Digital therapeutics (DTx) have seen significant interest from innovators, investors and health systems, but their realistic application remained elusive in the slow-to-change world of healthcarethat is, until the global pandemic forced the industry to scramble and adapt to the world of remote engagement and delivery of care.


DTx standardize care delivery, maximize the reach of care and act as a unique source of real-world data. The pathways for DTx commercial success are as diverse as the types of products within this category. Our interactive framework highlights three key determinants that will influence your journey:

  • Mechanism of action (MOA): The underlying MOA of a DTx that delivers the core therapeutic benefit can be built on digitized versions of existing MOAs (e.g., GAIA’s deprexis, Welldoc’s BlueStar) or new MOAs that are enabled by the digital modality (e.g., Akili’s EndeavorRx, Click Therapeutics’s CT-152)
  • FDA clearance: Interventional, higher-risk or novel DTx (e.g., like those Akili and Pear Therapeutics offer) often require regulatory oversight compared to lower-risk solutions intended to prevent or manage conditions (e.g., like those Omada Health and Hinge Health offer)
  • Business model: DTx can be covered by health plans and employers (e.g., Pear Therapeutics’s reSET, Freespira) or offered as direct-to-consumer products (e.g., Happify, Headspace), many of which are building evidence to evolve towards future reimbursement

Instead of wondering what the most successful path to scale for DTx is, consider the key characteristics of your DTx and think about what pathway is most ideal based on that.


The interactive framework below will allow you to explore, via three key parameters, how downstream DTx considerations change based on your inputs.