Medsider: Learn from Medtech and Healthtech Founders and CEOs - How Medtech Companies Should Approach the Consumer Health Market: Interview with Movano CEO John Mastrototaro

Episode Date: May 25, 2022

In this episode of Medsider Radio, we sat down with John Mastrototaro, CEO of Movano.John has more than 30 years’ worth of experience in the medical device industry and was part of the MiniMed team that helped develop the world’s first ambulatory continuous glucose monitoring system and sensor-augmented insulin pump. John is now CEO and Director of Movano, a health technology company that makes smart, personalized devices that can provide vital health information to users. In this conversation, we discuss how medtech companies can build a successful consumer-facing brand while developing products that meet the needs of payers and providers.  Before we jump into the discussion, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with John if you'd rather read it instead.

When we think about things as a medical device company, we think about those types of failure modes and we think about how are we going to address them. Can we tease out the signal from the noise? And if not, we won't report a value versus reporting something that may be grossly inaccurate because there's too much noise to discern the signal. So it's a different mindset and philosophy about how you collect and report data through all these activities that historically weren't done when you're evaluating a product like this. for medical grade. I think the lines are going to blur, as we've spoken about, periodically through this conversation between a formal medical device that looks like a clunky medical device and it's difficult to use and a consumer device that has a certain aesthetics and whatnot.

And I think those lines are blurring. 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. Hey everyone, it's Scott. In this episode of MedSider, I sat down with John Mastra Titoro,

the CEO of Mavano. John is a PhD in more than 30 years of experience in the medical device industry. He was part of the Minimed team that helped develop the world's first ambulatory continuous glucose monitoring system and sensor augmented insulin pump. After MinamMed was acquired by Medtronic,

John went on to hold a number of positions in their diabetes division, and now leads Mavano, a health technology company that makes smart, personalized devices that can provide vital, information to end users. Here are a few of the things that we discuss in this conversation. First, don't discount the real world. Clinical trials are essential, but when a device's data

also comes with applications beyond user intent, payers and investors will pay attention. Part of the appeal of Mavano's model is that the device provides valuable health metrics for users while also providing doctors and researchers with usable health data, creating a win-win for multiple parties. Two, aesthetics matter. The Mavano ring design was a direct result of listening to customers. Yes, a wearable device needs to function, but it also needs to appeal to the user. If customers don't want to wear it, they simply won't. At the end of the day, it's about form and function. Third, building an experientially diverse team leads to innovative solutions.

Think outside of the box when hiring. Look to experts in other areas beyond the medical device space who can offer broad knowledge and insight. Okay, so before we jump into the discussion, I wanted to let you know that we just released the first volume of MedSider mentors. A print-based book that summarizes the key learnings from my favorite medsider interviews over the past six months. Look, I fully realize it's tough to listen or read every medsider interview that comes out. Even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create medsider mentors.

It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Gar Hong Kong, founder of HealthQuest Capital, teaches you how to successfully pitch your startup. Patricia Ziliak, CEO of Ivinsons, discusses what you really need to know about clinical trials. Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to medsiderradio.com forward slash mentors. If you're a premium medsider member, you'll get free digital access and a print version sent straight to your door. If you're not a premium member yet, you should definitely consider signing up.

In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of LiveCore, and so many others. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. All right, John, welcome to Medsider. Appreciate you coming on. Thank you.

It's my pleasure to be here, Scott. All right. I'm really looking forward to this conversation because of the strong overlap with Mavano's technology and kind of this burgeoning consumer health trend that we both have experience in. So with that said, before we kind of dive into Mavano specifically, give us like a high level overview of your professional background before taking on the CEO role. Sure. Well, I was trained actually as a biomedical engineer. I have my PhD in that. I got that from Duke University. And then basically for the last over 30 years,

I've been working on the development of medical devices. Spent a little time at Eli Lilly in their medical device division at first when I came out looking at continuous glucose monitoring products and some other technologies. And then I got recruited to join a company called Minimed, where I worked. And I led the development of continuous glucose monitoring there. They had an insulin pump. And we actually worked through the process and were the first,

company to gain FDA clearance for a continuous glucose monitoring system back in 1999. And we followed that on with connecting it to the insulin pump and, you know, providing the data and inputs to people who have type 1 diabetes. And then later on did the initial steps toward development of an artificial pancreas. So it was a really great ride for me. Along the way, we got acquired by Medtronic and became Medtronic diabetes. And I did that for several years. and then a little bit later in my career, got really interested in digital health,

and that's going to be part of what we talk about today, because I felt there was a real need to leverage data from people remotely in their home and try to understand how well they're doing, especially when they're living with a chronic condition, like type 2 diabetes or hypertension or, you know, other situations like that. So I felt that data from the home would be very beneficial to understand how well people are doing and maybe identify when people are starting to kind of go off the rail, and be able to intervene more quickly before things deteriorate, you know, into something that

ends up in a hospitalization, for example. So I did that for a few years, really exciting work with the cardiac group, diabetes, and others. And then I actually retired. I did a little bit, but I came back and I worked at a startup doing some orthopedic-related sensors to help surgeons when they're doing joint replacement procedures. And then we got acquired by a larger company. and then I went to Mavano.

