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Topic: Opinions on this idea: an Open Source Ardunio based board for medical devices (Read 1 time) previous topic - next topic

dariosalvi

Dear all,

I work in the field of biomedical engineering and I see a strong need of open source boards for biomedical applications, spanning form biology to telemedicine.
There several examples on the Internet about the application of Arduino in the medical world, (like http://openpcr.org or href="http://medicarduino.net) and even shields and components (like http://www.cooking-hacks.com/index.php/ehealth-sensor-shield-biometric-medical-arduino-raspberry-pi.html or http://www.seeedstudio.com/depot/medical-c-197.html).
Now the problem is that none of these examples go beyond the pure experimentation AFAIK, so I have thought: why not to start a new project for making an open source board for medical applications with quality in mind? Arduino seems to me the perfect starting point for its wide adoption and simplicity, but the board should be particularly designed for medical applications.
The final objective would be the production of certified (FDA, CE) devices that could be used in clinical environments.

Possible applications can be:
- educational: students of biomedical engineering and even doctors who want to understand how these devices work
- research: making new devices, integrate cheap technologies
- home telemonitoring
- clinical environments, like hospitals, that want cheap but reliable devices


I am writing here to ask your opinions about the idea, do you see it feasible? do you see potential in it? do you know any other initiative like this one?

thanks for your replies..


Dario

Nick_Pyner

This can't be a bad idea but I can't see the point of it. The Arduino is open source now, as I understand it, so anybody who feels inclined can do what you describe.  Perhaps you are trying to tell us that the medical device type-approval authorities are run by mafias of vested interest.

CrossRoads

Just need to deal with this:

"Atmel products are not intended, authorized, or warranted for use as components in applications intended to support or sustain life."
Designing & building electrical circuits for over 25 years.  Screw Shield for Mega/Due/Uno,  Bobuino with ATMega1284P, & other '328P & '1284P creations & offerings at  my website.

retrolefty


Just need to deal with this:

"Atmel products are not intended, authorized, or warranted for use as components in applications intended to support or sustain life."


That is just Atmel absolving themselves of any possible liability and why medical electronics equipment is so expensive and time consuming to get all the proper certifications and approvals needed. I think if you look every semiconductor manufacture uses such legal boilerplate language in there datasheets.

Plus there is not just one jurisdiction that has control and approval authority as State and even local code requirements can be added on top the the national Federal approvals needed.

So while the concept of open source medical electronic might lead to new ideas and even help to 'bend the cost curve' of medical costs, I'm sure the capital investments needed to hire all the independent testing labs, lawyers, and other non technical hoop hoppers needed would suck the life and wallets right out of any open source group. At least that is my first impression of the idea.

Lefty

westfw

Quote
all the independent testing labs, lawyers, and other non technical hoop hoppers needed

Yeah; that's my impression.  The difference between a "medical device" and a non medical device has more to do with legal CYA issues than anything technical.  (Well, there's the power supply stuff, which makes a certain amount of sense, but that's outside the scope of "Arduino.")

Nick_Pyner


I'm sure the capital investments needed to hire all the independent testing labs, lawyers, and other non technical hoop hoppers needed would suck the life and wallets right out of any open source group.


That sounds about right........

dariosalvi

Thanks very much for your comments.

Just to clarify my idea a little bit:

the open source community shouldn't be responsible for the certification; producers could (if they see potential business) certify a product. Actually, AFAIK, you cannot certify a prototyping board as a medical device, you can certify the final, end-user toy.
Nonetheless, the open source community should take certification as a goal scenario and take high quality requirements into account in the design.


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