The B2B Podcast Index
Index
All categories
MarketingSalesSaaSFinanceHROpsLeadershipCustomer SuccessAI & DataProductStartups & FoundersRevOpsEngineering & DevTools
MethodologySubmit
Best of:MarketingSalesSaaSFinanceHROpsLeadershipCustomer SuccessAI & DataProductStartups & FoundersRevOpsEngineering & DevTools
An independent project byFame
SearchBest episodesGuestsInsightsMethodologySubmit a podcast
Index/Project Medtech
Project Medtech artwork

Episode 268 | Ethan Drower, Co-Founder & CEO of CiteMed | Breaking Down Barriers with Clinical Evidence

Project Medtech · 2026-07-06 · 39 min

0:00--:--

Key moments - from our scoring

Substance score

56 / 100

Five dimensions, 20 points each

Insight Density12 / 20
Originality11 / 20
Guest Caliber14 / 20
Specificity & Evidence9 / 20
Conversational Craft10 / 20

CiteMed's journey began at a kitchen table ten years ago when Ethan's father, a 30-40 year regulatory veteran, needed help automating clinical literature reviews during an EU MDR transition. What started as document generation has evolved into Evidence Cloud, an end-to-end clinical evidence platform that centralizes literature searches, extracts outcomes, removes duplicates, and generates regulatory documents while keeping evidence continuously searchable and queryable across device portfolios and claims. The platform serves two distinct customer segments: sophisticated teams with defined workflows using Excel and EndNote who need better tooling, and companies needing strategic guidance on how to structure evidence programs from scratch. Drower emphasizes that clinical evidence, when properly managed, becomes a pervasive organizational asset affecting marketing claims, valuation presentations, audit responses, and reimbursement strategy - far beyond just FDA submissions. He highlights how design and user experience were critical investments, with a core philosophy of traceability and verification ensuring users understand exactly how the platform arrived at recommendations rather than blindly trusting AI-generated outputs. The biggest challenge he observes at industry conferences is that founders underestimate how regulatory strategy impacts fundraising and acquisition viability, with investors carefully evaluating approval pathways and associated costs.

Key takeaways

  • →Evidence Cloud transforms clinical evidence from a regulatory checkbox into a strategic business asset usable for marketing claims, valuation, reimbursement, and M&A presentations.
  • →The platform eliminates the need for Word documents and Excel-based literature management by providing centralized, searchable storage of all extracted outcomes and references with complete audit trails.
  • →Design and traceability are core to CiteMed's philosophy - all AI recommendations and automations show their complete reasoning chain so users understand and verify every decision rather than blindly trusting outputs.
  • →Startups struggle most with understanding how regulatory strategy impacts fundraising; investors evaluate approval pathways and compliance costs as critical business metrics, not just technical hurdles.
  • →CiteMed serves two distinct customer profiles: sophisticated teams needing better tooling for existing workflows, and early-stage companies requiring education on how to structure evidence strategy from the ground up.

Guests

Ethan Drower

Topics in this episode

Evidence CloudEU MDRFDA submissionsClinical evaluation reportsClinical literature reviewsMedical device claimsPMA annual literature reviewsRegulatory compliance documentationReimbursement strategyMicrosoft Word automation in medical writing

Questions this episode answers

What is Evidence Cloud and what does it do?

Evidence Cloud is CiteMed's end-to-end clinical evidence generation platform that automates literature searching across global databases, removes duplicates, allows efficient review in an auditable way, extracts relevant endpoints, generates regulatory documents like clinical evaluation reports and FDA submissions, and maintains a continuously updated, searchable centralized evidence base queryable by device claims.

How does CiteMed help beyond just FDA regulatory submissions?

Evidence Cloud supports marketing claims validation, reimbursement strategy, acquisition valuation presentations, and M&A processes by keeping clinical evidence accessible and searchable across the entire organization - making evidence a pervasive strategic asset rather than just a regulatory requirement.

Who uses CiteMed - manufacturers, consultants, or both?

CiteMed serves a mixed client base of about 75% device manufacturers plus consultants; consultants use it to perform reviews and then give clients interactive access to references and extracted data instead of just static 2,000-page documents.

What are the two main types of CiteMed customers?

Sophisticated customers with dedicated evidence teams who need better tooling to execute their existing 40-page workflows, and companies needing education on how to structure their evidence strategy and claims from scratch.

Why is user experience and data traceability important in CiteMed's platform?

The platform shows all recommendations and AI-generated summaries alongside complete audit trails and direct references so users can verify and understand exactly how every decision was reached, preventing blind reliance on automation and ensuring regulatory defensibility.

