Medsider: Learn from Medtech and Healthtech Founders and CEOs - Clinical Trials as Revenue Drivers: Interview with Matthew Amsden, CEO of ProofPilot

Episode Date: July 22, 2020

In this episode of Medsider Radio, our guest is Matthew Amsden, the Founder, and CEO of ProofPilot, a platform designed to help people design, launch and participate in clinical trials.ProofPilot’s mission statement revolves around making it incredibly easy to run scientifically-valid research studies. They’re dedicated to making research study participation accessible, interesting, and fun.      In this discussion with Matthew, we chatted about the importance and feasibility of virtual clinical trials, how they can potentially become a revenue driver, the origin story of ProofPilot, and why their hybrid model is so popular.Interview Highlights with Matthew AmsdenWho is Matthew Amsden and where did the idea for ProofPilot begin?    The importance of letting early customers try product iterations.How clinical studies can become a revenue driver. Various types of clinical trials and how they’re conducted on the ProofPilot platform.Risky and costly approaches to traditional clinical studies.     The synergy between data, compliance, and incentives.How a virtual, hybrid model can solve problems when it comes to traditional clinical trials. Matthew’s favorite business book, the mentor he most admires, and the advice he’d give to his 30-year-old self.See more...

It's very unlikely in the real world, even if you're in a country with complete and total fantastic healthcare that's government supported, it's very unlikely that you are going to be paid to administer a treatment, and it's also very unlikely that you're going to receive things for free. There is a big problem in research right now that it's difficult to replicate research results from one research study to another. It's also extremely difficult to replicate research results from a clinical trial to the real world. Payments for components of a research study, that's just real life. In real life, an individual is going to pay for a treatment. They are going to pay to get services. So actually using that as part of the research study actually creates a more real life environment and gets, again, data that actually may be more applicable to what's going to happen in the real world.

Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Matthew Amsden is the founder and CEO of ProofPilot, a platform to design, launch, and participate in clinical trials. Nearly everyone accepts the fact that technology has democratized journalism and transportation and retail. Now ProofPilot is trying to democratize clinical trials by making it as easy to design and launch a clinical study as it is to write. and email. And at the same time, turn clinical trial participation into a universally accessible experience leading to a journey of self-discovery. Proof-Pilot medical device customers include a combination of consumer and medical brands like Juv, Asur, Fisher-Wallis, Inber, and ChiliPad, and

various others. In this interview with Matthew, here are a few of the topics we discussed. Why clinical trials are not only feasible, but critically important for all healthcare companies, the origin story of proof-pilot and how the company has evolved over time, the importance of letting your early customers drive product iterations, how clinical trials can become a revenue driver instead of a cost center, various types of remote and hybrid clinical studies that can be conducted on the proof pilot platform, the risky and costly approach to traditional clinical trials, and how those can be significantly resolved through a virtual hybrid model, Matthew's favorite business book, the mentor he most admires, and the advice he'd give to his 30-year-old self. There's a lot more

we cover in this wide-ranging discussion, but I wanted to call out a few things before we get started. First, if you're new to these med site or interviews and want to be updated when the next one goes live, head on over to medsider.com and enter your email address. Rest assured, you won't be spammed. In fact, the only time you'll hear from us is when a new conversation goes live. Again, it's super simple. Just visit medsider.com. And right there on the homepage, you'll see the opportunity to enter your email address.

Second, if you continue to enjoy these interviews, please give us a rating. In your podcast app, just open the reviews tab and click on the old five stars. Thanks again, it really helps us out. All right, without further ado, let's get to the interview. All right, Matthew Amden, founder and CEO of Proof Pilot. the program. Really appreciate you coming on. Thank you. It's my pleasure. I'm glad that we're finally able to record this because it's something that it's a conversation that is sort of our topic and conversation that's sort of near and dear to my heart just because I'm sort of personally

biased towards what you're doing with Proof Pilot. But, you know, having worked together for, gosh, probably close to a year now at least, it'll be fun to kind of riff a little bit about our experiences and learn a little bit more about the origin story, maybe some stuff that I didn't even realize before about Prove Pilot, but looking forward to the conversation. Yeah. For anyone who's listening, Here. First, I need to say thanks to Scott. Proof Pilot is where it is today. Without him, I don't think that we would know a lot about what we know now. And he's been one of our biggest champions. Though I hope that you actually do a balanced interview with us. But I just do have to say straight out. You've been great and you've been a huge supporter. And we couldn't have done it without you as a customer and a partner.

