Introducing COSMIIC - open source implantable devices

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Hello everyone,

I’m excited to introduce a new open source project coming out of a traditionally heavily-closed industry (medical device industry). Our COSMIIC team is taking an established device system currently being studied in human clinical trial and making it open source!

The COSMIIC System was originally designed to restore functional movements after paralysis injuries; it uses electrical stimulation to control muscles and has a modular design allowing it to restore multiple functions across the body at once. Now, we’re envisioning this technology being adapted to other neurological conditions by other researchers following the path we’ve established with regulatory bodies (the FDA in the United States). We’re looking to be a resource to researchers and startups in the neuromodulation field so that they don’t have to start from scratch when developing their own device or neuromodulation therapy. Read more here: Unlocking Health: Empowering Implantable Device Innovation Through Open Source Collaboration Excited to be apart of the GOSH community!

Posting in General to also promote the community call on Open Source Medical Devices on July 5th @ 1pm UTC.

Thanks,
Chris Rexroth & the COSMIIC team

P.S. We are funded by the NIH SPARC program, along with the CARSS/OpenNerve project introduced in this post, with the goal of creating open tools for developing bioeletronic medicines. Both projects will be presenting in the community call.

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Hi @crexroth ,

This looks like an incredible project. With the OpenFlexure Microscope we have also done a fair bit of thinking around open source for medical equipment. Obviously a microscope/slide scanner is an in vitro diagnostic device, so the regulations are far less strict than for an implantable medical device!

On thing with open source hardware, is that the software/platforms for doing development and tracking it openly are far less complete than they are in software. Thinking about design control for compliance with ISO 13485, while platforms like GitLab/GitHub will store the history, there is a lot more process needed to ensure it is controlled (much of which is available on this platforms) but the review side of it is made much harder with the number of binary files that need to be committed. We have done quite a lot of thinking about how we use this toolchain for hardware design, see for example: https://www.tandfonline.com/doi/full/10.1080/0951192X.2022.2028188

We also recently published a paper about the transition from academic project to medical use this paper is somewhat a follow up from an earlier paper when we were much earlier in the process.

Really excited to hear more about you project. I currently have a conflict on the 5th, but I’ll do my best to make it to your talk

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