Digital Therapeutics: In Between the Tech, Season 3, Episode 9, Part 3

Welcome to In Between the Tech. Today, we're wrapping up Mouser’s look at Digital Therapeutics. Mouser sits down with Simon Thomas, President at Freespira to get his thoughts on the momentum behind this technology and the opportunities for engineers in this space. Listen as he shares his unique perspective in this innovative new field of digital therapeutics.

Simon, thanks for joining us on In Between the Tech. To get started, how would you define Digital Therapeutics?

Well, according to the Digital Therapeutics Alliance of which we're a member, they're the major trade group for the industry. Digital therapeutics provide evidence based therapeutic intervention driven by high quality software programs to treat, manage, or prevent disease or disorder.

The way I look at them is they're really a subset of medical devices. I've spent my whole career in medical devices - patient monitoring, some other therapeutics. So, to my mind, digital therapeutics are just really another type of medical device. Now, most of them are software only, downloaded onto the user's own (typically) phone or tablet. And if they're a prescription digital therapeutic, then access to the app needs to be following receipt of prescription from the clinician typically, an MD. There are some digital therapeutics that include a dedicated hardware component. And it's kind of debatable whether a lot of the wearables that do patient monitoring, Apple watches and the like, monitoring blood pressure and CO2, if those should really count as digital therapeutics.
The key point about digital therapeutics, as defined by our trade association, is really that to be a true therapeutic, you need to have basically developed your product and then done some clinical studies to demonstrate that the intervention really works, targeted to a specific condition. Which certainly Freespira has done multiple clinical studies, etc., and all of the other leading prescription digital therapeutics have done that as well. So, we have a fair amount of clinical credibility that our interventions really do work.

You touched on hardware already, but as you know, Mouser sells to OEMs. What considerations should hardware engineers keep in mind as they design for Digital Therapeutics devices?

Well, the key is obviously to understand what the customer need is. I mean, that's elementary. But to the extent that there is a hardware component involved in the digital therapeutic solution, then that almost certainly says that's going to be used in the home environment rather than the professional medical environment. So, you have to design for home use and the FDA publishes useful guidance documents on medical devices for home use in terms of… for example, you've got to make sure that bugs and creatures can't get into any apertures. And there's a lot of usability and ergonomic features need to be considered once it's being used in the home rather than in a professional medical setting. So really, I'd say that if there is a custom piece of hardware, then figure that it's going to be designed for home use and act accordingly, design accordingly.

The other thing is, depending on the model, it may be deployed once to the user. And the user then keeps it forever, use it as they see fit or, in our model, because we are only a one-month course of treatment, we configure the system, send it to the patient, they use it for the month for the exercises assisted by our coaches, and then they send it back. We need to then sanitize it, test it, update firmware and software if necessary, and then get ready for the next patient. So that model puts more of a premium on durability because it's being constantly cycled back and forth across multiple patients.

What do you see as the overall market potential in this space?

Well, short answer is huge and for a couple of different reasons. Digital therapeutics are particularly well suited for treating behavioral health conditions where the existence of the condition can be diagnosed remotely via tele like we're talking now. And you don't need to go into a clinician office and get poked and prodded for physical testing. There's been, especially post pandemic, there's been an enormous increase in the need for behavioral health treatments to help a lot of folks who are out there suffering with different conditions. So, it's a growing market. Just in our space - we treat panic disorder, panic attacks and PTSD, and we estimate that to be an $18 billion market that's not being served particularly well by the currently available solutions, not least due to a lack of providers.

Interesting statistic, about 60% of US counties do not have a single psychiatrist within that county. So, it's not just for those patients living in those parts of the country, it's not a question of a three to six month wait to see a psychiatrist. There is none to go see. On the coast, we're a lot more fortunate in that we have more providers, but it's still quite long wait times and many of them don't take insurance. Access is just an enormous issue for behavioral health challenges that people are dealing with. And digital therapeutics, in my opinion, are kind of uniquely positioned to make a meaningful dent in that problem by both improving access because they're typically used at home rather than needing to trek into the physician office or therapist office for sessions. That has advantages because there's still a stigma around getting treatment for mental health conditions, unfortunately. What we hear from our health plan customers is that they're all trying to figure out how to make mental health solutions more accessible, and there's a huge provider shortage. So that's where I think digital therapeutics will have a major role to play over the next decade or so.

