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Ep03: Deep Dive Inside the Digital Therapeutics Alliance with Executive Director Megan Coder

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Transcript

Eugene Borukhovich 0:04
Welcome to Digital Therapeutics Edition of Digital Health Today. I’m your host, Eugene Borukhovich. In the last episode, Brian Dolan and I touched on the definition of digital therapeutics, and while the term itself has been used roughly since 2012, 2017 became a very pivotal year for the industry as the Digital Therapeutics Alliance, aka DTA, came on the scene. In this two-part deep dive we go inside the DTA and today, we will start with Megan Coder, the Executive Director. Followed by an episode with Jessica Shull, DTA European Lead. But before we dive in, I do remember meeting the energetic, polished and absolutely no BS, Megan, at the 2017 Frontiers Health in Berlin – yes, when face-to-face conferences were still a thing – and at that conference, the DTA was officially launched, which I strongly believe was a historic moment for the overall industry. And now we jump to my conversation with Megan.

Eugene Borukhovich 1:04
So here with Megan Coder, and we wanted to get into a little bit of the history of digital therapeutics, but I want to start actually, with you, and your personal journey to the DTA. So maybe just to our listeners, give a little bit of flavor of you, Megan, who are you? A little background and how you got to the Digital Therapeutics Alliance?

Megan Coder 1:26
Well, it’s great to be talking with you. And let’s see what I can do here. So in terms of me, I am a coder who doesn’t quite know how to code yet. But I’ve always really enjoyed this aspect of the industry. I’m a former pharmacist who really loves the potential, now, of digital therapeutics and its ability to actually change how patients both receive and benefit from healthcare. And I’m somebody who has an enduring fascination with anything that’s policy based, solution based, that can have a global impact. So putting all those together, looking at the technology side, the healthcare side, looking at the global aspect of what we’re doing, really, really embodies a lot of what DTA is. So in terms of what drove me here, I think it’s fair to say, it seems looking back now, that every single step I’ve ever taken has actually led me here, even though I quite didn’t know where I was heading at the time. But really, as soon as I heard about this industry, I fell in love with it. I really love what is going on. I love the international perspectives, I love the idea that we are able to take technologies and infuse them into healthcare settings and really provide patients with something they’ve never had the opportunity to receive before. So altogether, that’s a little bit of what drives me and who I am.

Eugene Borukhovich 2:37
Fantastic. Let’s dive back to, kind of, the early days of DTA. You know, I’m always curious how a lot of these alliances and organizations get formed. So for our listeners, and maybe you can describe a little bit on the history, kind of who was at the table, how it got formed? So just take us back a little bit the history train.

Megan Coder 3:01
I feel like we should be sitting on rocking chairs on a porch, reminiscing about the good old days of DTA.

Eugene Borukhovich 3:06
With our masks on, but.

Megan Coder 3:08
Well of course, only that. So Pierre Laurent, the current CEO of Voluntis, he actually conceptualized DTA back at JP Morgan in 2017. At that time, he had brought together a number of CEOs and leaders already involved in the space, really by spring, and I believe he had already been working with Eddie Martucci from Akili, he was working with Anand Iyer from Welldoc, David Van Sickle, from Propeller, and then in January, we started working with Alex Waldron from Pear Therapeutics. So by the time I came onto the scene in May 2017, DTA, was already in its early stages. And as soon as I had found out about the notion, it was really my passion over the coming months to really start to build out that vision and not only bring to life, the organization, but also critical aspects of the broader industry.

Eugene Borukhovich 4:00
And what was the original purpose? Right? And we’ll get into the next level of peeling the onion, but maybe you can describe as you joined, kind of, what was that mission for the DTA? It’s always important to say what it is, but it’s also probably important to say what it is not. But I’m just curious, a little bit on the background. As you got handed this beautiful baby, and you needed to grow. And um, you know, maybe or maybe not being facetious about it, but just describe a little bit on that for us.

