In this deep-dive episode, host Etienne Nichols shifts away from the "inspiring" fluff of entrepreneurship to deliver a gritty, practical masterclass for medical device founders. Drawing from his experience judging at MedTech Innovator and speaking with hundreds of founders, Etienne highlights a sobering reality: success in this industry isn't just about having the best technology. It is about getting the right specialized experts in the room at exactly the right time to avoid the "walls" that sink most startups.
The conversation centers on the critical importance of early-stage strategic planning. Etienne argues that the most important first step for any founder isn't building a prototype or filing a patent—it’s establishing a regulatory strategy. By understanding the classification and requirements of a device early on, founders can prevent the catastrophic loss of capital and time that occurs when a design doesn't match the eventual clinical or regulatory data requirements.
Finally, the episode walks listeners through the transition from design to commercialization. Etienne emphasizes the "valley of death" that occurs after FDA clearance, where many companies fail because they lacked a reimbursement strategy. This episode serves as the essential recording Etienne wishes he had ten years ago, offering a comprehensive blueprint for navigating the complex MedTech ecosystem in 2026.
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Design Controls Think of design controls like a rigorous "paper trail" for a recipe. If you were baking a cake for a grocery store, you couldn't just throw ingredients in a bowl. You would need to prove what the ingredients were (Inputs), show that the final cake matches the recipe (Verification), and confirm that people actually enjoy eating it (Validation). In MedTech, this process ensures the device you built is exactly what you intended to build and that it actually helps the patient.
510(k) vs. De Novo vs. PMA
"Your regulatory pathway is going to determine everything. It determines your timeline, your budget, your clinical requirements... it's like eating your vegetables before you're even allowed to look at dessert." - Etienne Nichols
"The companies that make it aren't always the ones with the best technology; they're the ones who get the right people in the room at the right time." - Etienne Nichols
We want to hear from you! Whether you have questions about the five stages or suggestions for a deep dive into reimbursement, send your thoughts to podcast@greenlight.guru. Etienne reads every email and provides personalized responses to help you on your founder journey.
Did this roadmap help you? Please leave us a review on Apple Podcasts or Spotify—it helps other MedTech founders find the show!
This episode is brought to you by Greenlight Guru. For founders navigating the design and development stage, Greenlight Guru offers a dedicated Medical Device QMS software that makes documenting design controls and risk management seamless. As you move into clinical testing, their EDC (Electronic Data Capture) solutions ensure your clinical data is high-quality and submission-ready. Align your technology with your regulatory strategy by visiting Greenlight Guru.
Etienne Nichols: Hey everyone, welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. Today's episode is for founders. If you've got an idea for a medical device, or maybe you're already building one, this is the episode I wish somebody had given me a recording of 10 years ago, and said, listen to this before you do anything. Because we're gonna talk… we're gonna walk through every stage of building a medical device company, not the inspiring stuff, this is not the follow your passion stuff, this is the actual, the practical, who do I need on my team, and what do I need to know at each stage stuff. Because… here's what happens to most MedTech company startups. They start with a brilliant technology, a real clinical need, maybe even early funding, then they hit a wall. Not because the science was bad, because they didn't know what they didn't know.
Etienne Nichols: I talk to founders every single week on this podcast. I've talked to hundreds of them over the years. Last week, I was at MedTech Innovator, got to judge 15 or 20 MedTech companies, and then listened to what the judges said about each one of them.
Etienne Nichols: The pattern is consistent. The companies that make it aren't always the ones with the best technology; they're the ones who get the right people in the room at the right time. So, we're gonna try to break this down.
Etienne Nichols: Starting with the idea stage, the, I think this could be a device, we've got a problem here, and I know how to solve it.
Etienne Nichols: You've got that idea. Maybe you're a clinician who's been frustrated by the same problem for years. Maybe you're an engineer who saw a gap. Maybe you're an entrepreneur who just discovered that the medical device market exists, and it's massive, and there are big margins. I don't know if that's actually really true, but maybe you've got that idea in your specific niche. Wherever you came from, the first thing you need is not a prototype. A lot of people think they need a prototype. It's not a prototype. It's not a patent.
Etienne Nichols: And it's not a pitch deck. It's a regulatory strategy.