And I was really excited to join Mavano almost about one year ago today. And I was excited about Mavano for a number of reasons that we'll get into in this conversation, especially because of my background in diabetes space and cardiovascular space and kind of what we were, what Mavano's technology was all about. So we can probably start delving into that a little bit here. Yeah, yeah. That's a great, that's a great overview. Sounds like I should have put sort of connected the doctor.

but I didn't realize that you started, you came into Medtronic and spent that time in the diabetes unit, but you were with Minimed. I should have like put those two together. But, okay, that's great. So with that said, yeah, let's use that as a transition to talking a little bit more about like the Mavano product, right? Let's, you know, help us better understand what it is and talk to us a little bit more about kind of what's unique about the technology and really really how it came about, how it came to life. Sure. Well, the founder of the company, his name is Michael Liebman. And he's been someone who has been a serial innovator for many years, an expert and advanced RF technologies. And I was doing a study and showed that there was a correlation between changes and signals

in this millimeter wave RF platform and glucose levels as they change. And so that was the basis of starting up the company. You know, it's an interesting technology. It's something that we've got a lot of patent protection. around something unique to us. And one of the things we'll talk about in terms of differentiation versus other wearable products on the market today is that we do have this unique technology

and we are using it to help us with determining how accurately we can measure both glucose and blood pressure, which are two big issues in the United States and globally, quite frankly, about a third of us are going to have type two diabetes probably and probably half, at least today, the way things are going to end up with hypertension or high blood pressure.

And so, you know, one of the things I think we want to do as a company is to maybe start to turn that whole boat ship around and get people to, people who are interested to allow them to live healthier and maybe avoid ever getting type 2 diabetes or high blood pressure. And so the way I think we're different and the way we're going to go about doing this that's different than a lot of the wearable companies out there is first and foremost, we've set up the company as a medical device company right out the gate. So we have a quality management system. We use a process called design control to make the medical device. And we're doing everything that you would do as if you're a medical device company because that's what we want to be. And I think that's really important. And it even goes to the end game where we've identified our manufacturing partner and

we'll be manufacturing this product in a medical device manufacturing facility. So all the way through in our thought process, how we think about the data, how we think about clinical trials, how we think about the accuracy of the metrics. that we provide, we're doing it through that lens of being a med device company. And as we looked at the landscape of wearable products out in the market today, one of the things we noticed is that women appeared to be an afterthought. A lot of the devices looked like they were made for men. You know, the app experience is a certain way. And so we had an announcement at the end of this of last year that we were going to develop our first product and it was going to be

specifically for women, not to say that ultimately we won't have a product for men too, but for now, our focus is on women. We were going to do it in a ring form factor that was going to be very appealing aesthetically and look more like jewelry, so it's something that they would enjoy wearing. We're going to make it medical grade, so we are going to be seeking FDA clearance for a lot of the measures that we're making, the ones that the FDA's interested in. I'll mention those in a moment. We want to provide insights to people.

I think this is really important. You know, we wear all the products that are out there today and we also read online about what customers are saying. And a lot of people say, you know, you're giving me all this stuff and I don't know what it means. I don't know, is this good or bad? Some people feel more stressed when they get numbers that, you know, maybe don't make as much sense. And so we want to distill it all down into insights for people. And we also want to show people the cause and effect. We want to help them understand how their activities of daily living affect their health metrics and maybe show how those are improving over time.