Megan Coder 4:29
So the purpose has really been consistent from the start. And the idea is that, and I’m a pharmacist by background, so and I’ve used this before, so I apologize for the repetition, but the notion that patients understand now that if they get a pill or medication from the pharmacy, if it comes in the color blue, it doesn’t necessarily mean that all colored blue, pills that are colored blue, are going to do the same thing. In digital, I don’t think that that’s fully understood. So if it’s a digital product, well, are there distinctions?Are there differences? So really when we’re looking at products that are using software to deliver actual medical interventions to a patient, and that those interventions are making the claims to prevent, manage or treat a disease or disorder, that is really different to me than something that’s going to be more on the adherence side, or monitoring side, or health and wellness or fitness tracking, or whatever the case is. So I think a lot of our mission has been from the start this idea of, let’s start to parse out the different types of products that are in this industry, full appreciation for all of them, but if you’re starting to look at this notion of therapeutic products that are digitally delivered, then what types of standards should they be adhering to? What types of requirements? How should you prove that it’s clinically effective and safe? So those are the initial tenants of what DTA formed around. And we’re still really focused on a lot of this notion of, let’s make sure it’s a strong industry with a lot of rigor across the board. And if a product is not in that therapeutic space, then they likely don’t have to adhere to the 10 principles that we seem to live and die by. But if you are in that space, then it’s really important for patients, clinicians, payers, I think, to really have something to look to, to say, oh, this is a therapeutic, this is what it means and this is there for what I should expect from it.

Eugene Borukhovich 6:14
And diving a little bit, and I know it’s been a journey to quote-unquote, ‘define’ digital therapeutics. Right? And there’s a lot of critics, always, in any new buzzword. And I think we’ve been talking about digital health as a buzzword, you know, connected health, then there was digital medicines and digital therapeutics. Maybe, and I know you’ve had these discussions, but I learned something recently; the moment, you get bored out of saying the same thing over, that’s when you know, when people are starting to hear it. So we’re going to continue repeating this. But maybe a little bit of a differentiation, or how do you clarify what DTx is, versus a digital medicine and versus the larger umbrella of digital health.

Megan Coder 6:56
So this is something that leads to the notion that DTA, we are not going to be solving the world’s problems on our own. And we really need to collaborate with others. So last year, we worked with Health Excel, and the Digital Medicine Society, and then also NODE.Health to start to look at what is that broader ecosystem. So we looked at the idea that digital health is everything, under that then, what would be those that fall into the digital medicine space. And I think that that’s still somewhat of a controversial term. But digital medicine, we’ve been looking at the notion of those that will either measure or intervene. And then under digital medicine sits the subset of digital therapeutics and we’re that intervention bucket. So that is one construct, there are many other constructs. I think that we will continue to see the industry evolve. But the idea is, though, that something is maybe not validated and not regulated, and for the sake of, I just want to feel happier tomorrow. That’s going to be slightly different in terms of the rigor than something that says, we’re going to treat you depression, and we’re going to move you from this side of the scale all the way to this side of the scale within six months. In that regard, then you really have to think about, is this going to do it? Is it safe? Is it going to be effective? And what should I be expecting from the value of this product for me? So that’s, I think, some of the distinction, why we started put some of this together. The one other thing I’ve heard many talk about, so it’s not an original idea, but the idea of digital banking. You don’t go to your app and say I’m gonna go digital banking today, you just do banking and it just happens to be in digital. In this realm, if we get rid of the word digital therapeutic eventually. Fantastic! Because it’s just part of therapy, it’s in clinical guidelines, it is in clinical practice. That’s really where we need to head. But until that day, I think we do need to have some distinction to help people understand, got it monitoring, and diagnostic, clinical decision support, therapeutic, and therefore, this is how I’m supposed to engage with it.