I know. I totally appreciate those kind of words. You make me sound way more instrumental than I have been for sure. But no, I appreciate the kind of word, especially coming from you. So on that note, I think that actually that serves as a little bit of a nice starting point. So I'm going to take people back in time to roughly about a year ago. We're knee-deep with Jew-related work. And for those that are listening, that's where I've spent, you know, the better part of what the past three or four years focused on is Jew, which is a direct-to-consumer kind of, kind of wellness general health company, even though our product are, you know, class two medical devices. It's very much a direct-to-consumer kind of wellness play. But this was, you know, close to a year ago. We're recording this in May of 2020. And I think, Matthew, if my memory serves me, right, you sent us a cold email or sent me a cold email, kind of with a reference to Jean Nimme, who's the founder of touch slash digital surgery, which recently sold to Medtronic. I think he's an investor in ProPilot or affiliated with ProPilot with a pitch around basically sponsoring or running remote clinical trials in a very cost-efficient or cost-effective fashion.

And it stood out to me because I know firsthand that clinical trials are super expensive, like doing it in the traditional way. And then at Juve, we had an interest in sponsoring more clinical trials, not necessarily for like a definitive regulatory pathway, but just to collect more clinical data about our devices in red light therapy in general. So it kind of stood out. It was good timing. but it really opened up some really interesting things with proof pilot and allowed us to explore some different channels.

So maybe let's start there and help people understand kind of what proof pilot is and what your platform and offering looks like today. So that is correct. I did. It was one of the very few cold emails I've ever written, but I had been hearing about Jouv on other podcasts in writing. And I believe I had recently read an article about Juv and its effect on testosterone. And I was in my thought, process was, you know, it's this legit, is this for real? And because of what I do, because of what ProofPilot is, which is a platform to design, launch, manage, and participate in trials, I thought, okay, well, let's actually reach out to these folks and see whether or not they are confident enough in their product to actually run trials to support some of these really very powerful claims and stories that I was seeing out there in the press, both social media press and

traditional press. So it is true, John Neme is a investor in proof pilot. We actually shared an office together for a period of time in New York when we were both very young companies. And I understood that you had worked together. That was our connection. So I reached out and you were one of those folks who just kind of got it immediately. And by get it immediately, I mean the following. So when we think of clinical trials across the board, the first thing that comes to mind is pharma, pills, vaccines, stuff like that, particularly right now. In the world that we're living in, we're recording this in May of 2020. So a vast majority of us around the world are still in lockdown, though some of us are starting to enter in the world again, and we're all looking for solutions to kind of get back to the world that we knew beforehand. But regardless of whether it's COVID-19, or any other issue, Ferma runs lots of clinical trials on an ongoing basis, about 25,000 a year actually. So that's number one, you think Ferma. Number two, when you think clinical trials, particularly folks who are in the industry, is big dollar signs. The average pharmaceutical

trial, this is phase three and phase four mostly, costs well over $10 million. From ProofPilot's perspective, that means only a very small number of the research questions that are out there, in the world actually get answered. In fact, when we look across the overall health care ecosystem, only about 30% of medical treatments that are conducted in a U.S. hospital actually have evidence to suggest that they actually work. And that evidence, the gold standard for that evidence to create that evidence is a clinical trial. And when you move outside of the hospital, which is where most health happens, when you look at health optimization, when you look at health prevention, there's even less evidence. There's even less clinical trials because they're so expensive. So ProofPilot was originally