Etienne Nichols: And I know that sounds really boring. Sounds like I'm telling you to, I don't know, eat your vegetables before you're even allowed to look at dessert. But the thing is, in MedTech.
Etienne Nichols: Your regulatory pathway is going to determine everything. It determines your timeline, your budget, your clinical requirements. It will tell you, what kind of manufacturing requirements you're going to have to have. It's going to really impact your ability to raise money.
Etienne Nichols: For example, I once talked to a founder who'd spent I think it was… somewhere between $400,000 and $500,000 on a prototype, and some pat… some IP, before talking to a single regulatory consultant. $400,000. And then they found out they needed a PMA, which is a Class III medical device, which also means clinical trials likely means millions of dollars more. And, as a result, that $400,000 prototype.
Etienne Nichols: It's likely going to be the wrong design for the data that they're going to need to collect. But all of its gonna have to change. So, if you're at the idea stage, this is who you need.
Etienne Nichols: I'm not gonna give you names, although if you reach out to me, I'll be glad to put you in touch with someone who, I believe is strong in any one of these categories, but the first thing you need is a regulatory consultant or advisor. And I'm not talking about a full-time hire, not yet. At some point, that might be required, but someone who can tell you what classification is this device. Is it a Class I, Class II, Class III? What's the pathway? Should it be 510(k)? Is it a De Novo?
Etienne Nichols: Are we going PMA? Maybe it's not even any of those. Maybe it's a clinical decision support software. Are there predicate devices?
Etienne Nichols: What standards apply to this device, or this industry specifically that you're going to have to adhere to?
Etienne Nichols: This person, this regulatory consultant, is going to save you years of pain. Literally years.
Etienne Nichols: Okay, that's the first person.
Etienne Nichols: The second person is a patent attorney. Most people understand this one, but I'm going to give you a little bit of a twist. It needs to be specifically one with MedTech experience, not your buddy who does real estate law, a patent attorney who understands medical devices, because the claims you write in your patent need to align with what you're actually going to bring to market, and that's a MedTech-specific skill.
Etienne Nichols: This isn't like going to your real estate lawyer and asking them to conduct your divorce, and him saying, well, you know what, divorce is mostly about real estate anyway. No, no, no. This is MedTech, and there's a lot of difference in how things need to be approached. So, find someone with MedTech experience.
Etienne Nichols: Okay, the third person you need is a clinical advisor. This is somebody who actually uses, or has used, something like what you're building, or has dealt with the problem that you're trying to fix.
Etienne Nichols: This is not a co-founder, necessarily, but this is someone who can pressure test your clinical device. And think about the claims that you're going to make. Is it actually going to do the things that you want it to do?
Etienne Nichols: Does this problem actually exist? In someone else's mind, in the way that exists in your mind? Is your solution one that a clinician would actually want to solve?
Etienne Nichols: And at this stage, your job as the founder is to answer one question.
Etienne Nichols: This is the only question that should be on your mind. Is this even worth pursuing?
Etienne Nichols: Because you can't answer that without a regulatory person, you can't answer that without an IP, most likely an IP attorney, and you can't answer that without the clinical input. So, get those 3 people, that's the first stage that you need to be in once you've decided, I'm going to be a MedTech, I'm gonna build a MedTech company, and I'm going to do these things. Okay.
Etienne Nichols: Second stage is the design and development stage.
Etienne Nichols: You've done your homework, you've talked to those 3 people, they've given you a little bit of an IP moat, they've given you a regulatory strategy, it's viable, the clinical need is real, the IP landscape is not a minefield, you start designing and developing. This is where most founders probably feel most comfortable, depending on what your background is.
Etienne Nichols: Because this is the building part, this is the engineering, this is the fun stuff. I love this, you know, I was a mechanical engineer, and I love playing around in SOLIDWORKS and making, you know, changing the tolerances and really mating it with other parts.
Etienne Nichols: But this is where it also gets tricky, and I can't stress this enough, because we forget about design controls. Remember, what I'm telling you is…
Etienne Nichols: One of the reasons this is so med-tech-specific, and design controls is one of the reasons the design and development stage does is unique to the medical device world.
