The Mix Tape: Ep. 8 — Digital Health

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Welcome to The Mix Tape.

Valerie McCandlish:

I’m Valerie.

Natalie Taylor:

And I’m Natalie. Thank you so much for joining us on another episode of The Mix Tape. Today, we’re excited to share with you a conversation around digital health, which I think will be really interesting. I am starting to learn a little bit more about digital health. But I can just speak from personal experience, I’ve only had a little bit of experience and that’s through telehealth. So I’ve had, I think, three providers do a virtual appointment with me, and I thought that those were very helpful and that they could be really beneficial to a lot of people who maybe couldn’t get to their appointment, maybe they were too sick to go, they couldn’t get a ride or couldn’t drive there. So I’m really enjoying seeing that area grow.

Valerie McCandlish:

Yeah, Natalie, I totally agree. And I think for me personally, digital health is a sector that I don’t know a ton about. I’ve been learning more about it over the past couple of months, and what’s been most fascinating for me is just how diverse the space is, because you consider telehealth being one really small portion of that, and almost boundless opportunities for all these companies to provide new therapies to an array of therapeutic areas.

Valerie McCandlish:

So I’m really grateful that we have an awesome guest to come on to today’s episode, and tell us more about his own personal experience, and kind of an insider scoop to the space. Our very own Andrew Jones is one of our recruiters here, and he has an awesome relationship with someone he’s worked with for a long time, Michael Seggev, who has been in the industry for quite a long time. He was really a career pharma guy for several years, having worked with Merck, and then later with Teva, and then recently made the transition into digital health.

Valerie McCandlish:

He saw a really cool opportunity for himself to transition into an area that he was really excited about, and he is now the VP of Commercial at Donisi Health, which is a company that’s pioneering contact-free and hassle-free health monitoring, delivered through multi-parameter, medical-grade patented nano vibration, motion detection solutions powered by AI enabled technology.

Natalie Taylor:

Woo. That was a mouthful, Val. You did a great job. So without further ado, let’s kick it over to Michael and Andrew to talk about digital health.

Andrew Jones:

So Michael, tell us a little bit more about who you are and how you got into or interested in digital health.

Michael Seggev:

Sure. So my name’s Michael Seggev. I’m currently the VP of Commercial at a digital health startup called Donisi Health. My journey started in healthcare, first in communications and then in marketing. And I would just say, I’m a long-term pharma guy, always on the commercial side, 22 years at Merck, launched great brands, made a huge difference. But I always felt distant from the patients who we were trying to help. In the typical, traditional pharma marketing world, you can develop a great brand, and a value proposition, and all the messaging around that. After the regulators are through with you, you have to wait for the scientific leaders to endorse you in guidelines, and then the payers to put you on the formulary, and then physicians to actually prescribe, and the pharmacists to actually dispense. And then finally, after all those lily pads, you get to the patient.

Michael Seggev:

And of course, the biggest issues in healthcare, especially in chronic healthcare, have more to do with how the patient behaves and how they use the medicines than the medicines themselves. And this was a tremendous frustration, even when I did a lot of DTC. The content of that was so balanced and the limitations on that were so significant that it never really felt like I could directly help those people help themselves.

Michael Seggev:

And when I discovered this thing called digital health, I had a sense that maybe if I could reach them through this, then I could speak to them a little bit more directly. And that was why I started looking around, looking into digital health. I had an opportunity at Teva in their digital health team. We developed and got approval for the first connected inhalers for asthma and COPD. And then I was fortunate enough to be selected to become a chief commercial officer of a startup in the digital health space. That one was called Vocalis Health. And now, just in the last few months, moved over to help lead the commercial efforts for Donisi.

Andrew Jones:

Got it. So you mentioned the first approved, connected device. At a high level, explain what digital health is, and maybe two or three of the main ways it’s being utilized.

Michael Seggev:

Okay. So digital health is a huge category. There’s a lot of things that have nothing to do with our industry, things like telehealth, and the services provided by either providers or people working for them. My focus and I think the area of interest is, in a sub-segment of that, sometimes called software as a medical device, sometimes labeled differently. But ultimately, the way I think about these products is in three categories, and I’m speaking specifically of things that are software based.

