The situation reminds me of the regulatory environment in aviation. Aviation in general is super regulated for the usual “people could die” set of reasons. If you buy a normal certificated airplane like one from Cessna or Piper, you are subject to heavy regulations around what you can do to it in terms of maintenance. You can’t do much as run a USB charger to the cockpit panel without the FAA coming down on you like a ton of bricks. You have to go to people with the right government $tamp to get anything fixed. It’s a huge burden but it’s all in the name of safety.

The FAA does however have a parallel track, called Experimental-Amateur Built (E-AB) where if you build the airplane yourself for educational or recreational purposes, it’s subject to a mostly separate set of rules. They are generally more relaxed in terms of what maintenance and modifications you can do but stricter in terms of what you can do while flying (can’t take passengers for hire, for example). Most pilots prefer the certified/safety-first/highly regulated track, but the government recognizes it’s a trade-off and offers the other option for those who prefer a more DIY-friendly world.

Not saying this would necessarily work for medical devices, but there is precedent for acknowledging the trade-offs when it comes to DIYing safety-critical stuff.