What our scoring noted

Our reviewer’s read on each dimension, with quotes from the episode.

Insight Density

12 / 20

The episode contains solid foundational insights about clinical evidence management and regulatory strategy, particularly around how evidence serves multiple functions beyond compliance (marketing, reimbursement, valuation). However, substantial portions are devoted to biographical details, Chicago sports banter, and generic industry observations that add little substantive value. The core business insights are present but diluted by filler.

the fastest you can close that loop of our competitors saying this, can we say this, can we say something better than this? Um, right now if you're not working with us and you're doing it manually, that's an expensive process
Evidence Cloud has to have contextual knowledge of what your claims are, what your device does, what your most recent IFU version is, and then of course, what are all of the pieces of literature that we've extracted and you've reviewed that pertain to that specific statement or claim

Originality

11 / 20

While the framing of evidence as a multi-use strategic asset (beyond regulatory compliance) is useful, it represents a logical extension of known industry practice rather than a genuinely novel insight. The point about regulatory strategy impacting fundraising and valuation is recognizable to most operators in medtech. The book recommendation about fraudulent studies touches on something fresher but arrives late and underdeveloped.

if your evidence is accessible and it's stored and it's searchable and usable, um, it can be very strategic for your company in terms of right marketing claims, what you can say, or in some cases what you should stop saying because new evidence is coming out
there's so much evidence and articles, clinical literature that's written today that's based off of evidence that was essentially fabricated

Guest Caliber

14 / 20

Ethan Drower is a legitimate operator: co-founder and CEO of a 10+ year-old company in a regulated space, with deep domain experience. However, he's primarily a software founder who entered medtech via his father's expertise, not a seasoned regulatory or clinical evidence expert in his own right. He has relevant perspective on the landscape but is somewhat limited in depth compared to pure regulatory veterans or founders who've scaled multiple medtech exits.

I'm Ethan Drower. I am, uh, one of the original founders of SiteMed. We've been in business about just over 10 years now
my background is actually in Software

Specificity & Evidence

9 / 20

The episode lacks concrete data, metrics, timelines, and named examples. No customer logos, growth figures, feature adoption rates, or comparative data on clinical evidence processing speed are provided. The regulatory strategy discussion remains largely abstract. The fraudulent evidence book recommendation is vague (title uncertain, author unnamed). This is a significant gap for a B2B software discussion.

about 75% would be actual manufacturers
we've been in business about just over 10 years now

Conversational Craft

10 / 20

The host asks relevant questions and does probe the guest on regulatory strategy, evidence integrity, and customer segmentation. However, follow-ups are often surface-level and redirect quickly. The long digression into Chicago sports (DePaul, Cubs vs. White Sox, Wrigley Field) consumes several minutes with no substantive purpose. The host fails to press on specifics: no pushback on claims, no request for concrete metrics, no challenge to the guest's framing.

Um, so is this, if we take it back 10 years, are you, you're in Chicago right?
Are you born and raised in Chicago?

Conversation analysis

Computed from the transcript - who did the talking, and the words that came up most.

Share of words spoken

  • Speaker A63%
  • Speaker C32%
  • Speaker B5%

Most-used words

evidence34clinical18literature16medtech15regulatory15data13industry11started11project10chicago10biggest10point9startup8first8sure8consultants8

Episode notes

In this episode, Ethan Drower, co-founder and CEO of CiteMed, shares the story behind Evidence Cloud, an AI-enabled platform transforming how medtech teams approach clinical evidence. Built to simplify complex literature reviews, strengthen regulatory submissions, and create a clear, traceable foundation for clinical claims, Evidence Cloud helps companies navigate one of the most critical steps in bringing innovation to patients. What began as a kitchen-table conversation evolved into a mission to reshape evidence generation and regulatory strategy. In this conversation, Ethan discusses how smarter evidence workflows can improve transparency, accelerate decision-making, and turn clinical evidence from a compliance requirement into a powerful strategic advantage. Ethan Drower LinkedIn CiteMed Website Duane Mancini LinkedIn Project Medtech Website Project Medtech LinkedIn Thank you to our sponsors: Ward Law , Wheelhouse DMG , and JumpStart Inc .

Full transcript

39 min

Transcribed and scored by The B2B Podcast Index.

Speaker A: Foreign. Starts with medical discussion. Talking about the future. What comes Next with Project MedTech?