developed with this idea, and I say this fully noting that I am a venture-backed startup, so pardon the colloquialisms here. We started ProofPilot to democratize clinical trials so that we could get to answers about what works and what doesn't to improve health much faster. So circling back to how we became connected, again, that cold email. And it was initially with a dose of, I don't want to say cynicism, but a dose of, you know, will they put their money where their mouth is? Can they actually, will they actually say, you know, sure, we are confident enough in our product that we actually would like to run some trials on these efforts. And you were. We were indeed. And we'll probably certainly circle back to kind of some of the lessons learned, which I think are particularly

interesting to most people that are going to be listening to this. But Matthew, a couple data points that really stood out based on kind of how you just described sort of the origins for proof pilot what you guys are doing is the average cost of a randomized clinical trial, at least in FARA being around 10 million, that cost probably holds true across, you know, biotech and med tech too. Or, you know, the numbers are going to be big, nonetheless. So your point about, you know, very few companies having the capital to allocate towards some of those clinical trials, which kind of leads to that second point that you mentioned, only about, you know, 30% roughly of devices or drugs used in the hospital setting are supported by, you know, by clinical data, which

is alarming to say to say the least. So I mentioned all of that and kind of repeating your points because this is a big need, not just for industry to support, you know, claims around products, but it's a big need for anyone that's, like, interested in health, wellness, a more invasive procedure inside of hospitals to know that these questions around these products or therapies are are being answered based on science. Right. Look, I'm relatively young at the moment. I'm 45 years old and in good health. I want to stay that way.

And there are so many things out there right now that I can look at to optimize my health and prevent disease because thankfully at the moment I don't really have any. You look at all the stuff out there and all the claims that are being made. It's very difficult to figure out what's what and what's not. In fact, so difficult that a lot of us just end up making. decisions based on blind faith or habit or whomever speaks the loudest or has the biggest false. So a lot of the impetus behind the health and wellness trials that Prove Pilot does, and we are very much kind of dual focused in the worlds of kind of traditional clinical trials

in pharma and medical devices and biotech, as well as the non-traditional health and wellness space, we do that due to personal interest. We actually want to know what works. And there just isn't a lot of data out there because the return on investment for a dietary supplement or a health and wellness device, it's just not there. It's not even there for a lot of the pharma and medical device world. And so there are a lot of treatments that might work for a very small group of individuals for a very unique disease state that don't get the attention that they deserve from an evidence perspective because there's simply not the return on investment to spend $12 million on a trial. Yeah, there's no doubt. And there has to be a lot of people that are listening

to this that are in positions to influence whether or not clinical trials get done. But because of that ROI concern, right, if it's not mandated by a regulatory body and the ROI isn't there, the study likely just won't just won't get done. And that's that's kind of sad because there's likely to be so many insights and learnings gleaned, you know, from a product or therapy in the marketplace. And, you know, because you have to look at, you know, ROI type of, you know, ROI numbers. It's a critical consideration. And another thing to note here is not every clinical trial needs to go to an FDA. Let me put it a different way. Not every clinical trial needs to be done because the FDA requires it. There are a lot of questions out there in the

world that do not require an FDA review or an FDA approval. And in many cases, you'd have to be a masochist to do a trial in the old model if the FDA wasn't requiring it. And that again just means that the FDA requires it. We don't get an answer to what works and what doesn't. And I think that that's a real blank space in our overall society. We're making a lot of decisions about really important concepts about what we're doing to prevent illness, what we're doing to treat illness. at home in society, we're not using real data to make those decisions because the data isn't there. And that's where we really got this concept of proof pilot going. Yeah, I could agree with you more. And I want to hear in a minute, kind of go back in time and learn a little bit more about

the origin stories of proof pilot and how your company has evolved over the years. But one quick point on this topic, just to kind of wrap a bow on this kind of this first part of the conversation is that what stood out, I'm going to speak from Jude's perspective, what stood out in kind of initially looking at proof pilot and what you were trying to do was a couple things. And one of them, I already mentioned that from my perspective, being involved in MedTech, most of my professional career, I know that clinical trials are expensive. They're very expensive to do in a traditional fashion. Even a small scale to clinical trial is going to be likely hundreds of thousands of dollars when it's all said and done. And so, you know, balancing that against a, you know,

