The Future of MedTech Trials w/ Jason Monteleone, CEO, Avania

When people talk about clinical trials, they usually think of drugs, but what about the tools that deliver, diagnose, and detect? Medical device Innovation often flies under the radar despite being essential to modern care.
 
In this episode of the HealthBiz Podcast, Jason Monteleone, CEO of Avania, discusses how his firm helps medtech, diagnostics, and digital health companies navigate clinical trials and regulatory hurdles.


🎙️⚕️JASON MONTELEONE
Having spent over 25 years in the CRO, medical device, and life sciences sectors, Jason Monteleone brings impressive experience in driving innovation, collaboration, and excellence to his role as the president and CEO of Avania. He has served as CEO and CFO at major organizations like Clinipace and Theorem Clinical Research, and he founded clinical research consultancy Pivotal Financial Consulting. Monteleone is also a board member and audit chair for the Drug Information Association (DIA). He earned a Bachelor of Science degree in business administration from Millersville University and a Master of Business Administration degree from Temple University.

🎙️⚕️ABOUT HEALTH BIZ PODCAST
HealthBiz is a CareTalk podcast that delivers in-depth interviews on healthcare business, technology, and policy with entrepreneurs and CEOs. Host David E. Williams — president of the healthcare strategy consulting boutique Health Business Group — is also a board member, investor in private healthcare companies, and author of the Health Business Blog. Known for his strategic insights and sharp humor, David offers a refreshing break from the usual healthcare industry BS.

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Transcript

David: 0:00

When people talk about clinical trials, they usually think of drugs, but what about the tools that deliver, diagnose, and detect medical device Innovation often flies under the radar despite being essential to modern care. Hi everyone. I'm David Williams, president of Strategy consulting firm, health Business Group, and host of the Health Biz Podcast, where I interview top healthcare leaders about their lives and careers. My guest today is Jason Monteleon, CEO of Avania, a global contract research organization specializing in medical technology, diagnostics, and digital health. We're gonna talk about the business of MedTech trials, how regulatory and commercial dynamics are shifting, and what it means for innovation. Worldwide. Do you like this show? If so, I hope you will subscribe and leave a review. Jason, welcome.

Jason: 0:52

Thanks, David. Excited to be here. I appreciate the opportunity.

David: 0:56

Outstanding. Well, you've spent your career in CROs and life sciences services, and so I'm wondering what led you to Avania and how is this company different from other companies that we would think about as CROs?

Jason: 1:10

Yeah, it's a great question. So from a personal standpoint, I, I've actually known Avania for more than a decade now. So I was at a clinical research organization called Theorem Clinical Research from 2000, uh, 2010 to 2015. And we actually had a medical device division inside of Theorem, and I got to know the former founders. Of Avania back then called Factory, CRO back then. Um, move forward a little bit. Uh, after Theorem was acquired, I left and I started doing consulting on my own for a couple of years. And Avania, uh, was a client of mine. So I actually did an acquisition for Avania and again, stayed close to the investors at the time and the former founders. And most recently when the opportunity came up to to be CEO of the business, I jumped at it.'cause I always liked the medical device space and just having knowledge of the business. Uh, it was a real opportunity to build something different in the clinical research landscape.

David: 2:06

You know, a lot of about the clinical development, whether for drugs or devices about reducing risk over time and seeing ahead. And so I can already see you have the mindset for it since you already. Worked with the company, worked for the company, and knew the space, uh, before jumping on board. So, uh, so, so nicely done. I guess there could still be surprises, but, uh, sounds like the right path. There

Jason: 2:26

are always surprises. So, uh, so yeah, and, and I think the other aspect too is it, you know, if you want to be in a space where we talk about AI and technology changes and we talk about software, uh, as a device as well, this is it. I mean, it's really evolved and changed so much in just the last 10 years. It's amazing.

David: 2:45

Well, let's talk a little bit about, uh, trials and maybe contrasting a trial for, uh, a pharma, uh, product compared with, uh, a device.

