Electronics > Open Source Hardware

Open Source Medical Device Project

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occamman:
I (an EE-turned-Systems-Engineer) have teamed up with a neuro-anesthesiologist to start a project to develop an open-source EEG. It will initially be used for research on optimizing anesthesia to minimize complications. Ultimately we'll have an FDA-cleared clinical device.

(Before you ask/EEsplain :D... Yes, I know that medical devices are "special" - I develop them for a living.)

We believe that open-source medical devices will be safer and less expensive, with the extra benefit of enabling medical innovation. Details on the project, and why it will lead to better devices, can be found at our GitHub site here: https://github.com/VolksEEG/VolksEEG.

For more info, I discussed this project last week on the Embedded.fm podcast: https://embedded.fm/episodes/388 (Not showing favoritism... I'd be happy to discuss it on The Amp Hour, too!)

We're looking for an EE to help on schematics and layout - since the design uses an "EEG-in-a-chip", the ADS1299, design is not particularly complex.

Please wish us luck!

SteveyG:
Several questions:
What up-front work have you done for your DHF? It looks like you're expecting to start straight away with the detailed design, but I see no evidence of the earlier work which would be required for submission to the FDA. 
I also don't see any specifications and thus no means to design with V&V in mind.

What device classification are you aiming for?
Software safety class?

You mention EEG machines are "lower safety risk", but for a device, this is entirely dependant on how the device and data is used. 

occamman:
Good questions!

First go-round is a proof-of-concept, outside of "real" device development, so no need for standard DHF material. This is described somewhat in our Project Overview document that's linked at the bottom of the readme, but maybe isn't so obvious. Better to keep heavyweight medical device process out of the way until we are clearer about what needs to be done - then we'll go through standard requirements through verification, traceable, conforming to IEC 62304 and ISO 13485, etc.

That said, EEG essential performance is spelled out by IEC 80601-2-26, so we'll be doing initial verification of the POP against that standard. Essential performance is what's... well essential, so that's nice to demonstrate.

FDA classifies these devices, both for depth of anesthesia and standard clinical EEG, as Class II. I believe that they're both IIA in the EU.

Software safety class is probably B, might be C (not so much difference between these in 62304). It also depends on the risk controls we decide to implement on the systems, e.g., one trick is to have redundant (but different) processors running different software and if there's a substantial difference then shut down. That could even drive it to Class A, which would be lovely.







Gallymimus:
What a cool idea to develop open source medical devices.  Kudos for the effort.

I am curious however.  In my experience, medical device development is requirements driven, flowed down from customer requirements, regulatory requirements, and hazard related requirements.

You mention 60601 and 80601 but you don't mention requirements derived from any other angles.  Is there an intended use, or group of intended uses?  This also would impact the hazard assessment which would of course impact the 62304 safety classification as well has hardware design mitigation strategies (do we need a redundant processor or not, what risk controls are we doing to use).  Typically an ISO-14971 type analysis would be performed to identify hazards and risk level, which often are dependent upon specific use case. 

Something like EEG might only seem to have electrical shock hazards, but obviously if the data is used to misdiagnose a patient the secondary hazard would need to be considered.

Finally, FDA approval/clearance are not only indicators that your design is safe but are also indicators that you have been cleared to manufacture and sell.  Given that you won't be manufacturing, how do you foresee clearance happening?  I imagine you guys won't be setting up GMP or ISO 13485 certification.  If you are using a 13485 CM there are still processes for 13485 and GMP that would need to be in place to build anything that would qualify as having FDA clearance.

I realize I'm preaching the the choir here as you are experienced with medical device development, but elucidation might be beneficial to those who are fans of the open source medical device prospect.

wizard69:

--- Quote from: occamman on October 06, 2021, 02:00:57 am ---I (an EE-turned-Systems-Engineer) have teamed up with a neuro-anesthesiologist to start a project to develop an open-source EEG. It will initially be used for research on optimizing anesthesia to minimize complications. Ultimately we'll have an FDA-cleared clinical device.

--- End quote ---
How will you produce an FDA cleared device if you don't have an FDA cleared production process?

--- Quote ---(Before you ask/EEsplain :D... Yes, I know that medical devices are "special" - I develop them for a living.)

We believe that open-source medical devices will be safer and less expensive, with the extra benefit of enabling medical innovation. Details on the project, and why it will lead to better devices, can be found at our GitHub site here: https://github.com/VolksEEG/VolksEEG.

--- End quote ---
The regulated environment is the direct opposite of the open source world.   For one every innovation would need to be cleared by the FDA.   since most people don't know what is involved in that there will not be a lot of innovation once they know what is required to implement their innovation.    Maybe open source would be useful outside the regulated world but I don't see it driving a lot of approved innovation in the regulated world.

--- Quote ---
For more info, I discussed this project last week on the Embedded.fm podcast: https://embedded.fm/episodes/388 (Not showing favoritism... I'd be happy to discuss it on The Amp Hour, too!)

We're looking for an EE to help on schematics and layout - since the design uses an "EEG-in-a-chip", the ADS1299, design is not particularly complex.

Please wish us luck!

--- End quote ---
I wish you all the luck in the world but I need to remind you that the investment required to get FDA approval can be massive.    I know where I work there is a massive reluctance to do anything with the design or production processes of approved products.    The costs and manpower requirements can be massive even for minor production changes.   

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