Not just in implantables, though implantables have that whole additional surgical risk aspect, but all medical devices have painful piles of paperwork required for each revision. They’re trying to lighten the load for “security patches” but so far it’s still a major pain. I suspect it’s the much the same in avionics and any other industry that requires documented validation against traceable requirements and all that jazz.
Oh yeah… I once had a project to change a 0 to a 1 in a file on a machine used to manufacture devices. Basically operator had to align crosshairs over a certain point before starting. At 4 of the systems the operator could just touch the screen at the point and go. At one they had to push x+ or x- or y+ or y- repeatedly to line it up because the configuration had a 0 in the option “Click To Align”… It took 8 months to validate changing that to be 1
Not just in implantables, though implantables have that whole additional surgical risk aspect, but all medical devices have painful piles of paperwork required for each revision. They’re trying to lighten the load for “security patches” but so far it’s still a major pain. I suspect it’s the much the same in avionics and any other industry that requires documented validation against traceable requirements and all that jazz.
Oh yeah… I once had a project to change a 0 to a 1 in a file on a machine used to manufacture devices. Basically operator had to align crosshairs over a certain point before starting. At 4 of the systems the operator could just touch the screen at the point and go. At one they had to push x+ or x- or y+ or y- repeatedly to line it up because the configuration had a 0 in the option “Click To Align”… It took 8 months to validate changing that to be 1