How easy do you think it is to convince people to allow a trial product to be used in their body? And then for the follow up exam a few days later?
I supposed that they will have to work with the FDA to set the parameters, define success and failure, and put a solid procedure and expectations on paper, then get FDA approval to begin.
It would seem to me that any surgery involved will have to be elective, so there is time to get all the paperwork and waivers done beforehand. First you have to convince a physician it's safe. Then you have find a patient who is willing, then convince them it is safe. Then you have to train the physician how to use the product, and then have a contingency device ready in the event of failure.
Do you think they just walk into a busy hospital, grab a surgeon and say 'here doc., try this"?
My bet is there is no way we can imagine how much BS and regulation is involved in dealing with the FDA on something like this.