Michael Seggev:

There’s companion apps, where an app on a patient’s phone is used to support their use of the medication that they’re taking. There are connected devices. So there’s a device with an inhaler, is an example. There are injectors. There are others where technology is built-in, and that technology connects via Bluetooth to the app on the phone, to the cloud, to a physician. And then there are digital therapeutics or prescription digital therapeutics, which I think a lot of the focus has been on this really new class, and it is a completely new concept. And that is that the software itself being used on a device, on a phone, sometimes in conjunction with other tools, but typically the software itself is delivering the therapeutic benefit. So you would prescribe this app, and I would use this app, and it would, in some way, modulate my disease state.

Andrew Jones:

So what I think I hear you saying is it has the potential to have the same maybe cognitive effect that a similar effect that the medication would, just in the form of an app versus a pill or some other form of medicine.

Michael Seggev:

Yeah. There are so many variations on this theme that I’m going to be very general here and miss some things. But as I understand, the PDT landscape, there are two big buckets of software-only therapeutics. Some of them revolve around cognitive behavioral therapy. An example is, for diabetes, when Better Therapeutics has their app, and a person uses it, it primarily focuses on changing their diet, and exercise, and other habits that contribute to their health. And in their hands, they’ve shown in phase two, I believe, basically comparable A1C improvements to Metformin, the first line standard of care. That’s one way in which these work, by modifying my behavior in service of improving my disease state.

Michael Seggev:

The other is typically for CNS-type diseases or disorders. Think about ADHD. There’s a couple of companies, Akili and Attentive, that have apps that, in this case, an adolescent with ADHD would use 30 minutes, three times a week, or something like that. And those apps, they’re designed in a gamified way so that kids will keep using them. And those apps are shown to actually stimulate different parts of the brain. And it’s through that neural of stimulation and other tactics that they provide improvement, either in place of medication or in conjunction with the medication that the patient is taking.

Michael Seggev:

Coming back to the other apps that are not really prescription digital therapeutics, but are helping support therapy, like the companion apps, I guess the most well known example is Medisafe, providing an app that, among other things, supports adherence. And we all know that adherence or non-adherence is one of the greatest reasons for medication failure. And Medisafe really has, after a decade of working on it, really cracked the code, shown data that, by deploying this app, you increase persistence. The rest is all based upon the more appropriate you use of the medication itself.

Andrew Jones:

And so could those companion apps that, the adherence focus apps, also use cognitive behavior therapy to get you to take your medications when you’re supposed to?

Michael Seggev:

Sure. Like I said, there are all sorts of stripes and there are many different regulatory approaches. If you’re strictly supporting adherence, for example, FDA has excluded that from its product regulatory. It basically becomes something that you have to treat like labeling or like DTC, and appropriately balance, but all the way the use of the app itself as a prescription digital therapeutic, which is just like any new drug, and requires a full development program, clinical trials demonstrating efficacy and safety, and going through that registration. But what you see now is a lot of mixing of these modalities.

Michael Seggev:

So I’ll use a connected device example. The Digihaler app, that I worked on at Teva, has components where it’s measuring your utilization and providing information based on that, for instance, “Hey, Andrew, you use your rescue inhaler more than X times per day. That’s a sign of something bad happening. Contact your physician.” So that’s one aspect of it. Another aspect of the app is, twice a day, a reminder comes up and says, “Hey, take your controller. Use your maintenance inhaler.” I mean, once you get into the app world, as we know, you can do pretty much anything, and you can add things, and over time…

Michael Seggev:

And this is one of the big differences for people who come from the pharma world where a life cycle is basically, seven to 10 years of study, you launch a drug and that’s what you have. And then you could do another study, and three years later. Get a second indication, but you’re basically stuck with those kind of development cycles, whereas in software, typically, you’re doing a new release every quarter. You may add new, significant features twice a year, and you really have to work in a very different, agile manner in order to keep people using your app, and in order to stay current with the latest trends and the latest offerings that are competing with you.

