Dew Point
Seven can't miss highlights at ISSCC
Don Scansen
2/16/2011 8:40 AM EST
A Telemetric Stress-Mapping CMOS Chip with 24 FET-Based Stress Sensors for Smart Orthodontic Brackets
Kuhl and a team including the University of Freiburg and HSG-IMIT presents early Monday afternoon. If you've worn braces before, you may have wished the orthodontist had better feedback than the terror in your eyes while he was cranking on the wires. I like this paper because it obviously fits the theme of healthy living and includes not only the measurement side but the telemetry that will be a key feature in future medical electronics.
Themes are a convenient marketing approach, but it is really the less glitzy sounding underlying technology that sets the tone for these conferences. The low power, low voltage underpinnings of this year's ISSCC will be just as comfortable with portable computing, green technology, or any number of other themes we are bound to see in the years ahead. Or just look back to System Integration for Life and Style (2008), or Multimedia for the Mobile World (2006).
Themes are a convenient marketing approach, but it is really the less glitzy sounding underlying technology that sets the tone for these conferences. The low power, low voltage underpinnings of this year's ISSCC will be just as comfortable with portable computing, green technology, or any number of other themes we are bound to see in the years ahead. Or just look back to System Integration for Life and Style (2008), or Multimedia for the Mobile World (2006).
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caiogubel
2/16/2011 6:07 PM EST
Basic questions:
1.How long does it take for a product to be approved by the FDA? (Average)
2. If long (and therefore $$$) how can a small company compete in this market?
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Sheetal.Pandey
2/19/2011 2:44 PM EST
Good questions! I wonder if FDA offers to answer these question on their website on FAQs. I guess working with any government body is just patience...
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Jose.Bohorquez
2/21/2011 8:02 AM EST
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).
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goafrit
2/16/2011 7:39 PM EST
ISSCC is a pre-eminent conference in its category. Please blog regularly about this conference.
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rick.merritt
2/16/2011 8:11 PM EST
@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.
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Charles.Desassure
2/18/2011 11:29 AM EST
Sound like an interesting conference. Please share more articles about this conference in the future.
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kinnar
2/18/2011 1:25 PM EST
It seems that solid state devices with be ruleing the world in the comming days, as the application of solid state devices in now not being limited to transistors and ics it is expanding its horizion.
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Luis Sanchez
2/18/2011 4:52 PM EST
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. :-)
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lifewingmate
2/19/2011 12:45 AM EST
@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.
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Sheetal.Pandey
2/19/2011 2:45 PM EST
Liked the conference details and awareness.
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ManasK.RayChaudhuri
2/20/2011 8:41 PM EST
The awareness interests me wholly.
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docdivakar
3/2/2011 12:07 PM EST
@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
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