Disclaimer: my opinions, not my company.

I worked as a project engineer for a major testing company (underwriters laboratories). This is a vast simplification, but in essence the difference between medical device testing verses say, household electronics, is that in practice household electronics get evaluated with a "safety checklist" of all the serious and common problems to that kind of device (plus additional testing if deemed necessary which is not common) that UL and industry have seen over the years.

In contrast, each and every kind medical device is torn apart and subject to a clean evaluation. There are still checklists and common issues they look out for of course, but in practice each device is considered novel while the same is not really true for more common devices.

I think the latter type of testing is fundamentally more expensive, that said I think there are tons of regulatory issues that add to cost - I just want to argue that medical device testing will probably never be cheap.

Testing should be as strict as is needed. I'm arguing/assuming that US testing standards for medical devices is overly strict.

I think* there is the same "maximum" standard for all medical devices. But what's appropriate for a pacemaker is overkill for a CPAP machine.

* but am happy to be corrected (Cunningham's Law)

There are multiple classifications for medical devices.

CPAPs are class 2 devices whereas a pacemaker is class 3. I don’t want to over simplify, so I will link you to the FDAs entry point into the Byzantine maze of classifications.

https://www.fda.gov/medical-devices/overview-device-regulati...

The machines are also not locked down, however they do still require a prescription so that part of the cost still exists.

Insurance is nice because they pay for the supplies (some of which are supposed to be replaced pretty frequently). However, I've found that it's pretty easy to stretch the life of any component, as long as you clean it thoroughly each day.