You'd think an easy enough change to the laws around IP for medical equipment would be that if they can't supply critical parts, particularly under extreme circumstances, they most hold harmless any supplier that is able to supply said parts.
I find it hard to believe that $11k was a justifiable price or that the valve design was novel or sophisticated enough that someone reproduced the geometry from scratch so trivially (without even using sophisticated 3D scanning techniques I might add, as I understand it).
A lot of businesses strategically buy and sell patents in processes to prevent others from implementing the full process and to force royalties on single pieces. Patents have really got out of hand and in my opinion, stifle innovation more than secure and foster it the way they're currently being abused.
IP protections do need to exist but there's a lot in terms of protection that is just garbage.
The prices would be insane, if that was the case.
I think a lot of the high prices charged for medical gear isn't so much to recoup the variable cost of production of that item, it's to recoup the initial/fixed cost of bringing the gizmo to market. If people can "photocopy" someone else's device by just covering the variable cost, it might cripple companies' incentives for developing for the medical market.
And I believe it's true that if a patent holder doesn't go after every known infringement, it becomes much more difficult to go after any known infringement.
Not saying that 3d printing these valves doesn't feel like the right thing to do in this case. Just saying that feels like a more nuanced situation, rather than being cut/dry.
It’s not too hard to convert a DICOM file, and most hospitals have a CT scanner than is up to the task if you give cake to the right person. Engineering departments know this well.
Its typically used outside of hospital environments for scanning. The large scanners won't give you the level of detail you'd need, at least not the ones I worked with.