In other words, there’s no free lunch. Regulations can be incredibly expensive to support and almost always stifle innovation and increase time to bring a product to market.
Sometimes it’s still worth it. The aviation industry has had to deal with this forever because its hard to hide a plane crash. But in the end we have a very reliable mode of transportation despite its inherent risks.
Accidentally overdosing an elderly or critical patient? Hell the nurse that did it might not even know.
I’m sure there are ways to classify products to help with this. Anything where operator error creates a life safety issue, like IV pumps, could have some pretty rigorous controls over UX modifications.
Note that the more rigorous the regs the more likely that a particular treatment or tool will not be affordable and the more likely someone will die because there just isn't enough X to go around.
There isn't a single definite answer, it depends on how expensive the regs are and how much they help avoid damage.
Sometimes it’s still worth it. The aviation industry has had to deal with this forever because its hard to hide a plane crash. But in the end we have a very reliable mode of transportation despite its inherent risks.
Accidentally overdosing an elderly or critical patient? Hell the nurse that did it might not even know.
I’m sure there are ways to classify products to help with this. Anything where operator error creates a life safety issue, like IV pumps, could have some pretty rigorous controls over UX modifications.