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Etienne Nichols: 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 and he's interviewed and talked with a lot of companies.
How are you doing?
Justin Bushko: Good. It's been a great event. I'm loving it here at lsi.
Etienne Nichols: 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, you're leading a session later.
You've 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 if there are any stats and trends that you would want to highlight.
Justin Bushko: 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 done 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.
Etienne Nichols: You'Re not doing the right job and timeout. So DFM designed for manufacturing, correct?
Justin Bushko: Yeah, designed for manufacturing or DFX designed for just about everything.
Etienne Nichols: Anything, yeah. Human factors, ergonomics, et cetera? Yeah, yeah, go ahead.
Justin Bushko: So we, I, I see a lot of people making major errors there right at the point that they're going to start buying tooling and they're, 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.
Etienne Nichols: So, so when, 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 gonna make.
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 wanna be a doomsday, but I mean, it's the year I feel like that we really have to hone in on what best companies do.
Justin Bushko: 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 gonna happen overseas and what's gonna 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 the 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.
Etienne Nichols: 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 tolerance 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.
Justin Bushko: I think the other thing is really testing a high level risk point that you're worried about. So 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.
Etienne Nichols: 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, 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.
Justin Bushko: 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, 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.
So I love that there's this one kind of meme video where they've got this ball and they're saying like, they gotta put the star into the star, but they just like put everything through the big square hole and it's like.
Etienne Nichols: Ah, I, 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, we'll figure out how to make that happen.
Okay, so some of these things I think, okay. From product development standpoint or an engineering standpoint, I'm with you. Right. 100% behind, 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, they're looking at a 10,000 foot view of how we get to market, what's our economic outlook and you know, our ramp and so on.
They're maybe not thinking about tolerance, stack up analysis,
what do you talk, what do you say at that level?
Justin Bushko: 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 it anything harder.
Etienne Nichols: Right.
Justin Bushko: 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, the founders that are pushing into commercialization, they're finding out that, you know, 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.
Etienne Nichols: 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 maybe 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.
Justin Bushko: Yeah. And I mean, there has to be a surgeon that's just really willing to do that extra step. And most of them will just be. Yeah, once it's here, I'll use it.
Etienne Nichols: Right.
Justin Bushko: And you have to find that advocate.
Etienne Nichols: Yeah. Any last piece of advice for companies out there who are, or 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.
Justin Bushko: 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.
Etienne Nichols: Ah,
I can see that. It's almost like if I wanted to build a car, but I'm not. 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. Yeah. 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.
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.
Etienne Nichols: Way I'm going to get better.
Etienne Nichols: Thanks again for listening and we'll see you next time.