Digital Therapeutics for Better Health with Dr. Smit Patel: Part 01 | The Tech Between Us s3 e7

Digital Therapeutics for Better Health with Dr. Smit Patel: Part 01 | The Tech Between Us s3 e7

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(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  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 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

2023-07-29 19:52

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