Etienne Nichols: Now, design controls are required by FDA. Well, okay 21 CFR Part 820 is the specific, Code of Federal… part of… the Code of Federal Regulations, if I can say that, now it's called the QMSR, which points to ISO 1345-2016 specifically, and they require that you have a documented design and development process. They don't call it design controls anymore, it's gonna be…hard to kill that, habit, but if you didn't document from the start, you're going to spend months, and I mean the expensive, painful months recreating documentation after the fact. I've seen it, I've lived it, I have done that myself, and it's ugly.
Etienne Nichols: I've worked for, even after I sort of left, being a project manager, since then, I've worked with about 50 companies at Greenlight Guru, helping them to understand exactly this, what the process is, how to do it, and how to do it right. The ones who started design controls early.
Etienne Nichols: This is a smooth process, because it's actually informing the design. The ones who wait it's kind of like putting toothpaste back in the tube. You're really going to be struggling there, and you're going to do a lot of reverse engineering. Most likely, you're going to have to change your design as well, depending on whether or not you, did things that are verifiable and validatable.
Etienne Nichols: Okay, this is what you need at this stage. I was talking about people. Here's who you need.
Etienne Nichols: The person you need is a quality system person. This doesn't have to be a full-time VP of quality yet; it can be a consultant. But you need someone who can set up your design controls, your document control, and your risk management file. You, you likely also need supplier quality as well, because most of the things that we build in MedTech have a lot of outsourcing components to them. But at the very least, design controls.
Etienne Nichols: Risk management and document control, and they need to understand ISO 14971, which is the risk management standard. This is… this is the one that matters. It's not just FMEA, Failure Mode Effects Analysis. We once hired someone, I won't… say what company I was working for at the time, but we hired a design engineer, and during the interview process, one of the other engineers said, so, what do you think of ISO for 1971? Any thoughts there? And he said, I don't know what standard that is.
Etienne Nichols: Kudos for your honesty, but you need to know about ISO 14971 if you're in product development. So, quality system person who understands all those things and could put those things in place, because when you build that design history file, you don't want… you don't… you want to make sure that the reviewer is paying attention to you, and that you have all those things buttoned up. Okay, so that's your quality system person. The second person you're going to need is a human factors or usability specialist.
Etienne Nichols: The FDA cares about this a lot. A lot more than they used to, especially for anything patient-facing.
Etienne Nichols: So, if you're building a device that is going to be used in the hands of the patient, not just the surgeon, but the actual person who… a layperson, if I can use that phrase, you need to prove that the real humans can use your device safely. This person plans your formative and your summative usability studies.
Etienne Nichols: So, they're going to be thinking a lot about the… I really treat human factors and usability as risk management, and they're going to be looking at it from how can the use of this device cause problems? Not just the device itself, but how can someone could potentially have issues with just trying to use it.
Etienne Nichols: Whether that's causing damage or not causing the benefit that you need to accomplish. Because remember, our devices both need to be safe and effective. If they're not effective, but they're safe, well, it's still not worthwhile.
Etienne Nichols: Alright, that's…
Etienne Nichols: Quality system person, human factors person. Third person you need is a manufacturing engineer, or a relationship with a CMO. Not marketing, but CMO being the contract manufacturing organization. You need to start thinking about how this thing is going to be made.
Etienne Nichols: Not in your garage, not how you're making it right now with prototypes, but at scale.
Etienne Nichols: Where? Where's it going to be made? By whom? What are the manufacturing controls? If you wait until after you finalize your design to think about manufacturing, you're going to have to redesign it, because part of the process with manufacturing is DFM, design for manufacturing.
Etienne Nichols: Hopefully, your design engineers have a solid understanding of manufacturing processes, but it's kind of like a VIN diagram. Most design engineers will tell you, we know how to manufacture this, and most manufacturing engineers will tell you, we know how to design this, but they have their own specialty, and there are things that they don't understand about each other's roles. I've worked in both roles, and I can tell you that there's…things product development engineers, are really good at, and manufacturing isn't always that part. So.
Etienne Nichols: All of those things aside, I'm sure there are lots of, what's the word for those people who can do just a little bit of anything? It'll come to me as soon as I stop recording.
Etienne Nichols: But I've seen it play out where you had to redesign it after product development was done with it because of manufacturing. Now, just last week, I had a founder ask me.
