In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man.

Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt.

Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape.

Key Timestamps:

• 00:00 – Introduction and Greenlight Guru sponsor message
• 02:45 – Welcoming Justin Bushko; background in MedTech and engineering
• 07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing
• 10:45 – Prototyping with a purpose: Ensuring design iterations target risks
• 16:00 – Balancing innovation, user needs, and cost-effectiveness
• 20:30 – Defining essential versus “nice-to-have” features in MedTech
• 26:45 – Strategic pivots in MedTech: When and why to change course
• 32:50 – The critical role of design freeze and usability studies
• 39:10 – Lessons from competitive benchmarking and reverse engineering
• 46:25 – Handling unique challenges in regulated industries like MedTech
• 52:15 – Opportunities for MedTech innovation and faster regulatory approvals
• 58:45 – Advice for founders and importance of building the right team

Standout Quotes:

1. "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko
2. "MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko

3 Key Takeaways:

1. Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages.
2. Simplicity is Often the Key: Resist the urge to over-engineer; clarify core features and eliminate unnecessary ones to save on costs and improve usability.
3. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration.

References:

• Connect with Justin Bushko on LinkedIn
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

MedTech 101:

Formative vs. Summative Usability Testing – Formative testing occurs early in the design process to gather feedback and iterate quickly, while summative testing is conducted later to validate that the design meets user needs and regulatory requirements.

Audience Engagement:

Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!"

Feedback:

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.

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: Compliance can be complicated, but it shouldn't hold your company back with Greenlight Guru Turn quality and compliance into a competitive advantage. Our QMS software is built for medtech innovators like you, helping you bring safer products to market faster. From design controls to post market surveillance, Greenlight GRU gives you the tools you need to thrive in a complex regulatory landscape. Ready to see how you can move faster with greater confidence? Head to www.greenlight.guru to learn more.

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. With me today is Justin Bushko. He's the president of Concise Engineering and the visionary behind MedTech Man. Maybe we can talk about what that is. A premier resource on medical device innovation. He's also the author of Medical Device Fireside Chats, Real conversations for your startup to prevail where he brings his expertise to entrepreneurs who are navigating the medtech landscape. I've looked some at his blog. I've not looked into it incredibly deeply, but I need to start subscribing to it myself because what I've seen, it looks like you offer some pretty in depth analysis of different technologies and trends and you take complex topics and you make those accessible and engaging. So the first time we met was at MDM west in California and then later on at lsi, which is where we decided we've got to do a podcast because I keep running into the Medtech man and so yeah, tell me, go ahead and fill in the gaps on your bio. I know I I missed a lot but those are the highlights that I wanted to catch.

Justin Bushko: I started this about nine years ago doing design consulting and also some manufacturing, light manufacturing in the MedTech space. 100% medical. But Mike first started over 20 years ago. I worked in industry at Conmed Limitech which competes with Arthrex and Stryker and I worked with Smith and Nephew as well. And I got to wear pretty much every hat you can find. So I worked in service and repair, I worked in quality, I worked in operations, I worked in R and D, setting up new mini startups, internal and then I wear all the electrical products, safety, usability, software compliance, all those hats, working with the FDA and BSI and those folks. So it's been a fun ride and always trying to Help give back to the community. So when I can find something to write about, that's what I'm trying to do.

Etienne Nichols: Fantastic. And you know, you mentioned Arthur, because I actually have one of those in my foot. I'm not sure exactly what it is they told me. So talking to a competitor, maybe I don't want to know about the competition, but I wonder, can you share us? Were there any pivotal moments early in your career that made you decide to go this direction or that direction? Because. And we'll cover a lot of ground. I hope that's, that's the hope. But you mentioned all of those different departments. Not everybody actually gets to see all the different sides that go into a medical device development. And a lot of people go deep into one. Obviously it sounds like you've gone deep into multiple. So I wonder how, how that, that path started.