Jason: 2:56

Yeah, so, um, pharmaceutical studies, so obviously safety and efficacy is, is what we're really looking for there. Uh, they tend to be, you know, small studies going up to really large projects. So you get the phase three studies. You can talk about projects that can be a couple hundred million of dollars. Um, when you add in the pass through expenses, et cetera. They tend to be a lot faster. They burn a lot faster. Um, and a lot more global in nature. Medical device study is a little bit different. They tend, don't tend to be as large, not as many patients need to be recruited. Um, cost isn't typically as high. Still looking for safety, uh, still looking for functionality of the device. Not really using placebos, uh, in medical device studies, you're, you're pretty much comparing to the existing therapeutic that's out there or the existing device that's out there from a comparison or is an operating better? Um, when I think about device studies though, they come in all shapes and sizes. I. So there's a big difference between inserting a, a valve, a heart valve into a patient, uh, versus a bandaid, right? You go from class one all the way up to class three, and so the trials tend to take different, uh, shapes and forms, and you might need to send somebody out to work, the physicians to have a better understanding of how to uses device. The monitoring tends to be a lot longer. You're not gonna stop monitoring a patient after a heart valve goes in after three years and say, Hey, the project's over. So, um, while we're looking for efficacy, safety, and as it's working, different ways of going about it, different size trials, and, uh, it's really a different mentality. I.

David: 4:28

Yeah, I was thinking what you said about placebos and of course on most drug trials, but not everything. So things like oncology would be an exception. You have phase one when it goes into a person, you start with healthy volunteers, and I'm thinking a healthy volunteer might be okay to have a bandaid on a cut that they don't have, but they might be a little hesitant to swap out one of their working, uh, heart valves or one that's, uh, that's more experimental.

Jason: 4:48

That's right.

David: 4:49

Does it also mean, what's the balance also between kind of pre and post-approval? You mentioned the monitoring times being longer. Do you see also a difference between how much of the, of the CRO work is done after products on the market versus before?

Jason: 5:03

Um, you're definitely always monitoring after the fact, uh, to, to just to make sure that there's no issues with the device longer term. I think with the device side, I've seen a little bit more of post-market monitoring than we have on the pharmaceutical side of things, but I, I still think that the aftermarket monitoring is still important with, with, with both drug and device. Um, once you start getting the, the drug or the device in the patients, you really wanna start collecting a lot of that data to make sure that everything's safe and, and the drug or device is acting as expected.

David: 5:33

Got it. Okay. So I, I more or less, um, understand the distinction between a. A drug, which is something I'm, you know, taking or injecting or whatever, and a device, and you mentioned a bandaid or a heart valve. But what about this software as a medical device? I mean, a device I think is something physical, but there's that and then there's like digital therapeutic. So what, what is a device?

Jason: 5:52

Uh, it's a great question. So I did some research on this when I joined Avania because we throw around the term MedTech and we throw around the term medical device a lot. And I was trying to figure out really what is the difference within the industry. If you ask the average person what a medical device is, they can explain it. If you ask them what med tech is. It's a little bit different. It's, it's new terminology. Um, it, you know, with all the research that I came up with, med tech is sort of the top of the umbrella, and then you've got three verticals beneath it, which is medical device, um, diagnostics and digital therapeutics, um, underneath there. And so you've kind of got these three different buckets. Um, if I take, if I take a step back and think more broadly about digital therapeutics and, and software as a device. I just, I really think about the last decade and I think about what amazing it was to have a Fitbit, right? Where you strapped this thing on your wrist and it would count how many steps that you did, and everyone was amazed at how many steps that they had taken. And if you did 10,000 steps, it was really great for your health. You fast forward to where we are today. We've got Apple watches, we've got all these different devices that we can wear. We've also got this new brand of, of MedTech, uh, called digital therapeutics, right? Or software as a device in, in different devices. And it's really amazing of how much it's pushing the forefront of preventative healthcare. You know, we ne we never had this before. I mean, I just think about, think about the, the area of mental health. Back when I first got a job, my first job, I actually worked for a mental health company. I. And most companies had an EAP plan where you might be able to pick up the phone, get two calls with a, with a clinician if you're having a challenge, and then you'd kind of move on from there. If I go to my insurance provider today, I can go on and I can do telehealth at mental health. Um, they have all different types of tools. It's really brought it to the forefront. You can go to your, your phone right now and you can get a therapist on call, or they'll track how you're feeling today. You fill out a questionnaire, so software as a device, digital therapeutics. It's, it's really, it's really amazing what it's doing as far as preventative healthcare today.