Eugene Borukhovich 8:46
And over the course of the last few years, and I know you mentioned earlier that you kind of stuck to the original mantra, but I mean, I remember the quote-unquote, ‘early days’ of even you guys getting invoice out, etc, you know, very startup style, which is great. Was there any pivots or pressures or things that, you know, if you look back again, you know, mid of 2017, to where you guys evolved to now, anything that jumps to mind as far as like a pivot or slight pivot or? To use the startup terms.

Megan Coder 9:15
So I will give you full credit, the day that we launched DTA in Berlin, you were the first person jumping onto the stage like, let’s talk. It was fantastic! So I loved your enthusiasm and your passion. I remember to this day and probably always will. But that said, looking at the definition and looking at who we are and what our mission and passion and vision is, it really hasn’t pivoted much. And I really respect that. What we’ve seen is necessarily not pivots per se. I would probably look at the idea around digital therapeutics as we have as an industry not really pivoted from our mission, but we have been making pivots to address the populations that we need to address.

Megan Coder 9:56
So in early 2018, we had a slide that I was using that really said, our goal as DTA is to provide patients, clinicians, payers and policymakers with the resources they need to better recognize, evaluate and utilize digital therapeutics. So since 2018, we have really stuck to that. And as we’ve gone, I think the pivots we’ve made are to look at, okay, we really need to help patients get this or nope, clinicians are really facing this issue right now, and policymakers, and payers. But 2020 brought along with it a few surprises and it really, I think, shows that digital therapeutics were basically made to shine during this time. Like, digital therapeutics, our mission, our purpose, what the goal is of this entire category, is really to serve the issues that we as a globe are facing at the time. But we realized that policymakers may need to have more insights. So in the United States, for example, we realized that Medicare and Medicaid, they don’t know how to recognize these products. So, therefore, we started a legislative campaign to help them create a benefit category.

Megan Coder 10:59
On the European side, we started a letter-writing campaign, we even went as far as translating our materials into Arabic and French and German, for the first time to ensure that different policymakers across the world can start to understand the value of these products. So I wouldn’t say we as an organization have made a massive pivot, but we’ve definitely pivoted to the needs that we’ve been seeing emerge as this pandemic and other aspects of the healthcare industry have continued to unfold.

Eugene Borukhovich 11:27
Where’s the actual health consumer in the patient? Right? Because I think if I talked to some of the family members and they’re closed when I said digital therapeutic, kind of the eyes just wide opened. Right? What, what is it? And kind of on the same note, I know, as I was one of the first to jump and say, you know, let’s talk, I’ve also been, you know, somewhat critical on that consumer picture or consumer part of the definition and the DTA. And, you know, I think in August of 2020, the Consumer Technology Association, convened 20, 30 companies to drive DTx standards. So it’s a two-fold question. One, you know, let’s start with where’s the consumer and the patient in this and how do we get broader adoption? And then the second part to this is the CES organization that notoriously have been consumer-facing, coming onto the scene, whatever that means, right?

Megan Coder 12:23
Yeah, this goes right back to the notion of collaboration for us. So we as DTA, our strength, I think, really is focused on payers and policymakers and clinicians. How do we help the decision-makers and leaders understand what these are? How to regulate, how to cover, and how to eventually integrate into practice? Given that we have 40 member companies right now, across 15 countries, we represent a lot of different viewpoints and product types. So it would be really difficult for DTA to go in and talk about the value of diabetes products only, or ADHD products, or those in insomnia or depression, to those patient communities across every single region of the world. We wouldn’t do it well. So the notion that we have collaborations in play, I think, is really important. One of our members, who I love, their passion about it, they’re a professional association for diabetes educators. So they are taking this message and really bringing it to their members who bring it to their patients. So it’s something that while DTA, I don’t see us being able to do incredibly well at this point. And nor is it really in our strength and ability to do so. But working with other groups and entities who have visibility and abilities to connect with patients who are much more specifically looking for, I want something that really addresses my specific needs in my specific time and way. That’s where we have to have those collaborations. So looking at CTA, looking at what they’ve been doing, I think is interesting in terms of, they’re working with a group, the Connected Health Initiative and right now one of their coalition’s that they’ve invited us to join them in, is how do we take technologies and really ensure that they’re able to address people that have health disparities from a variety of areas? Whether it’s learning disabilities, or financial, or cultural, or locational, or whatever the case is. How do we start to ensure that technologies are designed for these different groups and actually being accessible by them? So those types of partnerships to me are fantastic, and the more that we can do to collaborate together. I’m definitely in favor of that.

