The Problem With Digital Therapeutics — We Just Aren't Prepared for Them
The Digital Therapeutics (DTx) space has swelled in the sheer expanse of new companies in the space alongside a veritable flood of funding pouring in by investors. 2020 and 2021 saw multiple significant events that have solidified the maturation of DTx, including but not limited to:
Pear Therapeutics launches Somryst for insomnia
CVS and Sleepio partnership
Kaia expands into COPD
Mahana Therapeutics gets clearance on their CBT based DTx for IBS
NightWare's DTx gains clearance for PTSD and sleep disturbances
Due to the change by the FDA and fast-tracking psych related treatments during COVID-19, Akili gets their EndeavorRx DTx for ADHD cleared
EndeavorRx provides a novel means of engaging a DTx treatment through game mechanics.
Nonetheless, I have become a bit fickle about the nature of DTx. I should start by saying my background in digital health stemmed from early works with iMedicalApps where our teamed reviewed mobile medical apps for clinicians and patients, and my early work focused on apps that could clinically benefit patients. Keep in mind that this was in the early 2010s, and our team recognized that the deluge of apps on the market and lack of FDA involvement at the time leaned high credence towards a market whereby external organizations would attempt to vet apps for potential prescription based utilization. This was reinforced from my personal experience of having reviewed several thousand apps and finding virtually none with a clinical benefit for patients aside from digitalizing already conducted patient skills (e.g., data capture, monitoring of symptoms, health/wellness).
There are now over 300,000 health-related apps on the market, but many will likely never even see even a viable uptake by users to justify their creation. Instead, the FDA and market have been subsumed from mHealth towards DTx, which I think was a natural evolution of the space. And that arrives at my currently flummoxed position: I do not think most of the so-called DTx on the market are really DTx; many companies want to be labeled as a DTx to encourage investment to stand out from the overloaded digital health landscape. This position may be obtuse for some, but I have served as a clinical expert in this space for quite some time. My work with HealthXL (Read their recent report on DTx with Brian Dolan, it's quite good!), The Digital Therapeutics Alliance and others have solidified this viewpoint over time alongside my early experience.
Why isn't Digital Therapeutics Mainstream Yet?
I think DTx will become mainstream at some point, just as I think digital health just becomes a part of 'health.' However, this will probably take more time than most technophiles would like to admit or those hoping to make bank overnight want to consider. We are likely more than a decade from what I would even consider as 'mainstream' DTx utilization, though I would suspect in 3-5 years we'll see them being used much more frequently and in certain conditions.
The issue is not so much having products on the market or even cleared by the FDA. That is only half of the battle and the midpoint of a veritable marathon towards success. Rather, the crux of the matter is that the theoretical principle is sound and scientifically worthy of use, but now the practical implications of integration into society will be the real battle going forward, which I think many DTx companies are starting to realize.
Who are the Key Stakeholders?
There are three areas or stakeholders the DTx crowd will need to convince to achieve some manner of utilization this decade, I feel, including:
Patients - Many would argue that this group is the 'end user' of any DTx intervention, but I think providers and patients are both end-users but for different reasons. In the patient case, demonstrating the usability of a product will be critical. Similar to other medical interventions on the market, adherence to therapy, set-up, and administration will be key, and as such, they really remind me of current pharmacotherapy pathways - especially those that use a combination device for administration (e.g., autoinjector, inhaler). For those in pharma or related industries, we already know this is a considerable difficulty activating and onboarding patients already, but perhaps we can borrow certain interventions to solidify the process. Ultimately, I think DTx companies will need to borrow much from pharma in their go-to-market strategies primarily associated with market shaping to introduce this new field to their care process. I think we'll likely see direct-to-consumer advertisements hitting media in the next few months, similar to what has been occurring in the psych space.
Payors - This one is, I think, pretty self-explanatory and is one of the biggest hurdles that mature DTx companies are facing where they need someone to pay for their product, whether it be a B2B or B2C model. The B2B via an employer or other benefit management service would be ideal and likely eventually transform into larger insurance markets in the late 2020s. But, payors want evidence of utility, and financial value of service, which I think we are seeing the data slowly coming to light, hence by a conservative estimate of many digital health advances only being adopted end of the decade. It's almost like the 2010s were a decade of pilots, and the 2020s will be the efficacy studies at large.
