You have to admit that FDA approval can be onerous, and that a "mad scientist" way of demonstrating technology can be an effective way to build public demand.

Consider another technology: safe, effective, and reversible male birth control [1]. It's been used in India for decades, but happens to be illegal in the US right now due to the slow and expensive nature of the approval process.

[1] https://en.wikipedia.org/wiki/Reversible_inhibition_of_sperm...