Eugene Borukhovich 14:18
And I’m just going to stick on a little bit on the consumer stuff. And I know again, you’re representing 40 companies. Are there any statistics that either you guys publish as a combined, but an actual usage, right? Because again, while we’ll talk as well with others around reimbursements, and regulatory frameworks, and it’s coming, and it’s here, but just curious around any specific statistics on you know, the actual, call it, deployment to the patients and consumers.

Megan Coder 14:47
We’ve been talking about this and try and figure out how to best do this. And I think going into next year that’s going to be one of our priorities, and also just identifying other partners in the space who could help us create some of this. Looking at what Rock Health has done and looking at how they’ve seen, over years they’re able to track and find out, hey, in 2017, this is what was going on in 2018, and 2019, and so forth and starting to see trends. I would love to either help do that within DTA, or partner with other organizations to really get that sense. We have such a wealth of knowledge and insight already here, but I think it’s also fun to see that we have across our membership a wide variety of companies; those that are already in market, those that are still earlier stage, and those that are in supporting role, those that are actually delivering these products to patients and clinicians. So we have the ability to do quite a bit. And I’d love to get your thoughts eventually on what types of ideas you’d like to see that would really show a sense of assessing the growth and impact of the industry over time.

Eugene Borukhovich 15:45
I know DTA started, I guess, a combination of Europe and US with a big focus on the US initially. I know you’ve expanded with a limited team that you have across the EU, as well as Asia. Can you contrast a little bit on where DTx as an industry is, across at least some of the regions that you’re participating in and driving these things with? Especially from a regulatory company engagement, I mean, you can slice it and dice it, however, you want to just try to contrast a bit.

Megan Coder 16:18
So looking at DTA, we actually launched DTA, when I lived in Europe. So we really wanted to ensure that what we did, even though the organization was technically established in the United States, was applicable across multiple regions. And it should be. The idea is if you have a digital therapeutic that is going to be used by a patient, you don’t want it to have a less degree of security, or privacy oversight, or impact,, or rigor, if it’s used in a different country that may not have as strict of regulations or policies at that time. So what we’re doing, we are looking at this from a very global perspective in terms of let’s look at the entire industry and ensure that there’s quality across the board. That said how it’s broken down has been really interesting to see. So IMDRF has been a really interesting factor in this. IMDRF is a group of medical regulatory bodies that have come together and really categorize software as a medical device. And by and large digital therapeutics are a subset of the software as a medical device or SaMD framework. As such, it’s been really interesting to see that there are already frameworks that exist, that digital therapeutics can fit into, be it at the FDA level, or across Europe, or other aspects of Asia. So there’s already been this degree of harmonization and consistency, which we’ve really appreciated in the industry. That said, you definitely see different regulatory agencies taking different leadership roles, and others keep an eye on them.

Megan Coder 17:42
So the FDA’s work looking at pre-certs, the pre-certification pilot, and for those who aren’t familiar with it, it’s kind of like a TSA precheck idea. If you are a trusted traveler, you maybe don’t have to take off your shoes when you go through the security line. And you can keep your liquids and gels in your bag, as opposed to having to take every single thing out every single time. So that notion of having an expedited pathway of some sort that has still a strong level of rigor behind it, I think is important. So we have a lot of countries looking at, well, what’s the FDA doing there. And then you have entities like NICE in the UK. And they created this evidence framework, which I really fell in love with, was the notion of based upon the level of risk of the product and its function, these are the different levels of clinical outcomes they need to achieve, and then also the levels of health economic outcomes. So we finally saw that distinction for the first time. And then now we’re seeing aspects in Germany with the DiGA law underway and seeing that evolve.

