What all MedTech Founders Should Know with Duane Mancini CEO of Project MedTech

On the show today we have Duane Mancini, CEO & Managing Partner of Project MedTech and proud to be a “nerd” of the MedTech industry. Duane has extensive experience in go-to-market strategy including regulatory & reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design & execution. With all of the complexities of running a Medtech company and taking a product to the market, Duane partners with start-ups to develop strategies and milestones.

He runs the Project MedTech podcast series which has over 120 episodes. We’re excited to jump more into the medtech world and what companies need from inception to market. 

duane.mancini@projectmedtech.com 

Project Medtech Webpage 

Project Medtech LinkedIn

Duane Mancini LinkedIn

Qualio website:
https://www.qualio.com/

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https://www.qualio.com/from-lab-to-launch-podcast

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Music by keldez

Transcript

Kelly Stanton: 0:17

Hello and welcome to From Lab to Launch by Qualio. We're glad you're tuning in today. I'm Kelly, your host, and I'm really excited about today's guest. Before we jump in, just a reminder, please rate the show and share it with any of your science nerd friends. We know you have some. Also check out the show notes if you have a story or a product you'd like to share with us. We love hearing from you. Today we're welcoming Duane Mancini. He's the CEO in managing partner of Project MedTech, and proud to be a nerd of the MedTech industry. Yay nerds. Duane has extensive experience in go-to-market strategy, including regulatory reimbursement, biocompatibility, preclinical efficacy testing and clinical trial design and execution. With all of the complexities of running a med tech company and taking a product to market, Duane partners with startups to develop strategies and miles. He runs the Project MedTech podcast series, which has over 120 episodes of which I've gotten to participate. Thank you for that. We're excited to jump more into the MedTech world and what companies need to think about from inception to markets. Duane, thanks for joining me today.

Duance Mancini: 1:22

Yeah. Thanks for having me. This is exciting. Switch and Rolls

Kelly Stanton: 1:25

Right, right. Yeah. It's great to be talking to someone who also runs a podcast. It's, it's kind of fun, right?

Duance Mancini: 1:29

Yeah, it is. Yeah.

Kelly Stanton: 1:32

it's, it's something I was a little intimidated by at first, but now I'm having so much fun talking to all these people. I can't imagine not. Doing this.

Duance Mancini: 1:39

Yeah. That's a weird feeling for sure. Especially as you build that like number of episodes up, you're just like, what did I do before Right.

Kelly Stanton: 1:47

Right. Well, and just the, the, the conversations, the, you know, the, for us at least, it's a lot of, you know, innovators. Mm-hmm. I was just talking to someone who's using you know, um, computer generated personality technology, like he used to work for EA games and he's using this to improve the clinical trial space, like the applications are so incredible. Mm-hmm. Um, you know, so knowing all of that, tell us a little bit about how product Med Tech got started.

Duance Mancini: 2:15

Yeah, so, uh, project MedTech was, founded in 2020. Um, I was leaving a company called, uh, NAMSA. they're a C R O in the medical device space. And I was heading over to a, um, a company called Covance at the time that had been acquired by, LabCorp. And, I had had this idea for. Thought startups where I thought there were gaps in, in, in for startup companies. And, um, it was too early to do anything about it. So I said, let me launch a podcast and see if maybe just talking about some of these issues would've been helpful. So that's how we got our start. We started in 2020, April of 2020 to be exact. Um, started the podcast and then, um, over the next year and a half, added a couple of co-founders and, um, Launched our consulting advisory practice and, um, expanded our podcast into another podcast called MedTech Money. Um, and then also ran some events. Fun. Yeah,

Kelly Stanton: 3:14

it's, um, it's, it's good to see the organic growth around helping companies get to market too. I feel like. there's so many great ideas out there, but people have no idea, like, okay, I have this idea for a med device. How do I get it into a patient's hands? Like that's, yeah. So

Duance Mancini: 3:32

Yeah, it's, it's a, it's a difficult thing. And, and, and resources are generally s. You know, you're kind of strapped for cash and then therefore resources. And so you need to come up with innovative, innovative ideas to help get that product through some of that de-risking process. And so, uh, that's kind of where we started to form Project MedTech.

Kelly Stanton: 3:53

Nice. Nice. Yeah. Um, so one of your specialties is evaluating how early decisions in a company may impact other aspects in the future. Mm-hmm. this perspective is critical for med advice companies. What are some of the best or worst stories, uh, you've, you've got or you've seen of like having or not having this perspective as they try to navigate?

