2 ms·
FDA approval is very hard to obtain. And for good reason. For a 'simple' thing like an internal titanium staple to attach to bone, it'll be about 10 years befo
by Balgair 9y ago
FDA approval is very hard to obtain. And for good reason.
For a 'simple' thing like an internal titanium staple to attach to bone, it'll be about 10 years before the 'go/no-go' decision from the FDA. All the effort could go up in smoke 10 years in. That's ~10 years of investments, rat tests, lab research and upkeep, human trials and long term surveillance, paying the engineers and accountants, etc. That investment has to be re-couped plus a profit for the trouble.
The nice thing, though, is that once the medical-thingy is proofed, it is a near monopoly on it. So the re-coup is not bad. But the risk is pretty great. SV talks about risk and reward a lot, but they have nothing on bioengineering start-ups (that really do save lives and change the world).