Political Memes

It's also a medical devices being expensive in general issue. If you build something and you want it to get cleared for medical use you need to test the shit out of it and get several kinds of certification. And you need to do it all over everytime you make any change whatsoever. This can easily take two years for every change, even if you just change something trivial.

All of this is to prevent another Therac-25. For the uninitiated: That was a radiotherapy device that, due to design flaws on several levels, could inadvertantly be turned into a literal death ray. Several patients died because of this. In the aftermath, the regulations for medical decides were tightened considerably.

That's a major part of why medical devices are so insanely expensive. Much of what you're paying for is a titanic amount of certification work.

Unfortunately, this also makes it harder to implement a right to repair for these. Few people want to figure out who is responsible when e.g. a CPAP device that someone repaired themselves fails. The current approach is to make it damn near impossible for the manufacturers to screw up but that's a lot harder when the device can ever be in a configuration that hasn't been extensively tested and certified.