iBCI systems are inherently modular, and correctly harnessing this modularity could accelerate medical innovation. At a high level, the implant, the external hardware, and the software are three modules that could be developed independently. This creates two compelling opportunities: 1) to enable interoperability across different systems, and 2) to pioneer a pathway for regulatory approval of modular components. Interoperability requires close collaboration between developers, while paving the modular approval pathway necessitates coordination with FDA, standards agencies, and other regulatory bodies. Successfully implementing these strategies could dramatically improve patient outcomes by fostering innovation, speeding up commercialization, and enhancing system flexibility.

This Workgroup is dedicated to establishing a robust framework for modularity in iBCI systems, identifying and promoting opportunities for standardization and interoperability, and shaping the regulatory landscape to support modular approvals.