Duance Mancini: 4:13

Yeah, so I'll start with the really early one that we see happen a lot. Uh, and that's gonna. Going to the FDA in some format, whether it be a pre-submission meeting, um, or, uh, through the five 13 Jeep process, right? So we've seen. Companies, the five 13 g for pretty obvious reasons can be very detrimental to a company. Um, cuz once you go through that process, that's, that's how the FDA is going to classify your product. And so there's very, it, it, it could be a hard procedure, especially if you're very new and you're looking for that first thing to go well, I'm moving the needle. A lot of times people start in the regulatory area, right? And they'll go, well, I'll, I'll do this five 13 G. So we've seen one that, um, uh, teed on the line of a drug versus a device. Uh, they were definitely a device, but they wrote their five 13 g like a research dissertation. Um, oh no, they got classified as a drug. And so once that happens, That's kind of the nail in the coffin for you in, in the us right? I mean, that goes from like a five year process to a 20 year process. And so um, yep. That, that one stings. Um, Also companies going to pre sub meetings before they really are, they, they kind of go by themselves without like a regulatory consultant or a quality consultant. And that could be hard too because those meetings are very strategic. I think any good regulatory consultant would tell you that. And so from a regulatory quality side, that's the one, um, that I wanted to bring up. Um, the other one that really comes to mind, is keeping commercialization in mind, um, at all times. Right? Even through regulatory, you know, what claims do you wanna make? Why do you wanna make them, what's your reimbursement pathway look like? Um, the hardest thing you will do as a med tech company is sell your product. absolutely. The ft Absolutely. Yeah. So that's, that's my big thing. I've seen

Kelly Stanton: 6:17

that fail over and over again in my time in the startup space as well. You know, I'm not a regulatory expert, I'm a quality expert, and so I'm always looking at scalable quality systems. Mm-hmm. And, um, one of the things that drives me nuts whenever I deliver a design control process to a company, usually it's to an innovator who maybe has. Maybe somebody on the clinical regulatory side who's thinking about those things, but not really. And one of the requirements I always put in there is, what is your reimbursement pathway? And they're like, you know, what does your market share? What? What does that landscape look like? And they're like, why do I need to think about that right now? And I'm like, you could have the coolest product in the whole wide world and it's different because of X, Y, and Z. And it's amazing and you believe in it, and I love that for you. But the reality is that in the hospital space, you're one of 30 on the shelf and they're all charging. They're not even reimbursable because they're billed as part of a package. They're not even an individual unit. And you think people are gonna pay you$300 for this. Yeah. Right. And so it's, yeah, it's Is it mind blowing?

Duance Mancini: 7:20

That's it's, it's it's spot on. oh, that's, and this is such a mess. This is, this is what we try to educate them on is we'll see people go, well, yeah, I figured out reimbursement. I have a C P T code, or I have a hick pick code, or all other stuff. And it's like, no, no, no. Who is paying for your product, right? Yeah. That's the simple part of reimbursement. And and we do, we do a very, I heard this from a guy named Nick Anderson. He was, um, on one of our, uh, virtual events we did, uh, he did a thing on reimbursement and. He kind of gave you the rundown of, look at, at the simplest level, the US healthcare system is this, and it's a little cynical, but you need to figure out where you fit in. From a business perspective, it's, we all pay money into, a bunch of piles of money, which is insurance and. The healthcare groups across the, the, the country, their only mission is to extract as much money from those piles as possible. So if you don't help a healthcare system extract money or keep more money over here, you really don't have a business model. Um, yeah, so, so that's, that's a pretty. Basic way of looking at it.

Kelly Stanton: 8:31

Yeah, yeah, yeah. And then all ties back into your design process and your cost of goods sold, and all of those kinds of things that people are like, why do I need to think about that right now? Mm-hmm. I'm like, oh, because Yeah, You can go get a clearance, that's great. Yay. You met your milestone and you can't sell a unit. And I have seen that. uh, I, well, I'm sure you have too. Mm-hmm. lots of times. Mm-hmm. it's mm-hmm. It's so unfortunate. Yeah. Well, as long as we're riffing on what things MedTech founders need to know, Yeah. Besides the reimbursement pathways, what else would you add to that, uh, conversation?