Andrew Jones:

You. So Michael, why are so many pharma companies investing tens and hundreds of millions of dollars into what seems like uncharted territory?

Michael Seggev:

Yeah. I think for the same reasons that we undertake most activities, revenue enhancement and expense reduction. So in terms of the revenue, the first foray were these adherence apps, and they’re designed to increase the number of refills that a patient has. If in a typical chronic care condition, you get five or six refills when you should have 12. And because of this app, you can get seven or eight. You can do the math. It’s a significant uplift in the revenue stream. They do it for competitive reasons. You see, especially in higher priced, highly competitive chronic care settings, that there are a lot of people trying to either enhance how well their product works through digital health means, or add value to their offering by doing something else in addition to what their product does. I’ll give you an example, diabetes glucose monitoring.

Michael Seggev:

And there are companies who are attempting to use digital health tools to provide additional value, for instance, so that if I walk in and I’m, let’s say, Roche, and I’m competing with Abbott for your glucose monitoring business, and I say, “Hey, in addition to top-notch glucose monitoring, which, by the way, is fully connected, I can add a tool for your patients who are comorbid with CHF, will actually monitor their congestive heart failure status and alert the physician around deterioration.” So you can imagine that that makes good, competitive sense.

Michael Seggev:

And then there’s life cycle extension. This is perhaps a secondary objective, but I have seen a number of pharma companies, with big products that are three to five years from their patent cliff, investing in digital health versions of those products, or digitally empowered versions in order to try and extend that life cycle. And then there are non-product related digital health investments that pharma has made, the most notably around clinical trials. Extraordinarily expensive line item in a big pharma budget, and the use of digital health tools to conduct those trials in a decentralized manner, with less visits, with less requirements for costly requirements, and the ability to recruit more broadly, more quickly, all of those as by have driven a lot of adoption. And actually, I think in pharma, the greatest raw number of companies that have adopted digital health, it has been in the clinical development space.

Andrew Jones:

Very interesting. I actually worked, a couple years ago, with one of the large, wearable glucose… What’d you you call-

Michael Seggev:

Glucose monitor?

Andrew Jones:

Yeah. The CG… What is it?

Michael Seggev:

CG-

Andrew Jones:

CGM space?

Michael Seggev:

Mm-hmm (affirmative).

Andrew Jones:

All right. Very interesting. A couple years ago, I worked with a major CGM powerhouse company on a role that was looking for what the feature looks like, and what else they could track, and measure, and use that for clinical trials, from an HORRWE standpoint.

Michael Seggev:

Yeah.

Andrew Jones:

It was fascinating. And three years ago, I didn’t know enough, but now it all makes sense.

Michael Seggev:

Yeah.

Andrew Jones:

That’s very unique that they think about it that far out.

Michael Seggev:

Oh, yeah. And I think you’re observing the evolution. I mean, seven, eight years ago, people started talking about digital, and the incorporation of software. It was a lot of vision, and prototypes and ideas. And there were, after that, I think, a lot of learnings that were difficult. Pharma is not exactly designed to be agile, and experimental, and evolutionary. And developing software in that setting, I can tell you from experience, is a struggle.

Michael Seggev:

So there was a lot of investments that were then pulled back, I guess I would say, in the ’15, ’16, ’17. But you see definitely, a change over the last three years among pharma players who are getting serious about it, who are making real products, who are entering into real collaborations and making progress. This was happening, in a big way, for the pandemic. And once you unleash the full fury of telemedicine on the American public, and they recognize that there are so many things that they can do from home, from their phone with technology, the trend just accelerated. So I do think that that’s a big part of this sort of asymptotic growth in the investment. The last two years, I think I saw a figure that digital health investment overall, through August of this year, surpassed last year’s total. And I think last year was about double what the previous year was. So it really has taken off.

Andrew Jones:

Yeah. That was my next question is, how’s COVID’s impact been? I think maybe Akili Interactive got an expedited review on their ADHD product because of it, if I remember-

Michael Seggev:

You’re exactly right. You’re 100% right. Yeah.

