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
Do you know the cost to change the color on a box? Just the color, not the text, not the information, just the color?
Estimate:
$470,000
No scrap cost, old color boxes used until stock depleted.
Vendor didn’t charge us anything to change the color on the next and subsequent lots.
All that was engineering hours for the document revisions, meetings to support document changes, training, recording of documents, first article inspections, etc.
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
Do you know the cost to change the color on a box? Just the color, not the text, not the information, just the color?
Estimate:
$470,000
No scrap cost, old color boxes used until stock depleted.
Vendor didn’t charge us anything to change the color on the next and subsequent lots.
All that was engineering hours for the document revisions, meetings to support document changes, training, recording of documents, first article inspections, etc.