Duance Mancini: 9:05

Yeah, so I would say, for what founders need to know, as, as the founder, if, if you're in this like c e o role, just be prepared. it's lonely and it's a long process. Um, so depending on, on, and not all founders are going to assume that role, but if you find yourself in that chair, You just have to be prepared for the fact that it's, it's stressful and, and most people aren't going to understand the level of stress that you are going through and the level of weight that is on your shoulders, right? And we talk to all of our entrepreneurs about this. It's just, it's just difficult. Um, and to kind of tie into that piece, find yourself co-founders to compliment your skillsets. We see a lot of entrepreneurs who, um, try to be everything, uh, try to go at this alone and, it takes a village to, to build a successful med tech company. and so we, we encourage entrepreneurs to think about that. Um, especially as they grow of, you know, who, who should be on your team? What are you really good at? What do you need to mix in? And that's really where that conversation comes in of, as a founder, are you becoming a cto o are you becoming the c o or are you becoming the c e o? I mean, what, how are you, where's your role in this team based on your skillset and what you wanna do?

Kelly Stanton: 10:33

Yeah, absolutely. And, and a real, I think I would add to that, a real honest assessment of your strengths and weaknesses so that you can make sure your team compliments you. You know, I've, I've worked with a lot of those where it's like, well, I'm the founder. I wanna be the c e o. And it's like, eh. are you c e o material, right. You know, and Yeah. Or, or the cto o right? Like mm-hmm. I worked with one, uh, the same one where I was talking about the whole Medicare reimbursement situation. Our C T O was the innovator and he was a lovely gentleman in his seventies who just wanted to retire, but he wouldn't let go of the control over mm-hmm. and, and it just was like that constant back and forth and struggle with him to let go so that we could actually innovate the thing in order to be manufactur. Yeah, because he had this amazing idea and it was a great product and it was definitely, uh, an improvement from, you know, in its space, as far as, you know, how it worked and all those kinds of things. But same story, it was a liquid product, so it was like, is it a drug? Is it a device? We had to have that conversation with the F fda and then it wasn't manufacturable and he wouldn't. Like, oh, he wouldn't let the very intelligent chemist we hired who was trying to figure out how to engineer this thing in a way that couldn't, you know, same end result, but we could actually make it. And uh, yeah, that was

Grant: 11:49

Yeah. That

Duance Mancini: 11:50

was a struggle. Yeah, and I think to your point of letting go is once you get this super talented team around you, that's the kind of culture you have to build of, let them own the things they're good at, let them do the. that you brought them in to do, to compliment your skillset. We see a ton of them have this like inability to, well, this is my baby, this is my baby. And it's like, oh, it, it was your baby now it's everybody's baby was, yes. Right? Yeah. So you gotta let them do what they need to do. Uh, but that comes down to culture big time. Definitely.

Kelly Stanton: 12:25

Definitely. And it starts at the top. Mm-hmm. Yeah. Ugh. well, a little bit of a pivot, um, from the guests you've had on your podcast. I'm curious, what are some of your favorite moments or guests that really surprised

Duance Mancini: 12:37

you? Yeah, so this one, um, This isn't based on, you know, the most popular episodes that people listen to or anything like that. But I, I, I, I, I was thinking more along the lines of, these are the ones where I've taken a snippet from the podcast and used it in multiple conversations. Right? So the one that sticks out the most, uh, Brian Green was episode one of our med tech money series. He was the first person to, um, On the podcast, I kind like caught off guard. Um, but he was telling a story and it was a hilarious story around raising money. Um, and so that one we always talk about because it's just, it's, it's an epic story. We, we make him tell it anytime we talks at events too, uh, that we have. Um, nice. So, so Brian sticks out. Um, and then there were three other ones that I find myself quoting a lot. So episode four was Lance Black. Um, and he. Uh, was talking about understanding the problem that you're trying to solve and not just being, um, uh, not, not just like understanding the problem and expert in the problem, but actually being a historian of the problem. And what he meant there was understanding how people tried to solve it in the past, when they tried to solve it and why they failed. Did they fail because of a specific operational problem? Did they fail because their wi, their opportunity window closed because of. Circumstances they couldn't control. And so, um, that one I use quite frequently, uh, when doing some consulting work, but also talking another podcast. Um, two other ones. Uh, one is, uh, Dave Albert. Um, he is the founder and chief medical officer at a live core. Um, maybe episode 1 0 4 or something in that area. Um, he had. Be an orthogonal thinker. Um, and that one always rings pretty true, right? So it, it wasn't, Hey, if everyone's going this way, you should go in the opposite direction. It was just, Hey, if everyone's thinking like this, just go 90 degrees, right? It's, you're not going against the stream, but. You're, you're thinking over here. And, and that one I use quite a bit as well, just actually for like a motivational perspective. Right. I thought it was just a really cool, um, um, I like

Kelly Stanton: 14:59

that. Yeah. Yeah, yeah. That's, uh, bring your, bring your unique perspective. Don't just jump in the boat cuz everybody's going that way, right. Like, right. You know.

