Hi all,

I'm a founder of a digital therapeutics (evidence-based software interventions delivered directly to patients) startup focusing on lifestyle modifications to control high blood pressure.

As the finished product will be a (software) medical device (in the form of a phone app, in this case), there are quite a few difficulties (particularly regulatory) for conducting MVP testing that isn't itself a pilot study (which requires ethical approval, considerable documentation and wait time). Mostly, we generally do no/low code MVPs, using questionnaires (on diet, exercise, motivation, etc.), writing advice that will eventually be automated as an algorithm based on user inputs and conducting qualitative interviews with both patients and healthcare professionals. I'm a doctor and bioengineer, so I have access to patients and colleagues, and always ensure that patient safety is the first priority in any form of testing (e.g., when required anything with more than negligible risk gets implemented via a formal study process).

As the finished product will be prescription only, and the target market reimburses digital therapeutics fully (provided a randomised control trial provides sufficient positive results), it won't be patients choosing to purchase, but improving the quality will help the app's effectiveness and patient adherence, which we're dedicated to doing.

We will be running a pilot study in the next year, but the more feedback we get, the more improvement we can implement before that study. Also we're in the EU, in case that's of relevance (though quite a lot of legislation around software medical devices are similar to that in the US).

I was wondering what others think of this approach, and what they've done in highly regulated spaces - any thoughts, questions, etc. are very welcome.

Many thanks, and looking forward to engaging in this subreddit more regularly.