Digital Therapeutics for Better Health with Dr. Smit Patel: Part 01 | The Tech Between Us s3 e7
(Raymond Yin) Of all the technologies we talk about here on the tech between us, none affect us as intimately as the one we'll discuss today, Digital Therapeutics. Healthcare has been undergoing a digital transformation for many years, but it's been accelerated over the last few years because of the pandemic. Digital healthcare options such as telemedicine are now commonplace and frankly sometimes even preferred over face-to-face visits. So many aspects of healthcare have gone digital and have been integrated into daily life. Think connected devices like insulin pumps, blood glucose meters, and your own wearable device that sends data back to a central, unified system, big brother with a stethoscope, if you will, to explore this exciting new field of healthcare. I'm talking today with Dr. Smit Patel, Associate Director at the Digital Medicine Society. Hi, Smit. Welcome to the Tech Between Us.
(Smit Patel) Hi. Thanks for having me. (Raymond Yin) To start us off, can you tell us a little bit about what you do at the Digital Medicine Society? (Smit Patel) There's a lot we can do, but before I say what we do, I think I might jump into really quickly on why we do it and frame it in terms of why we are established in the first place. We are a global nonprofit dedicated and advancing ethical, effective, safe and equitable use of digital tools to optimize and better our health and health outcomes. So essentially, as we were founded in 2019 right before Pandemic. We were seeing this digitization of healthcare. All across the board individuals are using digital tools; however, there were staggering challenges when we think about in the healthcare space. We saw mainstreams of data coming out with these various digital tools, a lot of organizations not knowing what to do. We saw aggravating health equity concerns where tech
tools were being developed like a PPG monitor that was working great for individuals with lighter skin. But Duke Big Labs University found that it was not that accurate from the validation verification for individuals with lighter skin. So just aggravating concerns over health equity developments that was of rampant with less… no considerations of equity. When we think about AI, ML tools, and silo fragmented healthcare systems where payment infrastructures are still hard, and yet to be determined, when it comes to evidence assessment between these tools. And then last but not the least, how do we even define these various tools? As they're building, how can we make sure every stakeholder across the industry is speaking the same language? So, there was a lot of things happening. Healthcare was full of shift at that time when we digitized. Those problems are not different few years ago. But rather what was different is we now
have the tools of digital that we can use in our power. With Covid pandemic, shift in how people started using various tools and change of care that came with Covid was pretty significant. The shift came from individuals going to hospitals, to the now care being designed around individuals, around their homes, around their work settings was. (Raymond Yin) Much more personalized care.
(Smit Patel) Exactly. And that's where DiMe came in as this global nonprofit who sits right at the intersection of health and technology. And we call ourselves conveners. We bring stakeholders from investors, payers, regulators, health systems, clinicians, ethicists, engineers, from a hardware, software engineers, designers, all together to determine what good looks like; what is our North Star. We have seen these challenges in healthcare for a very long time. You add a digital layer to that digitization of healthcare. This is not the
time that we create more gaps, but rather how can we curb those gaps and build a good North Star that works for all individuals. That drives good health outcomes, that improves on equity that works, and that we do it in an ethical fashion across the tapestry of digital health solutions that are out there. So that's what DiMe does - convene various stakeholders together to build standards and frameworks and toolkits and resources that individuals can go back to with the common North Star in terms of what good looks like. (Raymond Yin) You're providing a lot of structure around this huge digital transformation of healthcare and medicine. (Smit Patel) You said it right in one line. (Raymond Yin) When we talk about healthcare and medicine, there has been a lot of talk on digital healthcare, digital medicine. Are they one and the same? Are they synonymous or is
there a difference between the overall digital healthcare and digital medicine? (Smit Patel) Really good question and we get this a lot. So, when DiMe founded, one of the first things we did, in a collaborative setting, with a strategic advisor is to essentially put down a few thoughts around what entails a digital health versus medicine versus therapeutics. So, if we think about digital health, which is like this largest category that includes technologies, platforms, health systems that essentially engage consumers, that has some kind of a lifestyle wellness or healthcare related measurements where there is a capture of the data, storage of the data, transmission of the data to help clinical operations, maybe health operations in a wellness setting. But those are not the ones which are regulated, those are not the ones that needs evidence-based clinical studies. Are categorized as this large digital health category. So, let's take an example: Fitbit or Apple Watch,