David: 7:55

You know, you talk about the history and looking back 10 years or maybe even a little bit more, and it's hard to remember this, but it was true that when they used to start to have these wearables and little devices that for people to carry around, the biggest issue is people didn't want 'em. They wouldn't hold 'em. And and now, and now it's the opposite. I. 'cause you've got your, everyone has their watch, everybody has their phone with 'em all the time. So that problem, which was a big problem before, has been, you know, resolved. And it, now it's almost like, how do you get the thing away, uh, from somebody. But it's really, it's really opened, it's really opened things up. So let's talk about how that then relates to kinda reg regulatory framework. And I was thinking about, you know, FDA's evolution, what's. Mind about whether this, like, you know, going from evolution to something else, a discontinuity, but if we look, there's been topics like real world evidence, digital endpoints, which is partly of what you're getting at and decentralized trials. How has that kind of evolution within FDA. Impacted the, the med tech studies that you do?

Jason: 8:53

I think the FDA has gotten a lot more progressive over the last five or 10 years when it comes to using real world evidence. Um, I think COVID really pushed us through with decentralized trials, right? It was really important to go that route because we didn't have the ability to get into sites. Uh, the FDA has a, has a document out there where they have 90 examples of how they've used real world evidence to augment the regulatory information and the clinical data in order to go forward and, uh, make decisions on projects, on products. So I, I think they're beginning to embrace it a lot more. I. Now it's important, right? That beginning regulatory strategy is really important. Uh, to collect the right clinical data or the right digital endpoints as you're pulling that data together is extremely important. But I think the FDA has shown an ability and a willingness to take that information, to make regulatory decisions, to get products out there on the market.

David: 9:45

There used to be a lot less, uh, data gathering because people would just come in, you know, for the occasional visit. Maybe the device would record something, but there's a lot more data now and it's sensitive and important patient data because it helps to determine whether, uh, a device is working. But that also means the flip side is there's a lot of personal sensitive data. It's around. Then of course the devices themselves are either their software themselves or they have software in them, and there's a lot of record, uh, reporting requirements. So you could imagine from a kind of data privacy standpoint, uh, this is a big deal. Patients are concerned about their data and clinical trials, and then there's just sort of the broader, you know, cybersecurity. Risk, I could imagine that, uh, these sort of trials would be, um, you know, juicy targets for someone looking to, to cause trouble. So is that in fact, uh, the case and is how, how do you think about, you know, privacy, data privacy and cybersecurity these days?

Jason: 10:36

Yeah, I think Avania and all zeros are, are thinking about this on a daily basis. So, uh, we're always gonna have individuals who are trying to crack in and, and take patient data. Or a personal data in order to, to use it for nefarious reasons. So we talk about it constantly. Um, we just hired a new CIO so, uh, on his docket, uh, I think within the top five things I had for him when I was going through the recruiting process, cyber cybersecurity was in the top five. And it's really important for global clinical research organizations that have access to patients, access to patient data, et cetera, to have the right structure in place to make sure that that data stays safe.

David: 11:13

When we look at trying to encourage innovation, which is always an, you know, a big thing. Patients want to get better. They want new treatments, new devices, presumably, and I kind of know the story in pharma, it's expensive to bring a product to market. There's a lot of hurdles to, to go through. Is it the same sort of a thing, only smaller in device or there's some unique elements about, uh, med tech for somebody who, let's say, has a new med tech invention and wants to get it to market.

Jason: 11:40

Yeah, I think they're both expensive. I think it's relative to the investment and the amount of investment dollars that one would typically get based upon the return. So, uh, the, the expense level is still there. Um, on the device side, I. It's the understanding, the regulatory and the reimbursement pathways are really important. Uh, you can create a great device, but if you don't have the right regulatory strategy and you can't find a way to get reimbursed for it, that device isn't going to go anywhere and investors are gonna end up losing a lot of money around that. So having that nailed at the front end is really important. And that's something that, that we at Avania do. We, we have a pretty strong regulatory and market access and market reimbursement side of the shop, and we work with a lot of our clients on the front end before they are ready to bring it through on the clinical side, and then we can pick it up from there. So that aspect, I think is, is, is critically important for medical device companies.

David: 12:33

And when you talk about the front end, does it go back? How, how early stage of a company might you work with? So I can imagine, you know, in order to get funding for these device companies, you need to demonstrate some sort of a, some sort of a plan at the same time. Those are probably not, uh, terrific clients, but. Or do you get involved in providing evidence that helps with, um, fundraising and, and if so, at how early of a stage?

