3 ms·
Looks beautiful. Its always exciting to push the boundaries of what an app can do. I wonder if my breathing makes any sound at all. What is your experience wit
by macilacilove 3y ago
Looks beautiful. Its always exciting to push the boundaries of what an app can do. I wonder if my breathing makes any sound at all.
What is your experience with the medical device registration process so far? Is such medical innovation well recepted or does regulation seem to largely benefit established players?
- lukko 3y agoHey, thanks so much. Currently breathing doesn’t influence the sound, as it would also influence the detection of breathing which might set up a feedback loop if that makes sense. So we’d need to cancel out the generated audio - I’d really like to have that interaction though. The medical device regulation process is long and quite difficult. I don’t think that’s necessarily a bad thing, but it is also an opaque process with expensive consultancies charging a lot for any guidance - this makes it very difficult for small companies without a lot of funding to even know where to start. I think just the prospect of having to go through registration does exclude quite a lot of innovative companies / products, which means patients are left with a limited selection of fairly mediocre products - the registration is very boring and difficult, but obviously necessary.