Justin Bushko: Yeah. So I think it was an early career misdirection from my, from my side. Right. So I started in design, doing board level design outside the medical industry and then quickly took a shift into marketing and sales which started to be a little too awkward for what I wanted to do. And then working my way back pushed me through all those other departments. So from sales and marketing to get back to R and D, I had to go through service and operations to fight my way back in. And then after I was in R and D, I actually took a, like a side path to do some quality and regulatory stuff as I was mentioning. But that was primarily because I had my first child and only child. So it was. Let's take a step back a little bit and figure out what's going on.

Etienne Nichols: First only and favorite. That's. That's.

Justin Bushko: Not.

Etienne Nichols: Everybody can say that.

Justin Bushko: That's very good. Yeah.

Etienne Nichols: What I would. One of the things I'm curious about because you talk to a lot of different. Are they different stage companies or where do you really focus the most? Maybe I should ask that.

Justin Bushko: Yeah, we're everywhere actually. I like this early stage startups. A couple people with a reasonable funding, with a, you know, a patent or a napkin sketch and we'll take them as far as we can get them on their funding and then hopefully help them across that finish line. But we also work a lot of the big players helping fulfill augmentation gaps or just working on a specific focus. We've even done like major EU MDR projects for really large companies that just needed some support.

Etienne Nichols: So when you're looking at these different companies, are there consistent things that you see across the board where they. I'm Thinking of strategies and early design or maybe in the middle prototyping phase, are there certain things that you. You pretty much can pluck out and say, I know that this is likely going to be a problem. Anything come to mind?

Justin Bushko: Well, I think when you're doing things related to autoclavability and sealing, those are typically major issues. Also, electronics in sterile product tends to get a little bit tricky there as well. So a lot of early stage things you can do to do some testing to work through those details. So those are common challenges. I've seen one of the.

Etienne Nichols: One of the articles I read that I believe you were the author of it on your website you talk about the process of prototyping with a purpose. I wonder if you could go into a little bit more detail about that.

Justin Bushko: Sure. I think one of the biggest things that you want to do is make sure that your prototype has a purpose. And that purpose is related to some risk or some need within your project scope to be successful. So oftentimes you're going to. You would just want to put together a functional prototype that looks pretty to maybe show your investor, but really focusing on the front end that may have a fracture point and then specifically testing that area is going to be more beneficial than putting together a functional prototype. So really focused on what's necessary to take you to that next step is critical and to eliminate risk and then hopefully refine that design before you go to capital tooling or anything else that's going to be very cost.

Etienne Nichols: Yeah. So the engineering side, we don't actually talk about that a lot on this podcast, oddly enough. And it's something I'm really interested in. Having been a mechanical engineer, maybe I still am, I don't know. But just some of the things that you see, I mean, we talk about regulatory and quality a lot because it's very specific, or at least a lot of the regulatory things that we talk about, they are specific to medical devices. When it comes to engineering. Obviously, if you're going to build an electrical device or a mechanical device, that mechanical device has to work in an automobile. If it's a mechanical thing, it has to work in a medical device. Are there specific things that you think are unique to the medical device industry when it comes to the engineering side? I wonder if you could speak to that.

Justin Bushko: Sure. I mean. Well, one of the things I kind of mentioned before is autoclave ability. That's definitely unique to Medtech. And I think also we do very complex designs that often don't need to work very long. Right. If you Got a single use device that maybe has to, you know, advance 10 or 12 sutures or something along those lines. They're very critical products that need to work very well, but they also be very, need to be very cost effective but fail outside of its life. So you can over engineer it very easily. But you got that sweet spot of making sure that it works and it works well.

Etienne Nichols: That's, that's a really good point. I'm curious how you would balance. A lot of people want to be the most res. The most cutting edge, but they also need to be user friendly, but they also need to be cheap. How do you kind of navigate that trifecta? And I'm sure there's others I'm not thinking of.

Justin Bushko: Yeah, I, I think the biggest thing is really narrow, narrowing down your features at the beginning. There's always a few features that would be nice to have that if you can kill them on day one, maybe you can bring them back, but just try to kill them all together and just get rid of them. You know, why do I need a display on a mechanical device now? I've added a battery, a charging mechanism, all these other features and it might be really cool, but in most cases it's not going to, it's not going to make or break the product. So let's, let's focus down on what's really necessary and be successful on day one.

