Comment by derektank
2 days ago
Research and subsequently clinical testing is expensive so you have to acquire capital, usually from grant providers or working with private industry. Grant providers tend to be conservative and risk-averse so that means individuals with new ideas often won't be able to explore them until later in their career. Private industry is less risk averse but will only fund research if it has the potential to bring a patentable product to market before the parent expires.
Even once you have funding secured, the regulatory approval process is long and requires hundreds of pages of documentation, reporting, and compliance. Then you have to get insurance to cover it, which can require a procedural code being generated for it by the AMA and requires convincing insurers it's worth it, particularly Medicare in the US which other insurers take their cues from. And even once a procedure is approved and a patient can get it paid for, you still have inertia from human physicians who have been trained to perform certain kinds of treatments and not others.
If safety regulations are really such a high barrier, then explain why this passed them:
https://news.ycombinator.com/item?id=15834006
Safety regulations were just one of the many hurdles in the pipeline from idea to therapy.
But to answer your question, that uterus transplantation was (a) an experimental therapy overseen by an IRB to treat a diagnosed medical condition, (b) almost certainly funded by grants acquired by Baylor and not insurance, and (c) the therapy is still in clinical testing and not available to indicated patients today in 2025, 8 years later, unless they are part of a clinical study, which demonstrates how lengthy the process is.
Surgeries aren't regulated in the same way that drugs are, though. AFAIK the bureaucratic threshold for experimental surgeries is much lower.
You're entirely correct. I was trying to speak about medical therapies generally but the FDA doesn't regulate surgical techniques. Some new surgical techniques do require experimental medical devices which would require FDA approval though. And you still have to deal with the bureaucratic hurdles of acquiring grants for clinical trials and getting insurers to cover treatments of course, but it's certainly a lower barrier.
What about the Breakthrough Device Designation or the Investigational Device Exemption?