OSHWA Healthware Highlight: OpenNerve

This piece is part of a highlight series on OSHWA.org.

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We started this series by looking at COSMIIC and you cannot talk about them without mentioning their sister project, OpenNerve developed by the Center for Autonomic Nerve Recording and Stimulation Systems (CARRS). OpenNerve is the other project supported by the National Institute of Health, the US-based government organization that funds medical research. Both projects were selected as part of the SPARC grant that was looking to explore bringing open source into medical care, especially with implantable devices. 

As we noted in the COSMIIC Healthware Highlight there are multiple classes to medical devices, and many open source devices sit in Class 1. OpenNerve is another exception to this rule, and are using their funding support from the NIH to develop a Class 3 implant for therapies involving neuromodulation. 

OpenNerve was developed to be placed in the body to work with the vagus nerve. This nerve comes down on both sides of the neck and controls all of the organs, such as your heartbeat, pancreas, liver, etc., and by interfacing with this nerve we can adjust those organ activities. This idea can also be utilized for the sacral nerves that affect your bowel and bladder activity, or other peripheral nerves like the phrenic nerve, which controls the diaphragm and breathing, or nerves near the throat which control tongue movement and swallowing. 

Neuromodulation of these nerves using OpenNerve could treat many different diseases, from heart disease to sleep apnea. One group of people who may see significant benefit are those with paralysis due to spinal cord injury. 

“If you look into it and talk to these patients, walking is not always the highest priority for somebody with a spinal injury,” notes Dr. Alex Baldwin, Director of Technology Integration and Dissemination at CARSS. “What they prioritize is to be able to use the bathroom in a dignified way. Bladder, bowel and sexual function are much more important to them.” 

With this technology in development there could be some significant advances for people who have nerve damage, an area that is not extraordinarily funded because it’s not often seen as profitable. 

The medical industry is complicated in many ways, especially in the context of access. We have simultaneously some of the strongest healthcare in the history of humankind as well as enormous issues with having access to said care. Through the expansion of Open Healthware and an accompanying certification procedure we can try to bridge some of these gaps by providing reassurance that these devices have transparency to the source, effective reproducibility, and allow for a level of user freedom that is invaluable. 

OpenNerve is one of the first Class 3 implantable devices developed to be open source from the very beginning. 

“Before the center existed, before I worked here, the NIH said, ‘we want you to make this system, but it has to be open source, and all the data has to be released to the community,’” Baldwin said.

Many scientists seek ways to create more flexible systems that can get products to patients faster but are hit with the roadblocks of production and fighting through the regulatory requirements. When a device is developed as open source from the beginning other groups can take advantage of the regulations already being met and see what ways they can adjust to meet their needs.

“It was important for us that we have our core system open forever. Everything we’re building will be out there as open source. We’re not going to get rid of any of the resources we put out,” Baldwin notes. “Other groups will probably take our device and heavily modify it, making their own proprietary device. And we’re very happy with that because that sort of community adoption and modification is what’s necessary to help treat many different patients.”

The device has already resonated with other groups doing research who are working on taking the core system and doing minor modifications to meet their own needs looking at different diseases or medical situations. 

“I believe that having these designs publicly available will have a huge impact on translating therapies from academic labs to the clinic, and I think we’re having an effect on how the neuromodulation field as a whole sees these types of therapy platforms,” Baldwin said. 

Baldwin has previously worked for a startup as a hardware engineer and noted that had there been a set of validated design documents for an implantable neuromodulation device to use as a template, that they knew worked and complied with all regulatory requirements for human use, it would have been an absolute game changer. 

“I saw firsthand how an open source hardware implant like this would have helped my own work and accelerated our hardware development. I knew this was a problem that many other companies, especially academic spin-out startups, are facing,” Baldwin said. 

The institutional knowledge being created in OpenNerve is so important to see more development of open source medical devices. Their experience bringing a device from research to market with the continued commitment to honour openness is going to help many more open source healthware devices make it to their end users. 

“We  hope that by releasing everything we do as open source that we can enable more people to participate in this project. And maybe this will lower the barrier to developing new therapies and reaching patients in need,” Baldwin said.  

There’s bound to be exciting progress in this area as more groups get involved and begin finding more ways to use this technology in new ways for different patient needs. We are certainly excited to see further work from them and their partner groups as they bring OpenNerve to the forefront of neuromodulation therapy development.