Testbed as a RegUlatory Science Tool (TRUST): A Testbed Design for Evaluating 5G-Enabled Medical Devices.

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. In this paper, we propose a design model for 5G testbed as a regulatory science tool (TRUST) for assessing 5G connectivity enablers of medical device functions. Specifically, we first identify application specific testing needs and general testing protocols. Next, we outline the selection and customization of key system components to create a 5G testbed. A TRUST demonstration is documented through a realistic 5G testbed implementation along with the deployment of a custom-built example use-case for 5G-enabled medical extended reality (MXR). Detailed configurations, example collected data, and implementation challenges are presented. The openness of the TRUST design model allows a TRUST testbed to be easily extended and customized to incorporate available resources and address the evaluation needs of different stakeholders.