Re:An ER visit, a $12,000 bill – and a health insurer that w...
by Balgair on Monday January 29, 2018 @04:58PM
(#16260999)
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).
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).