Etienne Nichols: How do, how do those conversations go when you tell people that is it. Is, is it received well?

Justin Bushko: Or I would say it's typically not even heard the first few times like yeah, yeah, of course that'll be there and then we'll talk about that again later. So I think it really comes down to when you're starting to talk about the cost of goods and you're creating that bill of material and you're showing them that hey, like 40% of the cost is going to this feature that nobody really wants. And now I need to add these extra components or extra features and the, the mechanism for plastics and now the mold's gonna be more expensive. Having that upfront as early as possible is the easiest way to kill those features.

Etienne Nichols: If we jumped into design controls and pull that with us early on, a lot of people will, well, a lot of companies I've worked with, they'll have their list of user needs and in their mind they're all necessary. And so we sit down in a conference room and say, okay, what's actually necessary to meet this indication for use that like you said, maybe okay, it's a 30 70, 30% are truly necessary. Maybe 70% are nice to have, but we're going to leave them in there somehow. How do you handle that? I mean, you said it'd be nice to just kill them all together, but how do you handle that when you have some people who just can't let go?

Justin Bushko: It really depends on the project and the framework of each company. I've done some where you use the word shall for what must be there and you use the word should for. For what would be nice to have, which is kind of an awkward code that doesn't really work because at some point you have to delete the shoulds at the end of the design history file to get your 510 approved. But I think that's a good place to start. And then start having those conversations about cost of goods on those things that are more nice to have. And then testing those informative studies with KOLs. Ask the question, would it be cool if you had this knob? Yeah, it would be cool. Would you pay extra for it? No. Okay.

Etienne Nichols: That market feedback is really important. It kind of leads into what we were talking about before we hit record, which is pivoting your product development strategy. Can you speak a little bit to the pivots? I know you have a chapter in your book about this, but.

Justin Bushko: Yeah. So pivots happen all across the entire path. Right. They're going to happen early at the beginning in regulatory, whether it's you're trying to go for a PMA or a de novo or you want to find an indication that's lower that gives you a Class 1 or Class 2 device. Right. So there are long term strategies on that, on that side. And making those early stage changes can get you on the market faster, into revenue faster. Same thing on design. Making those pivots related to a specific feature, whether it be a knob or an advancement with a trigger and testing with those early stage KOLs and having them tell you that like, no, I'm. While this is cool, I'm not going to use that because every other procedure is done with this other method that's going to lower your chance of adoption. So you want to hear those things up front and sometimes you have to kind of cave to what everybody else is doing in order to just avoid failure when you go to commercialize. And they happen all across the entire, the entire realm. So there's, there's plenty of them out there.

Etienne Nichols: Do you have any examples of a really good. Or. We could sanitize the details or however you want to do it, but Anything where you thought, wow, this is not going to work this way. And the pivot just was, was really an impressive one.

Justin Bushko: Well, we have one where we were able to reduce the number of parts from about 15 components to four. Wow. Because we eliminated one feature. So pretty. I think that was pretty impressive. But that feature may be a follow on product. Right. But let's get in the market with the first product and then we'll talk about that follow on product later.

Etienne Nichols: Yeah.

Justin Bushko: So I mean, cost of goods and the capital tooling for that reduction of parts is significantly easier to address when.

Etienne Nichols: You have that product. At what point we talk about how much more expensive it gets to, to change the product the further you go along. But at what point in your mind do you think design freezes happen or there's no turning back or is that ever the case?

Justin Bushko: Well, I typically am looking at like version one, version two, version three kind of concepts and sometimes those are different products. Right. So that particular one, it's basically there's going to be two or three different products as we push through that system, but we can get to revenue significantly faster. And the second and third follow on projects add to the portfolio. So it's a, it's a good long term strategy anyway. But there is, there's generally a design freeze that's going to happen as early as physically possible. Right. I mean, to me, like phase zero, phase one is like design freeze from a requirement standpoint. I don't want them to change ever again unless we start to need to get creative based on the way that the product works.

