#408: What MedTech Startups Miss: Design Mistakes, Risk Testing & the Myth of the Quick Exit

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. In the medtech world, success hinges on seamlessly integrating product development, quality management, and clinical investigation. Because let's face it, one of the most important parts of being a medical device company is maintaining traceability.

Greenlight.guru is at this vital crossroads. It's a single solution empowering your entire journey. Expertly designed for medtech professionals, Greenlight Guru merges these critical areas into one intuitive platform. Streamline your processes, maintain compliance, and accelerate innovation. With Greenlight Guru, you're not just managing, you're mastering the medtech landscape.

Discover how at greenlight.guru, where development, quality, and investigation converge. Check us out at www.greenlight.guru. Hey, everyone. Welcome back. My name is Etienne Nichols. I'm at LSI with Justin Bushko. He's the MedTech man, if you haven't heard of him. Also the author of Medical Device Fireside Chats. He's interviewed and talked with a lot of companies. How are you doing?

Good. It's been a great event. I'm loving it here at LSI. We're all starting to lag a little bit. It's been too good in some ways, but it's been really good to see you again. I wanted to talk to you because I know you're leading a session later.

seen so many different companies some failed some success and having talked to so many i'm curious just what advice you would have and and if there are any stats and trends that you would want to highlight yeah I think one of the most important things is your team and who you're picking in order to do the engineering work. So we've been doing a lot of interesting kind of.

top-level reviews of existing designs when you have two or three different firms looking at things. Somebody just to take a look at DFM and top-level tolerance analysis to make sure your molds are actually going to work, things are going to go together later.

It's a really major inflection point where you lose a lot of money if you're not doing a right job. And time out. So DFM, design for manufacturing. Correct. Yeah. Design for manufacturing. Or DFX, design for just about everything. Anything. Yeah. Human factors, ergonomics, et cetera. Yeah. Yeah. Go ahead.

I see a lot of people making major errors. They're right at the point that they're going to start buying tooling. And that's when they're starting to run out of money anyway and looking for the next trench. So if it's not successful, it puts a really big stall on everything else.

So when you talk about that, what are some of the things that you think the most successful companies do in that regard versus the ones that just really aren't, you don't think they're going to make it. And before I go too far in that. 2025 has been an uncertain year and I have a lot of concerns myself. I don't want to be a doomsdayer, but I mean, it's the year I feel like that we really have to hone in on what best companies do.

Absolutely. We know funding has been tight forever and it's starting to loosen up a little bit. But when you're doing, you're worried about what's going to happen overseas and what's going to come back to the U.S.

I think the biggest thing that we've seen there is when you really have the right engineers honing in on like a tolerance analysis and looking at those low level details, that's when you're going to be the most successful. If you're leaning on your partners and they're saying they're taking care of that stuff for you. If they're not showing you how and why and explaining that low-level detail, there's a likelihood they just kind of took a shortcut.

And that really hurts you in the end, like nine months later. You know, I've interviewed a lot of people and you're one of two people, I think, that have brought up tolerance stack analysis or the tolerance stack ups. And that is something that is so important and critical in product development. But what else? What are some other things that you feel like? I mean, these are incredibly critical and companies often overlook them or wait till the end to talk about them.

I think the other thing is really testing a high-level risk point that you're worried about. Okay. For example, if you're doing an inserter for an implant, looking at that break point and making sure that that's like above the actual flex loads that they expect because some surgeons can really kind of torque on a product. And if you're...

If you're not paying attention to that, then they start breaking in the field. And that's really something you want to avoid. Yeah. I was actually reminded this earlier this year. I think it was in 2017, the FDA put up, put out a letter just on cranial fixation devices because there was a torque, you know, you would, you would pinch the head and you would twist the knob and surgeons were doing this, but then they would go by and they just, OCD would kick in, they'd twist it in, twist again.

Well, that would relax and they would twist it until it finally twisted off and then the head could fall. And they basically issued a warning about those things just to all cranial fixation companies or any surgeon who might be doing any kind of brain surgery.

Those are real. And knowing the types of materials, knowing the types of things like that is important. And that's an ergonomics and human factors challenge that you have to be actually asking the KOLs and watching and monitoring them ahead of time to really understand.

What do you need to test for? What might they start doing? And when you're doing a feature, you know, maybe something like a lock or something like that, if they've never seen it before, they might not know how to use it or they'll use it differently than what you intended. I love that there's this one kind of meme video where they've got this ball and they're saying like they got to put the star into the star, but they just like put everything through the big square hole.

And it's like, oh, I think I've seen that one. And those of you, if you don't know Justin and if you don't follow him on LinkedIn, some of your stuff that you put out is hilarious and so applicable to the medical device industry. And yeah, so.

Appreciate it. That's a good one. We'll have to put a link to that one somehow. I'll tag you on LinkedIn and figure out how to make that happen. Okay. So some of these things, I think, okay, from a product development standpoint or an engineering standpoint, I'm with you right 100% behind you.

From a CEO or physician idea standpoint, some of these things might not make sense. What are the things you recommend when it comes to that level of just, you know, they're looking at a 10,000-foot view of how we get to market, what's our economic outlook, and... or a ramp and so on, maybe not thinking about tolerance, stack-up analysis. What do you say at that level? Yeah, so really at that level, you're looking at who are your users?

And are they actually ever going to use your product? What's that level of adoption look like? And how are you meshing with the rest of the stuff in the surgical suite, the rest of the stuff in that procedure? Because you don't want to make anything harder, right? Unless your outcomes are.

way better than everything else. Nobody wants to hear that it's going to be more difficult to do the work. So you've got to go through those steps with them. And it can't just be your one or two KOLs like you want. a large group of KOLs all saying like, yes, this is, and I want to pay for it. And here's how much I will pay for it. So you have to push for those.

those conversations. But then as a lot of these guys are doing now with the founders that are pushing into commercialization, they're finding out that those KOLs who say they'll buy it, they still don't want to support the economic discussion with... with their board and procurement to bring those things in so looking for that that main leader that's actually going to drive it into the to that business that commercialization aspect is huge yeah

You know, there's a couple things that people can give you when it comes to investing in you. I feel like there's their time. And we talk about that as being the most important, valuable resource.

Money is kind of the air companies breathe. They have to have a little bit of money. But then there's the third one, which is testimony, which you've kind of hit on. And it may be it bleeds over the time. But giving that testimony, giving that belief to the value added committee or whoever it may be in the hospital.

That's pretty valuable. Yeah. And I mean, there has to be a surgeon that's just really willing to do that extra step. And most of them would just be like, yeah, once it's here, I'll use it. Right. And you have to find that advocate. Yeah. Any last piece of advice for companies out there who are maybe early stage and maybe they're already commercial? I'm sure you've worked with both, but however you want to break that up. Well, I think one of the things I've been hearing a lot is.

I just want to get this thing across the finish line, or I just want to license this deal. I just need to find my acquirer. I think people jump to that a little bit too soon, right? Like your goal is to set up a company that's going to have longevity, that you're going to work until you die.

because you're growing the revenue. And that's what everybody wants to hear. And the fact that you get acquired is a secondary. So if you're aiming for this exit, I think that's where you're always going to struggle because people are just hearing you say you don't want to do it anymore.

I can see that. It's almost like if I wanted to build a car, but it's going to look beautiful. Maybe I'm not going to put the engine in it just yet and trying to sell it. Someone else will put the engine in it. Yeah, I can see that being a problem. Awesome. Well, Justin. I hope your session goes well and always good to see you. And those of you listening, thanks so much for listening. I'm ending just in the nick of time. We'll see you all next time. Take care.

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.

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.