How does the bench-to-bedside model intersect with regulatory oversight?
It seems to me the central problem in the Durona Group vision is that you are largely prohibited from offering such a device to treat the rare condition, even if it gets built and works. I suspect that the optimizations a bench-to-bedside model would make to deliver the product quickly enough and cheaply enough to be useful to that patient would also leave the company drastically short of the amount of data usually demanded to establish safety/​efficacy.
I feel like this idea would be a good match for the META Program concept, the goal of which was to speed up delivery of cyber-physical systems for the military by a factor of 5. The regulatory challenges of the FDA are considerable, but defense procurement is worse.
How does the bench-to-bedside model intersect with regulatory oversight?
It seems to me the central problem in the Durona Group vision is that you are largely prohibited from offering such a device to treat the rare condition, even if it gets built and works. I suspect that the optimizations a bench-to-bedside model would make to deliver the product quickly enough and cheaply enough to be useful to that patient would also leave the company drastically short of the amount of data usually demanded to establish safety/​efficacy.
I feel like this idea would be a good match for the META Program concept, the goal of which was to speed up delivery of cyber-physical systems for the military by a factor of 5. The regulatory challenges of the FDA are considerable, but defense procurement is worse.