3 ms·

What would it actually take to get this type of device approved for human use in terms of regulatory approval? The article doesn't go into details. I have a heu

by otoburb 14y ago

What would it actually take to get this type of device approved for human use in terms of regulatory approval? The article doesn't go into details. I have a heuristic that projects at least 10 years into the future for drugs/devices at this early stage of development assuming funding is secured, but not sure if this still holds.

mrsebastian 14y ago
It's usually pretty quick/easy to get stuff approved for in-lab, early human trials. But yeah, much longer until it's available to the public.
- otoburb 14y ago
  >>It's usually pretty quick/easy to get stuff approved for in-lab, early human trials. I'm surprised -- I thought that even if you had an eager group of volunteers for in-lab, early human trials you still needed to jump through understandably onerous red tape and provide reams of documentation and evidence that the device was safe. Or does signing a (supposedly ironclad) waiver absolve your right as an early human trial participant to sue in the event of failure or adverse side effects?
  - caycep 14y ago
    shortcut is a humanitarian device exemption (HDE) if you have some good preliminary data, not sure what the exact rules are.
jsr 14y ago
The wired version of this device was in human trials ~10 years ago through cyberkinetics, a startup spun out of brown to commercialize the technology. See NYT article from 2004 talking about the start of their clinical trials: http://www.nytimes.com/2004/04/13/health/13BRAI.html http://www.nytimes.com/2004/04/13/health/13BRAI.html
caycep 14y ago
there is deep brain stimulation - has been around for 2 decades, although innovation was stagnant because of the patent on its use (basically a rejiggered cardiac pacemaker design). patent now expired, 2 competitor companies readying devices on the market...all sorts of exciting new stuff on the horizon (well FDA timescale which 5 years or so)...

by otoburb 14y ago

mrsebastian 14y ago

It's usually pretty quick/easy to get stuff approved for in-lab, early human trials. But yeah, much longer until it's available to the public.

otoburb 14y ago
>>It's usually pretty quick/easy to get stuff approved for in-lab, early human trials. I'm surprised -- I thought that even if you had an eager group of volunteers for in-lab, early human trials you still needed to jump through understandably onerous red tape and provide reams of documentation and evidence that the device was safe. Or does signing a (supposedly ironclad) waiver absolve your right as an early human trial participant to sue in the event of failure or adverse side effects?
- caycep 14y ago
  shortcut is a humanitarian device exemption (HDE) if you have some good preliminary data, not sure what the exact rules are.

jsr 14y ago

The wired version of this device was in human trials ~10 years ago through cyberkinetics, a startup spun out of brown to commercialize the technology. See NYT article from 2004 talking about the start of their clinical trials: http://www.nytimes.com/2004/04/13/health/13BRAI.html http://www.nytimes.com/2004/04/13/health/13BRAI.html

caycep 14y ago

there is deep brain stimulation - has been around for 2 decades, although innovation was stagnant because of the patent on its use (basically a rejiggered cardiac pacemaker design). patent now expired, 2 competitor companies readying devices on the market...all sorts of exciting new stuff on the horizon (well FDA timescale which 5 years or so)...