Etienne Nichols: What do you recommend? Do you recommend bringing the manufacturing in-house, or do you recommend, taking it to a CMO and doing a small-scale production and then ramping it up as they get larger?
Etienne Nichols: It's going to depend on your numbers, it's a numbers game at that point, but honestly, even all of that aside, what I would tell you…
Etienne Nichols: This is what… if I were building a medical device company today, in 2026, I would go to the CMO. I would not be bringing manufacturing in-house. Obviously, it's going to depend on do you just want a medical device manufacturing facility, if that's what you're after. You want that on your resume, that I own a manufacturing medical device manufacturing facility, we've designed the product, we manufacture the product. Okay, that's… if you want to stroke your ego that way, or if you feel like you can save a little bit of money that way, that's fine.
Etienne Nichols: I will say, if you go ahead and go with that good CMO, it will shave years off of your… maybe, maybe I should say inches off your hairline, I don't know, whatever the analogy needs to be, it's gonna make your life easier.
Etienne Nichols: Go with the CMO, because not only will they be able to help you with the design for manufacturing, that DFM, they have manufacturing engineers on staff.
Etienne Nichols: They can help you understand, should you go with a single cavity mold or a multi-cabinity mold? What's the benefit of injection mold versus, casts and all these different things. There's lots of different, there's lots of different things, questions they can answer.
Etienne Nichols: And not only do they apply the learnings from your product line, but they have all the other product lines they work with, and they know how to IQ OQPQ, which is the qualification of equipment. They know how to validate their processes and go through the PFMEA, the process failure mode effects analysis. There's lots of benefits to having a CMO build your product versus bringing the manufacturing in-house. So.
Etienne Nichols: That is just my recommendation. Obviously, it's gonna vary case by case, and you're not gonna hurt my feelings if you don't take my advice on that one, because again, it is kind of up in the air and depends on what your ultimate goals are. But a quality system person, human factors, manufacturing… I'm gonna go back to this regulatory person as a fourth at this stage, because they should be involved in the design reviews.
Etienne Nichols: They should be looking at your design inputs and making sure that you're building, what you're building matches what you said you'd build in your regulatory strategy from the beginning. So, this isn't a one-and-done conversation. It needs to be cyclical, it needs to be circular, and you need to be asking them, okay, are we ready to move forward with our submission? Or just lots of different questions you can be asking at that stage.
Etienne Nichols: Third stage, the testing and verification stage.
Etienne Nichols: So, at this point.
Etienne Nichols: We ideated already, that was stage one. We have, built our prototype, and we…
Etienne Nichols: Got ready to build everything, that's stage 2, the design and development stage. Now we get to the testing and verification, your design is coming together, you need to prove it works.
Etienne Nichols: This is where the money starts to move really fast. Testing is expensive, because you have, let's see here, you got verification and validation testing, biocompatibility testing, most likely.
Etienne Nichols: IEC 60601, which would include electrical safety testing, but other things as well. There's more to it than that. Software verification, if you've got software. Sterilization validation, if it's a sterile product, or shelf-life testing. Well, all the packaging validation, which includes drop tests, or dry, what is that? Bubble dye test? I got involved peripherally with that at one point.
Etienne Nichols: They can be fun stuff, some of the destructive testing you do with packaging, but people forget about that. Sometimes they leave it till the end.
Etienne Nichols: I should have said this at the beginning, that packaging needs to be a part of your product, because when you think of your product.
Etienne Nichols: That is the entire thing you're going to put in the hands of the user. That includes the box, that includes the wrapping, that includes the shipping and the labeling, the UDI, which is… stands for Unique Device Identification. A lot of traumas around that when that got rolled out in, what was it, 2016 for the FDA? I can't remember if that was… for Class II medical device. Anyway, someone will correct me, I'm sure, if I'm wrong about the year, but yeah.
Etienne Nichols: Had a lot of scars from that one, but every single one of these different testing things, whether it's biocompatibility or whatever, has specific standards. ISO 10993 for biocompatibility, and that just recently got updated. It may be being updated actively as we speak again.
Etienne Nichols: Spoke with, an expert in that field recently, and I have another episode if you're interested, reach out. I'm happy to put you in touch with that. I mentioned IEC 60601, for electrical, IEC 62304 for software development, if you're, developing software. Each one requires specialized knowledge.
