flarets
flarets on Hacker News
It depends if the implant does more good than if it wasn't implanted. All regulated devices require post market monitoring by the company and reporting to the FDA. If the data shows harm is being done to patients the FDA can issue a recall.
"Unlike drugs, implants don’t need to go through clinical trials in most cases."
The artical says "surgical innovations" which probably means instruments and procedures. Also "some implants" are exempt from showing efficacy in clinical trials under HDE for cases in which the patient would have died anyway (e.g. pacemakers).
All medical devices of Class 2 and 3 must go through clinical trials to prove safety and efficacy as part of the FDA IDE. Spinal implants would certainly be Class 3.
Edit: clarification
And if you classified Kickstarter as a kind of patronage would it still pale in comparison? If nothing else, no-one backs a project to get rich.
Paraphrasing from that article: "So, realising I had created a bomb, I surrounded the bomb in shrapnel and took it to a crowded part of the city".
Interesting talk. Some parts of the reasoning that might need work:
"if there was no possibility to get rich, there would be no startups".
Does not explain patronage, i.e. people investing in people for reasons other than getting rich.
"without start-ups, there would be slower rates of technological growth".
Prizes, like the Ansari X-Prize, is another model that drives innovation, it can be viewed as a low-risk investment.
Exactly, the "specialized circuits" is the part that should be open-sourced.
Really? I thought ICs were more along the lines of microcontrollers which have things like USB controllers, PWM controllers, GPIO etc. For these, it's mostly programming.
The library I described was supposed to be about all the external bits: signal conditioning, power conditioning, sensors etc.
With respect, I don't know if he's suggesting the right approach. Why not build up a "library" of smaller circuits (e.g. voltage divider, butterworth filter, debounce circuit etc), that allow people to make bigger circuits by combining them. Do it on a breadboard to test, then modify.
no. he's made a fluorescent tube.