Medicine is expensive, the set of knowledge a good doctor needs to have is extremely expansive. Instead of collecting data about patients we should collect data about diseases and indications. Imagine the remote village doctor being supported by an AI that can make suggestions about rare diseases that are often not correctly diagnosed. No doctor can know everything, especially if he is a practitioner that takes his whole day to see patients.
Different countries have different problems with financing medicare and for smaller developers of medicine or medicine tech a clinical trial is hard to do. You probably will seek collaboration with educational facilities for these studies but you need to have enough capital to survive a few years. Maybe we could allow people to undergo more experimental tech and drugs, but that would come with a whole new set of problems, especially in society with a lot of impoverished people.
I worked for a medtech startup. It is tough financially but there are way to bring product to the market even for completely new startups. A higher starting capital might be required.
People often say that Europe is more regulated than the US. Generally true perhaps but there certainly is an exception with the FDA, which every drug and tech provider in Europe is slightly afraid of. Perhaps the best balance for stringency is somewhere in between but I also do not see any large problems. The cautious approach is very reasonable.