Etienne Nichols: And each one of those testing labs has to do that work. So, here's what you need.
Etienne Nichols: Here's who you need. I know that's… that's really the more important, thing, isn't it? A testing lab, usually multiple testing labs. You're going to need to get accredited labs for that biocompatibility, performance testing, probably sterilization validation if it's a sterile product, like I mentioned. And these labs have backlogs, month-long backlogs.
Etienne Nichols: You've got to talk to them early, not when you're ready to submit, not when you're ready to start selling. You need to be talking to them early. Think about that backlog, get ahold of them quickly. Get this whole list of people in front of you and find out, just get them on the phone and figure out when you need to be talking to them. Alright, testing labs is one thing.
Etienne Nichols: But in addition to that, you need a biocompatibility expert.
Etienne Nichols: ISO 10993 is… I'm… okay.
Etienne Nichols: This may come from a mechanical engineer, but I think it's a tough situation that you're in if you're doing Biocomp. The biological evaluation plan alone is something you want an expert to write, or at least review, because if you get that wrong, it could sink your submission. It's not just going to delay it, it could sink you, if you get that wrong, and have to go back to the drawing board and do all of that over again. So, I would have a biocompatibility expert, expert on, on speed dial. They may be rolled up into that testing lab, and that's fine if that's the case, but…
Etienne Nichols: They… if you find the biocompatibility expert first, they may be able to put you in touch with the test lab that they recommend.
Etienne Nichols: Alright.
Etienne Nichols: A clinical affairs specialist.
Etienne Nichols: So, if your pathway requires clinical data, this is the person who designs your clinical study, writes the protocol, manages the IRB relationship.
Etienne Nichols: Make sure the data you collect actually answers the question that the FDA is going to ask. So, I have a few people who I really love for this sort of thing, that I worked with in the past, but they… they are special people, because they have the mind of a project manager, they have the heart of a doctor, and they just, you know, know people, those IRB relationships, and somehow have the technical savvy to… to manage all those protocols. So, a clinical affairs specialist is also, I'll say, the third person, or, or, if we call the test lab a person. And then fourth, a statistician.
Etienne Nichols: I know, you might roll your eyes at this, we have AI for everything now, but sample sizes, test methods, acceptance criteria, these all have statistical requirements, and a good biostatistician can make sure that your testing is designed to actually demonstrate what you need it to demonstrate. So.
Etienne Nichols: I've seen companies redo entire test programs because they didn't get the stats right up front. So, you don't want to be off on those numbers, because if you go over, you're spending way too much money. If you go under, you could, really… cause problems with your submission layer.
Etienne Nichols: Okay. Again, if you find that biocompatibility expert, they may be the one who can open the doors to the other areas, or that test lab, either one, whichever one you want to start with, but that's what I recommend there. And again, happy to put in touch with any of these people if you reach out.
Etienne Nichols: I've been in the industry long enough and been to enough events. Wow, even this year, I've been, you know, just, busting up the seams. Okay.
Etienne Nichols: Fourth stage would be the submission and clearance stage.
Etienne Nichols: Let's say you've built your medical device, you've tested it, now you need to get it cleared, granted, or approved, and I know those are different words for 3 different things. 510(k) devices are cleared, De Novo devices are granted, PMA devices are approved.
Etienne Nichols: Use the wrong one at a conference, and somebody will correct you, trust me. But I won't be the one correcting you, but I'll always correct myself. But here's who you need for this section.
Etienne Nichols: First, a regulatory affairs specialist who has written submissions before. Not just someone who understands the regulations and theory. Now.
Etienne Nichols: Someday, I'm going to write a regulatory submission, but to be completely open, I've notarized them, I've signed off on them, I've done it from the product development side. I've not written a regulatory submission myself. And so, someone who has put together a 510(k) or De Novo package and gotten it across the finish line, that is a craft.
Etienne Nichols: The organization of the submission, the way you tell the story, the way you address risks and mitigations, it does matter. So, get someone who's done it before. I would recommend doing… making sure that you do that. eStar is making things a lot easier, yes.