Speaker B: Hello everybody, I'm Lindsey Deneen, Director of Marketing engagement at Project MedTech. And welcome to another episode of the Project MedTech podcast. If we can help you in any way, or you would like to suggest a future guest, you can email us@infoorojectmedtech.com if conversations like this are helpful. That's exactly why we bring people together at our signature events, the Midwest Showcase, the Startup Symposium, um, and Coming to America. For more on our events that include networking, education and pitch competitions for startups, check them out@www.projectmedtech.com. we even have sponsorship options. If your company is also dedicated to accelerating medical technology to impact patient lives, reach out. Um, today to get involved. The Project Mentech podcast is proudly sponsored by Ward Law. Wardlaw Office, LLC is a boutique law firm specializing in the practice of patent and trademark law. They are committed to providing inventors, entrepreneurs and businesses of all types with personal and professional services and are flexible to meet your unique needs. It is their goal to both educate on how to secure valuable patent and trademark protection and to provide high quality services at, uh, rates affordable to independent inventors, startups and small businesses alike.

Speaker A: Today's episode of Project MedTech is brought to you by Wheelhouse DMG Performance Marketing for privacy first industries like MedTech and Healthcare. Every Wheelhouse client experienced record growth in 2025.

Speaker C: That's the result of more than a

Speaker A: decade building the data infrastructure, measurement systems and domain expertise that healthcare and medical device marketing actually requires. Find out how every Wheelhouse client experienced record growth in 2025@wheelhousedmg.com without further ado, let's dive in.

Speaker C: All right, Ethan, welcome to the podcast.

Speaker A: Thanks, Duane. It's good to be here.

Speaker C: Yeah. So, Ethan, let's start with a introduction, uh, to, um, who you are, um, your background, and then kind of take us up to what you're currently doing now.

Speaker A: Yeah, sure. Um, so I'm Ethan Drower. I am, uh, one of the original founders of SiteMed. We've been in business about just over 10 years now. Um, my background is actually in Software. So, uh, SiteMed is my first and only venture in kind of the med tech, uh, regulatory, clinical evidence, uh, space. Um, it's a pretty interesting story how I got there, um, because I was primarily working in finance doing some, you know, startups that were more consumer apps, um, a lot of very tech heavy, data heavy type of applications. And Site Med got its start originally, um, because my father, who is a Um, I don't know, 30, 40 year quality regulatory veteran, ah, running clinical trials and kind of um, being very deeply embedded into um, pharma and medtech companies quality uh, departments. Um, he was tasked with shifting a large manufacturer's portfolio to mdr. So it was an MDR transition. And um, back then the big issue and concern was there were a whole lot of medium risk class devices that were being up classified and now needed heavier clinical evidence. So heavier clinical evaluation, literature review. They needed to present their evidence in a way that they never had to before. And um, that's incredibly expensive uh, for a company that's not used to paying for it at all. So he was struggling to build budgets, hire consultants. Um, there weren't enough bodies in the entire industry to complete all of these uh, documents and kind of technical files. And um, you know they always, people always talk about startups being founded at a kitchen table. It literally was at a kitchen table. And um, Ed, my father was complaining about how he was going to get all this work done and um, he just kind of had a moment and he was like ah, hey, if I show you one of these things, how much of it do you think we could automate? And um, you know I took a look at the structures and kind of that was my first look into clinical literature, evidence processing, how to build tables, things like that. And um, turns out quite a bit can be uh, can be automated and can be helpful. So that's where it all started. We um, kind of dove in and immediately found traction and interest because it was such a painful problem and we really just never looked back. Um, so, so yeah, that's a little bit about me and kind of how SiteMed got Ah, going super cool.

Speaker C: Um, so is this, if we take it back 10 years, are you, you're in Chicago right?

Speaker A: Yeah, basically.

Speaker C: Are you, are you born and raised in Chicago?

Speaker A: Uh, born in Chicago, educated in the suburbs. Back to Chicago for university. I went to DePaul, studied computer science, um, and then never left except in the winters. I try to leave every single winter if possible for as long as possible.

Speaker C: So it's, it's funny um, when, so one of my best friends, Corey, who I was telling you before the show, he runs a few Ah, YouTube channels in Chicago. It's all about uh, food to eat, things to do. He does a bunch of vlogging. It's, it's pretty cool. Like if, if, if someone was new to Chicago, I, I would point them to his YouTube channel because he goes over all these different things that you could do in Chicago. It's pretty cool. Um, but I moved him there in 2015, and he lived near DePaul. That's where his first apartment was. And so I helped him, like, move everything in. We were walking one day and I'm like, oh, this is DePaul. And it's so funny. Like, I was a, um, a big sports fan growing up. So I know the names of a bunch of universities because of March Madness, but I don't really know where most of them are. And DePaul was always one of those because they were always a decent basketball program as a kid for me. And then I was like, oh, they're in Chicago. But it's a really cool campus. Just kind of right in the middle, integrated. You, uh, know. Yeah, it's integrated into Chicago. I thought it was really interesting, um, how it was. Um, so most important questions are, um, Cubs or white socks?

