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?
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.