time and what's their risk of getting diabetes and hypertension and other things? And so I think that's a differentiator. And then the last thing I'll mention is we want to make it affordable. In fact, we're even looking at a model where it's pure subscription and we'll give you the hardware and technology for free. We think that's important too because as we add enhancements to it over time, we don't want people to be waiting for the next thing to come out. We want them to take advantage of what we have today and know that they can continue to leverage and get access to the future enhancements that we make through the subscription model that we create for customers. Because when we think about health care in the U.S. today, and if we think about really helping

people from a health-related perspective, there's a lot of the population is underserved today, don't have good access to health care. And a lot of big companies are trying to figure out how we can bring health care to these people in a very affordable way. And we think we may have a solution that will help in that regard that we're really excited about. And so I think those are the things that we're doing differently. And what we'll provide to people out the gate are heart rate, heart rate variability, oxygen levels, respiration, temperature. We will monitor activity levels, calories burned, we'll monitor sleep, sleep stages. And we will also be diagnosing a couple conditions that we're

looking at, some specific for women. Again, this is a female related product. There'll be some female related features. And I think the whole app experience is going to be very different and tailored to the audience that we intend to provide the product to. So that's kind of where we are today. And our goal is to get a beta launch of this out later this year and then ramp up from there. So we're very excited about the stage that we're at right now in the organization. That's great. There's a lot to tackle there. But I do have a couple follow-up questions. And so just for everyone that's listening, that may, that may, they may listen to this after the fact. We're recording this in kind of early Q2 of 2022.

So it looks like the Mavada beta launch is kind of tentatively scheduled for later, later in 2022, in case you're listening to this, you know, months after we're recording this, this conversation. But you mentioned a couple of things that really stood out to me, John. One is that your your whole framework or mindset, you know, as you're building out this company is very, it's medical, it's centered around like doing things in a med tech kind of fashion, right? You mentioned design controls, you know, manufacturing your devices in a probably a facility that has, you know, 1345 certs and, you know, potentially MBS sap and, you know, on and on and on. That's very different from, I think, from the kind of the other players in the space.

And I don't want to discount what they're doing, right, because there's, there's great brands, like, ORA, Woop, you know, Fitbit, you know, that was acquired by, gosh, how long ago were they required by by Google, I think, I don't know, probably five years, you know, three, four, five years ago, something like that now. No, no, more recently within. Oh, it was recently. Oh, okay, okay, I didn't realize that. Okay, so it is even more recent. But it sounds like you're doing things a lot different, differently. And you also mentioned the fact that you're, you definitely see the clinician as as it like, like a, you know, a very, like they're going to have a really, they're going to

strongly integrated in with your model, which I couldn't agree with, agree with you more. I mean, as the space becomes more, as the technology becomes more sophisticated, it definitely seems like that is going to be a growing need. And so maybe let's start there. And then I want to learn a little bit more about kind of like your approach to the regulatory path. Sure. For sure. But let's start there.

Like help us better understand how you see clinicians being involved, right, with your technology and really the overarching kind of business model as you move the company forward. Yeah. Well, I guess maybe the best way to describe this is I'll do it by way of example. You know, most people maybe have an annual visit with their doctor. Many of those visits today are remote, right? And maybe a lot will stay remote. And certainly for underserved populations I've talked about earlier,

they may often be remote for a variety of reasons. And, you know, one of the things, I think clinicians are now more accepting of getting data from alternate sources than where they were before. You know, there's a real luxury of having more continuous data day after day that you can look at. And so, you know, what I envision with what we're trying to do is developing a very clear, concise, simple kind of summary report may summarize your data for the last 30, 60 days, give an indication to your healthcare professional. How well have you been sleeping? You know, what level of activity do you have? What's your average heart rate been looking like? your SPO2, you know, other things like that and kind of give them a good framework from which

they can have a conversation with you about your health. You know, naturally, if they're going to have need blood work done and whatnot, you know, often you got to go and get that done. But now a lot of people are going to separate labs to get the blood work done for that. And so, but I think to get a general sense of someone's health, I think we have something that would add value and provide the doctor some information so they could have a more meaningful conversation with people about their health and use a little bit of the data to assess it. So I think I think that's where we'd like to see things go moving forward. And whether you're dealing with a chronic condition, you know, if you've got diabetes,

type 2 diabetes or hypertension, understanding how well you're sleeping, what activity levels look, what your heart rate been looking like, SPO2, et cetera, are important, you know, inputs. Yeah, got it. Makes sense. And you kind of, I think like the very first question I had for you. You kind of, you mentioned the fact that like, you know, like as is the amount of data, right, that you can, you can extract from new wearables like this, it's becoming, we're getting closer and closer like information overload, right? And you almost get, you know, patients almost, their health worsens, right? As we're expecting them to kind of digest all of this data. So it seems almost that much more important, right, to be able to, to, to see this kind of integrated in with

like a normal, you know, primary carry visit, right? Where a physician can say, look, look at your HRV, do you know what HRV is? You know, do you know what matters? You know, this is what this actually means because that's a lot different than, you know, of course, you can read about it, you know, through a number of different websites, but to have an actual acquisition provide some color commentary, you know, that's, that's going to be, I think, you know, pretty important moving forward. But on that note, I think that's a good, a good transition into kind of this regulatory topic in general, right? Because if, if we've got clinicians that are relying upon the accuracy, right, of HRV, of blood oxygen levels, et cetera, really, really important that that actually, that