Etienne Nichols: So, so if I, if I just look at this as kind of a flyover of the entire process. If we freeze, freeze those early. You mentioned being in usability as well at one point and maybe this earlier we did a webinar on usability. So I'm still, I guess it's fresh in mind. What about that, those usability studies, sometimes they lag quite a bit in the product development phase. How do you, how do you approach that and handle those kinds of changes?

Justin Bushko: Yeah, well, you're supposed to, you're supposed to do a formative usability study, which is early as possible. You create something that looks and feels like the actual. It can be made out of different materials, machined. You get something really close and get that positive feedback that you're on the right path and then you can use that to keep pushing you forward. And then the better you do those formatives, you can get those to be in essence the summative protocol that you're using with less people. So you're almost done with your, you've got preliminary evidence that your final summative will be successful with a lower number of people if you wait and just do it at the end like, you know, the final summative. The worst thing that can happen is your final summative becomes your first formative and you're starting from scratch, redesigning and doing another formative to make sure you're good before you do your next summative. So you end up doing three studies instead of maybe, you know, one, you know, two, one small formative in a summative or a couple formatives. Early on with, you know, very similar.

Etienne Nichols: KOLs, with all the companies that you've worked with, I'm sure you probably got into a feel where you get dropped in, in the middle of a project and you can kind of look around, you probably get a feel of, well, this is gonna, this is gonna change. Are there any indicators you look for that really? I don't know, not red flags, but just indicators that this is gonna have to change or we're gonna be influenced by that, maybe that final summative and so on?

Justin Bushko: Yeah, well, I think early on, knowing the state of the requirements, especially if it's a complex device and it has software involved, where are those software requirements documented? If that's not documented, then obviously we're going to have some challenges. If you don't have good UI UX design upfront, that's going to create a lot of challenges. But just if it's a relatively simple mechanical component, listening to them talk about the one or two KOLs that have given them a lot of feedback is often an indication that they didn't test it with enough. Right. Because one or two can stay on the same page for a long time, but 7 to 10 generally will give you different opinions.

Etienne Nichols: How do you know you got the right KOLs?

Justin Bushko: I think you just have to have a bunch of KOLs. Right. Having a diverse set of KOLs is good. And it has to be people that are likely to buy something or do something or maybe kind of influence something. But, you know, in most cases you can, you can recruit a kol. They're probably going to be. But you, you ask them questions. I mean, if you're, if you're bringing in nurses, that's going to be significantly different than if you're bringing in surgeons, because nurses are all, you know, you have so many different varieties. But if you've got a specific surgeon in your, your atmosphere, they're likely going to have some good feedback, but they're also going to give you their opinions on how you could change it for, for an advantage for another patent thing or something. That's cool over here. And so you have to be able to selectively filter as well. So it's not an easy task to listen to feedback.

Etienne Nichols: So I want to talk more about your book, the Medical Device Fireside Chats. I haven't gotten to read it yet, but I'm curious, can you tell us about the origin story behind it and just tell us a little bit about what it is?

Justin Bushko: Sure. So, in essence, I work with a lot of startups and oftentimes I hear similar stories or similar challenges from each of the startups where they don't understand a specific step or specific activity within a design. Whether it be, when do I gather more information from Kols, when do I do my testing, how hard is testing, how long does it take, those types of things? So having those repetitive questions, I said, hey, it would be cool if I could kind of write this stuff down and try to figure out how to communicate this information for anybody who's trying to do a medtech startup. So kind of like the reason for the title is it's really me and you having a chat over your medtech startup, but I'm just asking you questions. Have you thought about this? Have you considered this? And it's broken into 16 chapters that kind of COVID different phases of inputs, outputs, competitive benchmarking, design verification, design validation, et cetera. So you're thinking through what's going on and hopefully maybe you're reading about something you haven't done yet. You're like, oh, I gotta go check with the team. Did we do this yet? Because if not, maybe we could test it earlier. So that's the intent is to help educate folks in the, that have never done it before. Maybe it helps somebody that has done it before. But, you know, it's. I started off with the beginners in.

