Blather

I want to re-iterate that this is basic science 101 stuff. You can simply lift material from: http://en.wikipedia.org/wiki/Scientific_method http://en.wikipedia.org/wiki/Reproducibility

The FDA stuff is just a formal way to discuss all of this using language invented by this guy: http://en.wikipedia.org/wiki/Stephen_Toulmin Notice that the FDA process puts the onus on the vendor to make the claim that their product is safe. They are on the hook for producing a structured argument that supports or proves this claim all the way up and down. This is where it starts to get into the advanced stuff, the "how do we know?" stuff that independent reproducibility helps solve is known as http://en.wikipedia.org/wiki/Epistemology. What we need to do is get the FDA to force the vendor to claim that the device is safe because the user can get http://en.wikipedia.org/wiki/Scientific_method#Confirmation that their therapy is correct and that the easiest way is to put the protocols in the user manual.

Agree, this will boil down to property rights, and the FDA loathes infringing. What's frustrating is that I mentioned the W3 and the IETF, who protect technologies that Medtronic is actively using, and they were completely unaware of the effect this open technology has already had on their business, partly because they chose to buy closed implementations of the same thing (from vendors who hold minority shares of the markets).

The entire argument hinges on first acknowledging that secret software is inherently unsafe. This is a conservative position on safety backed by science and easily supported using http://en.wikipedia.org/wiki/Stephen_Toulmin methods. Independent reproducibility solves the issue.

I think it'd be possible to take the Netflix and http://www.ideaconnection.com/open-innovation-success/Open-Innovation-Goldcorp-Challenge-00031.html model to make open science projects out of devices until they are proven safe and vetted by users. There would be bounties placed on concrete deliverables representing different components needed to vet safety for the FDA to easily review and accept the device. Once done, the company could sell the device and the services accompanying them, already having a significant lead in responding to user feedback in the overall design.