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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 MedTechMan. Maybe we can talk about what that is.
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 MD&M 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 med tech man.
So yeah, tell me, go ahead and fill in the gaps on your bio. I know I missed a lot, but those are the highlights that I wanted to catch. I started this about nine years ago doing design consulting. And also some manufacturing, light manufacturing in the med tech space, 100% medical. But my career started over 20 years ago. I worked in industry at ConMed Limit Tech, which competes with Arthrax 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&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. I'm 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. Fantastic.
you know you mentioned arthrox i actually have one of those in my foot i'm not sure exactly what it is they told me so i'm not 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?
and we'll cover a lot of ground i hope that's that's the hope but you mentioned all 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 multiples
So I wonder how that path started. Yeah, so I think it was an early career misdirection 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 d i had to go through service and operations to fight my way back in and then after i was in r 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 first only and favorite that's that's not everybody can say that yeah 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. Yeah, we're everywhere actually. I like this early stage startups, a couple people.
with reasonable funding, with 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 with 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. 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 in early design or maybe in the middle prototyping phase. Are there certain things that you pretty much can pluck out and say, I know that this is likely going to be a problem? Anything come to mind? 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.
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 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.
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. Oftentimes, 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 costly.
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. Sure. I mean, well, one of the things I kind of mentioned before is autoclavability. 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've got a single use device that maybe has to, you know.
advanced 10 or 12 sutures or something along those lines. They're very critical products that need to work very well, but they also 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. That's a really good point. I'm curious how you would balance. A lot of people want to be 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? I'm sure there's others I'm not thinking of. Yeah, I think the biggest thing is really 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. 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 make or break the product. So let's focus down on what's really necessary and be successful on day one. How do those conversations go when you tell people that? Is it? is it received well or i would say it's typically not even heard the first few 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 in the.
the mechanism for plastics and how the mold is going to be more expensive. Having that up front as early as possible is the easiest way to kill those features. 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 the conference room and say, okay, what's actually necessary to meet this indication for use?
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? It really depends on the project and the framework of each company. I've done somewhere.
you use the word shall for what must be there and you use the word should for what would be nice to have which is you know 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 510k 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. 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.
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 a... an indication that's lower that gives you a class one or class two device right so there are long-term strategies on the on that side and making those early stage changes 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 realm. So there's plenty of them out there. Do you have any examples of a really good... We can 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.
Well, we have one where we were able to reduce the number of parts from about 15 components to four because we eliminated one feature. So I think that was pretty impressive. But that feature... maybe 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 yeah so i mean cost of goods and the capital tooling for for the that reduction of parts is significantly
easier to address when you have that that product at what point and 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? Well, I typically am looking at like version one, version two, version three kind of concepts. And sometimes those are different products, right? So...
and that particular one it's basically there's going to be two or three different products as we push through that that system but we can get to revenue significantly faster and the second third following projects add to the portfolio so it's a it's a good long-term strategy anyway. But 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. So if I just look, this is kind of a flyover of the entire process. If we 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 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 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 the final summative the 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 one small formative and a summative or a couple formatives early on with
you know, very similar KOLs. With all the companies that you've worked with, I'm sure you've probably gotten to 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 going to change. Are there any... indicators you look for that really i don't know not not red flags but just indicators that this is going to have to change or we're going to be influenced by that maybe that final summative and so on
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 their same page for a long time, but seven to 10 generally will give you different opinions. How do you know you got the right KOLs? I think you just have to have a bunch of KOL, 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 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 atmosphere, they're likely going to have some good feedback.
But they're also going to give you their opinions on how you can change it 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. 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?
Just tell us a little bit about what it is. 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 what 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 was trying to do a med tech startup so kind of like the the reason for the title is It's really me and you having a chat over your med tech 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 cover.
You know, 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 got to 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 that have never done it before. Maybe it helps somebody that has done it before.
I started off with the beginners in mind. And I've worked at Fortune 500 companies and I've worked at startups. And sometimes the big companies have just the same beginner mindset or beginner mindset. 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 not always. What are some of those questions that you ask? I'm curious if you could just give us some samples. 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? Because you might be selling this really nifty part that goes in a kit of 50 components. Well, 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, cause 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. 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 where 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's a lot of...
A lot of stuff 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 can take advantage of? Or did they just take some shortcuts and now you can really actually make yours better? So that's fun work.
made me think of reverse engineering. I used to work at a gear manufacturer and we had to reverse some gears 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
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. 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. Yeah. Yeah. We just assume if it's in the universe, then it's accessible to everybody. 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. So you talk about the prototype and the testing. How do you feel about the iterative design verification using prototype to verify certain features and so on?
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 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 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 kind of advice would you have for someone like that? I would say, first off, we're not like any other industry. Medtech 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 the 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 a nuclear i did it military i can do it here no because we have a hidden playbook you have to understand all of that i think i yeah 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. Yeah. Do you have any specific examples of that? 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 miss, 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 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. implementing and forcing new guidance that may or may not be published yet. 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.
yeah it's always fun it's always a really good point yeah and i could i guess i asked for an example maybe i'll give one as well just the fda this is more on the quality management side we're talking about the product but you talk about the actual quality management that that governs your approach to quality, the FDA part 820, the final ruling.
is not very long. In fact, they've harmonized the requirements for the FDA requirements with ISO 1345, but they've also provided all of their thinking on it and why they did this, why they did that. So, I mean, I guess that right there is a good example. potentially an example of the writing between the lines. 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. I think the proportions are correct. Yeah, that's amazing. So entire industry just around reading that regulation, it feels like. Interesting. 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?
Well, I mean, obviously there's a lot of stuff going on in technology, but med tech 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, you know, 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.
It'll be interesting to see where we end up. I'm not overly optimistic, though. Well, I was going to say you're more optimistic than I am because I just want... you know when they ask for comments on a draft guidance i just want to 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 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 what are your opinions
Well, I think you're right. We don't do it very often. I mean, just looking at a de novo, right? So if you have a specific product with an indication and you've 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 Alan 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. It works differently. So 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.
Again, it's got to be part of your primary plan. Any other thoughts from your book or a piece of advice you'd give people out there, the audience? Well, I think 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.
find the right folks and if you don't have the right folks or even if you do you need to continue to networking 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 critical for success. If you're trying to work in a vacuum, you're going to struggle. 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 well it seems about right though i mean you get to the point where management just keeps moving up to the chain and just driving direction
No, I totally agree with that. The right people on the bus is incredibly important. Yeah, it is. It is one of the industries that I don't know. 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 you you can it's got to 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
And what your exit potential is, is usually significantly lower than if you had a team. And it can take you a lot more years than the team would take. considerably less enjoyable. Well, that's for sure. Absolutely. Where can people find you and where can they find your book? Sure. So medtechman.com is 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.
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. I'll send you a copy. I just got to get an address. Awesome. Yeah. I love doing book reports. I have a whole pile right next to me.
My wife says, oh, you got another book. I guess I'll see you in three weeks. 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. 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.