Providers - Now, this one may surprise many of my readers, but I think the most significant limiting factor will be providers or those involved in direct patient care. They are your other end-user that I think get largely ignored. I mean, I can understand the logic; you have a clinically viable product that patients want, payors will cover, and you just have to sign off on it! Get going! And yet, I don't think medical practice changes overnight, and even after the pandemic, we will see the pendulum turn but ever so slightly. Look at best practices, they take years to adopt half of the time, and medical professionals will bicker about evidence-based medicine until the next best RCT. Trying to convince the medical establishment that digital health is useful is going to be an uphill battle. Modeling after pharma companies that have to expend considerable money into their medical affairs and commercial teams to get providers to learn and possibly utilize their products is a substantial affair, DTx faces the same hurdle. And I have yet to see a MSL for DTx (I do know they are hiring) or a similar push at scale that convinces me that providers are rapt to be approached. So, if I had to place a bet until medical training adjusts to digital health and DTx as an area of focus, nothing changes quickly.
As you can probably take away, one of my most significant concerns is going to be the health provider market which could highly limit the buy-in of DTx. Others have talked about this, but I think the angle that many are focused upon is getting DTx into the hands of providers right now and expect almost a trickle-down approach where DTx would then propagate through the whole market. A belief that if some providers see the benefit, then they'll help the marketing strategy. I think that could be a decent market-shaping strategy, but not one that will really get to the root problem digital health faces. Rather, I honestly think getting digital health education off the ground and embedded amongst future health professionals will be critical for longstanding change.
Considering this, you may be wondering, what would it take to just teach medical professionals about DTx? It can't be hard, right? Well... let me do some theory crafting on the current barriers facing DTx and digital health at large and some possible solutions I have been considering.
Theory Crafting: How to bring Digital Health into mainstream medical education
First off, I will base this theory craft on my academic background and previous work exploring digital health in pharmacy and related medical education. I've had some time to play with this and discuss it with peers, but I would argue the following are some of the most significant areas of concern I currently have at this time.
How do you integrate digital health education? This is going to be the penultimate question at this point, and we are obviously at a transition period where we need to start somewhere prior to it being built-in. I look at it similar to when we used to teach pharmacognosy and now just jump into pharmacology and pharmacotherapeutics. In any event, there are three sub approaches currently available for tackling educating current students (without even getting into post-grad/residency, new practitioner, and related education), each with pros and cons:
Three Approaches:
Certificate Model - Probably the most widespread model of introducing digital health into medical programs at this time, though predominantly focused on the 'business aspect' whereby encouraging future/current health practitioners to create their own company. I have not seen many digital health certificates as a knowledge-based model. I am unsure if the value of these certificates will increase the candidate's desirability or serve as a crash course. Given the nature of digital health being so obtuse now, it is a safe model but not likely to extend past the 2020s.
Co-Curriculum/Track Model - Several medical schools are looking to build internal 'tracks' whereby students will have the opportunity to get didactic and rotation/internship experiences in digital health. Hard to determine if this a la business offering again, or more so on the clinical side. But, I would say the 2020s will likely see this be the breakout point for most health professional schools to engage in due to limited logistics and no direct need to integrate into the curriculum, thus beneficial for those interested.
Built-In Curriculum Model - Likely the standard to engage upon if we think digital health becomes mainstream and part of the wider health care landscape. I'll touch on issues about this in #2.
Resource Issues - No matter what model you go with at this time, you face similar issues, including:
Access to devices/software/technology in the classroom
Faculty capable of teaching and demonstration
Teaching staff and training of ancillary staff
Losing staff to digital health companies and pharma (brain drain for $$$)
Support from administration and related academic peers
Hypothetical Built-In Model or Clinical Fundamental using Digital Health. Assuming that a built-in digital health model for medical education is the end goal, let's get into the fine-tuning. First, though, let me make an analogy of DTx to pharmaceutical products. Understanding medications does take a significant amount of work, including a basic understanding of, but not limited to, the following: pharmacology, biochemistry, pharmacokinetics, pharmacodynamics, anatomy and physiology, clinical studies and design, and current understanding of disease therapeutics (often taught on a systems-based approach [e.g., cardiology, nephrology]). So if we think about extending the same principles to digital health and DTx, we run into several issues:
What are the prereqs? Thinking about most doctorate-level health professions, we see a certain level of pre-required courses, such as organic chemistry, biology, and related health sciences courses. But, when we enter digital health, is there now a need for digital health sciences, and what does that entail? Suppose AI/ML or more expansive areas are wrapped under digital health. Is there a scope of basic understanding of computer and mathematical sciences beyond calculus and physics that future medical practitioners now need is something I wonder.
