What’s the quality of a DTx app? Pascal Werner 12 March 2024

What’s the quality of a DTx app?


What is the quality of Digital Therapeutics (DTX), and why is it not necessarily intuitive?

Let’s have a closer look at what DTX often is: it’s an app providing indication-specific content and functions to support patients to reflect and learn about it with the goal of behavior change.

So, as it’s an app you have software development. But the app mostly provides the structure/framework to serve the content (video, images, text, etc). And that content is often provided by another team.

Often you cannot pinpoint the exact software function that provides the clinical benefit. And the software team may think that the software doesn’t provide the clinical benefit.

The content team thinks they just provide content and, since there is no norm for it like IEC 62304, the content development is not QMS relevant. In other words, with DTX we have a device where the relation of the clinical benefit to technical function is rather blurry as well as organizational structures that may not feel responsible for compliance/quality either.

There are plenty of companies doing fantastic work here. It’s just not as obvious as the development and production of more traditional medical devices like e.g. face masks.X