> CPAPs > automotive diagnostic/programming software The regulatory evidence you need to submit, the standards you need to comply with and the quality control

> CPAPs > automotive diagnostic/programming software The regulatory evidence you need to submit, the standards you need to comply with and the quality control you need throughout the whole manufacturing process makes it near impossible to deliver community driven open-source medical devices unless it's a 'wellness' (not medical device) or maybe class I medical device. You could argue that Manufacturers could design open hardware and let people modify code at will on their custom CPAP but it would be very difficult to navigate legal liability. If someone modifies their custom CPAP and makes a firmware change that drastically increases pressure and a patient suffers barotrauma who is liable? The same can be said for safety critical firmware in automotive (excluding infotainment etc.). Diagnostics/Logging sure have at it, but actual firmware changes I would prefer that we let manufacturers do that. A 4 tonne vehicle at 100 Km/h can hurt a lot more people than just a tinkering driver.