Speaker A: White socks when I was a kid. Um, and I'd say Cubs now because my mother's a huge fan and I also live about, uh, two blocks from Wrigley. Yeah. So I feel like at this point, at this point, I'm officially converted.

Speaker C: Yeah. Wrigley, Wrigleyville, Wrigley Field and the Chicago Cubs. It has to be the best experience to go watch a ball game. Yeah, I, I, a huge baseball fan. I just, I'm not sure anything touches that.

Speaker A: No, um, the Red Sox do do it well with the neighborhood and.

Speaker C: Yeah.

Speaker A: Um, but I feel like the energy of Wrigleyville is, um, it's just something special in the summers. I don't know. I've never. I have never come across anything like it. You're right.

Speaker C: Yeah, yeah, yeah. It's pretty cool. Um, okay, perfect. So, um, so do you. Is this, like, right as you're finishing school that you and your dad start site Med.

Speaker A: No, no, this was. I, um, wish I was that, ah, young. Uh, this is about. This is about five years after, um, I went, I picked DePaul so that I could work at the same time. Um, it's a huge advantage to be an intern college kid and be able to work year round at, um, some of these firms. So I worked in finance, electronic trading, things like that.

Speaker C: Yeah.

Speaker A: Um, and then I kind of started traveling and building my own projects. Ah, you know, small things, trying to support just kind of lifestyle based things. And I never really had any big, um, you know, funded growth startup aspirations, really, until I got more deeply embedded into med tech, life sciences, and kind of the evidence path. So that was about yeah, five or six year journey for me outside of school.

Speaker C: Yeah. Now, so obviously having your dad as uh, founder here is like, really helpful because he obviously knows the space really well. You know, like you said, 30, 40 years in the industry. What was your biggest learning curve? Kind of coming up to speed. Right? Because obviously, yeah, you know, from like, um, a software perspective, I'm sure you were like, hey, yeah, if you show me things, I'm sure I could figure out how to build what we need here. But what were some of those, what were like the, the biggest things you look back and go, oh, boy, that was, that was a tough hurdle to get over or that was a real big learning curve for me to understand this.

Speaker A: I think, uh, one of the reasons why I love this industry so much and you know, I became a, ah, regulatory person. Right. It was, it wasn't a, it wasn't really a conflict for me. I just kind of fell in love with, with the idea that you don't need a ton of credentials to be effective. What you need is you need experience and you need to be able to read a lot of very large, very intricate documents. So I think, I think getting started, that was the, that, that's the, that's the biggest hurdle. It's why people don't, it's why people don't innovate in this space, um, as much as they do in others. Because you really have to know what you're doing and you really have to care. You cannot, you cannot fake it, build a quick product, throw it out there and see if people buy it like you can. In some, in, in some less regulated industries, people, um, you know, customers won't have it, first of all. And second of all, there's all kinds of legal and regulatory ramifications of doing that. So I, um, think that initial ramp up of, okay, you need to sit down and read as many of the guidances and regulations as possible to be able to put together what an effective product is going to look like. Um, and that's still a process that, you know, you have to continuously do. So, um, most daunting at first, for sure.

Speaker C: Yeah. Yeah. Okay. Um, so you, you know, the idea started kitchen table around the EU mdr, which, you know, that's been a thing that has just lingered for years, um, the switch from MDD to MDR in Europe. Um, so obviously you kind of start with this regulatory focus. Where have you taken it from now? Where have you taken it from? From just strictly that regulatory focus to where it is now. What are all the Features of it, what can you do? Because, and, and to set the stage even further on this, you know, we talk about, um, clinical evidence is the like most valuable thing a startup can collect. That's uh, your biggest value inflection point is the ability to say we got strong clinical data. Now when we talk about clinical data, there's hey, a physician used my catheter in a procedure. But then there's also all the data that's available to you and all the research that's available, uh, and all the clinical studies that have been done. And that is a daunting research project. And so, yeah, walk me through the evolution of this and maybe how people are using it outside of just, hey, fda, here's my clinical data. But hey, my marketing data is based off this, my reimbursement data. There's just so many areas where clinical evidence is important. So um, yeah, maybe talk about the evolution.

