I vote you do it underground and illegally until the law catches up. "If a law is unjust, a man is not only right to disobey it, he is obligated to do so." - Thomas Jefferson
That said if I had Type 1 diabetes and the skills I absolutely would do it.
Given the amazing things open source software and hardware folks have done and that you can manufacture small run electronics easier than ever it seems like a healthy underground is likely to emerge.
I'm in favour of the FDA and organisations generally (otherwise we are back to snake oil again) but it has massive issues with technology, they simply can't move fast enough to keep up.
I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
That way technology would get into the hands of the people who need it, the FDA would have a better understanding of what is going on and oversight and small manufacturers can enter the market.
Drug trials to an extent already have such legal frameworks present otherwise we wouldn't be able to perform the trials.
> I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
My proposed solution is to make the FDA optional. If somebody elects to use a non-FDA approved device or substance, that's their decision to make -- not a group of faceless bureaucrats in Washington D.C. New regulatory institutions should be permitted to form, and so long as they're transparent about their process, and sellers are honest about who they've been audited b, false advertising and other species of fraud can be dealt with in the courts. People ought to be free to choose for themselves which institutions to trust and which to be skeptical of.
As soon as an institution becomes involuntary, it becomes immune to rational inquiry and revision. "Because we said so" is the ultimate axiom of any idea enforced by the FDA - if any individual disagrees with their thinking, well too bad you have to do as they say, regardless. Independent thought is the foundation of all truth, so its not really a mystery why domains where its illegal to disagree with the status quo, like medical regulation, are so fucked up.
> I think a pro-tem solution is a law allowing a patient to waive all rights to sue in return for been able to use a device.
I think we arrived at the same conclusion from opposite ends.
The big advantage to the FDA for the drug companies is that if they get FDA approval they top cover from that when they get sued.
Also the cost and scope of getting through the FDA makes it harder for smaller companies to get to market without either selling out to the larger companies or merging which also favours the larger companies.
It's an interesting dynamic, we definitely need some oversight of what is in the market but no so much that will stifle the market entirely.
It is already legal to produce your own insulin at home and take it yourself. AFAIK its even legal to give it away for free. The problem is
1. It's expensive. The final production setup is estimated at $10k
2. The R&D non-trivial. We're still building the platform.
3. Production still must be highly self-regulated to ensure that the insulin is safe.
People need a way to fund this sort of work, but the second we try to sell anything we need to go through a multi-year, multi-million dollar FDA approval process or we'll be shut down. We're currently exploring other funding models, certainly open to ideas.