Jason: 12:57

Uh, all the time. So the medical device industry is not unlike the pharmaceutical industry where there are a lot of really big players, the Medtronics and the Boston Scientifics of the world. The majority of the companies are emerging medical device companies, emerging med tech companies, and they are raising funds throughout the entire process. So quite often we have, we have opportunities in our pipeline that we talk about. Client X, uh, is in the process of getting a next round of funding. They need to do this analysis before they can get that. Can we help out with that? So, um, it's ongoing. We help at all stages. We work with companies of all shapes and sizes. So we really, our job is to find out what do you need? Maybe advise what you need and deliver for them.

David: 13:40

Got it. So, you know, devices are, are kind of cool 'cause it's like, you know, drugs have, it hits this target or hits that target. They've got different mechanisms, they've got different kind of delivery approaches. But there's more of a variety, I think, in the med tech world and, and not just based on the three different categories you laid out, but even like within devices, there's all sorts of things that are, uh, that are, that are, that are pretty cool. So you get to see a lot of things, I'm sure, um, in your role. Are there particular innovations that you're most excited about? Whether that's some, you know, some new, uh, technologies that are coming out or, or even processes for, uh, running clinical trials.

Jason: 14:15

Uh, I mean, you, you've probably heard me say this already, so I, I love the idea of preventative medicine. So a lot of the devices coming down the pike that are, I call kind of smart devices, where they can give you a status update, um, with your data. You can then change behaviors around any of that data, or it can tell you you need to have a particular therapy or medicine or whatever. Um, I, I love the concept of that. So, I mean, I use my Apple Watch. I, I've got some apps. I, I, I step on a scale every morning and it reads out like 25 different things and I'll just kind of track it, monitor it. Some of it's just be interesting and some of it is okay. What has changed over the last couple of days when you think about smart pacemakers or smart implants that will come into the future and where you can get real time information on how your body is functioning. Uh, it's really invaluable.'cause again, it can drive behaviors where you might be able to make some changes before you actually have to take that drug. There are some changes that we can do from our healthcare standpoint that we won't need to actually take a drug at that point in time.

David: 15:20

So artificial intelligence is becoming pervasive and I'm sure it has, uh, implications within the devices, um, and other kinds of, of medical technology. I. How do you look at AI from the Avania uh, standpoint in terms of what you do and what are you seeing clients do with ai?

Jason: 15:38

Yeah, from a, from a business and operational standpoint, we're in the process of developing our AI strategy. We think it can be helpful. From administrative standpoint, um, we're talking about can it help with pricing and writing proposals? Uh, can it help with doing some basic accounting functions? Um, we'll be looking to put a new CRM in place so it will help from a sales standpoint. All the new CRMs have some type of artificial intelligence included in it from an operational standpoint for running studies. Uh, can it, can it. Help recruit patients at a much faster pace by going through patient records. We know there are a lot of companies out there that are applying this to that. Uh, can it help with filing documents with the FDA, where it looks for errors, um, do medical writing a little bit faster? Uh, there are some tools out there. These are all things that we'll be taking a look at. I think today for us though, uh, we do think that there is a human element that really needs to still be involved to take a look at this, but it might speed up the administrative process in a lot of these areas.

David: 16:38

And one of the areas that I'd been interested in, uh, for the application of AI in clinical trial recruitment is partly what you're describing to go look through the medical record and find all these patterns. But I think one of the issues is also just that then connection with the patient and, and really kind of, I. Culturally competent, personalized, however you wanna, uh, describe it. And I think that AI can do a decent first shot at that.'cause I know if you look at some of these like drugstore chains like CVS and Walgreens, they thought, Hey, we can do, you know, clinical trial recruitment 'cause we know a lot about the patients, they trust us, et cetera. But I think the breakdown was really in the, not in the identification of who might be eligible, but really how to communicate with them. So I think that has some, uh, potential there.

Jason: 17:18

Yeah, I'm fine using Siri to play the next song in my playlist. I'm not quite ready to have Siri diagnose me and make recommendations, you know, for my health. But, but you bring up a great point. Still, most patients who go into clinical trials go in under the recommendation of their physician and that that relationship is still incredibly important.

David: 17:35

So we've, you've talked about this to a certain extent, but I'm wondering what your vision is for Avania, you know, over the next, pick your timeframe, three or five years. Will we see a different customer base, different, uh, geographical, uh, side, you know, what's, what's gonna be different in your vision?