a desire to collect more data kind of creates a little bit of a conflict, right? There's a, those two things typically don't, don't align or something has to give, right? Either you have to allocate more funds towards clinical trials or just not do them. And so the fact that Prove Pilot was, in essence, allowing through a really, you know, innovative, kind of compelling software platform to to fund clinical trials in a remote fashion, it seemed like, wow, this could be, this could be a way to actually, you know, do some early, you know, early clinical studies on our on our products in a very, very efficient way. And on top of that, which I think maybe you'll get to as you kind of, you know, as we chat about kind of the,

how proof pilot has evolved. But instead of just looking at clinical trials as a cost center, that you need to allocate capital. It's a hard cost to get data in return. We kind of theorize that, you know, maybe this actually could be a revenue driver, right? If people, and Juva's a little bit different just because we serve a direct-to-consumer kind of wellness audience. But I think it's an important consideration for anyone that's listening that does have a little bit of a similar type of commercialization approach and that you actually, by getting customers involved early in some of this clinical data, there's a high likelihood that they may actually, they may actually become customers, which is really unique, to my knowledge, that hasn't really been explored in great detail previously. So

anyway, it's kind of a cool concept where now, you know, clinical trials could be actually, could be a revenue driver or at least a break-even kind of channel for a lot of a lot of companies. And we can kind of get into that in a little bit more detail later on in the discussion, but I wanted to kind of call it out in case those who are listening are trying to wonder like how what's the big takeaway, you know, for biotech, med tech, you know, pharma companies. So unless there's anything else that you want to add right now, maybe now is a good time to kind of go back, rewind the clock a little bit and go back and learn a little bit about how you got proof pilot off the ground and, you know, kind of how it's evolved over.

time. Yeah, sure. So first I should say, and this will come to a surprise to a lot of people, I'm actually not a trained researcher. I don't have a PhD. I didn't go to university or to college to be a researcher. I have a business background, and that business specifically is in service logistics and marketing. But what's really unique about the kind of approach that we take is clinical trials are actually really complex logistical challenges that have a science question built into them. So as opposed to me being more focused like a lot of researchers are on my actual research question, like maybe I'm an ophthalmologist, or maybe I'm a cardiologist, or maybe I'm an immunologist, someone that their primary focus is on what the research question is. My primary focus is on the

research methods, essentially the logistics. So I started my career in a big public policy research and consulting firm, and this was about 10 years ago. At that point, many Western governments identified HIV as a solvable issue. We know what causes HIV. We know how to prevent HIV. And so if we experiment with a lot of different things, maybe we can change people's behaviors and actually make HIV go away. Now, that sounds super naive today, but 10 years ago, there were a lot of policymakers in the Western Hemisphere in Europe that really thought that. I was one of the younger people in that particular organization, and they were noting that I was doing a lot of things online. And by online at that point 10 years ago, it meant that I was doing some

blogs. And they came to me and said, you know, we're having a hard time engaging our population in the ways that we used to do so. And we're having a hard time using traditional clinical trial recruitment techniques to get young gay men and intervenious drug users into trials. This is a situation where most of the individuals that they were looking for considered themselves healthy. They saw zero incentive to go into a sunny clinic to be involved in a HIV trial. And in fact, many of them were afraid to go into that clinic because they might be outed by someone on the street. So noting that a lot of the traditional locations that were recruiting tools were closing because this population was moving online in large numbers, gay men tend to be technology early adopters,

they said, you know, can you recruit a couple of people for us online? And we shrugged our shoulders and said, sure, I didn't really know that there was a whole world at that point of clinical trial recruitment, but certainly the world that existed 10 years ago was not looking at online recruitment mechanisms like they are today. We became fairly successful with that. And the next step was, you know, a number of academic institutions got involved. We became a separate company. And they started to say, you know, we're having a really good, great time recruiting individuals online.

