Digital Therapeutics 2.0, Part Two: Connecting Users to Outcomes

Once a DTx company has determined the value its software provides, it’s time to consider regulation and commercialization

Structuring a Clinical Development Program

DTx developers need to consider the sources of value that the SaMD will provide when determining how to structure a clinical program. While a device theoretically can provide all four sources of value — direct monetization, new data, pass-through drug revenue, and capability building — it’s advisable to prioritize one, keeping in mind that this decision will have material implications on product design and the development roadmap. For example, a focus on direct monetization would call for a rapid development program with streamlined product design, all geared towards a clinical trial that met payer demands. But emphasizing new data could support the need for a more expansive product experience, tested through a broader set of clinical trials that explore the potential of the DTX platform to capture real-world evidence.

Executing a Hybrid Development Program

To combine the traditional and software development processes successfully, the following practices are key:

  1. Test for usability. Prototype the device quickly (but not completely) and move into testing. Test for user engagement first, under the guidance of a clinician principal investigator, continuously iterating the product until it is effective for its intended use. Iterate testing pilots to balance between usability metrics and outcome measures. This will take multiple rounds with increasingly larger subject populations. Depending on the clinical trial partner and principal investigator, this activity may trigger the need for an IRB approval to ensure the methods of testing are ethical and are a manageable burden for the care team.
  2. Test for clinical outcomes. After usability optimization starts to taper and an efficacy signal indicates the testing should continue, the next step is to run a true clinical trial. Of course, the product and user experience need to be kept as is throughout the course of the clinical trial to ensure scientific rigor.
  3. Don’t assume that an RCT is required. There may be no good mechanism for randomization or control, and regulators or payers may not require it. Pharma companies often fall into this thinking based on experience in the drug development world.
  4. Keep testing. Once the clinical testing has come to an end, don’t assume testing is over for good. Continue to iterate and optimize for version 2.0. Digital products must be treated as living solutions, not static apps.



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