Etienne Nichols: Mind and I've worked at Fortune 500 companies and I've worked at startups and sometimes the, the, the big companies have just the same beginner mindset or beginner mindful mindset is actually more positive than I would like to call that. But they truly act as if they're beginners, whether it's around design controls or. And I'm not trying to throw anyone, anyone under the bus necessarily. But yeah, well, you would think they would be the leaders in an industry. Sometimes they're, they're not always. What are some of those Questions that you ask. I'm curious if you, if you could just give us some samples.

Justin Bushko: Well, I think when we get into the details of competitive benchmarking, like have you actually looked at all your competitors and see what they do have, those features that they have in place, are they all necessary? Are you adding features that are not necessary? Have you negated a feature that you need to be successful? Another thing would be like, are there other platform tools that are necessary to sell your product? Cause you might be selling this really nifty part that goes in a kit of 50 components. Well, nobody's, you're never going to commercialize that one part. You need everything. So now you have to maybe license your product to somebody else because you're not going to be able to commercialize without the rest of the kit. So it's just thinking through all these different strategies of trying to be comprehensive and successful as you push forward and not, you know, because you're, you're running a startup, you're an entrepreneur, you're niche focused, you like, you're not trying to derail yourself. And you missed all this stuff on the side, like, let's pull that into your project.

Etienne Nichols: One of the things you said about that, the competitor, if I just kind of go back to that, you said, okay, does your competitor have a feature that might not be necessary? I, as their competitor, I might look at their, their product and say, well, it has that feature, so we have to have it too, because the market's going to demand it. I'm assuming, though just having said that, that's probably not accurate. And how do you handle those kinds of things or that thinking, well, that's.

Justin Bushko: Where you, you bring those into the formative discussions, right? You're asking those questions about those features to see do they really use it. But there could be something else where there is a feature that you think you can get rid of, but they absolutely have to have it. Like for example, a battery powered device, which sounds really cool, but maybe there is a solution where they must plug it in and it's going to sit in this one place for four days straight. And if you forget that case, then you can't be using that environment and you might just be excluded completely. So there, there's a lot of, a lot of stuff that goes into competitive analysis and that benchmarking to make sure that you know what you're going to do. And then the fun part is taking that whole thing apart, destroying the competitive stuff, looking at reverse engineering what's already been done and trying to understand did they do something really well that, you know, you can take advantage of, or do they just take some shortcuts and now you can really actually make yours better? So that's, that's fun work.

Etienne Nichols: Made me think of reverse engineering. I used to work at a gear manufacturer and we had to reverse some gears from, from a competitor just so that we could mesh with them. And they were a French gear maker, so they would use like 17 and a half degree, you know, angles. And we were like, why? Why is it? Yeah, but, but anyway, that's interesting to think about. Just, you know, and in the medical device industry, we do. I would, I would assume there's a certain amount of reverse engineering that has to happen just to mate with additional components even. Is that something that people think about very often, or are we trying to reinvent the wheel more often than not? Just curious.

Justin Bushko: I would say a lot of times people are trying to reinvent the wheel, but just interfacing with something else too. A common challenge that we get with entrepreneurs is, well, there's already one out there, so that's easy. Like as if it's already done, but it's not done for your product. You haven't even started. So. So while it will be straightforward, it has to actually be done. It's not already done. So that's always fun. They're like, well, these four features already exist on other products.

Etienne Nichols: Yeah, yeah. We just assume if it's in the universe, then it's accessible to everybody. So.

Justin Bushko: Yeah, which actually is part of the thing I was mentioning when I was talking about, you know, early stage, purposeful built test. You know, when you're looking at those things early on, making sure your prototypes are going to be testing what you need, look at those things and make sure you're testing what's really necessary. Because you could, you could be testing something that you think nobody's ever done, but there's 20 other products that do exactly the same thing. So why are you testing that? You know, don't build something that's got a, you know, it transfers data. Because I've got a phone that already does that. We know we can do that. Don't prototype it, just do it. Right.

Etienne Nichols: Curious what you. So you talk about the prototype and the testing. How do you feel about the iterative design, verification using. Using prototype to verify certain features and so on?