Can we actually collect a little data online as well? And we shrugged our shoulders and said, sure. A little bit later, they said, you know, we're collecting a little bit of data online. Can we actually do some interventions online as well? And again, we looked our shoulders and said, sure. Fast forward to 2012, 2013, we were doing large-scale phase two, three, and four trials completely and totally online. Primarily, again, for a gay male audience looking at various interventions and techniques to reduce and treat HIV. I don't think I'm being overdramatic when I say this, but every single one of these efforts was a complete unmitigated management disaster.

And remember here, I actually came from a management. marketing and business background. So what I was seeing these researchers go through might have been common to them. It was a complete new challenge for me. I was just, I considered a lot of what I saw completely unacceptable. I don't think that any one of the studies that we were doing could have been even more of a problem. We at that point were creating every technology solution from scratch. We were pulling together different open-source solutions, and we were just layering that software development process on top of the already fraught research planning process. It took a year or more for the researchers to actually design the protocol, and then they'd give us a big Microsoft Word document

and say, go for it. We'd take six months and develop the infrastructure. In inevitably, two weeks before the study was about ready to launch, the researcher would say, hey, wait, wait, I've got a new idea and they'd change that idea and their protocol document and expect that it would take that same 15 seconds to change the research infrastructure that we created. Anyone who has ever developed software before knows that making a change in a piece of software, particularly an important one, often has a whole variety of cascading effects. And so we were often pushing out software that was very fragile because we were making changes at the last minute. In addition, all of these research studies, because they were designed by researchers, oftentimes in conferences and in Microsoft Word,

these studies were completely oriented around the researcher. Participants were often treated as an afterthought, and they felt like cows that were jabbed with treatments and milked for data. And then there were all of these inconsistently applied regulations and folklore around these regulations. It made disconnected systems. It made success really difficult in any one of these efforts. And for those of those, of us who are part of the LGBT community, finding solutions for HIV and sexually transmitted diseases, it's a really important issue. And so it was really frustrating. For every one of these efforts, before we got one of these contracts, we would always look for a solution. And there simply

wasn't one, which we found completely bizarre, because there are so many of these studies that are launched every year. And at about the same time, a lot of non-HIV studies researchers started to come to us and say, you know, my population is moving online. I want to run a study like the ones that I see you doing in HIV. And we go great. And we'd say it's going to be a couple hundred thousand dollars for us to create the research infrastructure. And they'd go, oh, I've got $10,000 or I've got $20,000. So the very first version of Prove Pilot was literally developed for two reasons. The first was, I couldn't continue with the chaos that I saw in the research world any longer without a solution that would allow us to be more flexible and

adaptable to the research questions that were out there in the world. And secondly, as much as I think HIV is an important issue, there are lots of other issues out there in the world related to health that I'm also interested in. And I wanted a way to bring the efficiencies that I saw in business and technology to the world of research. You know, technology has democratized transportation and journalism and created efficiencies for retail and a whole variety of other sectors. I wanted to bring those same concepts to the world of research. And that was where Proof Pilot was born. Got it.

I love the fact that in kind of hearing you explain sort of like some of those origin stories and kind of the early beginnings of Proof Pilot, you know, basically shipping and getting your product at the time at least in the hands of researchers really allowed you to see two things. One is like kind of the maddening logistical nightmares. you kind of explain to them that they go through and running these clinical trials. And then also basically letting your customer base tell you what they need. Maybe they weren't overly specific in saying, Matthew, we need this.