The more significant issue of digital health education - what depth of knowledge is needed for future practitioners? This is my struggle, especially as an educator of medical professionals. When I teach pharmacology, I scale my approach across different professions on how in-depth on a topic I am willing to take. For instance, I could be responsible for cramming infectious diseases into a 2-hour lecture for physical therapy students, which may be reasonable depending on their knowledge responsibilities. But for a prescriber or pharmacists? We know they are getting hours of knowledge in that space. So, does the same extend to DTx, for instance? Do we teach topic knowledge of concepts such as RPM and workflow design for those that will be involved in DTx, while those that may be ultimately prescribing and monitoring DTx usage and patient outcomes then need to understand the clinical foundations of the topic? Similar to say, talking about an SGLT2 inhibitor and its mechanism of action, related physiological response, monitoring parameters, and clinical indications of use with applicable guidelines of approach? That stuff does not even exist, and we have to make it. That is a big issue right now. I have my theories going beyond this, which I may write about in the future. But in any event, if this material eventually becomes available in a teachable format, I suspect DTx and other digital health interventions will not be a separate course, but the material would then be passed into the systems-based approach. So, for instance, if you were learning about cardiology, you would also learn about any DTx products available for treatment, how they work into practice, how to manage patients with them and other interventions, etc.
Space in the current curriculum. Look, let me be honest, all health programs are slammed right now. If the pandemic has taught me anything, it is that over time, students are more pressed than ever to compress a veritable endless glass of knowledge that they will not be able to take in without drowning under mental fatigue. So someone reading this says we just add it into the curriculum; that sounds nice, so what do you cut from the curriculum? Do you want your future doctor, for instance, to take a step back from XYZ to add in DTx? Then think about current practitioners, who by and large have not bought into digital health. Do you think they want to make a cut out of what they teach for something they do not think is mature at this point? Lastly, keep in mind most curriculums are designed around accreditation bodies that dictate what needs to be taught.
When should we start integrating Digital Health into the Curriculum? This may be self-explanatory but worth talking about as I think it really may drive issue #2. Right now, we see early adoption with medical continuing education and seminars, but the issue for mainstream medical education is the bigger area. Currently, I would say there are several items to consider limiting formal education adoption:
FDA Clearance does not mean clinical adoption. Face it, there are many medications approved that fell to the wayside due to ongoing clinical evidence on best practice and medical treatment, along with therapies that took years to take off. I point out Entresto, for instance, as a new kid-on-the-block for heart failure that had initial problems because the field had seen no significant changes in almost a decade. DTx just showing up with FDA clearance will not be the magic bullet for these things being adopted into practice, which leads to the next point.
Clinical Evidence of Utilization
Landmark research that we can point to as clinical validation for patient care
Integration of evidence into clinical practice guidelines, which I think we are seeing right now with diabetes, especially with the use of some technology such as insulin dosing and CGM technology
A push across industry, academia, and general medical education
As more products come to market, it will cause a shift of thought on how to adopt them at some point with growing awareness -- Likely digital health companies and their pharma partners will play a marketing role
Board requirements on licensure exams would be a game-changer as it demonstrates key knowledge gains, which would be because of...
Adoption of digital health push from health profession education accreditation bodies
Future job aspects that require an understanding of using digital health tools and services would also spur educational institutions to adopt digital health, even if not globally supported, to give themselves an edge in student recruitment
That would sum up my three concerns related to DTx and digital health education at this point for the health professions. And I think this could be the rate-limiting step for the global adoption of digital health and DTx into clinical practice. I look at it like this, if EBM is supported by the best evidence, patient preference, and clinical judgment, we could argue the evidence is coming along (still not great), patients are growing acceptance (growth of telehealth and app-based care), but clinician judgment is missing because they lack the education.
What can we expect then to occur?