which everyone knows about. Is this digital health product because it's a consumer product. They don't claim that they're doing anything other than wellness and prevention. So that falls under their digital health. They are clinical decision supports in digital health
categories. They are health system supports, they are health IT technology (HIT) and consumer health exchange information infrastructure. Those all fall under the digital health. When we talk about digital medicine, it becomes a little specific. So digital medicine is essentially evidence-based software and or hardware product that essentially can measure or intervene as some of the other kind of human related measurements. So,
think about if I'm wearing a Fitbit or an Apple Watch. A wearable sensor or a connected sensor product, which measures say my sleeping activity, my physical activity. Those become a smaller subset, which is a digital medicine product. When something is a digital
medicine product, it is a measurement product that gives objective data using a hardware or software tech component, but has some evidence needed for it. You can't say like, oh, and a software app on my Apple store is going to measure my sleep if I keep it 500 meters away. There are accurate measurement criteria that goes under it, verification and validation that goes under it. That becomes a digital medicine product. And there are implications on regulatory side for digital biomarkers. We talked about Fitbit and Apple Watch. Let's, let's continue with that. Right now, in the field, from a clinical side, Parkinson's, we have seen over 30 years, there has been multiple drugs that came down to the market for Parkinson's.
Yet there has been not a single drug that has been completely effective because until now we were not able to measure Parkinson's patients’ activities. When we did some of the studies, we found out that the Parkinson patients, for example, says that for them it's important to have the walking ability. So that becomes a measurement of interest for digital Medicine. Or Myopathy is like a block in the heart that leads to someone not being able to perform daily activities as they want. They want to include or understand a patient's activity. That activity could be number of steps per day. That activity could be how much physical activity they have in one day,
in 60 seconds, how many steps a person is taking. Those are critical measurement points. That becomes interest for research. Then the walking ability, when used with an accelerator or gyrometer, as a tech device can help with an accelerator meter unit. Again, I'm talking very research focused, but now an Apple watch being used for Parkinson's patient, or an Apple watch being used, say in clinical trials, the consumer data now becomes a health data. There are implications to what we are measuring in clinical trials, even though a
patient or user is still using the same Apple watch, but the measurement has changed. We are changing what we are measuring for that patient. It's very specific. So now that same Apple Watch or Fitbit has transitioned from a digital health product based on intended use, which was wellness. (Raymond Yin) In the common market, just fitness. (Smit Patel) Yeah, to now more health measurement, to something that has clear implications on regulatory privacy, security data, becomes a digital medicine product. (Raymond Yin) So really, digital medicine is a subset of digital healthcare. That device is taking the measurements and
actually applying them to a regimen or something that is specific to a patient. (Smit Patel) A hundred percent. Specific for their disease, their disorder, their physiological function, their behavioral function that becomes a digital medicine because it has moved beyond fitness. That's how the infrastructure of digital
health, which encompasses all tools to digital medicine, which becomes very specific based on what purpose it has or what purpose that tool has in context to clinical care or clinical research. (Raymond Yin) Okay. So, let's take a step down. How does digital therapeutics fit into the framework of digital medicine? (Smit Patel) This is a new class of categorization. Digital therapeutics is like a subset of digital medicine. So digital health, digital medicine and then digital therapeutics, which is a medical intervention driven by software that does one or the other things, which is treatment management or prevention of a disease or a disorder. So, it is very specific to not measurement, like digital medicine, not overall consumer facing like digital health, but rather one that is software driven. It is clinically
evaluated, and it does treatment management for prevention of a disease or disorder. One that can be prescribed or cannot be a prescribed digital therapeutic product. One that can act as a standalone digital therapeutic versus one that can also be connected to a drug, or a biologic can become a digital therapeutic product. And there are few foundational principles for that, and I'm happy to share an example in a second. What constitutes actual digital therapeutics is not only the prevention and management, but also incorporates the end user.