But based on kind of what they were expressing, you were able to see like this would be needed via technology to meet, you know, to satisfy this demand. So I love that idea of basically showcase, it showcases this concept of right, of the lean startup, right, and Eric Reese's model of getting, you know, shipping early, getting, you know, shipping early, getting, a minimum viable product, even if you don't believe entirely in that idea. But the concept of getting your product in the hands of customers as early as possible to learn, right? And then iterate, make improvements, maybe pivot a bit, et cetera. Right. Let's be really clear, though, that the kind of ship early often make mistakes and break things, that's not really something that you can do in a clinical trial. Regardless, even when we're bringing the price down quite a bit, there often was a lot

writing on the results of these trials. Whether it was a situation in which an organization was trying to figure out whether or not a product could get an FDA approval or whether it was a government agency trying to make policy, putting out a piece of technology out there and having it not work is really problematic. So a lot of what we were doing was creating a solution so we could quickly adapt to trials and as opposed to creating something new every single time and a lot of applying fixes in a software development type orientation, we created a platform that would allow us to author in the same way that you might author a blog post or you might do this podcast and allow changes and adjustments very quickly without having to rely on a developer. And that approach

means that we have a validated system without having to go that kind of, let's put something out there and fingers crossed, hope it works, because that's really problematic in the healthcare sector. No doubt. And I'm glad you brought that up because I don't want to underappreciate that shipping software is a lot different than shipping something in kind of a regulated, you know, healthcare environment. But from my perspective, at least, and, you know, I'm sure there's people that would disagree. But the concept of getting some version of your product in health care, it's got to be something that actually is sellable and et cetera. So maybe the better description would be a minimum, minimum sellable product.

But nonetheless, I think people, this idea of getting your product in the hands of customers as early as possible in order to glean feedback is critical, I think, to any startup. But it sounds like that was especially true with proof pilot. Right. And today, let me tell you a little bit about how we learn and test in a way that allows us to really think about things in a lower risk environment and then bring them to the higher risk environment. And it's a relatively controversial approach that we've taken. And we get a lot of gruff from it from folks who believe that clinical trials, like serious

clinical trials, they're really only done by pharma and a select group of medical devices. Prove Pilot, as I mentioned at the top of this program, we really have two focuses. And the first is that traditional research world. But this traditional research world, they're really risk averse. there's a lot of money in whatever research, whatever interventional elements that someone is putting out there into the world. And so those organizations, by design, because they have to try to de-risk everything else. And that's probably one of the reasons why this concept of a remote and hybrid trial has taken a long time to gain traction within that space. It's because there's so much

risk and whatever that focus item is, that it's really hard to think about experimenting with something different in the actual execution of that trial. So we don't introduce a lot of innovation from a clinical trial perspective in that particular group that we haven't tested and used and refined many, many times in the health and wellness sector. And that health and wellness sector, particularly now, is very open to looking at clinical trials and doing things in new and innovative ways, because a lot of them are existing in extremely competitive environments. You know, how many supplement manufacturers are there right now that all create the same vitamin D supplement. They're all looking for ways to kind of switch it up and change and find a competitive advantage,

create a little additional credibility. So a lot of the innovation from a logistical perspective that ProofPilot does, we actually do with the health and wellness sector first. And in that, we learn what's working and what's not from a logistical perspective and can bring it back to the pharmaceutical and medical device worlds and say, look, you know, we've tried this many times. and because our focus is logistics, the logistical component of a clinical trial. We can bring this to you with these lessons. And the scientific questions between health and wellness and the pharmaceutical industry may be different.

The business reasons for doing that clinical trial between the pharmaceutical sector and the health and wellness sector may be different. But the logistical components that make that clinical trial run, they're very similar. So we're able to bring those lessons to those risk-averse areas. So when we talk about this world of kind of put things out there early, make mistakes and break things, we don't do that in any sector now, but in the sectors where we are pushing the envelope a little bit, we're doing it in the health and wellness sector first, where if something doesn't go quite right, the product is probably still out there, and the primary

goal is not an FDA submission. we're able to bring that material back to the pharmaceutical sector with much less risk than we would have otherwise. So everybody wins. The health and wellness sector gets the credibility and the innovative field that gives them the competitive advantage. And the pharmaceutical and medical device sector and academics as well get those solutions that have been tested a couple of times in a very similar experience. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available.

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