Speaker A: Yeah, and that's a great question. It's a, it's a very interesting arc for us because when we started everything was very much hair on fire. We need to complete reviews. You know, we were document generators, right? How many literature reviews can we complete so that we can update technical files and actually get devices submitted? Um, a few years into that there started to be a little bit more breathing room. MDR was delayed, there was a little bit less pressure. And that's really when um, we started to understand that there's so much more to clinical evidence for a startup and for a mature organization beyond just A to B. I need to complete my regulatory requirement, my annual update, etc. So, um, over the last few years we, we started to really expand our use case to the bigger picture. Right? Which is if your evidence is accessible and it's stored and it's, it's searchable and usable, um, it can be very strategic for your company in terms of right marketing claims, what you can say, or in some cases what you should stop saying because new evidence is coming out. Um, it can be incredibly useful in terms of increasing your valuation if you're trying to sell your startup, how you can present that and how you can present kind of a cohesive journey. Um, so it, we started to realize that evidence, when properly kept, is an incredible asset for a medtech organization. Um, and the majority of our customers, majority of the people that were using our platform, which is evidence cloud, uh, weren't necessarily also sharing and seeing that big picture. They were still very focused in just need to get these documents out and then forget about it and move on. Um, and so the deeper we were embedded into that, how do we actually turn evidence into supporting claims, how do we make responses to auditors faster? Right. Um, all of these kind of day to day processes, how do we decide what to claim and what to market? Um, that's really where we've gone now because it's, the impact is so much bigger than, okay, we can create our annual literature updates faster. Right. It's a, it's a pervasive thing, it's across the entire organization now and didn't used to be when we started.

Speaker C: And um, when you are pulling together, um, well actually before we do that, I have a question about data integrity, how you filter that out. Also the importance of how you deliver the um, uh, uh, findings and the research and the user interface, because that really does matter too. Uh, um, but before we get to that. Yeah. You talked about Evidence Cloud, right. Is the platform just high level to walk me through the different individual pillars of that?

Speaker A: Yeah, sure, that's probably, it's probably good context at this point. Um, so we call Evidence Cloud an end to end clinical evidence generation platform. And so what that means is we're trying to, we're trying to make for our users the process of figuring out how to collect literature and evidence. So what to search, where to search it, uh, collecting it in an automated and reproducible way. So how do we run searches on a whole host of global databases, how do we then process that, clean it, remove duplicates, et cetera, and then how do we allow them to review it, review it quickly and efficiently, um, in an auditable way, extract the right endpoints, the right data that they care about that's pertinent to their device portfolio, and then of course generate either generate outputs, which would be documents, your clinical evaluation reports, your fda, pma, annual literature review, that kind of stuff. Um, and then full circle, how do we keep that cycle running in perpetuity in a way that keeps your evidence base updated and queryable? So um, the big thing that we try and do is it's not just conduct your literature review and forget about it, it's you're accumulating the centralized store of evidence that is now searchable across your devices and your claims. Right. So we're not just searching by an author name. Okay. We're searching for, we want to make this statement about X product. Okay. So Evidence Cloud has to have contextual knowledge of what your claims are, what your device does, what your most recent IFU version is, and then of course, what are all of the pieces of literature that we've extracted and you've reviewed that pertain to that specific statement or claim or research question. Um, so that's kind of where we've headed with it. Uh, how's that. How's that as an overview?

Speaker C: That's perfect. Yeah. Are most of your clients, um, uh, you know, original? Like, are they. Are they the manufacturers of these medical devices? Are they consultants? Are they a kind of mixed bag of both? Like, who's, who's mostly using site. Site med.

Speaker A: Uh, mixed m. Bag. The. The consultants are very interesting. I mean, we essentially were consultants for years. Right. So we built it to help our team be more effective and kind of speed up our internal processes. Um, what's interesting about consultants is that once the consultants perform the reviews and do the evidence, they want to make that accessible and usable for their clients. So, um, that's kind of the path that the consultants take. Now, the clients don't just get a document that's 2,000 pages that they'll never read. Um, but they also have a way to see all of their references, find the full text, see what was extracted for those texts, and they have direct access to it. Um, on the medtech side, the manufacturer side, I'd say that's probably about 75% would be actual manufacturers. Um, they love central store, central place for all of their references, all of their extractions, that cumulative history. And then they love not having to write and copy paste into giant word documents all of their, uh, their analysis and all of their evidence. We are, I, um, could do an entire podcast on my crusade against Microsoft Word. We, um, are working very hard to eliminate that part of the, the workflow for, uh, for medical writers. It's just. Yeah, it's just horrible. There's no other way to say it. It's not the right tool, but it's the only tool. Until now.