Megan Coder 18:38
So it’s been really great to see different agencies and different entities taking on leadership roles in this space, really paving a path forward. But I think that gets us back to this notion of harmonization. So, if you have the United States doing one thing, and Germany, France, Belgium, Netherlands doing their own things, then the ability to actually scale and implement across these regions is gonna be really difficult. So any degree of harmonization we can have in terms of the clinical studies that are required, or the levels of evaluations that are done, or the types of standards that should be implemented in order for these products to get to market, I think is really important. So again, it brings us back to this notion we’ve discussed on the call, the more voices, the better in this realm. We really want to ensure that as many people and entities and alliances are coming together to really work on this, but having some degree of harmonization understanding around, this is what we’re going to align around and then we all divide and conquer from there, I think is really critical.

Eugene Borukhovich 19:36
And I mean, there’s a lot of work that has been done by you guys and the industry in the last three, five years. Right? Depending on how far you want to go back. What’s next for the DTA? And then I’d like to get your thoughts on what’s next for the DTx as a market? So first and then no that should be tied together.

Megan Coder 19:56
They should also be separate too and I appreciate that we as DTA, we are not the entire industry, nor should we be. The idea, I think, for DTA is that we have learned quite a bit during this COVID era, we’ve really seen the value of what these products can deliver to patients. And we’ve seen that they really should be working alongside different telehealth platforms, remote patient monitoring processes, virtual care options, and things of that nature.

Megan Coder 20:19
So looking across the entire continuum, we as DTA have focused a lot of our efforts traditionally on let’s just really define and really coalesce around this idea around what the definition is, the core principles, and so forth. But where they fit into the broader ecosystem is really important. So I think that will be a really important step for us in the coming year, to really start to figure out moving from this a point solution idea into more of an integrated platform idea and helping deliver to patients, this idea around a continual virtual care model is going to be important; that integrated with the current in-person care models, too. So all of that to say I think that’s one area.

Megan Coder 20:58
We’re also seeing a lot of healthcare decision-makers, asking a lot of questions of how should I evaluate these products? What questions should I be asking? Does every single thing need a pilot every single time I want to go live? And try to myth bust some of that, but then also bring some consistency into how these products are developed will be, I think, a really big step for us next year. And then I think, on the European front, too. Even the notion of trying to figure out how we create a harmonized definition, so at least HTA bodies and other regulatory agencies can get an understanding of, ah, this is what it is, this is what I’m looking for, and this is how we can move forward, I think will be important. We don’t anticipate having one single policy in place for all of Europe, but notions around let’s bring some, again, consistency – word of the day – and clarity, I think would be really valuable there, too.

Megan Coder 21:47
So, there’s a lot at hand for DTA. In terms of digital therapeutics, it’s been fascinating to see the industry grow over the last three years. When we started, we started off with five companies, and they are all in very different areas of the industry, which I love to see. We’re now starting to see solutions and products come into play that I never would have dreamed of. And it’s so great to see and say, huh, I never would have considered that this would have been an option, and not only is an option, it’s possibly becoming the standard of care and being integrated into all these different clinical guidelines, and so forth. So it’s been really fun to see just the creativity of the products that are existing.

Megan Coder 22:27
It’s been really interesting working with groups like the American Medical Association, to figure out how do we help really create the right coding infrastructure and pathways and processes for clinicians? So they understand how to engage, utilize and benefit from these. How can we extend care to patients that have never been able to have care before? So all of these ideas, I think we’ll continue to see grow. We’re still early, we’ve had products on the market as a true digital therapeutic for at least 10 years now. So it’s not new, but we’re definitely emerging and we’re probably not at that level of scale yet that others would like to talk about. But we’re making really critical steps toward that. And that, to me, has been really, really fascinating.

