able to use those so waiting so long so that you have all of your clinical data done and then submitting it. You're not going to get a lot of benefit out of that if your submission is two months down the line. So you want to make sure you're submitting it at a time where you're going to quickly be able to follow up and leverage the Sprint discussions or the protocol agreements that it allows for the other point that I was going to make, but I'm now forgetting.

Etienne Nichols: Okay. Yeah. If we go back to the benefit that makes total sense, if we go back to the benefits you mentioned a couple. There was a third one that I think you'd mentioned to me, something about Reimbursement. I know it's a different topic, but are there any let's see if I can run through these. The benefit of more interaction with the FDA, those more touch points, the potential for that marketing and investing, that third one with Reimbursement. Are you able to speak to that? It's okay if it's a little bit outside this discussion.

Ellie Reynolds: Yeah. High level. It used to be guaranteed that a breakthrough device, once it made it onto market, would receive automatic CMS reimbursement. No longer the case that was revoked, reviewed. It may still be under review. It changes all the time. The main benefit is that these technologies, when devices are being considered for reimbursement of being the novel for new technology, add on payments breakthrough is an obvious check mark for that. So it almost guarantees that it makes that decision easier. But it doesn't necessarily guarantee any particular coverage like it did in the early days of the program. You are muted.

Etienne Nichols: I guess it's still post pandemic. I don't know. Thank you. What else, as a company, do I need to be thinking about if I have a breakthrough device designation, or at least think that I do, and I want to approach this pathway again. One of the points that I wanted to really emphasize that you made was really good is that you still have to follow these other pathways. If it's de novo, if it's 510K PMA. You still have all of the other interactions that you have to go through in those submissions. But I'm still leading up to my submission. What are those things that I need to be really grappling with and really hammering down? Did I already ask this question?

Ellie Reynolds: Sort of, but I did think of my third point.

Etienne Nichols: Yes. All right. I stalled you for it. Okay.

Ellie Reynolds: Yeah. So another thing to consider is that FDA in general doesn't like having a bunch of Q subs under the same docket under one device at the same time. It's possible, but say you absolutely need a pre sub in the know, three months, submitting your breakthrough device designation, just making sure all of your planned interactions sort of align. You don't want one slowing down for the other. And you still give FDA time to review your breakthrough designation. So you can't submit it one week and hope the next week you're having a Sprint discussion. There's still the time built in and making sure those all fit in your schedule. And that one is not slowing down. The.

Etienne Nichols: To. I want you to say that just one more time. I just want to make sure I fully understand. So just one pre sub is getting in front of the other. I don't know that I completely followed. Apologies for that.

Ellie Reynolds: Yeah. So you can submit a bunch of different Q submissions to FDA prior to your market submission. Breakthrough is required to happen and be a closed Q sub. Ideally before you submit, say, your 510K. So that's something to consider. If you want breakthrough, you need to build in that 60 day timeline before you're approaching with your pre market submission. Likewise, in general, the review teams don't love having several Q subs open at the same time. So just taking into account if you really need to have a presub about a topic, you can continue your validation efforts, for example. But you also really want breakthrough in that same quarter, making sure that there's a way that the schedules align so that one Q sub isn't in review for one device, while you're also trying to get breakthrough at the same time. Just being realistic about how those timelines play out for the sake of your review team. Technically, it is not like illegal or it is not banned to submit multiple Q subs at the same time, but in best practices, making sure your review team is on the same page as you so that the story is consistent.

Etienne Nichols: Yeah, that does make sense. I can see that being a definite benefit because it's almost as if you're trying to get in front of everybody else. I mean, if you're just submitting multiple Q subs at the same time. Okay, yeah, that's a really good point. I'm glad you remembered that point then. Have you seen companies get rejected for this for any common cause besides the clinical and technical? They're not ready. We don't have enough information. What about other issues?

Ellie Reynolds: Yeah, we've had FDA disagree on what the definition of an irreversibly debilitating disease is. Sometimes you can make the argument maybe phases of the disease are more progressive or longer lasting, something like that, and if you catch it early on, it's something that can be treated or solved completely. We've had disagreements on that. Some that are actually pretty surprising that they would disagree with certain indications. You can work with FDA, so if that's the main hang up of either the evidence that you've shown only those benefits so far in this subset of population, or they only consider that subset to be irreversibly debilitating or life threatening, there can be negotiation on the indication for which your device is granted breakthrough. So they may want specificity built into your indications for use statement that specifies or that limits that population down to either the most severe or a certain age range or something like that. That can happen though. Something to consider is that if you're planning if your whole marketing strategy is based upon a population that is being excluded by that, yes, you could agree to get breakthrough but then your Breakthrough designation doesn't actually cover what your marketing strategy might be. So it's not usually super limiting, but it is something to consider that if you're cutting off a large market, you can still submit your device for the indication you're seeking a bigger one. Something that may not fall under what you have for Breakthrough, but then your Breakthrough designation may not apply if the team, the review team believes that that's outside of what the designation was granted for.

Etienne Nichols: Okay, so you're saying maybe the breakthrough is going to limit me to a population? We'll just say 60 to 70, just for round numbers. And then after, when it's time for me to submit the 510k portion, I'm still going to just submit it for a broader range than that. And maybe I'll get my hand slapped, but maybe I'll be able to convince them as well. Is that the thought?

