> Screw up a medical device, you get sued out of existence.
Or, you know, people die.
Or, you know, people die.
Of course this is nothing new (Economic version: "That Which is Seen, and That Which is Not Seen"). Just another cognitive bias.
There is some more-or-less optimal middle ground between too little and too much regulation, but I don't think we're on it now. In fact, maybe it would be worthwhile to have a two-tier system, one for ordinary medical devices, another for experimental "this will probably kill you but perhaps you have nothing to lose" situations.
Also it did help that the users grew confident in it over time. It was not like these overnight success stories (not even success story) which you hear all over the news :)