measurement has been validated. It's actually, it's accurate, et cetera. So help us better understand kind of your approach, especially the interactions with FDA and how kind of you're tackling this in general. Because I think there's probably going to be some insights for other, you know, life science, med tech entrepreneurs that are that are listening. And, you know, it'd be good to kind of get your, get your feedback on that, especially considering your wealth of experience in kind of the, you know, the wearable space, in the CGM space at many metatronic. Yeah. Well, first off, it's a really important topic here. And, you know, for some of the metrics like heart rate, SPO2, respiration rate, there are standards that the FDA has already published. It talks to you about what are the accuracy

guidelines that you need to meet to be able to have a product that would be commensurate with being cleared by the agency. And so a lot of the legwork has been done at some level. And then it's just a matter of, you know, working with a third party to conduct the clinical testing that's commensurate with that and getting it completed. So retaining a regulatory expert to help with this is something that maybe some of the other companies should be doing, you know, to help them along the way. Again, for us, you know, we're setting up the company as a med device company. So we've already set up the system to do things a particular way that meets the FDA standards. For others who have already developed products, they're already out there. It's a little bit different in that regard,

because they probably haven't, you know, set it up that way. And so there are some challenges. But I think one fundamental thing I want to talk about is that historically, when you're evaluating blood, when you're evaluating a heart rate or SPO2 or other, you know, measures, the person is at rest. They're sitting in a chair or sitting in a bed and you make the measurement. And that, and that's actually how all the clinical trials are run, is you're evaluating the accuracy of someone there. Now, when you're using one of these wearable products, you know, people are going to be walking, running, you know, sledding, do whatever they're going to do. And then the question is, is it accurate then, too? And, you know, we're very conscious about that because we have seen

some data from other companies suggesting what people's heart rates are during different activities. And in some cases, we've done some work to confirm that they're not quite accurate. and there's some noise in the system that they're not accounting for. And so when we think about things as a medical device company, we think about those types of failure modes and we think about how are we going to address them. Can we tease out the signal from the noise? And if not, we won't report a value versus reporting something that may be grossly inaccurate because there's too much noise to discern the signal. So it's a different mindset and philosophy about how you collect and report data. data doing all these activities that historically weren't done when you're evaluating a product like

this for medical grade. So that's something that's very important to us because we do want the, you know, we're thinking about a doctor relying on some of this data to help them with, you know, understanding the state of someone's health that they're treating. So it's important to us to look at it that way. Got it. Got it. That makes a lot of sense. And I can't underscore enough that, that different mindset, right? And maybe it maybe it's, it's, it's, it especially stands out to me because I, you know, I started a company in the consumer health space. And that's very, very different than, than the traditional med tech space, right? It requires a whole level, a whole different set of experience, skill sets, etc. to be able to

navigate, you know, some of these, some of these complexities. So very interesting that you guys are kind of starting out with that, that framework in mind. Looking, you kind of mentioned this already, but there's a lot of really, there's a lot of really compelling, I guess, things that you could do with a product like this, right? Collecting data, using it for using it as a way to inform, you know, other clinical studies. So generally speaking, how are you thinking about like how Mavano fits into, you know, remote, decentralized, you know, trials moving forward? Well, talk to some more about that. There's a huge opportunity, I think, in the clinical trial space, or, you know, in post-market surveillance space when you think about pharmaceutical therapies for

various things. I mean, pharmaceutical companies have to spend an enormous amount of money, you know, both for clinical trials and then for follow-up and post-market surveillance, where they surveil people who are on the therapy. And, you know, if you have a technology like ours where it's medical grade, it's been validated to provide medically accurate data, and you can provide that to people who are in a clinical trial or a post-market trial following up. The wealth of data that you're able to collect that you've never had access to before and being able to monitor it longitudinally and being able to see what's happening in the home of the person as they're on the therapy or, you know, whatever they're taking as the medication is incredibly valuable. And when you think about the cost associated with getting that data where, you know, we're looking at very affordable models that may be pure subscription.

So over the, a year, it may be, you know, a couple hundred dollars or whatever for a year's worth of all this data from all these metrics continuously. I mean, they normally would pay more than that in a single office visit to, you know, get a one set of blood work done. So you can imagine the value that this could provide to them to really understand. what's happening. And I think that there's up, and this then expands, expands beyond that to insurance companies or your health care plans and others who are trying to do the best they can to help people who are their members, you know, lead a happier, healthier life and see what they're,

you know, how well they're doing and maybe offer insights and suggestions on things they can do to improve their health and well-being. So I think this has a number of applications where it could be phased in in a way that's so much more affordable than anything that's ever been, you know, accessible in the past. Right. Do you see a future, John, where this almost becomes like a default for most clinical studies, right, where patients, whether it's a drug or device for a different type of biotech therapy, it's kind of entry into the game, so to speak, right, where a patient is wearing a mobano device, you know, as part of the trial? I think it makes a lot of sense. I think that with the amount of data that it provides.