I will take a leap here and say I expect that DTx and many digital health companies will start paying more attention to the knowledge gap of clinicians now. They know they have a product, they know where their research/evidence is at, they are reaching out on patient market-shaping strategies, but they haven't figured out the educational market.
Yes, I would fully expect to see CMEs start popping up and multiple invited dinners and outreach by MSLs and commercial teams to current practitioners, but that does not necessarily mean widespread adoption quickly. More often than not, current medical knowledge is very horizontal once you get out of an educational campus. We learn independently, depending on our passion for lifelong learning or need to keep up on information for our exams and board certifications, and passively absorb knowledge from our peers or institutions. But, health education in a formal scape is very top-down and presents a large opportunity to drive expectations of what is to come once you graduate and escape your rotations for actual practice.
I think the most aggressive companies will go the same route as some EHR companies and support the use of their technologies in the classroom or reach out to academics to get them on board about their products. I am seeing that now with manufacturers of CGM devices who are working with faculty so they can educate their students on the technology. The same will likely happen with DTx. Because that's the rub, medications by and large aren't something that needs to be touched (aside from learning how to administer them and related topics), and we don't have students experience the effects of medications or procedures (aside from some hands-on practice experiences ranging across roles and responsibility of said health professional), but since DTx comes in many forms and facets this may be an interesting point where students could 'play with' a DTx to better understand how they work and what their patients could expect.
Timing is going to be the biggest issue and will rely on a convergence of multiple factors. I feel academic units will start taking this seriously in the next 24-months as they acclimate towards telehealth/medicine services that their students will need to adapt to and focus on other targets of opportunity going on. After all, we saw that the AMA has put out two practice documents on telehealth and RPM at this point, and I would suspect that with changing CMS billing codes and services opening up, DTx and other digital health products and services will be scrutinized.
What are possible solutions?
I am not going to claim I have any immediate solution to what I think will be a transitory period in acclimating the medical establishment towards the digitalization of clinical services and new therapeutics arising on the market at this time. Rather, I think most of what I could propose are stop-gaps or introductory mechanisms to make the change, not a sudden wave of drive to change by outside stakeholders that could push academics and students to the brink unnecessarily. So here are some thoughts:
DTx and related pharma partners need to expand their educational outreach. Target three layers of health students, 1)Current Practitioners, 2) New Practitioners (e.g., residents, post-grad), and 3) Health Students. Each would need a different style and educational material, but I do not think that would be incredibly difficult to put together. The issue is that a team should assume that, by and large, most of those they engage upon may not know or have limited knowledge about digital health and DTx as a whole.
I should probably put my experience here about that last statement. I've heard from people that they think most people know about digital health, but pharmacy focuses on informatics and related automation. So I would always encourage you to explore what people's definitions are if you broach the topic.
Health programs and professions need to start discussing how we are going to tackle digital health education. One issue is that I feel everyone wants to define digital health and then figure out how to just plug it into the curriculum. This may be fine, but we will likely come back to the drawing board in 5-10 years when new technology or approaches come out. I feel like we are on the razor's edge where we really need to rethink the approach to healthcare, even the health consumer mindset, and how health care is going to be delivered this century compared to the past century. So, getting organizations to start deciding what digital health means for their profession and what needs is there should be discussed and explored before it gets to a point where institutions realize they've fallen vastly behind. Case in point, look at how many programs are trying to now implement telehealth discussions and education despite it being something available for more than a decade. We weren't ready.
Again, some personal experiences. Within pharmacy, we are now seeing a push towards talking about digital health, and our organizations are tackling it, which I am greatly appreciative of, as this has been a professional goal of mine for the past decade. I am grateful to be part of this process.
I could add more, but I think from a meaningful viewpoint, these two issues need to be addressed first. Other points I could make, but those would be more tactical, like actually delivering digital health content, which I have written about other places or spoken about. If there is interest in that, I could probably dedicate another longer piece towards int the future.
But, if you take anything from this piece, it's this: We are not ready, and medical education will play a pivotal role in the growth of digital health adoption but needs resources. The question will be, who will provide those resources and be the partners of health care education?
If you enjoyed this piece and want to read some of my more formal research into this topic, please feel free to read the following articles. Lastly, I greatly appreciate the work I have done with Ravi Patel, PharmD, who has played a significant role in helping me process these concepts and ideas over time.