@Luis Sanchez: well, if you want to see which tooth has high stress, that is quite easy, we can quote or stick thin-film pressure sensors! Remember those plastic rulers with this feature where you press your thumb to see how stressed you are? We have come a long way from that in advancements of materials technology. Now a days, you can get transparent electronic films that do the same!
Overall, I liked most of the 'can't miss' list but I reminisce those days when life was far less complicated! I wonder if we are unnecessarily complicating humanity's survival in the name of technological advancements!
Dr. MP Divakar
It really all depends on the technology. Medical devices are divided into there classes (1,2,3), with class 1 being very simple things like crutches, class 2 being low to medium risk devices like EKG machines, and class 3 devices being high risk or life sustaining devices (think pacemakers). Most class 2 devices require "premarket notification (510k)" and most class 3 require "premarket approval (PMA)". The caveat is that to do a 510k, you need to be "substantially equivalent" to a "predicate device". Confused yet? Wait.. there's more. If you're a class 2 device and don't have a clear predicate, you are automatically classified as class 3 and have to do a PMA... EXCEPT, you can file for a "de novo" review which is much simpler :)
Bottom line is that the regulatory process is a big hurdle, but it's not insurmountable; even for a startup. You need good consultants, a solid plan, and a good quality management system. Check out the FDA website; it's actually quite helpful (although there is a LOT to read).
@Don, Thank you for these highlights and for your best tips on how to make the most of the ISSCC. The round table plenaries sound like an excellent new feature. I was wondering on a social media front if there are hash tags and other ways we can track and follow the conference via Twitter, LinkedIn, or Facebook.
The winner for me is the: A Telemetric Stress-Mapping CMOS Chip with 24 FET-Based Stress Sensors for Smart Orthodontic Brackets.
I never imagine before putting some electronics in the mouth for teeth purposes.
Sounds like a pretty good idea if the do it right.
I can imagine the data going to the mobile phone and perhaps creating a stress-scopic image that will show with a color code which teeth are under more stress or so.
If we allow our imagination to go even further in the future the brackets might become self adjusting and the visits to the doctor might become seldom. Sorry doctors.
Don't worry... that's the far future. :-)
@caiogubel: There are two major FDA pathways. The simplest is called 510(k) aimed at devices similar to things already on the market. I am told it can take 9-18 months to prepare data for it and another 9-18 months to go through the formal FDA process to get it. Costs are all over the map. The more extensive path called PMA for new kinds of devices is longer and more expensive with costs varying greatly for both paths. Anyone please feel free to chime in if you have more detailed info.
Blog That A-Ha Moment Larry Desjardin 4 comments Have you ever had an a-ha moment? Sure, you have. The Merriam-Webster dictionary defines it as "a moment of sudden realization, inspiration, insight, recognition, or ...