Etienne Nichols: But it's still a big chore, and you're gonna be better off, and you're gonna have a lot more peace of mind if you have that regulatory affairs specialists do it. Somebody's done it before. Alright.
Etienne Nichols: Secondly, is a labeling expert. Now, I used to be this guy, I'm not anymore because I don't like it that much, but your labeling has to comply with FDA requirements. If you're going to sell in the EU, it also has to comply with EUMDR requirements.
Etienne Nichols: Those are different. Trust me, the UDI for FDA is different than EMDR.
Etienne Nichols: I had seen that EMDR could possibly be changing, and that would be great if it does, but even if it changes drastically, it could still be more difficult than the FDA. They're different, the symbols, the content, the IFU, all of it has specific rules. So, getting that wrong is one of the most common reasons for FDA RTAs, which is a refuse to accept letter. And, you know, I saw something recently that RTAs, with eStar, you shouldn't have that problem, but anyway.
Etienne Nichols: You write in and let me know. Find me on LinkedIn and let me know what your experience has been. I'd love to hear more about, how your experience is, especially more recently. Okay. The next person will be a reimbursement advisor. This is one almost everybody forgets or leaves till the end.
Etienne Nichols: You can get FDA clearance and still fail, because nobody will pay for your advice, or maybe they would love to, but they have to have insurance pay for it, and you don't have a CPT code. You need to understand the reimbursement landscape before you submit. Is there an existing CPT code? Do you need a new one? What's the coverage determination process?
Etienne Nichols: This can save your business. This person can save your business, this reimbursement advisor. Not only that, if you get them in early enough.
Etienne Nichols: They may actually be able to say, hey, with this feature, I can tell you right now, you're not going to get reimbursed, because they never reimburse. I was speaking to a friend of mine who is a really good reimbursement guy, at LSI, I believe it was, and he was giving… he was just telling me stories about how…
Etienne Nichols: If you, if he had gotten there early, he… he… well… what's… what was the exact punchline?
Etienne Nichols: He actually had to tell them that they had to remove certain features and add another one in order to get to the certain CPT code, otherwise there were going to be an over-the-counter device, or something like that. Anyway, I'm not a reimbursement specialist, but I know who he is, happy to help if that's helpful, but… you've got to talk to a reimbursement specialist. I can't tell you how many founders who have gotten there at 510(k) clearance and then realized they had no reimbursement strategy. The FDA might tell you that it's safe and effective, but if the hospital says, okay, how do we get paid for using it? Nobody gets paid, nobody buys your device, that's a problem.
Etienne Nichols: Alright, the fifth stage, and that is the commercialization stage. Let's say you've got your clearance, you've got.
Etienne Nichols: That's huge, first of all, congratulations. Most devices never make it this far. Now you need to sell it. And I'm not trying to scare anybody, but this is a huge value of death that we don't always think about.
Etienne Nichols: It's a completely different skill set than everything that's come before. Building a medical device and selling a medical device, those are two different disciplines, and they require two different kinds of people. So, this is who you need at this stage.
Etienne Nichols: First, a commercial leader who knows your market.
Etienne Nichols: This is not a generic sales VP. This is someone who is sold into the specific clinical environment where your device will be used. Selling into the OR is different than selling into the primary clinical, the primary healthcare clinic.
Etienne Nichols: Which is different from selling to home health. The person who knows the buying cycle, the decision makers, the committee structures, that is who you need at this time. So that commercial leader who knows your market.
Etienne Nichols: And next, a marketing person who understands MedTech.
Etienne Nichols: And I don't just mean someone who can make a really nice brochure, I mean someone who understands clinical messaging, who can translate your technical claims into language that resonates with physicians procurement teams, and someone who understands the difference between marketing a consumer product and marketing a regulated medical device, where every claim has to be substantiated. Someone who understands anti-kickback laws, False Claims Act, things along those lines. And, you know, the pitfalls when you get into ad promo.
Etienne Nichols: And off-label use, and all the regulations behind that. They don't have to know all the regulations; they have to understand it well enough to avoid those.
Etienne Nichols: And, and to understand MedTech.