Eugene Borukhovich 23:09
Very cool. As you know, I’ve come out of pharma. Right? And while we were trying to lead the way, it takes some time. So I’m curious on your personal thoughts around the pharma DTx relationship. And, you know, a while back I published a little bit of, because DTx is kind of, know the end consumer, right? And much more tech-oriented with clinical background, pharma is clinical background and learning the technical skills for lack of a better term. And so what I published back then was, will DTx companies and the way they approach the consumer, the end consumer, swallow the pill inside, it will be part of it, or will pharma companies swallow the DTx and either as an add on or as a standalone therapeutic, right? So I’m just, again, to the level of what you feel comfortable about that relationship. What you saw out in the wild without naming any names, but just out of curiosity, where do you see that going?

Megan Coder 24:09
When I first started with DTA, we had our membership categories, and we talked about a digital therapeutic company as one category and pharma life science was another category, and there are obviously other categories. But what I’m starting to see is really interesting to me, is that, that line is blurring. So what used to be just your traditional DTx company as a tech company based out of wherever with a decent staff, but not the same size as a pharma, not the same scope or bandwidth, whatever the case is. When we’re looking at what pharma is doing, they’re no longer being discussed as, like the quote ‘supportive role’, or we’re just here just to get it out to the patient and use our marketing force or whatever the case is. And yes, I think those are really valuable aspects. But the notion that we are seeing pharmaceutical life science companies developing their own digital therapeutics, creating partnerships to really do so, really mirror a lot of what the drug development process looks like. I think it’s a really interesting testament to where this industry is heading.

Megan Coder 25:05
So obviously, we have a number of DTx companies that are all-in on the partnership model, we have a number of companies that are all-in on the we’ve got this, we’re gonna move forward on our own path. And then we’re starting to see a lot of the pharmaceutical companies start to debate, do we build in house? Do we partner with external companies? Or what does that business model look like? And I haven’t seen a one-size-fits-all yet. We’re seeing such a wide variety in the industry, which I think is really healthy for this time period of everyone’s trying to figure out what’s best for them. And I like that there is no one-size-fits-all at this point yet.

Eugene Borukhovich 25:38
Awesome. Another one that came up as we were talking, so, and it’s interesting, right? Because back to this pharma, because when we talk about the pills, right, and I personally hate that term, but you know, you’re non-adherent, and there are all these programs around adherence to the pills and the molecule. What I’m curious about is just to a certain extent, a therapeutic to your point, let’s remove the word digital, right, and it’s a therapeutic. At the core of all of this is human behavior, right? And again, I don’t like using the term adherence, but this is what the industry knows. The actual even adherence to the digital therapeutics, what are you seeing around that? Right? Because, for example, with Your Coach, we’ve actually been approached quite a lot, by digital therapeutic companies realizing that, you know, the technology itself is great, but then how do you help people reach their goals? There’s still empathy, there’s still a human relation. And you know, to a certain extent, health coaches to some of the rescue, not all of it, but, etc. So I’m curious what you’ve been seeing, hearing, how is that relationship of technology and human beings interacting with digital therapeutics?