Jason: 17:53

Yeah. We, we are trying to fill a niche at a need that doesn't exist today. So if we take a look at the MedTech medical device, clinical research organization industry, uh, it's very different than the pharmaceutical zero industry. On the pharmaceutical zero industry, there are eight to nine.$2 billion plus revenue. Clinical research organizations. There's probably another 30 to 40 that are a hundred million dollars revenue, global organizations and probably a thousand others that are kind of smaller than that in that next year. Uh, so you've got your choice as a customer. Do I really want to push volume and go work with a really large CRO or do I wanna really personalize service, but on a global footprint where they have the size and scale to run my study and work with a mid-size player on the med device side? We've got a few of the giants. I-Q-V-I-A has a med tech division icon, has a med tech division for Reya, has a smaller one and the bigger guys do, but they're predominantly pharmaceutical CROs, right? 90% of their revenue is pharmaceutical revenue. It's not med device, med tech revenue. I. And if you, if you're a small med tech player, even a mid-size player, do you wanna work with a, a company that's that large? It's not to say they're not good CROs at all, but that that value proposition's very different in the mid-size space for med tech. You've got four players with Avania being one of them, we are the only one that's really pure play clinical. So our focus is very simple. We are to become the leading, uh, MedTech clinical development and advisory practice partner for these companies out there. Our sole focus is to build that for our client base. We're not looking to do preclinical, we're not looking to become the biggest CRO in the world. We're just looking to be the best MedTech partner. Do it at a mid-size level, do with a little bit of scale, and, and that's the business plan. That's what our goal is singularly focused.

David: 19:41

That sounds good. It's actually simpler than, uh, it's good. You can articulate it in a simple way. Unlike some of this other medical device stuff, which I find complicated, once I start looking down at it, try and understand it better. So that's, I think that's a terrific vision. You know, you mentioned you work with companies at all sorts of stages and a lot of them, uh, need some kind of clinical data in order to be able to raise that next round of funding or maybe even their first round. So I wonder, uh, if you look at it another way and say what kind of advice. Would you give a first time founder that wants to build a new medical device or diagnostic product today? They may not ask you that now, but I'm asking 'cause I think based on your experience, you might have something to say about it.

Jason: 20:20

Yeah, I mean, I think to go in addition to, you know, really have that regulatory and reimbursement strategy in place ahead of time. Having a solid business plan, right? Like any, any other type of business, how's the funding gonna come in, going to the right investors? Um, and then picking a partner that you can rely on through that whole process. Uh, if you've get, if you get a partner in who've who have got that experience under the roof. Um, it goes a long way. You won't go down the wrong pathway or waste a lot of time making mistakes. That's why we work with clients of all sizes. Ivana can help with all of those strategies. We can kind of work with our clients as a partner. Hold, hold their hand, if you will. Um. Probably not the best phrase of going about it, but be there all along the way so you're not taking any missteps. Just like you know, we would in our personalized, whether it's a financial planner or a tax planner, or a physician, or et cetera. Having the right strategy, having the right partner enables the most success down the road.

David: 21:19

Great. I'm gonna end with a question that I ask all of my guests, and that's about if you have any book that you would recommend, uh, to our audience doesn't have to be, uh, business oriented. And of course, if you have something that you would recommend people avoid, uh, feel free to add that as well.

Jason: 21:33

Oh, from a book standpoint, um, I. Great question. I, I'm gonna go with two because they kind of center a little bit around the same topic. I, I really like the process of how we make decisions, um, how humans make decisions. And I always think when you, when you meet someone or you see someone how they present, how they, how they talk or discuss, you can think about how their mind works and how they think about things. So there, there's two books that I, I found really impactful. The first one is called The Paradox of Choice by Barry Schwartz. It was written by a professor here in Swarthmore University, not far from where I live. It, it's a great book talking about how we have so many choices in today's world and how, how do we as humans try to make decisions around all that and the different steps that we take, the different ways that people make decisions. And then kind of a, a bookend to that will be Malcolm Gladwell's Blink. Which, uh, I've really enjoyed with you talks about how your first impression of somebody is probably your best impression. And again, that book talks a little bit about decision making as well, so I found them both fascinating.

David: 22:33

Great. Well, I won't press you on something that you recommend to avoid, but occasionally I have somebody, uh, offer one. Good. Well, that's it for another episode of the Health Biz Podcast. I've been speaking today with Jason Monteleone. He is CEO of Avania, which is a global contract research organization specializing in medical technology, diagnostics, and digital health. Thank you, Jason. Thanks, David.

Jason: 22:54

Thanks

David: 22:55

again.

Jason: 22:56

Take care.