I also suspect that the high cost of FDA approval is not treated as a negative by many in the medical industry, as it provides a nice high barrier to entry which helps reduce competition. This seems to be especially true of some of the producers of medical devices.
While this is a valid issue, it does demonstrate how strict a gate-keeper the FDA is. You can't sell anything with a purely medical purpose to anyone without the right certifications. I'm sure there's a lock on something as simple as tongue-depressors that can't be broken because getting your product certified is non-trivial. There isn't even an invention involved here.