Andrew Jones:

Okay. At least we dipped our toe in the water of the capabilities of digital and telemedicine and how the wearables all kind of fit in. I would imagine that we’re going to continue with this exponential growth over the next couple years, if you could imagine.

Michael Seggev:

Yeah. Not just because people are getting deeper into the pool, or applying digital to new therapeutic areas, or new challenges, but also because the digital health industry is maturing. So one thing I’ve observed last year or so is, we used to be in a space that was purely innovative like, “I’m going to have the first contact-free tool that monitors this.” And it was that novelty and innovation that was really the spark that caught people’s eyes. At this point in digital health, and I work in a startup where we do this, we’re very cognizant that there are six or seven others trying to do exactly what we’re doing. And so you see a much more competitive landscape. You see a lot of emphasis on incremental features and on developing better data that supports the tool.

Michael Seggev:

I think all of these are positive developments, because it’s that sort of competition that yields the best products. And I think we also learned that in order to get the consumer to play along, to take part, when they pick up their phone and click on an app, they’re not comparing my Teva app to my Novartis app, they’re comparing to their Amazon app and the games that they play. And so you have to deliver an excellent product. We used to hear MVP, which in this case stands for minimally viable product. I think the days of putting products like that into the market and crossing your fingers are passed. The bar is getting higher and higher, and that’s a good thing.

Andrew Jones:

So it sounds like competition will fuel innovation, and continue and continue. When I go to the doctor or have a telehealth visit with the doctor, and he or she prescribes a PDT, how is that process different than a regular prescription for an oral pill, for example?

Michael Seggev:

Yeah.

Andrew Jones:

What does that look like?

Michael Seggev:

So this has been a significant challenge for those folks working at Pair and Akili, and these other places that are doing prescription digital therapeutics, because it didn’t exist basically, a path for doing that. But it’s beginning to take shape. There are a number of payers who are reimbursing for a select group of prescription digital therapeutics. So they have a formulary. A couple of our friends in Europe, particularly in Germany and in the NHS, in UK, were a little bit ahead, but now you see express scripts as a formulary and others. They do a rigorous assessment process, and elect those apps which they believe have sufficient evidence to be worth it.

Michael Seggev:

And so if your physician is an adopter… And that’s another big question. I mean, it takes years to get docs to change their habits from writing one class of antihypertensive to the next. Imagine getting that same doc to say, “I’m going to write for a piece of software that’s going to be on your phone.” But if they do, and there are definitely tech savvy, digital health first physicians who are trying to use these tools, they can prescribe them. And then it depends on the payer. And it depends on what the company does, has done, to facilitate the receipt of the delivery of that app, the payment for it. And it’s not just the insurer paying the company, or the patient paying the company.

Michael Seggev:

Yeah. There’s also a piece of this, which a lot of people miss, which is, “So how are you paying the physician?” In other words, you’re asking now that physician to monitor something, or to receive information, or to somehow… Even to onboard the patient, to have their nurse say, “Here’s the app. Here’s how it works. Here’s you connect it.” That’s time away from their practice. And so it wasn’t until a couple years ago that CPT codes were created. So now Medicare, Medicaid reimburse for a handful of activities. They don’t reimburse enough, but they reimburse. So you’re beginning to see more adoption because of all of these tools being put together.

Michael Seggev:

But I’ll tell you my analogies. I see that part of that part of digital health as still being like a car engine that’s not yet put together. The gears are there, you’ve tested certain things. You may have created a path to enable the physician to click a button, to prescribe, to reach the payer, the payer to approve, but then what? So now you have to make sure that patient… I mean, it’s quite a bit more complicated than, “Here’s your prescription. Go to CVS, and they’ll…” I mean, those channels are so well established for the last however many decades. And that’s actually one of the reasons why you see some in pharma trying to attach these two.

Michael Seggev:

So when you have a connected device, for instance, and you have an app that supports it, you’re just paying me for the connected device. The app comes with it, and the connected device, it’s going to have a higher price point, it’s going to have different reimbursement pressures, of course, but the method of payment and delivery is very well established. And so from a pharma perspective, that’s an easier one to forecast and to envision being adopted and being fulfilled in a normal fashion.

