3 ms·
Hey, 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 i
by lukko 3y ago
Hey, 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.