Believe it or not, new surgical procedures are neither patentable nor approved by any Federal regulator. Typically I think there's an IRB and you ought to have hacked around with some pigs or something. Other than that - take a knife, start cutting. At least that's my understanding.
Has this regime resulted in (a) an absence of innovation, (b) an epidemic of horrific quack surgery disasters, (c) both? I'd love to hear someone argue for applying the drug/device regulation regime to surgical procedures. The argument for the converse sure seems pretty obvious.
Clearly, you can't have the FDA process without patent monopoly protection. If you kill one, you need to kill both. Bearing in mind, of course, that Washington being Washington, nothing short of a revolution can kill either...
Has this regime resulted in (a) an absence of innovation, (b) an epidemic of horrific quack surgery disasters, (c) both? I'd love to hear someone argue for applying the drug/device regulation regime to surgical procedures. The argument for the converse sure seems pretty obvious.
Clearly, you can't have the FDA process without patent monopoly protection. If you kill one, you need to kill both. Bearing in mind, of course, that Washington being Washington, nothing short of a revolution can kill either...