Andrew Jones:

Sure. That makes a lot of sense. It sounds adoption and just making sure all these separate pieces mesh together is a big obstacle. What’s another maybe one or two of the other bigger obstacles or barriers that remain today?

Michael Seggev:

Yeah. So in broad terms, the regulatory landscape is very complicated, very variable, and very open to interpretation. To their credit, FDA have tried really hard to adapt to having to review software as a product. But sometimes, the rules of the road are unknown, and sometimes those rules of the road have changed. I can tell you in my experience with the Digihaler, filing, review and approval, actually some of those rules changed in the middle of that and then changed back. And they weren’t written, they weren’t codified. There is at least some draft guidance that everybody can refer to that I think is FDA’s attempt to clarify it. But you are working in a relatively new field. And so is it a 510(k)? Or is it an NDA or an SNDA? Is it a class one or class two or… I would say this, if you’re looking for a burgeoning career field, do software and AI regulatory consulting. That’s a high demand position at the moment. So I think regulatory is a big one.

Michael Seggev:

Again, coming back to the notion of especially when it’s pharma, and they’re responsible for the software piece of it, being able to keep people engaged, being able to develop apps… This is fairly old data, so from probably 2015 or ’16. At that time, pharma had gone haywire launching apps like, “Oh, we have a new product. We got to launch an app with it. And it’s going to provide education, it’s going to support adherence. It’ll engage.” So I remember a study. I remember presenting data that 72%, or some crazy number, of the apps that I had been launched by pharma into the app store had either never been updated or updated once in their lifespan. And if you have a favorite app, if anything, it probably updates too often, and they change the graphics, and they do this.

Michael Seggev:

The science of software says in order to keep someone clicking, pressing that app button, and opening it and using it, you have to show them something new, you have to keep them engaged with up-to-date, interesting content, you have to make it either fun, or useful, or both. And I think it’s going to be a struggle for pharma to live in those sorts of quarterly life site development life cycles. It doesn’t have to be quarterly, but you cannot treat an app like you do your promotional material and say, “Okay, it’s been working for two years. Maybe this year, I’ll do a new version with some new pictures, change some of the headlines, or get a new agency to make it look different.” It really is a commitment.

Andrew Jones:

So I guess you couldn’t just put Instagram, Facebook, name your favorite social media site, behind, “After you’ve taken your medicine, then you have access to those.” That would do the trick. Everybody’d be 100% adhering.

Michael Seggev:

Fortnite.

Andrew Jones:

There you go.

Michael Seggev:

Yeah.

Andrew Jones:

So it sounds like the ability for the HCPs and the caregivers even just to… Like you said, in between visits, has the great potential to reduce readmission rates in hospitals for some of these major diseases, or just that much more adherent, which helps obviously relieve the burden as well.

Michael Seggev:

Yeah.

Andrew Jones:

Any kind of parting shots or closing comments?

Michael Seggev:

I’ll just reflect on my own journey. Maybe it’s an apt analogy for either other people or for the industry. I’m not such a young guy and I spent decades honing my pharmaceutical marketing craft. And at a certain point, you get to a point where you go onto your next assignment and you sort of have this voice in the back of your head saying, “I’ve seen this movie before. I know what’s coming next.” And it’s important work. You’d certainly grow, and you learn, and all that stuff, but it feels a little old.

Michael Seggev:

And the fact that there’s this new field, relatively new, with tons of opportunity for growth, but with also a big gap in the kind of experience that people like me have in terms of how you deal with regulations, and how you deal with physicians and payers, and all of those things that are sort of second nature to people in pharma, I think it’s a… If you have the interest in digital technology, whatever, and the willingness to step outside of comfort zone a little bit, but bring what you know to a new frontier, I think digital health is a tremendous opportunity.

Michael Seggev:

And in some ways, the same is true for pharma. I think we have seen the old way work less and less well. You can’t just slightly improve the efficacy or safety of a compound, increase your prices 10% every year, deploy 2000 sales reps, and tens of millions of dollars in DTC, and then count how far past a billion have you gotten this year. That’s not the industry that we work in anymore, and it’s obviously migrated to more specialty, to more serious thing. So I think pharma has grown a lot in multiple directions. I would submit that this is one where you could really see, not just dramatic growth in our ability to impact patients and generate revenue, but really just whole, new ways of thinking, and whole new ways of making an impact on top of what we already do, delivering the medicines that save people’s lives.