Grant: 15:07

Exactly. I like that.

Duance Mancini: 15:08

I like that. And then the la the last one on fundraising was Renee Ryan. She said this on our podcast and she also said this at our Houston startup symposium. Um, someone was asking about fundraising and negotiating with an investors and who gets better deals, investors or entrepreneurs, which way is shifting? People talk about this all the time. And her whole point was like, honestly, I don't really care. Um, cuz no one ever died from dilution. Uh, but companies do die from running outta cash. And so, We use that one quite a bit as well.

Kelly Stanton: 15:39

Yeah. But did you die? Yeah.

Grant: 15:43

I love it. Right,

Kelly Stanton: 15:44

right. I love it. Yeah. Awesome. That's great, Tony. Well, if you could go back to the start of your career, what would you tell yourself based on what you know

Duance Mancini: 15:52

now? Yeah. Um, patience is key, but don't be too patient. There's, there's a fine line. Um, and then I think the biggest thing is when you're starting your career, um, and, and, and spend more time listening to folks, uh, who are experts in this space. and then don't ever stop doing that because that's, I feel like people get caught up in this transition of, well now I'm the subject matter expert. Or, you know, and it's like, you very well could be, but don't stop learning from other people. at least for me, that's how I learned the best. Um, and I think it took me a little bit to figure that out of just being around like-minded individuals who are really intelligent and smart and good at what they do and listening to them, um, and. talking so much is beneficial.

Kelly Stanton: 16:44

definitely. Yeah. Yeah. Especially, I mean, you know, we can talk about how lots of industries are evolving and that sort of thing, but this is an industry for sure that is evolving in leaps and bounds it feels like. And so if you're not still talking to people and not still learning, then experience and your knowledge is dated. Yeah, very quickly. Right? Very quickly. You quickly and, and yeah. I run into that every now and then. It's so frustrating. It's like, ugh, you know, things have changed. You, you, we don't have to do IQ o kp Q on software anymore, right? Like stuff like that, you know? And it's like, come on, it's, it's. You gotta gotta stay current. So that's, yeah,

Duance Mancini: 17:22

I like that. Yeah. Yeah, yeah. And I think following those thought leaders there, um, is important. Like sometimes there's this, well, you know, we, we, you, you graduate from school or whatever, and then like, you're, you're, you're done learning somehow. Like the industry's just gonna stay stagnant for the next 30 years. Yeah. Like, that's not reality.

Grant: 17:40

Not at all. Not

Kelly Stanton: 17:42

at all. Yeah. Yeah. Uh, so a fine question. We heard from another guest on, uh, a while back on the episode. Uh, and so we ask it all the time. Now, if I walked into Barnes and Noble, where would I find you? What section?

Duance Mancini: 17:55

Oh yeah, this is good. Um, that's right. I saw this one. So, so, so this would be for me, non-fiction. more specifically, like, I'll just give you a f a few of my favorite a authors. So like anything in like the human history or how humans think about things or make decisions, right? So therefore, like, um, uh, so that, that's my favorite space. But then like, uh, um, Amos Traverse Key, or Danny Kahneman, um, they were both, um, professors, um, that studied, uh, oh boy, I gotta look at this real quick. Behavioral economics, so how humans make decisions, right? So they wrote a lot of really fascinating books in that space. so I, I spend a lot of time reading those. And then my other favorite author would be Michael Lewis, who writes in the non-fiction area as well. He actually wrote a, a book on Amos Traversy and Danny K, and called the Un Undoing Project, but he also wrote, um, the Big. which was about the financial crisis in oh eight, um, Moneyball, which is about a baseball team, the Oakland Athletics, who essentially went to the playoffs and spent zero, like no money compared to everybody else. And then wrote another one called The Blindside. So those kind of non-fiction true story books, uh, and then those like psychological ones about the history of humans and why we make the decisions we make are fascinating.

Kelly Stanton: 19:21

Those are interesting. Yeah. The blind side, is that the, the story about the football

Grant: 19:25

player? That's exactly, yeah. That one. Yeah. Yep. Yeah.

Kelly Stanton: 19:28

God, I love, I love, love, love that

Duance Mancini: 19:29

story so much. Right? Yeah. So Michael Lewis wrote that original book. He wrote one, uh, just recently on the Pandemic, which, um, I'm sure is, is controversial because the pandemic somehow became controversial. Um, but, um, yeah, uh, it, it's a really good book on. The decision making process of how everything kind of came about. so yeah, he writes some, some really good books I like to read.