Speaker C: Yeah. Yeah. Um, awesome. Um, okay, so, yeah, tell me about research, uh, integrity, and then also the importance of user experience and how you display this information. Um, uh, because I think, you know, one, the integrity of the data is really important. Um, where you're pulling it from, how you're pulling in the data, but then also how a client interfaces with all this information is also, you know, really important. So for you, as, you know, being on the software side. Yeah. I mean, how much time did you put into each one of those buckets? Um, because it feels like that's a pretty important step.

Speaker A: Yeah. And I think it's a complicated, uh, user experience problem. Um, and this is definitely an Industry where I think users get very shortchanged on design and user experience. Um, so we've tried to swing the other way and we've invested very heavily in design and in testing and trying to make the platform and a much more intuitive way to interface with the literature. Um, our big mantra is traceability when it comes to actions that are taken on the platform. So, um, there's a lot of things that happen behind the scenes, like removing duplicates, you know, organizing literature and ordering it, serving recommendations, AI based recommendations, summaries, things like that. Um, um, but everything that our interface shows and presents is rooted in kind of the philosophy of verification. So we don't want to make a decision for a user or a writer. What we want to do is we want to show a suggestion and then a complete kind of train of thought and direct reference to that specific literature. Um, so that's very, that's very challenging to be able to show in a way that makes sense. Um, but we find it kind of essential. Um, you cannot be, you cannot be making assessments or screening decisions without justifying why. And the user needs to be able to take all of that in and make their own judgment. Um, yeah, so I think that's kind of our core philosophy when it comes to that. Uh, we want to obviously do as much as possible, make things faster, but we don't want to overcorrect and create a situation where you've now generated an entire report and you can't really explain or understand how you got there. Um, that's not really acceptable. And um, it's not a good use of time. It uh, creates more problems than uh, it selves in my opinion.

Speaker C: Okay, um, how about like when you see people, you know, uh, uh, clients interfacing with the platform, but when they come to you, where do you see people struggle the most with this clinical evidence? Like, you know, obviously you're, we know what you're solving for. Um, but, but where are people really struggling as they reach out to you and say, hey, I'm interested in the platform because of, because of this, you know, is it mostly on the regulatory side of it? Is it, is it mostly on the reimbursement marketing side?

Speaker A: Yeah, um, that's a great question. I think there's, I think there's two camps of customers, um, that we serve and work with every day. The, the first camp is um, what we would call a kind of a proactive and a more in a sophisticated evidence processor, meaning they have a team that's dedicated to handling and processing evidence um, their biggest problem is that they don't really have adequate tooling and support to do what they know needs to be done. Okay. They know that they want to extract specific outcome measures in kind of a polymorphic way on every single article and they want to store that in perpetuity and be able to search it. Can't do that in Excel and EndNote. It's not possible. Um, so that's kind of the sophisticated buyer. The other side is a company that needs help understanding how they should even structure their strategy in the first place. So they need more than just a tool to execute what they're already doing. They need a little bit more education as to how they should be writing their claims, um, how they should be attempting to present their evidence, um, to support those kind of claims and statements and things like that. So I think that's kind of the divergence. There's very hardcore workflow focused people and then there's also people that want more of the, you know, what we would call the out of box experience. They say, tell me how to do the literature review in the correct way. Give me the right structure. I don't want to have to define it myself. Um, whereas the other side is, here's our 40 page workflow document of how we do an evaluation. Let's support that. Right. Uh, so those are kind of the two big differences. Um, there's a strategy know how gap, um, in, in our clients.

Speaker C: Mhm. Yeah.

Speaker B: Um.

Speaker C: Okay, next question. Not, doesn't have to be related to clinical, uh, evidence generation, anything like this, or research, um, regulatory. Could your, your pick. Um, but I think you might have an interesting perspective on this because you, you came from outside the industry so you, you attend conferences, you work with companies, you've seen a lot at this point. Um, where, where do you think, um, in, in your experience of going to conferences, where do you think startups struggle the most? And in life sciences, um, and again it could be something you're really comfortable with or it could just be, hey, I've been going to a lot of conferences and you know, talk to a lot of startups and they really struggle with fundraising, um, reimbursement, you know, but, but you get, you get to pick here. It doesn't have to be, it doesn't have to be what site Med does.

