Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction

Background: The fifth generation (5G) cellular communication technology introduces technical advances that can expand medical device access to connectivity services. However, assessing the safety and effectiveness of emerging 5G-enabled medical devices is challenging as relevant evaluation methods have not yet been established. FDA's Office of Science and Engineering Labs (OSEL) has developed and published a design model for 5G testbed as a regulatory science tool (TRUST) for assessing 5G connectivity enablers of medical device functions. OSEL also integrated a TRUST deployment using commercial grade and emulated 5G equipment, allowing end-to-end over-the-air 5G connectivity.

Research Plan: REU students will be mentored by OSEL staff members (all PhDs) to select, deploy, and test publicly available open-source software components that emulate parts of the 5G network. The students will integrate the open-source components with the existing lab 5G testbed and help identify and overcome interoperability issues.

Prerequisites: an introductory course in Linux is required. Desired course but not required: Python, C++, and communication networks.