Megan Coder 26:46
So one of the initial things that were part of the 10 principles that I religiously speak about, it appears to be, one of them was engaging the end-user through every step of the way. So the idea that you would create a product and be so proud of yourself to just reveal it to the patient at the end of the day, and say, you are welcome and now you shall use this and use it perfectly. That’s not realistic, and nor should it be. So the idea of talking with patients, clinicians, caregivers, from the start making sure that they see value and purpose and make sure that the product is designed so that it’s actually useful and delivering on the outcomes that it needs to be delivering on. Showing that the right buttons are in the right places, the right language is being used, the right cultural nuances – whatever the case is. So appropriateness of product development, I think, is one of the first steps. And then from there, that notion of how then do you ensure that it’s fitting into their lifestyle? So it’s not only the product itself, but then making sure that the patient can use it nights and weekends or on their breaks during work, or whatever the case is. So those are all factors that go into it. But then moving from there for more of that healthcare decision-maker side, how do you assess it? Is a net promoter score sufficient? That’s something that I’ve been trying to think through too. What are the metrics that we as an industry could be using to really start to show that, hey, there is a level of retention, engagement? But maybe you don’t need to have 100% retention all the time, because the product isn’t designed for that, what level of retention is sufficient to say, we’ve actually achieved and not only achieved but actually surpassed the outcomes we anticipated with this level that we’ve had. So it’s a dynamic conversation, that we have a lot to still figure out as an industry.

Eugene Borukhovich 28:27
That’s what makes it all fun. Right? And then the last one, because you mentioned AMA, at one point, what’s been their acceptance relationship to DTx? You know, as a, obviously a key component of the ecosystem. So just curious on that. And where’s their head in some of your discussions to the, to the extent you can disclose it?

Megan Coder 28:47
Yeah, they have been, I’ve really enjoyed working with them. They’ve been really, a great partner. And I like that they’re taking this from a very open viewpoint of they have invited us multiple times just to come and present to them around here are some examples of products. And here’s, again, the level of rigor, the level of clinical validation, you should look for, and all of that, to really ensure that clinicians can have confidence in using these products in practice. But then, what types of settings are they used in? And how are they being deployed? And all of these questions have been really great to work through with them. The notion then of looking at what types of CPT codes that currently exist, which ones can be applied to digital therapeutic, which ones may need to be modified, if necessary? All of these ideas I really appreciate and I liked that we’re taking from the industry level, we’re not coming to them and saying, hey, we want 18 different codes for these 18 different products, please do that by tomorrow. Thanks. But instead, we’re looking at from the industry level of, okay, if we have this evolving product category that will continue to iterate over time, and has the ability to actually serve clinicians in a variety of ways, let’s figure out what that looks like. And they’ve really welcomed those conversations. And I’ve really enjoyed the initial work we’ve had with them.

Eugene Borukhovich 30:03
Yeah, and maybe this is a little bit of a call to action to the listeners as well, and then we’ll obviously publish the contact notes and all of that.

Eugene Borukhovich 30:15
Well, that sound means it’s time for a question from my journalistic partner in this podcast, Brian Dolan, who is the founder Exits & Outcomes, and as I like to call him, the digital health detective. Let’s see what question Brian has for our guests today.

Brain Dolan 30:29
Ok. Here’s my question. I think companies that develop prescription digital therapeutics that make a treatment claim in their label end up being a different kind of company than those that maybe help manage a chronic condition like, say, diabetes. To me that first software as a treatment cohort of digital therapeutics companies is really the new category that has emerged in recent years. And I know DTA members include companies from probably both of those buckets that I just outlined. So does DTA recognize that distinction? Do these two groups and I think, you know, oftentimes, there’s even a third group focused on prevention. But do these groups share many of the same regulatory and business challenges? Or do we need a more precise term than digital therapeutic?

