Also, I suspect this is FUD by some entrenched medical devices companies who know how to play the game of complying with standards. Anyone here ever gone through compliance testing with software? I've seen systems pass that are worse than what I would have just thought up in 30 minutes and coded up for fun. It's just a warm fuzzy feeling.
1) certification that takes 10 years (more like 3, but ...) means you, at the very best, have 10 year old technology
2) Certified at a higher level. That can for various reasons be very different from reliable at a different level. For instance, circumstances change or knowledge advances.
For instance certification tends to take "proof" that something works. Yet the most reliable robots are pretty bad hardware, with the ability for multiple components to do the same job "most" of the time. Such a device, despite being much more reliable, is disqualified a priori in nearly all certification processes I've seen.
(needless to say, every time the things they take as proof tend to be ... less than proof)
Plus we've all been in a company having this discussion. "For the price of this one 'reliable' server we could have 20 normal ones, and they would be a hell of a lot more reliable together. Hell, just give me 3 of the cheap ones and I'll make it more reliable". And we all know what the boss's answer and the resulting reliability was.
3) You assume no regulatory capture (or outright dishonesty on the part of government employees and/or lawmakers)
How do you verify that the display controller is not acting up and not blanking out a region of the display that contains essential data?
If you cannot prove things like that for your medical device, you won't be allowed to sell it.
Meeting the FDA guidelines is more about finding the cheapest way to technically meet the spec rather than trying to build something safe.
But gaming the certification process is unfortunately also a thing. In the EU the certification is performed by private companies who are themselves certified by the government for this job. The kicker is that they are competing against each other on a free market. Potentially shopping around for the most lenient certification process could be a thing. I haven't witnessed it yet but it certainly is possible in that system. The thought alone scares me.
I'm sure the price is rigged for margins. This shouldn't be a market, it should be an open duty to make these cost efficient.