What are digital therapeutics?
I would be remiss not to acknowledge that there is some vagueness around what constitutes a digital therapeutic. One presentation in this conference track put forth a definition that essentially described digital therapeutics as any therapy with a digital component – from a VR simulator used for a type of immersion therapy to treat PTSD, to a companion mobile app that diabetics use to track their insulin intake. While useful to get a general grasp of the proliferation of digital therapeutics, this definition does lump together two very different types of therapies, each with unique considerations from both a regulatory and user experience perspective. An article from the MIT Review last year defined digital therapeutics in two categories, “medication augmentation” and “medication replacement,” and further described how the devices differentiate themselves from wellness tech. There is typically clinical testing conducted to demonstrate efficacy, and sometimes even regulatory approval sought with a digital therapeutic.
The lack of clarity around what constitutes a digital therapeutic does have the potential to, for example, hinder prescribing behavior if all manner of digital enhancements are perceived to be “alternative-to-drug” therapies facing the same barriers to adoption. Regardless of which definition the industry ultimately settles on one thing is clear – whether as standalone therapies or a component of a broader care program, digital and digitally augmented therapies are on the rise.
Current barriers to adoption
The same session that put forward the broad definition of digital therapeutics reported some descriptive statistics around patient populations most likely to adopt these therapies successfully with respect to their demographics, online behavior, technology usage, etc. Not surprisingly, those more receptive to use of technology in general are also more likely to adopt a digital therapeutic to manage their condition. Also not surprisingly, payer reluctance to reimburse for new digital and digitally augmented therapies was at the top of the list of prescribing barriers. The UX afforded by the digital therapeutics currently on the market however, was also very near the top of that list.
Interestingly, physicians who have experience prescribing digital therapeutics were much more likely to cite “lack of innovative and user-friendly solutions” as a key barrier to more widespread prescription and adoption. There was a huge jump – from 8% of those without experience prescribing digital therapeutics to 30% of those with experience citing this reason as a barrier. So – those who have exposure to these types of therapies recognize that in order for them to succeed, the end user experience needs to receive a greater focus.
Implications of reaching critical mass
It would be easy to see payer willingness to reimburse for digital therapeutics (or lack thereof) as a sufficiently large barrier such that most effort would be dedicated to navigating this challenge. However, in another session focused on the positive future of value-based healthcare, it was pointed out that history has shown us that payer behavior tends to shift once a critical mass is established for a therapy or therapy category. Attention was called to recent legislation outlining a change in Medicare reimbursement rules for 2018. For the first time in history, physicians will be reimbursed for time they spend monitoring Medicare patients’ health remotely. As this remote monitoring capability is one key benefit of many digitally enhanced therapies, it is not much of a stretch to view this as an important step closer to a fundamental shift in payer mindset. With reimbursement practices shifting, manufacturers of digital therapeutics can benefit from looking to the next horizon of how they will differentiate themselves in a rapidly growing market.
Spend the time now to get the UX right and win the market
Aside from reimbursement, lack of user-friendly solutions was cited as one of the largest barriers to more favorable prescribing behavior for digital therapeutics. With extensive experience conducting research to inform the design of digital interfaces both from within and outside of healthcare, we know that safe and effective use of these digital products is fundamentally tied to their design – not just their functionality. There is a tendency to focus on usability and UX as a confirmatory or validation-based activity (ok, we’ve built it as we planned, now let’s test it to make sure people can use it). In fact, there is much more value and ROI to be gained from incorporating user feedback early and often in the development process. Doing so helps shape early concepts for product and interface design, leading to the kind of best-in-class UX that wins market share. It also prepares manufacturers to successfully navigate regulatory requirements for the application of human factors engineering to the development of medical devices for products that are so regulated.
If history has shown that payer behavior tends to shift once a critical mass has been achieved, and we are on the precipice of achieving that critical mass for digital therapeutics, having a “user friendly solution” is about to replace “having a reimbursable solution” as the #1 factor affecting physician prescribing behavior. Regardless of whether the digital asset in question is a standalone therapy in its own right (medication replacement), or a component of a broader care management program (medication augmentation), now is the time for manufacturers to turn more attention to developing useful, usable, and engaging products to give patients and care providers alike the kind of best-in-class experience that will catapult digital therapeutics into the mainstream.