If it's a patient, then end users in the product design and development and the deployment of it that also incorporates patient's privacy and security measures in place that also applies or has some kind of trial data that supports the evidence underneath. To give you a context, is opioid use disorder, for example, it's such a large problem in US. There are therapies like buprenorphine. Drugs that are given for opioid disorder patients. A digital therapeutic of an opioid use disorder by a company called Pear Therapeutics.
It's called Reset O, it's a DTX product, buprenorphine assisted treatment. So, someone who is already under a Buprenorphine drug is given this DTX therapy, a digital therapy or digital therapeutic, that they can take at their home. Essentially, it's a 48-day adjunct treatment where individuals will have cognitive behavioral therapy on their phones or on their laptop, where they'll see some videos. They will interact with this digital therapeutic app/software app. And it was found that 71% of patients essentially were craving - between 10:00 PM and 7:00 AM - opiates. When doctor's offices are closed. So, what do these opioid OUD patients do? They go back to taking opioids. So that's why digital therapeutics are important, where they can
be intervened whenever they want, on their phones. They can continue their treatment at their home, at their convenience, which is prescribed, which also has some clinical support or evidence underneath that because it has been tested in clinical trials on how it works for the patient. (Raymond Yin) So, the therapeutic is for a specific disease or a specific issue, rather than general measurements or general data collection? (Smit Patel) Correct. It is for treatment or management. (Raymond Yin) I had read that one of the original areas of DTX was diabetes. Is that still a major area? Or what areas
has digital therapeutics kind of branched out into? I wasn't aware of the opioid treatment. (Smit Patel) It has evolved into multiple areas. As you said, Raymond, it started with diabetes because it was the most common chronic condition that a lot of individuals in America or globally have. It's a wonderful way to have tools,
not go to the doctor's office and worry about all the co-payments that comes later. We can cut that part. There are multiple therapeutic areas that DTX has matured into, and the field has become ready for, and I'll walk you through a few examples. It has from cardiovascular, from neurology, from dermatology to gastroenterology, to even behavioral. ADHD that a lot of kids have
across the globe, it is also something that is prevalent for adults too. There's this company called Akili, Interactive building EndeavorRX, which is a DTX solution prescribed for kids aged 8 to 14. It's a video game, first video game that is cleared via the FDA, based on their effectiveness database, on the safety data, and which kids can play essentially 25 minutes a day, five days a week for four weeks. A treatment plan for ADHD. And it has shown significant
improvement in attention spans for kids aged 8 to 12. We have also seen in musculoskeletal space, so for pain management. I'll give you two examples on pain management. One for musculoskeletal, and one for normal addictive pain. Kaia Health, which uses motion sensors attached to an individual's body. So, an individual can use their phone, keep that in front of wherever they are. They can do virtual PT sessions, which becomes a DTX because they study it, they have real time monitoring on how they're doing. And what it was found is DTX reduced 58% of the pain
compared to 40% in the controlled setting. So, at home pain management through these motion sensors is considered as a DTX. Another one, Relief VRX, which is a virtual reality, product that was first cleared by FDA that uses virtual reality headsets that individuals wear. It's for adults 18 and over, where daily treatment, for an eight-week treatment, showed improvements significantly in pain skills and pain levels that were compared to in the controlled setting. I'm a clinician, so I speak more from the data. But these are some of the
therapies that are prevalent and are being used, essentially. They're neurology like for stroke rehabilitation and multiple sclerosis patients who have movement disorder. There's a DTX, MedRhythms, uses music and something called a rhythmic auditory stimulation, which is a clinical term that uses music and sensors to essentially help them rehabilitate. There are therapies in smoking cessation, in oncology or cancer care management, there are therapies in insomnia for sleep disorders. So, across the board, now, field is ready to mature beyond that diabetes space. And now innovators are looking forward to exploring various different spaces for digital therapeutics.