Kelly Stanton: 19:55

Nice. Yeah. I'll have to check. I have to check those out. I've read the blindside, but yeah, I have to check out the pandemic one cuz. Yeah. You know, I feel like in this industry, I feel like we're at the center of that controversy. Right. I've got friends who are like, you know, ah, the vaccine's terrible and co you know, COVID was just a government thing. And I'm like, oh, really? You know? And then you've got the other side of it. And as a health, you know, someone who's in the healthcare industry, you know, you've got both sides sort of trying to validate their position by talking to you, and it's like, it's, it's uh, it's a

Duance Mancini: 20:24

challenge. Yeah. Yeah. It's crazy. and also like, you know, like part of like the, the pandemic piece of it is like, You know, the, the pharma industry got so much attention around this. but then you have like the med tech industry, the diagnostic industry, which like we kind of did, but also like it was very short-lived compared to like the attention the vaccine gets and still gets. but like the rapid covid tests that came out Yeah. All the respirators, the other ways to. The really sick covid patients like that was all the MedTech industry. And sometimes we don't get the, the attention that maybe we should

Kelly Stanton: 21:06

No, I totally agree. But you know, if they don't have that, uh, p name that rhymes with iser, they don't make the news. Right. So it's uh, that's exactly, and I love those guys. I love those guys. Don't get me wrong. Like, I think BioNTech and I always feel the need to e. BioNTech was the vaccine company working on it? Yeah. Pfizer just made it possible, right? Yeah. That's how, and, and I love that. It may. Made those pathways more visible, I think to to folks, right? People all of a sudden we had to pull back the curtain and go, why is this ticking so long? Why can't we just go back to our lives tomorrow? Right? It's like, well, cuz there's a process here. And you know, then of course everybody likes to conspiracy theory, the whole process, but yeah. Yeah. Love to read that book, pandemic. That sounds really

Grant: 21:48

interesting.

Duance Mancini: 21:49

Um, and, and actually Kelly, I remembered one thing that I needed to mention too. Um, for the co, for the founders. Is while I said it was lonely and you wanted to co-founders, the other thing too is if you are going to go down this path, you need to make sure if you have a family, your family is on board. Because it is a sacrifice for not just you and your decisions, but if you have a family, for me, I have a wife, a daughter, and, and another one on the way. Um, if they're not on, congratulations. Thank you, If they're not on board, That could create some stress too, cuz there are gonna be those, you know, stressful situations that they're involved in as well. I mean from a financial standpoint, but also, um, Helping you deal with the stresses and the wild ride of being a, a founder, c e o?

Kelly Stanton: 22:44

Yeah, definitely. Yeah, because it's your problem. It's not like working for another company where you can leave it at, at the office when you, you know, five o'clock, right? Right. Yep. Yeah. Yeah, that is a different, uh, and, and too, I think the number of, of those risks that, that don't make it correct, um, you know, there's, there's some definite, you know, valley of death situations in the, in the whole industry that, that, you know, the number of things that you try to get through that fail. People don't realize how big that number is. Right. Um,

Grant: 23:15

Yeah.

Duance Mancini: 23:16

Yeah. Yep, for sure. So definitely I wanted to share that as well.

Kelly Stanton: 23:19

Yeah, no important. Absolutely. Yeah. I'm glad you brought that back up cuz Yeah. I, I think people just to get well, and there, there's a little bit of a personality type there, I think in my experience. Mm-hmm. And they are, they're, they're exciting, they're innovators, they're entrepreneurs, they're visionaries. And, and then yeah, the ones that decide to take that vision forward and actually turn it into operational execution, uh, again, those are not always the same personality. Um, because we're always still bootstrapped for cash. We had kind of have to, right? Yeah. Yep. And so yeah, I can, I, I have seen the toll that takes on, on fa. Like I said, I've been supporting those kinds of companies myself for a lot of years and, and you see that toll, so I'm glad you brought that up. Yeah, right. Perfect. Excellent. Well, we'll, uh, we'll wrap it up here. Where can folks go to connect with you and, and follow along on, uh, your company's?

Duance Mancini: 24:09

Yeah. Uh, www.projectmedtech.com. Pretty straightforward. Um, we're very active on, uh, LinkedIn, um, and myself and the, the Project MedTech page. And, um, outside of that, you can, you know, catch us at industry events. We also host our own events, but that's all on the, uh, the.

Kelly Stanton: 24:30

Excellent. Well, thank you so much. It was, uh, it was good to catch up with you again, and we'll, we'll have to, we'll have to have another follow up here in the future.

Duance Mancini: 24:36

Sounds great, Kelly. Thank you.

Kelly Stanton: 24:38

Thank you.