Natalie Taylor:

Excellent. Because this is Mix Tape, a question that we ask everybody, what is your favorite song, whether it’s recent or all time favorite?

Michael Seggev:

Right.

Andrew Jones:

Give us one.

Michael Seggev:

So I’m weird because I have… My Spotify has rap, reggae, jazz, indie, hard rock. I mean, it’s some country, some music from all over the world. And so it depends on the day. I started working for this company called Donisi Health in the last couple of months, and I recently learned that the word Donisi means vibrations in Greek, because what our tool does is actually measure nano vibrations through your clothes that help us understand what’s happening in your heart and your lungs. So I’ll say Positive Vibration by Bob Marley and the Wailers, off the-

Andrew Jones:

Can’t go wrong-

Michael Seggev:

Off the Rastaman Vibrations album. Yeah.

Andrew Jones:

Can’t go wrong with that. And then last question for you, what is your favorite job interview question you’ve either asked or have been asked in your career?

Michael Seggev:

Well, a very long time ago in an interview, I was asked, and I learned later that everybody was asked this question by this very legendary market research leader. The question was, “Your job is to estimate the number of barber shops in Chicago. Please describe the methodology that you would use.” And the funniest thing is that he would ask that same question. I gave an answer, he’d say, “Okay, give me another methodology.” He’s like, “Okay. How about a different one?” Just a probing question to, “Do you know how to think about the questions that you’re going to have to ask to be successful?” I never forget that. I haven’t used that in an interview because that that’s one of those that should be retired, but that’s my favorite.

Andrew Jones:

Yeah. Pre-Google days, right? Pre-Google.

Michael Seggev:

Yeah. Yeah. I definitely was interviewing for jobs at Merck way Pre-Google.

Andrew Jones:

Excellent. Well, thank you so much, Michael. It’s been a pleasure.

Michael Seggev:

Thanks, Andrew. I really appreciate the opportunity.

Valerie McCandlish:

Thank you so much to Michael and Andrew for being our guests on this week’s episode. And I’m just really blown away by how much I’ve learned about this space, just from what Michael had to say. And I know earlier in the episode, we were talking about just how much the landscape has changed for digital health. It’s not surprising when you hear Michael talk about how, in digital health, because of their software and needing to stay relevant, some of these companies are releasing new therapies every quarter. And in the world of pharma, we’re used to a new drug launch being maybe every seven to 10 years for a company, and then not another three years until they have a new indication. That need to stay relevant and competitive in the landscape is mind-boggling how quickly they are able to pull together some of that technology.

Natalie Taylor:

And I think it’s so interesting that doctors can monitor patients in real time and then intervene when needed, which I think is, of course, so beneficial to patients, but also healthcare systems in terms of advancing efficiency.

Valerie McCandlish:

Yeah, that part actually really resonated with me and Natalie. My dad would probably be embarrassed that I’m sharing this on a podcast actually, but earlier this year, he did have a bit of a heart episode. And following his visit with his cardiologist, he was then recommended to purchase a digital health device where he’s able to, in the moment, record his heart rate. And it actually transmits that data straight to his cardiologist where he’s able to get feedback on what exactly is going on. So it’s, for me, really personal to know that a lot as therapies are not… They’re helping people exactly like my family.

Natalie Taylor:

Thank you for sharing that personal story with us, Val. It’s a great reminder that the work that we’re doing in this space really impacts patients, and our friends and family members. So I just want to send you and your family some positive vibrations, just like Michael’s song choice, which was Bob Marley’s Positive Vibrations, which we will be adding to The Mix Tape playlist. So as a reminder, check out our Mix Tape song playlist on Spotify, as well as the podcast episodes. You can find the podcast episodes wherever you listen to your podcast. So please give us a follow on Instagram and LinkedIn. And as always, thank you for being in the mix. We’ll see you next week.