Justin Bushko: Yeah, so I definitely enjoy doing that early stage stuff. When you have a. For example, we've done a lot of implants and inserters and things along those lines. When you have a lever arm that's going to be bent and you're going to have a potential torque or fracture situation. You can really quickly kind of just narrow it down to that, that small minuscule piece that is going to be important and you can test that section instead of waiting six months for all the molded components to come in. You can retest that when all that stuff comes in. But hopefully you've already designed out all the flaws of, you know, sharp corners and short rods and things like that. And you've, you've bolstered that design through iterative testing on those early stage prototypes.

Etienne Nichols: You mentioned that you wrote the book for kind of with beginners in mind, but what advice would you have for someone starting out in Medtech or someone, a founder who. And maybe if they've even founded another company in a different industry, but now they're in Medtech. What, what kind of advice would you have for someone like that?

Justin Bushko: I would say first off, it's. We're not like any other industry. You know, Medtech is, is way different. And I've worked in nuclear power and industrial gas detection, so I know other industries that are fairly regulated. We are regulated in a different way. So everything that's written down is not contractual. You can't just kind of follow it by the letter of law. There's a hidden intent that you have to know the industry to know that intent. And so if you're just like, oh, I did this in industrial, or I did it in nuclear, I did it in military, I can do it here. No, because we have a hidden playbook. You have to understand all of it. I think I. Yeah, it's so different in Medtech. There, it's just. There's hidden information and if you haven't worked it and seen the battles, you don't have the scars to be able to understand.

Etienne Nichols: Yeah. Do you have any specific examples of that?

Justin Bushko: Well, I mean, just following an electrical product safety standard. Right. I mean, there's 27 clauses you need to read. And I've had people actually grab a standard and start to meet the standard, and the standard doesn't even apply because they didn't read the first sentence. Right. So they've gone through two, three months of trying to figure out how to execute a test that's not required. So, you know, that's like missed, you know, excess work that wasn't required from the other side. You're going to have where you believe you've met everything you need, everything is simply there. But you didn't run like, for example, in electrical product safety, there's this thing called coexistence testing when you're looking at communication of devices. And, you know, a few years back, nothing was really written up about coexistence testing. It was kind of expected. If you've done it before, you kind of. The FDA walked you through what needed to be done, but it wasn't really out there, so you could see it. And you're seeing the same thing today with cybersecurity. Those standards keep changing. The rules are changing every day. They're implementing and forcing new guidance that may or may not be published yet. So. And that happens every project. It could be three months from now. That project's going to be handled differently than the one you just did. So. Yeah, it's always fun. It's always a good point.

Justin Bushko: Yeah. And I think that their thoughts are like 91 pages long, and the whole document's only like 115 or something. So I know those numbers aren't 100% correct, but it's somewhere in that range.

Etienne Nichols: I think the proportions are correct. Yeah. That's amazing. So entire industry just around reading that, that regulation, it feels like so interesting. What are, what do you think are some of the biggest opportunities for innovation in medtech over the next few years, just from what you've seen so far?

Justin Bushko: Well, I mean, obviously there's a lot of stuff going on in technology, but medtech in general, we're laggards, so we don't really push anything out there. So I think really the innovation is going to be from the other side. How do we get things approved faster, how are we creative? And we're pushing things through benchtop testing instead of some clinicals and things like that. So there's a lot of shortcuts that can be made if you have the right types of products. And then you're using clinicals for marketing. So I think there could be some advances in executing clinical trials for marketing that would be beneficial to ramp up commercialization. But I think with the changes with the fda, I'm hoping at some point in time they'll find some good AI guys and they'll be crunching the data with AI and throwing darts back that way instead of simply sending the form letter that they've been using for the last 10 years. So it'll be interesting to see where we end up. I'm not overly optimistic though.

Etienne Nichols: Well, I was going to say you're more optimistic than I am because I just want, you know, when, when they ask for comments on a draft guidance, I just want a, something similar to a Google Doc that, where we can comment on it instead of, you know, actually, anyway, I do want to ask you a little bit more about that. The one layer deeper when you talk about the opportunities for innovation. If we go back to the beginning when we talked about reducing features, taking features off, it's not really an argument in one way or another, but I have seen for the. Because we have to go through this submission process and because we want, we have to be as simple as possible to reduce our window for the indications for use, we want that simplified product where we could potentially in the. There might be an ideal case where you have a product that actually does, has quite a bit of functionality. So you don't have a hundred devices in a surgical unit and instead you only have a few. But we also don't seem to be very good at that. While there are industries that have figured that out. What do you think about that? What are your, are your opinions?

