(62) The Cleveland Open Source Modular Implant Innovators Community (COSMIIC)

Introduction: Active implantable devices are an important means of treating disease and disability, in large part due to their ability to achieve direct control of portions of the nervous system, typically via electrical stimulation. However, access to this technology often limits research progress. The goal of our project is to address this limitation by making our existing modular implantable system available as an open-source hardware system, will all design, testing, and regulatory documents available free of charge, without any limits imposed on its future use, modification, dissemination, or commercialization.

Methods: Our open-source system, the COSMIIC System, is based on the platform modular implant system developed at Case Western Reserve University (CWRU) known as the networked neuroprosthesis (NNP) [1][2]. This system is a full-featured neuro-device that has already achieved use in human studies under an Early Feasibility Investigational Device Exemption. The COSMIIC System is a network of implantable components embodying critical features of: 1) full implantability, 2) modularity, and 3) capacity to stimulate and sense from disparate regions in a living organism. The core existing implanted components of the COSMIIC are a Power Module (PM), a four-channel Pulse Generator Module (PG4), a two-channel Biopotential Recording Module (BP2), Network Cabling, and Stimulating and Recording Electrodes. The COSMIIC System functions as a distributed peer-to-peer network using the controller area network (CAN) protocol. This system is designed for real-time closed-loop control.

Results: Our initial set of open-source documents are now available at cosmiic.org. Documents available for download include the first fully open-source Early Feasibility Study Investigational Device Exemption (IDE). We are currently finalizing the entire set of design documents, but a substantial portion are already available. Current work involves developing a full-featured COSMIIC System Evaluation Kit as well as establishing a manufacturing pipeline that would allow all researchers to obtain finished products if they so desired. Finally, we intend to develop a version of the implanted components that are designed for pre-clinical testing (low cost). We are also significantly expanding the features of the original modular system so that it meets the needs of a broader array of experimental and clinical applications.

Conclusion: A key focus at this stage of the COSMIIC project is to establish long-term sustainability. This will involve developing a stable supply-chain and a critical mass of COSMIIC System users with ongoing customer support. We seek continued input from the community to guide our future development.