Speaker A: Yeah, yeah, sure. Um, that's a great, that's a great question and it's um, I feel like I have a lot of answers because we've gone to a few of the Project Medtech, uh, events and that's very top of mind there. Yeah. Um, the biggest challenge, I think, um, you know, from, from our side of the fence, the biggest challenge is awareness of how much their regulatory strategy can impact their viability for acquisition and fundraising. So I guess fundraising is the biggest challenge. Um, but I think that a lot of founders who are these incredibly, uh, intelligent and capable either engineers or healthcare professionals that can build some fantastic, revolutionary device, um, they don't always see, they don't always come back to the hardcore business case of how an investor values that. And, um, investors are very realistic about cost pathways to approval, uh, the costs in doing so. And um, if you as a founder don't have a firm handle on what that's going to look like for your strategy, then you're, you're worth far less, um, for in terms of an investor's perspective, at least that's what we've seen. So, yeah, I think that's, I think that's the biggest, the connection between that and how do we, how do we use that strategy as a way to demonstrate our value and our sophistication as a company? Um, I think it's underrated, know, in a lot of cases.

Speaker C: Yeah, I think, um, that's a, that's a great, great call out. And I think to your point, regulatory is way more complex than people understand. Like, it's, it's not as simple as, um, like, oh, this is my cell phone and it makes phone calls. And you know, this is how it's regulated at the fda. It's like, oh, no, this is my cell phone, but it makes phone calls, but it's also a camera and, and it could diagnose this disease or do this. It's like, you know, your, your regulatory strategy can change drastically when you talk about not even technically how the product works, but the claims you want to make and what it's going to be used to do. And um, you know, those have real implications on your commercial success, um, and your reimbursement. And so if you're not taking that all in at the very beginning, it's very easy to see how one little mistake in regulatory and then you get to market, you know, three or four years later. And you can't make the claim that you want to make, um, or your competitor reimbursement, but your competitor can, you know, and, and that can affect a lot of different things. So, yeah, to your point, I think taking time and evaluating that not in a silo is super important. Um, and that's probably where it's very Hard, Yeah, of course, you know, um, it's very difficult, um, to get not only the information you need around the table, but also the resources. Right. Um, yeah, it's a, it's a, it's a difficult task. Um, so I think it's.

Speaker A: Yeah. Uh, and I, I think what, what's so fascinating about this industry to me is that um, in most, in almost every other startup industry, uh, you can kind of claim whatever you want. Right. Site Med, we can claim. I can change our website today. I could say anything. Yeah. And um, if our competitors change how they're pitching their products, we can change too very quickly. Same day. Right. Um, but in medtech, what you can claim is, is so incredibly strategic and potentially expensive and painful to change. So, um, the faster you can close that loop of our competitors saying this, can we say this, can we say something better than this? Um, right now if you're not working with us and you're doing it manually, that's an expensive process. Right. You send an email to regulatory, the they start cranking up the machine and they start reading papers and trying to go back through their history and find things. Then they send a reply and that can take weeks, uh, depending on how busy they are, if you even have those people. Um, so I just think that's, I think that's the most interesting thing about this industry. And if you could be good at defining your claims and maximizing them, um, it's a huge competitive advantage. Some of these markets for these devices are winner take all. The product with the best presented evidence is going to be the one that's recommended in every case.

Speaker C: Yeah. And if you're at an early stage startup, that to your point too, on the um, clinical, um, evidence, what you're claiming, all of these things, I mean that is what drives value for an acquisition, uh, and investments. So I mean it all adds up. Um, Ethan, what's been your favorite part about being in Life Sciences and Medtech now?

Speaker A: Um, favorite part? Well, I would say by far, I would say the team that we've built and that we get to work with, um, you know, starting with, with my father, I feel like that's a unique kind m of startup journey, especially for a tech company. Um, and then the people that we've come across along the way and kind of built our team, uh, with, um, it's really a pleasure. And I've never been in an industry where almost across everybody that we interact with, you're talking with thoughtful, uh, intelligent and just kind people from, from the people that we Sell to, to the people that we hire. Um, seems it's very unique. Um, I mean I've worked across many industries and I just, I've never seen anything like it. Um, everybody's just kind of a joy to uh, collaborate with the uh, overwhelming majority. Right. Um, so I think, think that's, I think that's a special thing. Ah, about this industry, especially regulatory within life sciences, I would say.

Speaker C: Yeah, yeah, yeah, totally. I mean it's a, it's a. What's the saying? Big little world or whatever it is. I mean it's, it's like, uh, it's amazing. Um, everyone seems to be a few connections away from everyone else. Everyone is generally speaking, really easy to get along with. Um, it's very collaborative, you know. I totally agree with you. Um.

Speaker B: Uh.