(Raymond Yin) Going back to the ADHD, my son has ADHD, and he is prescribed Adderall. So, you're saying that the digital therapeutics have a similar efficacy to pharmaceutical solutions. (Smit Patel) Yes, so, one of the things that even as a clinician we don't want is, and as a parent rightly, we don't want kids to give pills and more and more pills when we can have a digital solution to it. So yes, the EndeavorRX,
which is FDA cleared product, has really strong results. It has been tested for the last seven years in clinical trials to show the efficacy levels as good as the drugs that are being taken for example, in Adderall, in comparative settings, and it has been shown, really impressive results for ADHD. I'm an adult, I don't even have ADHD, and I want to play that video game just to improve my attention span and focus. Imagine that for kids. (Raymond Yin) Yeah. If that was around that would've been the way my son would've gone, rather than the Adderall. And there are all kinds of issues with medication. Whereas it seems that the regimen for the digital therapeutic is four weeks and we're done.
(Smit Patel) Yeah; 25 minutes a day, four day, five days a week, and then four weeks, which is a month's regimen. And an individual can have an increased attention span compared to continuous drug treatment that could be repeated if symptoms are not improving. So, I think it's shifting the way we care. Again, this has not been incorporated as clinical guidelines. (Raymond Yin) Oh, sure.
(Smit Patel) But because being new, it takes some time to get there. However, solutions like these will change the health and the care for our parents, ourselves, our kids, in the next few years. (Raymond Yin) Interesting. So, I know we've all seen commercials for Prevagen that's supposed to help improve attention and mental capabilities as we age. Is
that something that could be accomplished through a digital therapeutic, maybe in the future? (Smit Patel) I think yes and no. I'm hopeful it can be accomplished because there are various areas from attention from sleep, from activity measurements that are being looked at, that are being researched. And I come from a stance where time, we believe that hire a research scientist first who creates labels for your product. (Smit Patel) Hire a scientist first, hire engineer second, and then then hire marketing manager. Because that's how you build the right infrastructure for good evidence-based product that will be not just out in the market but will be adopted by multiple different end users. If it's patient,
then definitely patients will want to use that. So, the long, long answer to that, I think yes, we will see a lot more digital therapeutics that will be developed over the years. We have seen a span of right now over a hundred digital therapeutics in the research phase. (Raymond Yin) Wow, that's huge. (Smit Patel) And interestingly, I was reading this survey from TLG Consulting, not the most accurate data, because I've not seen their statistical analysis, but what they had captured was the brand prescription drugs percent rate, and then the new digital health product rates growth, which was I think 22% versus brand prescription drug is 7%. What's correlated in 2035 so 12 years from now equal in number of products that we will have from brand prescription products versus the digital health products. And a subset, hopefully in the digital therapeutics
that we will be able to see a lot more of something that can improve care significantly. (Raymond Yin) That's really impressive. It is such a new area. I think I read the first time the term was even used was less than 10 years ago. And yet we've already got over a hundred therapeutic products in the pipeline to cure this huge neurological, cardiovascular, mental health, diabetes, on and on as therapies for the different ailments. That's huge growth.
