As we delve deeper into the world of open healthware we have been amazed at the sheer number of projects that are out there. Open source medical devices have been thriving in fields of research, and various distribution networks have been sharing open health hardware with the world. One of the biggest things we want to make clear in our investigations is that this field is not new. OSHWA is exploring how we can expand the current open source hardware frameworks for healthware. There are decades of work navigating our current healthcare systems by wonderful individuals and organizations to bring open source into the medical world in numerous ways. We want to highlight just a few of the excellent groups that are currently and effectively making open source healthware, proving time and again that there are many ways to approach a problem. We will be doing this through a series of Healthware Highlights, spotlighting the work that people have been doing to expand this field. Our first feature is the Cleveland Open Source Modular Implant Innovators Community (COSMIIC).
COSMIIC has a unique story that starts in the city of Cleveland in the 1960s when a set of closed source implantable devices for commercial and research use were first being designed and produced. Now 60 years later, the culmination of their work–The COSMIIC System–is open source and available to researchers working in the field of neuromodulation.
“ Neuromodulation is the technique of using electrical signals to change nerve activity, either to restore some type of bodily function or to reduce unwanted symptoms,” Chris Rexroth explains. Rexroth leads outreach for COSMIIC. Over the course of almost 20 years, the founders of COSMIIC at Case Western Reserve University in Cleveland had worked to develop the new generation COSMIIC System to restore muscular function in people with spinal cord injury.
Using the principles of neuromodulation in a fully implanted form, the device has a unique modular design and, as their site states, “is customized to the needs and goals of each recipient. Modules are placed near the target muscles for stimulation and recording, and in locations that can be accessed for future surgical repair.”
Within the medical device world, there are different tiers of devices based on the risk they pose, starting from a Class 1 external aid to a Class 3 implant or life-support device. When it comes to open source medical devices, we primarily see Class 1 devices; support tools like a wrist brace, mobility devices made from accessible materials and 3D printed pieces to fix other machinery. The COSMIIC System is a Class 3 device as it is permanently implanted through a surgical procedure.
“It is very hard for researchers and startups to design a device of this classification and then to get approvals to use that device in humans,” Rexroth points out.
In 2022 when the National Institute of Health, a US-based government organization that funds medical research, launched a special program under their Stimulating Peripheral Activity to Relieve Conditions (SPARC) funding, COSMIIC was given the opportunity to bring their device into the open source world. This program was intended to accelerate the development of new therapies and devices underpinning those therapies through the redesign and repurposing of two major open source medical device tools, COSMIIC and CARSS. But it came with its share of complications.
“ Our device had existed for over a decade as a closed device with associated patents at Case Western Reserve University,” Rexroth explained.The SPARC program was the catalyst to bringing this device from the closed source to the open source–the funding being a necessary push in the context of these patents being tied to academic institutions and their tech transfer offices, which focus on protecting intellectual property and licensing.
Rexroth notes that it was a “ very involved part of our project, figuring out how to open up something that’s patented at the university and has existed in this culture ingrained with holding intellectual property.”
The group had to form a startup known as COSMIIC Inc because they knew the university would never fully be on board for taking on the liability of an open source design due to a lack of understanding on how it could be used by the open source community.
“ COSMIIC Inc brokered a licensing agreement with Case Western Reserve University to be able to sub-license the design of the device and related documentation to open source users,” Rexroth explained.
The original use of the COSMIIC System applies to the relatively small population of people living with spinal cord injury. It has been realized that it is extremely difficult to commercialize this device for spinal cord injury in specific, the commercial market may not be sustainable enough.
“With the goal of spreading this technology to open access to new therapies for patients, we realized that this technology may be better off instead used as a research tool at the translational stage of clinical research,” Rexroth noted.
Which meant the pivot to open source felt natural to the group and they are excited to be able to help others do the same.
“ Making sure that people are sharing resources, sharing knowledge with each other instead of recreating the wheel across startups and universities will create a major resource for this field.” Rexroth said. “ We really hope to get towards the point where we have a vibrant community that's contributing and collaborating in a multitude of ways. I could see the device being totally different in 10 years.”
The COSMIIC System will soon begin early benchtop development work with several research groups and a new human trial with Dr. Nathan Makowski in Cleveland. Dr.Makowski’s team will be making tweaks to the open source software and using a new orientation of the system modules to adopt the system for coordination of walking. They were able to get an Investigational Device Exemption from the FDA by using the existing documentation from COSMIIC.
“ Our goal is for this to be used across medical indications and across the globe. We are looking for collaborators outside of spinal cord injury and physically outside of the United States. We want to empower others to apply our FDA-intended regulatory resources to other international regulatory agencies,” Rexroth said.
This is the very core of open source, and the exact thing we hope to see come from further explorations into open healthware. With the support and knowledge of groups like COSMIIC we can find more ways to bring healthware into open source and how we can properly support organizations that have already been doing the work.