Speaker C: Okay, um, last question as we wrap up here. Um. And you can give more than one. I um, have, uh. Obviously you could see in my background I enjoy reading. I get most of my book recommendations from guests. Um, I uh, don't read all of them, but you know, it's like uh, I have a five and a two year old. Right. So, um, you know, reading is hard to come by. Um, but I'd be curious, um, if you had a book recommendation or two. Fiction or nonfiction? Um, uh, for the uh, listeners.

Speaker A: Um, yes, I do. I think, um, I'm going to have to, I'm going to, I'm going to have to look up the title for you. Um. Yeah, the. I think it was the, the most powerful and triggering book that I've read in probably the last year.

Speaker B: Um.

Speaker C: Okay.

Speaker A: It was called something like, um, like, like Bad Evidence. Um, and the. I'm trying to look up the author. But the premise of the book was essentially that there's so much, um. There's so much evidence and articles, clinical literature that's written today that's based off of evidence that was essentially fabricated. Okay. And it was about how the perpetuation of this article cites this article and cites this article and the original research was flawed. Creates, um. This um, creates this cascading effect of essentially just fraudulent and useless evidence. Um. Yeah, but I read that. I mean I saw the summary of the book and I was like, okay, well this is essentially refuting everything that we've built our company on. So we should probably take a look at this. Yeah. And um, it's. I mean it was meant to be scary, but it's also one of the biggest opportunities for technology. Right. You cannot, A human cannot reasonably drill through all of this, references all of the cited literature, look at the underlying data, and then calculate if statistically those results make sense and are legitimate. Right. It's not possible to do that on a, uh, several thousand abstract review of a flagship Class 3 product. Um, you can't do that by yourself. Uh, but we can do that because the math is actually fairly simple. The hard part is the sheer volume of connected literature. Um, so that's something that we've started spending a lot more time on. And you mentioned validity. Right? It's not just validity of our process of reviewing literature, it's validity of the studies themselves. Um, you cannot assume that just because it's been published means that it is correct and that it's valid. Unfortunately. Um, so I think it's a huge opportunity. But, um, it was fairly terrifying, uh, to read some of these stories of, uh, entire bodies of evidence built off of a couple studies that were made up.

Speaker C: Yeah. Ah, yeah, for sure. Very cool. Awesome. Yeah. Um, Ethan, we'll have a link to site Med here in the show, notes your LinkedIn as well. Thanks so much for taking some time today and joining me. Hang on for one minute. Uh, we'll chat offline.

Speaker A: Yeah, thank you, Dwayne. Um, it's great to see Project MedTech, uh, growing so quickly and um, really expanding over the last several years.

Speaker C: Yeah, thank you. Hi, I'm Freddy Coffey, Director of Marketing at Jumpstart. The Project MedTech podcast is proudly sponsored by Jumpstart Inc. Jumpstart's trailblazer accelerator helps Ohio's most innovative early stage health tech startups fast track their growth with tailored advising from serial entrepreneurs, non dilutive funding to fuel their journey, and unrivaled access to a network of experts, resources and investment opportunities. Whether it's improving patient outcomes, advancing digital health, or reimagining care delivery, Jumpstart provides the high impact services and critical resources to bring big ideas to life.

Speaker B: Thank you for listening. At our core, we at Project MedTech are networkers, educators and consultants. We meet you where you are to bring value and to create impact. We care deeply about helping medtech companies succeed right from the start through to exit for providing consulting and fractional services, hosting impactful industry events, and of course sharing incredible guest insights like the ones you heard today day through our podcast. Please reach out at any time. If we can be of assistance, check out our website at www.projectvetch.com or email us at info@projectmedtech.com.

Related episodes across the Index

Other episodes covering the same guests and topics, from across The B2B Podcast Index.

  • Why inclusive HealthTech product design requires much more than quantitative researchShine: a podcast by Star · on Reimbursement strategy79 / 100

More from Project Medtech

All episodes →
  • Episode 277 | Merom Klein, Principal at Courage Growth Partners | Building Courage in Medtech: Turning Fear Into Adoption, Investment & Innovation79 / 100
  • Episode 272 | Mike Monovoukas, CEO & Co-founder at AcuityMD | The Future of Medtech Commercialization: AI, Data, and Smarter Growth78 / 100
  • Episode 266 | Laura Corcoran, CEO & Founder of Dignity Care | Innovating Compassionate Solutions for Pregnancy Loss76 / 100
  • Episode 265 | Dr. Malcolm Townes, Innovation Fund Manager at Washington University | Strategic Medtech Commercialization: Lessons from the Gap Fund71 / 100
  • Episode 264 | Will Kaigler & Megan Shaw | From Innovation to Impact: Crafting Medtech Culture and Success in Pittsburgh65 / 100
All Project Medtech episodes →