Problem
Active implantable devices, such as pacemakers or cochlear implants, are an important means of treatment for a range of diseases and disabilities. These types of devices function in large part through direct and targeted control of the nervous system via electrical stimulation. As clinical researchers’ understanding of nervous system anatomy and physiology continues to deepen, the development of additional implantable devices has high potential to underpin new therapies. However, researchers and clinicians commonly find their translational studies stifled by the inaccessibility and fixed specifications of devices from major medical device companies.
Solution
Open source collaboration has been an integral tool used across tech industries to elevate products while also boosting community identity and user literacy. The Cleveland Open Source Modular Implant Innovators Community (COSMIIC) is creating an open source neuromodulation platform aimed at jumpstarting translational research that requires innovative implantable technology. COSMIIC is a team of investigators, clinicians, and engineers; in practice, it is a re-envisioning of how translational neuromodulation research can be performed in the collaborative modern world. With funding from SPARC, COSMIIC hopes to lead a major mindset shift towards open source concepts for the development of clinical research tools.
Fig. 1. The modular design allows for interconnected stimulating and sensing components to reach wide-ranging locations throughout the body to treat multiple symptoms.
The open source COSMIIC System is based on the modular implant system developed at Case Western Reserve University known as the networked neuroprosthesis (Fig. 1). It consists of an implanted battery and communication module, pulse generators, biopotential recording units, and various electrodes. Specialized components, currently in development by collaborators, will add functions related to health monitoring, movement tracking, high-density recording and stimulating, and high-frequency nerve conduction block. The modular design allows daisy-chaining of components in limitless orientations to provide both specific and body-wide functions (Fig. 2). This system has already been used in human studies under an Early Feasibility Investigational Device Exemption from the FDA.
Fig. 2. First look at a COSMIIC-branded module. Shown is a pulse generator module connected to stimulating electrodes (red) and a network cable (blue) that can link to other system modules.
Impact
We plan to release all source materials on the SPARC Portal and GitHub including: circuit designs and layouts; mechanical drawings for enclosures, connectors, cabling; annotated code for software, firmware, bootloaders; written instructions of fabrication techniques; regulatory documents and test data. In addition to promoting open technology, COSMIIC will build a collaborative ecosystem across neuromodulation indications and support users with educational and regulatory resources from the benchtop to animal studies to human use. Above all, the COSMIIC System will advance new and improved therapies leading to better patient outcomes (Fig. 3).
Fig. 3. COSMIIC collaborators are developing network-integrated modules for targeted therapies that return functionality to daily living. They aim to integrate implanted stimulation and sensing for improved mobility, pain management, and brain-computer interface (BCI) control.
We are currently seeking input from the research community to determine areas of greatest need related to technical features, support for regulatory submissions, customer support, and implementation. We are open to discussing how adopting the open source COSMIIC System can fit the needs of individual studies. Those interested may interact with our community by following our LinkedIn page (linkedin.com/company/cosmiic) or by clicking "Join Now" on our website (cosmiic.org) to subscribe to our newsletter.
