Even with perfect enforcement, how do you tell if/when the laws stifle innovation?
If a company makes a bad implant, it's very visible, but all the potentially improved hip implants that never get built because of the barrier these laws create are invisible.
There’s one story about a hip implant that went bad. Turns out the doctor recommending and performing the surgery was also the patent holder and had a vested interest in getting this particular implant in as many patients as possible. Turns out the patient was actually patient #8 who received this particular implant. Also the implant wasn’t fully approved yet and the FDA simply trusted the doctor to monitor the device for problems.
Also this isn’t isolated. The chapter has several examples of medical devices going into patients and patients experience negative health outcomes. Turns out laws are only as good as the agencies that enforce them.