Justin Bushko: Well, I think you're right. We don't do it very often. The, I mean, just looking at a de novo, right. So if you have a specific product with an indication, you got three other products with different indications, you want to merge them together, nothing exists that have them all merged together. So you're likely going to get pushed into a de novo or a pma, depending on what other thing you're pulling in. So it really gets tricky and people are likely to, to shy away from that. So I think as we're continuing forward, we are going to find more and more companies that are willing to take that, take that on. And mainly because the complexity of the projects and the safety and efficacy require things to be kind of in sync. And so that's going to force them to do that. And so maybe it'll make it easier in the future. But you know, I think in the short term it's still going to be very difficult to do those complex modular products. It could be. And it is kind of interesting to maybe think about an Allen Bradley approach where you just snap on a bunch of PLCs, you know, little extra pieces and things work differently, or like an oscilloscope where you just plug in the little extra data cards and it works differently. So I, I've worked with a few people that claim to have been able to do that and tried and failed miserably like 10 to 15 years ago. But I think some of that would be possible. But again, it's got to be part of your primary plan.

Etienne Nichols: Any other thoughts from your book or a piece of advice you'd give people out there, the audience?

Justin Bushko: Well, I think that the biggest thing that I kind of focus on in the book, that's kind of a tangential thing, is that your team is important and the people around you and part of your ecosystem are very critical. So Medtech's not a solo sport. You've got to find the right folks. And if you don't have the right folks, or even if you do, you need to continue to network and continue to meet more people because you're going to find better folks that have had something maybe more recent experience or have done something very similar. And that's, that's critical for success. If you're trying to work in a vacuum, you're going to struggle.

Etienne Nichols: I read something recently that talked about how in the beginning phase, founders do everything and then they hire generalists to help them and then they hire specialists and then eventually the specialists do everything when the company gets big enough. I'm butchering that quote. I'll have to find the real one.

Justin Bushko: Well, it seems about right. So, I mean, you get to the point where management just keeps moving up the chain and just driving direction.

Etienne Nichols: No, I totally agree with that. The right people on the bus is incredibly important. And.

Justin Bushko: Yep, it is.

Etienne Nichols: It is one of the, One of the industries that. I don't know. I, I'm just trying to think. I'm like, could you get a product to market by yourself? I don't know. That would be maybe a.

Justin Bushko: You, you can. It's gotta be very simple. I've seen a couple guys do it. It's. But it's very tricky. And, and how you get to the end, you know, and what your exit potential is, is usually significantly lower than if you had a team.

Etienne Nichols: Yeah.

Justin Bushko: And it can take you a lot more years than the team would take.

Etienne Nichols: Considerably less enjoyable, that's for sure.

Justin Bushko: Absolutely.

Etienne Nichols: Where can people find You. And where can they find your book?

Justin Bushko: Sure. So medtechman.com is the probably the easiest way to find the blog. I'm also on LinkedIn. Justin Bushko. I'm the only one on LinkedIn with that name, so it should be easy to find me. And then the book is available on Amazon. So if you see this picture, you can just click that link and buy that.

Etienne Nichols: Well, we'll put the links in the show notes so people can find that and I'll have to get it myself so I can do my own review, my own book report.

Justin Bushko: Well, I'll send you a copy. I just gotta get an address.

Etienne Nichols: Awesome. Yeah, I love doing book reports. I have a whole pile right next to me that my, my wife says, oh, you got another book? I guess I'll see you in three weeks. Like, no. Thank you so much for coming on the podcast. Really enjoyed the conversation and I look forward to reading the book. And yeah, those of you who are listening, you've been listening to the Global Medical Device podcast. We'll see you all next time. Everybody. Take care.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on itunes? I know most of us have never done that before, but if you're listening on the phone, look at the itunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.