(Raymond Yin) Let's pivot to a set of rapid-fire questions, which come from our sponsored partner, Microchip, providing engineers innovative products to reduce risk, lower cost, and speed time to market for applications across industrial communications, automotive, and more. Explore more from them by visiting mouser.com/microchip. What is the most innovative - and I'll let you define that yourself – innovative therapy that you’ve come across in your experience with digital therapeutics or even digital medicine, in general. (Smit Patel) I have one on top of my mind. It's the smart toilet seat. It's one of the most amazing therapies. So, smart toilet seat,
developed by one of the Rochester University’s researchers. They are a startup applying for FDA process. They have three different sensors on the toilet seats that essentially measures fluid overload for heart failure patients. So, what happens in a heart failure patient,
there's a buildup of fluids over five to six kilograms in three to five days. That means that someone is going to have a heart failure, an indication on the clinical side that we always look for. This smart toilet seat essentially does not ask for anything. Individuals go do their potty, sit on the toilet seat for 30 to 60 seconds and measures the fluid overload. (Raymond Yin) That's amazing! (Smit Patel) Which is incredible because patient has to change in nothing. And in a preventative sense, we are able to find such rich data, identify if someone
is going to have a heart failure or heart attack. So, I think that would be the most innovative one. (Raymond Yin) That is amazing! As an advocate for digital medicine, I know you've traveled a zillion different places. What has been your most favorite place to travel over the last few years? (Smit Patel) That place is actually somewhere where there was a little less digital. It was Madagascar, so pre-pandemic, I, and a couple of my friends, we love non-traditional places, and Madagascar was one of the ones, and I had on my checklist to climb mountains. We were
on this bay, which is a national park that is very close to a calcite form naturally formed mountains where you can do rock climbing, very dangerous, thrilling experience and do like night hikes in the rainforest and things like that. So that was my most interesting experience. (Raymond Yin) Sounds a lot like exercise! (Smit Patel) It does. And I had no wearable sensors at that time, no connectivity when I was in the rainforest. So, it was perfect because I was not measuring anything. I was just living there. (Raymond Yin) Oh, that's great! So, going back to specifically therapeutics, as a clinician, I know you've been involved in a lot of different trials. Have you had of a favorite one, in other words,
one that really, touched you in some way or one that really stood out? (Smit Patel) Because I'm not the patient for a lot of these digital therapeutics. I don't have ADHD or like cardiovascular problems, I have not tested, but in an ideal world, if I had to or if I have a wish list, Akili Interactive is working on expansion of EndeavorRx, the video game for ADHD in adult population. They're testing on adult population to see if it has similar results, if they have to make any changes. But a video game that you can actually use in a real-life setting. I think it's magnificent. I'm an adult, I don't even play video games, but I would totally play that game to increase my attention span. So, I would have to go with that.
(Raymond Yin) I am a gamer. I'm always playing at least one game. And you're right, it would be the best of both worlds being able to play in a game that I enjoy plus actually get a benefit from it. That would be amazing fun. (Smit Patel) What a great way to shift medicine is making it fun. Because who likes to go to doctors, who likes to get drugs. I mean, we all have to at some point in our life, but can we make healthcare a little bit more fun? (Raymond Yin) Absolutely. Last rapid fire, if you could do anything other than what you're doing today as a job, what would that be? (Smit Patel) Oh goodness. I have not thought about it because
this is from my pharmacy world, which I was in the past, to this is my favorite ideal state world. If I was doing anything other than what I'm doing right now, I think I would do policy writing or more on the world of advocacy because I see a lot of passionate individuals, intelligent individuals in this space. Whatever I can do to influence policies that impacts individuals, health, individuals living be it climate or food security, be it home security, I would shift my career in the advocacy world. Essentially to just make it bigger, make it better for all of us living. So that the short timeline that we have, we all can live more peaceful and healthier and better.
(Raymond Yin) I think you'd be awesome at it. Just from the time that we spent together. You would be amazing at that. (Smit Patel) Oh, thank you. (Raymond Yin) Thanks for joining us for part one of our conversation with Dr. Smit Patel. Be sure to catch the next episode of our
discussion as we dive deeper into digital therapeutics. If you'd like to learn more, the Tech Between Us Podcast is just one piece of Mouser’s in-depth look at this subject, explore the entire Empowering Innovation Together content series at mouser.com/empowering innovation for technical articles, use cases and more. (Sponsor) A leading provider of embedded solutions, Microchip Technology provides engineers an innovative and comprehensive product portfolio aimed to reduce risk, lower cost, and speed time-to-market for applications across industrial, communications, automotive, and more. To learn more, visit mouser.com/microchip.