Megan Coder 31:21
Well, thank you, Brian, for your question. Looking at this, maybe I can even take it a step further. In 2018, we came up with a categorization of digital therapeutics, recognizing that not all digital therapeutics are the same, as you pointed out. So the idea that we looked at was let’s instead of looking at the types of interventions being delivered, or the modalities being used to it, or else does it work with a hardware, whatever the case is, or a drug, we looked at it based upon treatment claims. So we categorize these products in three different groups. The first was, treat a disease, second was, manage a disease, and then the third was prevent and/or improve a health function. And really, that was at that notion of preventing the disease. And when you look at all three, the entire purpose of that diagram was to say, no matter where you fall on this spectrum, as long as you’re using software to impact a disease state, and making claims as such, you have to abide by the 10 principles that we as DTA, have established. Looking at product quality, end-user engagement, clinical evaluation, regulatory oversight as appropriate to the claims you’re making, and ongoing real-world evidence development. But that said, we recognize that when you have these different levels of claims, you have likely different pathways to market and different access points. So by and large, and this is a generalization, and I’m sure we’ll see evolutions in this, but in that treatment category, they generally are prescription only products. In the manage, you could see a prescription and or non-prescription pathway, depending on the market access, and depending on the patient needs at the time, and clinical workflows, and so forth. And then usually in that prevent a disease area, those are generally non-prescription products. So we have already broken those down, and we did it based upon disease state claims.

Eugene Borukhovich 33:04
Amazing. Finally, what is your personal why? Cause we also want to get to know the individuals that have been driving the digital therapeutics industry.

Megan Coder 33:14
Yeah, I should have had a really great answer, thought about this one.

Eugene Borukhovich 33:18
What makes you get up in the morning, right? What is your why?

Megan Coder 33:22
I really believe in this. I really love what the notion is. I love the idea that you can start to deliver care that is rigorous care that’s consistent, that has a level of validity to it to patients who have never been able to access care before. Whether it is in remote areas of South America or Inner city, Milwaukee, or wherever the case is. It’s the idea that we’re finally able to do something that has never, never really been done before, but has the potential to infiltrate everything and really make an impact. And so, that notion of, I think it’s the notion of the potential that is just the best part of this and seeing what we can do and trying to plan out what steps do we need to take to get there, and not necessarily getting caught up just in definitions. Because definitions are great, but you know, they’re still just definitions. It’s really the technologies. It’s really the notion of healthcare. And it’s a notion of making changes and improvements when you’ve never had that option before. And when I was on the stage, gosh, I almost said recently, last year when there used to be stages, I was talking with I think it was Eddie Martucci from Akili and the idea was as a pharmacist, his father was a pharmacist so he grew up in a pharmacy realm, but I’d often consult patients and ask them hey, how’s it been going for you? Have you had nausea, diarrhea, vomiting? Like it’s very much in that realm and it should be, because you know, it’s medications and medications are fantastic. But the notion now that you can take a digital therapeutic and start to add it to a patient’s life and start to address aspects of the disease that have never been addressed before, I love that. But then not only are you asking about some of these negative effects but did you enjoy that? Was it engaging? What benefits did you achieve from that? I think there’s a whole other set of questions that not only pharmacists, but other healthcare practitioners can start to ask patients and really engage in and get actual data and all of this. So I will remember it for a while. But really, it’s the mission, I really believe in it. And I really, I love the potential of what has already been started to be accomplished, but what really could be accomplished in the coming years.

Eugene Borukhovich 35:23
Well, that was Megan Coder, the Executive Director of the DTA. In our next episode, we continue the conversation with a Digital Therapeutics Alliance and my guest will be Jessica Shull, European Lead for the DTA who is based right here in Barcelona. In this second part of the deep dive, we contrast the European landscape to the US, dive even deeper into activities of the DTA across EU, LATAM, and Australia, and much more.

Eugene Borukhovich 35:51
Thanks so much for tuning into Digital Therapeutics Edition of Digital Health Today, production of Mission Based Media. Be sure to hit that subscribe button to this podcast on your favorite podcast player. So you’re then automatically notified when we post our upcoming episodes where I speak with dozens of leaders and trailblazers who are forging the path for digital therapeutics. If you’d like to learn more about Your Coach Health, or Brian Dolan’s Exit & Outcomes, you can always find the links to this and more in the show notes for this episode. You can connect with me personally on Twitter @HealthEugene, or follow my journey of writing my first book Hard Pill to Swallow at hardpilltoswallow.substack.com I’m Eugene Borukhovich, and catch you next time.

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