Government ... as usual. Any work done on the human body is tightly restricted to "medical practitioners", i.e. doctors. Think FDA.

The good news ... entrepreneurs always find ways around malevolent monopolies. We know of several countries with lower regulatory barriers; "bring us your entrepreneurs" is their call. Too, partnering with medical people can mitigate the regulatory "barrier to entry".

Pharmaceuticals is a trillion dollar per year industry ... it will seek to destroy us from day one; we've already experienced some of that opposition.

"Not ready yet" ... from people who know all the reasons "why not". "The world doesn't need more than six computers" was the thinking before Apple Computer started a whole new industry.