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

Area of Science:

• Biomedical Engineering
• Telecommunications
• Regulatory Science

Background:

• Fifth-generation (5G) cellular technology offers advanced connectivity for medical devices.
• Current evaluation methods are insufficient for assessing the safety and effectiveness of 5G-enabled medical devices.
• Regulatory science needs novel tools to address emerging technologies.

Purpose of the Study:

• To propose a design model for a 5G testbed as a regulatory science tool (TRUST).
• To facilitate the assessment of 5G connectivity for medical device functions.
• To provide a framework for evaluating emerging 5G medical technologies.

Main Methods:

• Identified application-specific testing needs and general testing protocols for 5G medical devices.
• Outlined the selection and customization of system components for a 5G testbed.
• Demonstrated the TRUST model with a 5G-enabled medical extended reality (MXR) use-case.

Main Results:

• A functional 5G testbed (TRUST) was implemented for evaluating 5G medical device connectivity.
• A realistic use-case involving medical extended reality (MXR) was successfully deployed and tested.
• Detailed configurations, collected data, and implementation challenges were documented.

Conclusions:

• The TRUST design model provides a flexible and extensible platform for evaluating 5G medical devices.
• This approach supports regulatory science by offering a method to assess emerging connected health technologies.
• The TRUST testbed can be adapted to various resources and stakeholder needs for comprehensive evaluation.