Our next question is a “fill in the blank”. Digital Therapeutics is the solution for ____.
Well, I can name a few conditions where I know there's a digital therapeutic that's available. ADHD in kids and adults, insomnia, obviously, we treat panic attacks and PTSD symptoms. There's one for treating nightmares associated with PTSD and there's another called Applied VR that has a more comprehensive PTSD treatment solution where they send a VR headset to the patient, and then they go through a set of exercises on that. They have a standard digital therapeutic backend. So, all the data that's collected from their headset is sent up to the Cloud so they can see what's going on in terms of the patient being adherent to the protocol and how well their symptomology is changing over time. And there's a lot of other conditions that you can go on the DTA website and cruise around, and you'll find lots of interesting solutions.

Can you tell us more about the VR headset and how it works?
Sure, there's been a fair amount of work on the virtual reality solutions for treating PTSD symptoms, especially for former service members. It works around going through exercises, simulations using the VR headset. So, it's a more immersive experience, and it's all derived from the successful treatments, which are called prolonged exposure therapy. That's a treatment which is delivered by a clinician, typically in the office, where through prolonged exposure to the memories of what triggered the PTSD symptom in the first place, patient gradually learns to come to the terms with it and move beyond it and isn't triggered by flashbacks and the like.

Several companies, over the years, have adapted this to work in a VR contract rather than with a live therapist, again, trying to improve access. And so Applied VR is just one of the latest to develop their own solution. They're fortunate. Recently they were granted a specific HCPCS by CMS. So that will enable them to directly bill for that treatment. Because, without getting off too far off on the tangent, one of the other major challenges that the digital therapeutics industry is dealing with is how do we all get these treatments get paid for? Because, at the moment, there aren't codes for digital therapeutic treatment. There is a code for a standard psychotherapy session or for most all the medical interventions that you can think of.

So that's why there's some legislation being introduced in Congress. Both the House and the Senate have a prescription digital therapeutics access bill. And the goal there is to require basically in a mandate that CMS create a category for digital therapeutics. Within six months, I think the bill gets passed, and then do the work to start a pricing mechanism for the digital therapeutics, and that will enable two things. One, third party payers typically follow Medicare's lead in terms of adopting new treatments and paying for them. And two, there'll then be a coding mechanism available for the industry to use to turn in bills for the services which are being provided.
Outside of legislation being passed, what are the other challenges?

It's change. Change is slow in medicine. I've worked on a few breakthroughs, first-of-their-kind devices in my career and without exception, it just takes a while because practice in medicine doesn't change very quickly. You are intervening in people's lives, and you want to make sure that what's being done, one, really works, and two, really works in this specific patient, which means generally that providers need to get comfortable with what you're doing, otherwise they won't endorse it. And if providers aren't going to endorse it, then it's not going to go anywhere.
Now, digital Therapeutics, we have the option of reaching out directly to patients. We can basically do our own medical education and present data and information to reassure the patient that this is not snake oil. This has really been tested, it really works, here's some data. Not just testimonials from a celebrity. But ultimately it takes a while for patients to become comfortable with the idea that using an app on my phone could make me better, just like taking a pill does. That's a little hard to get my head around. So it just takes a while to internalize that and start believing it and be willing to try it. Same thing, you know with a provider. So, really just awareness, acceptance of this new paradigm for treatments. That's another challenge. And then I already talked about getting paid for the interventions that they're delivered.

Tell us how Freespira’s CO2 sensor fits into that solution?

So, the Freespira solution is interesting. We've been around for a while, and we started out thinking that our solution would actually end up being sold to patients. That's one reason why we developed our custom CO2 sensors, at a lower price point then current commercially available ones. We tried that for a little bit, explored that, and then had realized it wasn't going to work because patients told us, “Hey, I'm suffering from panic attacks.” The symptoms of those, as you probably know, are mostly physical. So, they seek treatment for them, mostly on the medical side of the healthcare system, not on the behavioral side. That sets up an expectation that if I'm going to see a provider or go into the ER, then insurance is going to cover it.

