Comment by lukko
6 days ago
Hey, I'm a doctor and work in a similar area. I really like the name and well done on shipping. You can tell the app is made by a patient who suffers from the condition, which is amazing.
I would be really careful in this area though, especially using ChatGPT to generate suggestions. This to me this does venture into medical device territory, based on the intended use. Check the guidelines here https://www.gov.uk/government/publications/medical-devices-s... - UK specific, but will be similar for FDA.
Honestly, I would seek proper consultancy advice, remove any suggestions / recommendations for now, and just have it as a data-logging platform. The disclaimer unfortunately will not stand up.
Congratulations on getting this far - I really hope you continue on this path, just make sure you are on firm ground.
I don't know, I understand the advice and I guess that's probably one of the reasons Loop (https://loopkit.github.io/loopdocs/) is not on the App Store. If they had turned their project into another data-logging platform we wouldn't have commercial closed loop systems.
Thanks for the link. Yep - exactly, they took a leap, but importantly didn't release a full product / package on the App Store, or charge for features. This falls much more into a grey area, but is clearly DIY, and demonstrates demand/need for the commercial / regulated systems.
Especially when the problematic features are charged for, it gives the recommendations / suggestions an air of legitimacy which could be dangerous.
A lot of the research from Loop and AndroidAPS is used in commercial closed loop platforms; many of the people working for these open source utilities also work for medical companies.
So you either get lucky and your doctor can prescribe you a commercial loop, or you compile one from source.
I came here to say the same as the parent comment - it's an amazing achievement, but you may well have built a medical device which needs certification in order to be on the market in the territories you want to use it in.
I work (freelance) with a consultancy [1] that helps specifically with software-as-a-medical-device (SaMD). My email is in my profile if you want to chat about what might be the best way forward.
[1]: https://www.hardianhealth.com/