Ellie Reynolds: So they will still review it in light of what you're submitting. So if you're going 50 to 70, they will still look at your evidence of data. It's just that those interactions you had under Breakthrough would have been limited to the 60 to 70 scope. So the expedited review nature that you or priority review you're afforded with your Breakthrough designation, if you have changed certain indications enough, your device may not actually be covered by the designation anymore. So you may just fall in line where you fall in line. The other thing being is say you had all sorts of conversations of how to run a clinical study on 60 to 70. You did all of that. You followed all their instructions, but then you approached them with population that you didn't study. That's an oversight on the bigger part, but it is something to keep in mind of where that aligns and what they're reviewing you in light of versus what your ultimate goals are.

Etienne Nichols: Okay. Any reasons you just tell people I wouldn't go that direction. Any reasons you just typically do?

Ellie Reynolds: Or is it something breakthrough designation?

Etienne Nichols: Yeah, for Breakthrough designation, I guess I'm thinking are you kind of conservative or liberal on it as far as yeah, I would go ahead and try. Obviously there's some cut and dried cases.

Ellie Reynolds: Yeah, it doesn't hurt to try. It's not going to cast an unfavorable light from FDA if you get rejected for whatever reason at the same time. Again, if your marketing submission is on the cusp and it is absolutely critical you get it in at a certain time in which the Breakthrough submission would slow that down, that's probably not worth it at that case. And FDA also might realize that and know you're not benefiting from this program. Why would we designate you and waste our resources on promising them to you if you're done with what you're doing? So I would say that if there's an obvious thing that you're a me too device, yes, you do something different. But the case for. Making a more effective benefit or diagnosis. Again, you can submit it. But if you're spending the time, resources, whether they're internal or external, on preparing that packet, interacting with FDA, you have the time to give go for it. But if that time is better spent elsewhere, then it's not make or break. Plenty of devices make it onto the market without breakthrough designation, even if they should have gotten it. So it's only a benefit. And I don't know if it's always worth the effort if it's something that's going to slow you down or is ultimately just kind of a waste of time for a particular device.

Etienne Nichols: That makes sense. Since there is a guidance out there and there's precedent and so forth, it makes sense that you should be relatively in line with what they're expecting by the time you actually get around to doing it. So that makes sense. Any other pieces of advice that you have for companies? It feels like we covered a lot of ground and a lot of both the perimeter and then the technical details around the breakthrough designation. But what other advice do you have for companies, if any?

Ellie Reynolds: I would say with regards to competitors. So breakthrough designation, one of the criterion is that no approved or cleared alternatives exist. That can be a little bit hand wavy as to is it an alternative procedure? It may not have a device. There may be a device that does the same thing or treats the same condition. But then the other option is do you provide significant advantages over that? Do you eliminate steps? Do you eliminate risk? Do you change how it interacts with the care pathway? You can have competitors that have received breakthroughs. So say you are a direct competitor with someone else, they got breakthrough, they're not on the market yet, though. You can still get breakthrough for the same indication. FDA does not consider that as a cleared or approved alternative. Even if they're miles ahead of you. They're in clinical study, you just got it out of your animal study. You can still get breakthrough based on that. Once that they are approved, cleared, whatever their pathway is to the market, then that makes it a much harder case. And technically, no one else can get breakthrough for the same indication unless you're selling a different kind of benefit for that. So I guess the advice is that don't be discouraged if your competitors have received breakthrough. It's actually a good sign that FDA has considered that indication irreversibly, debilitating, or life threatening. If you know kind of the stage of development of that device too, you can get a sense for what kind of evidence they might be looking for in your breakthrough designation as well.

Etienne Nichols: Okay, yeah, that's really good to hear. That makes sense. And it doesn't affect anything as well. If they get onto the market after you've been designated and you're not on the market yet, that doesn't really disqualify you.

Ellie Reynolds: Yeah, I don't think there's anything that would say, oh, now they're all revoked. It's just what someone makes on the market. That indication would be hard pressed to say there's no cleared or approved alternatives and how you demonstrate that you're better than them if you are a very similar comparator.

Etienne Nichols: Well, very cool. That's really cool. I really appreciate you breaking down this topic and talking about this designation. This expediting the pathway, really, so I really appreciate that. Where can people find you? And I don't know if you necessarily want people reaching out to you, but if you did, where would they reach out to talk to you?

Ellie Reynolds: Yeah, I can be found on LinkedIn. Again. My name is Ellie Reynolds. Or via email. My email is Ellie@proximatro.com. Feel free to reach out. We do breakthrough device designations all the time. We do step designation requests. We also will do assessments for companies or devices that are maybe early stage, maybe not sure how the argument is going to be made. We can do an assessment that breaks down the checklist or breaks down the criteria into a more in depth checklist of how you might be able to make a case for breakthrough. Where does your evidence stand? So that's something we are happy to do. We do so all the time. We love breakthrough devices, but also it's okay if you're not breakthrough. Everything's important. I think that's also good to remember.

Etienne Nichols: Really cool. All right, thank you so much and we'll put your information in the show notes so those of you listening, you can definitely look there and be able to get a hold of her or proxima directly. So fantastic. Thank you so much for being on the show today. Ellie and I will let you all get back to the rest of your day. Take care.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, reach out and let us know either on LinkedIn or I'd personally love to hear from you via email. Check us out if you're interested in learning about our software built for Medtech, whether it's our document management system, our Kappa management system, the design controls risk management system, or our electronic data capture for clinical investigations, this is software built by Medtech professionals for Medtech specials. You can check it out at WW greenlight guru or check the show notes for a link. Thanks so much for stopping in. Lastly, please consider leaving us a review on itunes. It helps others find us. It lets us know how we're doing. We appreciate any comments that you may have. Thank you so much.

Etienne Nichols: Take care.

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Etienne Nichols

Mechanical Engineer, Medical Device Guru, and host of the Global Medical Device Podcast