We developed an evidence generation strategy for a diabetes digital therapeutic in the US, Germany and UK
What was the digital health solution?
A digital therapeutic with tens of millions of users designed to support the daily management of type 1 and type 2 diabetes. The solution is as a Class IIa medical device, with plans for rollout of a Class IIb feature.
What were the objectives?
To develop a strategy for the evidence required to achieve regulatory approval and support procurement in the US, Germany and the UK, including what standard of evidence was required, how it should be generated, and when.
How did we do it?
Conducted a literature review to identify successful case studies of analogous solutions.
Interviewed payors, policymakers and regulators in the US, UK and Germany to understand what evidence they considered most important for this solution.
Provided the client with a list of research methods suitable to evaluate the digital therapeutic, including strengths and limitations of each method and practical considerations such as cost and timeline.
Recommended studies to be conducted in each market, matching proposed outcomes with evidence requirements