Etienne Nichols: Okay, that's the second person. So, you have your specialized commercial operator who's sold into your market, you have the marketing person who understands overall MedTech, and then a post-market surveillance person. The FDA doesn't stop paying attention after you get clearance, after you get…
Etienne Nichols: Granted, whatever the case may be, whether you are
Etienne Nichols: I'm not even gonna list them all right now, but you've got… you've got complaint handling that could come up, MDR reporting, MDR stands for medical device.
Etienne Nichols: Medical device?
Etienne Nichols: What am I saying here?
Etienne Nichols: I'm gonna make sure I got that right.
Etienne Nichols: MDR… medical device reporting. Yeah, medical device… MDR reporting. That's kind of… I just realized that, as I'm saying this, that, I'm saying reporting twice.
Etienne Nichols: Shame on me. Anyway, you've got all of these different things. You've got CAPA’s, you've got post-market clinical follow-up, BMCF, that we typically call it, you have all of these different… things, that one's if you're in the EU, but your quality system has to be able to handle all these things. You need somebody watching this, so you need a post-market surveillance system. This is getting more and more and more important with the advent of AI, and how, there's been a lot of different talk about how the FDA's gonna move towards more of a… less of a gatekeeper to the industry, and more of a watchdog as things are in the industry. I don't know if that's true or not. Those are some of the different talks that I hear at conferences.
Etienne Nichols: But either way, post-market surveillance is becoming higher and higher priority. So, you need someone doing that, watching that. And then, finally, you need a… and I say finally for this segment, not totally yet, we're not done just yet. But finally, you need a supply chain and operations person.
Etienne Nichols: Getting your device manufactured at scale, reliably, with consistent quality.
Etienne Nichols: That's its own world. Supplier qualification, incoming inspection, manufacturing controls, change management. If one of your suppliers changes a material and you don't catch it, that could be a potential recall. You know whether it's
Etienne Nichols: A serious recall or not is TBD, but, based on the actual material, that does change, but that can be something that you have to, recall from the field and rework, etc. It's lots of different things that could happen. So having that supply chain and operations person is going to prevent that at that stage. Okay, let's move on.
Etienne Nichols: The role that nobody talks about, last thing I'll say, is might be the most important one of all, and that is the connector. The person who knows who the good regulatory consultants are, who knows which testing labs have short backlogs, who knows which reimbursement advisors have actually gotten codes through, who knows which clinical sites are goods for studies, and which ones will ghost you after two patients.
Etienne Nichols: It's not a job title, it's a network. This person has a network, and it's something you either build over time.
Etienne Nichols: Where you borrow from someone who already has it. One of the things I love most about doing this podcast is I get to talk to all of these people.
Etienne Nichols: The regulatory experts, the quality specialists, the founders, the investors, the clinical researchers, the FDA reviewers, and what I've learned is that the companies that move fastest are the ones that ask for introductions instead of trying to figure out everything for themselves. So, you don't have to know all the answers, you just have to know who does. Find that person, and
Etienne Nichols: They'll help make your life a whole lot easier.
Etienne Nichols: Alright, let's see if we can close this thing down. Building a medical device company is hard, and I'm sure I left out a lot of different things that maybe you've already thought of, and if you have, let me know. I'd love to know what I missed. But I'll tell you, it's really hard. There are more ways to fail than there are to succeed.
Etienne Nichols: And most of the failure points aren't about the technology, they're about… they're about not having the right expertise at the right time. So, my last piece of advice, and really, if I were to wrap this all up into one piece of advice.
Etienne Nichols: Before you spend another dollar, ask yourself, do I have the right people around me for the stage I'm in right now?
Etienne Nichols: If you don't, go find them. Ask around, talk to people in the industry, come to events, listen to podcasts, not just this one, but I appreciate it if you do. The MedTech community is smaller than you think, and most people in it genuinely want to help.
Etienne Nichols: Thanks for listening. If you're a founder and you've got questions about any of this, who to talk to, where to start, where you might be missing, feel free to reach out. I'm on LinkedIn. I might not have all the answers, but I probably know someone who does.
Etienne Nichols: I'll catch y'all next time.
Etienne Nichols: I'll say… well, one last thing. The connector role I talked about. If you've been in this industry for more than a couple years and you don't have one, you might be the one your network needs, so think about that, too. Maybe you're the network, connector that your industry needs. All right, everybody, thanks so much for listening. See you next time.
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.