To be a credible player in treating a condition which has mostly physical symptoms, it's got to be covered by insurance, otherwise just not going to be adopted. So that really told us that we needed to start working with insurance companies. So, we did that, eventually got our first contract in 2018 with Highmark Health, which is a big blues plan on the East Coast, Pennsylvania area. And that launched with them through their network of providers and then kind of leverage that to get additional contracts in couple of Midwest Medicaid plans. And most recently we just launched with Point 32, which is the Tufts Harvard Pilgrim plan up in Massachusetts. Along the way, started with the Veterans Administration as well. So treated a few hundred vets with very good results.
But the key point about our treatment is that patients suffering from panic attacks and PTSD symptoms, many of them suffer from an underlying condition called CO2 hypersensitivity. Over time, they accommodate to this condition by developing a habit of breathing in irregular patterns, and in many cases, breathing in way too much air for the level of activity. If you breathe - kind of over breathing - you'll lower your exhaled CO2. All this is totally unconscious. The patient has no idea what their breathing pattern looks like or how they're breathing. So our CO2 sensor measures their exhaled CO2, which is kind of a surrogate for the volume of air that they're bringing in. If you're bringing more air, CO2 goes down and vice versa. So the tablet that we supply preloaded with their app lets the patient visualize their breathing pattern, and so they can see kind of what's going on.
And when they're being trained by our coaches, we have a network of coaches who work with the patients. They're not doing therapy. They're really training the patient about what the Freespira treatment is all about. And a good way of thinking about them is a Sherpa. They're here to guide the patient along the patient journey. And so, they have the patients do some little exercises, breathe fast, see what happens, breathe slowly, see what happens, bring in more air, bring in less air. And so, the patient can see on the screen what the effect of the breathing pattern is in turn - both of the rate and the CO2 level. There was a study out of the UK, which attempted to replicate the same kind of breathing protocol that we used, but without the CO2 component. And it didn't work. They didn't show a difference. So, you really need, for the proper treatment to work, you really do have to have a CO2 measurement. And so that means we need to have custom hardware that provides same.
Simon, how did you and Freespira get into Digital Therapeutics?

Well, I'll tell you the Freespira origin story to start. Cause it's very cool. There was a woman called Beth. She lives in Northern California, and she suffered from panic attacks for decades, pretty debilitating. I know her well; she tells this story herself. She tried all the usual treatments, meds and psychotherapy-based treatments, nothing worked. She saw an ad for a clinical study at Stanford down the road where she lives with a new approach for treating panic attacks, which was the protocol that we then incorporated into the Freespira treatment. So she enrolled in that study and went through it, and I quote it, it changed her life. It really made a huge difference in terms of reducing panic attacks almost down to nothing.

And so, she was obviously a true believer. Her husband, Russ, had been a pretty successful venture capitalist. And so, as you know, many people are living around Silicon Valley. You kind of expect this is a really good idea. Somebody should start a company and make this available. So, they waited, Russ and Beth waited around for a bit, hoping, expecting somebody to do that, nobody did. She decided to do it herself as is relatively easy in Silicon Valley. You go looking for talent, you can find contract medical device developers, software engineers, and you’re really only limited by your own imagination and how much money you can put into the project. She basically started developing what became first generation system and found some consulting regulatory help because this needed a 510K from the FDA.

She's a very smart woman, engineering degree out of MIT, but she’d never run a med device company before. So, Russ and Beth went looking for a founding CEO to come in, run the company, take a set up the company, and then determine is there really a market for this. And then what should go to market strategy be. So, they hired our founding CEO, Deborah Reisenthel, who started working with the founders in 2013, 10 years ago now. I'd worked with her previously in a couple of other companies. One larger one doing patient monitoring for fetuses and then a digital therapeutic that we worked on. So, she called me and said, “Hey, this is really interesting opportunity. You're interested in joining?”

At the time, I was working for a company doing an in-home kidney dialysis machine. They went on to be pretty successful, called Outset now. But there was a horrible commute from where I lived, so shall we say, I was receptive to alternative offers. I joined Freespira as the second employee in 2013. And the reason I thought it was an interesting opportunity was, as I said, I've worked my whole career in medical devices and kind of understand the ecosystem pretty well from a tech point of view. Also, clinical studies, data analysis, some go to market experience with new devices, but it's all been on the physical medicine side. Never worked in mental health before. So, this was a really interesting opportunity to take a medical device that I understand well, basically CO2 measurements, which did that a long time ago. And I worked for a couple of other companies, and then apply it to the mental health solution, which was pretty novel to me and had no awareness that this could even work. But, read the studies, thought they looked reasonable, thought it was an interesting opportunity to leverage medical device patient monitoring tech into a totally different area of care. So that's what we do.

Any final thoughts to wrap up our conversation on Digital Therapeutics?
It's a really, really exciting piece of the medical device industry that's just getting going. So, for, Mouser engineers and other people out there, do some research and figure out how you can join the industry and help drive it forward so we can help more patients.
We hope you enjoyed this episode of In Between the Tech. This podcast is part of Mouser’s in-depth look at digital therapeutics and its impact on both technology and medicine. Explore the entire Empowering Innovation Together offering on this subject with videos, articles, and more at mouser.com/empowering-innovation.

Simon Thomas is President of Freespira. He is a proven leader with experience developing and bringing to market powerful new medical devices and treatments. Simon joined at Freespira’s founding and in the years since has led product development, clinical studies, quality, biostatistics, finance, operations, and regulatory approvals, including the company’s two Food and Drug Administration clearances. Before Freespira, he led engineering, research and development, QA/RA and operations for a number of successful medical technology companies.