There's of course a third danger: all the people that won't use their skills to try to develop new technologies due to the costs of FDA approval and the lack of

There's of course a third danger: all the people that won't use their skills to try to develop new technologies due to the costs of FDA approval and the lack of knowledge about those processes. What you end up with is handing the market to huge corporations that can afford the not-product-related huge upfront costs, and who have the institutional knowledge of navigating the approval process. Its interesting that SV is often criticized for not taking on these "big important problems", but at the same time these are markets that can be impenetrable given that the entire fate of the company can be in limbo for years during approval, requiring tremendous up front investment that is harder to predict.