And if you think about the different types of therapies that you may be providing, if it's a cardiac related therapy, if it's a, you know, even a mental wellness related therapies, quite frankly, the signals that we're measuring really, how well are you sleeping?

Are you getting up walking around? Do you be inactive? What your heart rate look like, etc. Can be really strong indicators of levels of stress and well-being there. There's a big mental health problem in our, and everywhere because of code. bit and other things that have happened in the recent past. And so when you think about all these

different possible applications, there's a role to be played from the sensors that we're going to have and the metrics that they're going to be providing where I think it seems like you would do it seamlessly. The other thing I want to mention clinically is that a lot of clinical research organizations, CROs have really been trying to transition more to remote monitoring, remote office visits, everything done through, you know, e-clinical trials and whatnot. Because if you're enrolling people into studies, then they have to take a half day off from work and they've got to go park the car and they got to pay for parking and they get to go into an office visit and they got to do that every three months or six months or whatever. Getting enrollment, getting people to

want to do it, you know, easing the burden of participants. These are all historical challenges, which you can start to remove from the equation as you start to do, provide more of this to the person in their home. And I think that in general, whether it's in clinical trials or just basic health care, the more we can transition this to the home, the better off everyone is. It's lower costs of care. It's less burden for the health care system. It's less burden for the person themselves, you know, who ultimately we want to serve with solutions like this. Yeah, I could agree more. I mean, if there's an opportunity for someone to use a therapy or a diagnostic in home, that's so much better across the board. I mean, there's,

really very little downsides, especially if it's a technology that's been been developed with your traditional kind of medical device design controls. And you know with a high degree of confidence that the data that's that it's producing is accurate. So yeah, really good point. John, you mentioned payers. And I guess I don't want to throw, I don't want to fit too many questions kind of in one when we talk about this, you know, this topic in general. But what has been your, you're like I guess let's start out with you mentioned earlier on your technology at least at least in early phases will be cash pay right talk to us a little bit about how you see that changing right and what it's what it's going to take to get payers kind of on board with seeing the that sort of the

benefit and kind of their they're covered kind of populations so to speak utilizing a technology like this and actually covering it and reimbursement for it sure well you know first off I think historically most payers were interested in spending the money on treating the sick, right? We were waiting for people to be sick and then we treated them. I think things are transitioning now to try to see what can be done to be more preventative with our care, you know, and that's the way we should really go as a country. You know, let's not wait until people are sick and then spend the exorbitant costs of treating that.

What can we do to maybe help avoid people ever getting sick or minimize how sick. that they can get and spend more money there to avoid the huge costs that result from the alternative. And so I think that I think things are changing in that direction. And because if they're changing in that direction, I think there are opportunities to have things that are relatively low cost where we can show the value of them that work their way into the system where, yeah, you don't have to be sick. and we're going to give you something that's really easy to wear, easy to use, something you may find

value in yourself. Because I also think a lot of people are maybe more conscious of their health now than ever before, you know, more attuned to their health than ever before. And are, you know, there's a lot of people who are now looking for things they can do as individuals to be healthier. I think everyone heard through COVID that people who have preexisting conditions have a much higher likelihood of severe disease and real big problems associated with it. So a lot of people are thinking, well, what can I do to not be in that category and live healthier? I'm going to feel better. And also, if, you know, God forbid something happens to me, I'll be in a better position to be

able to manage through it with what I have. And so I think that we're going to have to show the value of what we do to health care payers at some level. But if the burden to them financially isn't so great, it's going to be. it's going to kind of make that bar that we have to get above a lot lower to demonstrate something where they may want to provide this to their members. And, you know, in long term, you know, there's been a lot of talk over time about people getting paid for their data, medical data, you know, being able to monetize information

about themselves. A lot of companies want to have population data, all de-identified, don't know anything about you specifically, but just people in your age range, your gender, et cetera, those types things. And, you know, it could be that in the future that people may be able to use this for free, you know, or get paid, you know. And so I think that, you know, those opportunities do exist long term when you think about, you know, getting this into both clinical trials as well as, you know, even with payers and others who are, who have their members that they're trying to figure out what's the best way and, you know, most cost effective way of achieving good health.

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