Evaluating 5G-Enabled Medical Devices: Failure Modes Analysis and Graph Database Implementation

The use of wireless connectivity in medical devices is increasingly widespread. 5G communication emerges as a promising wireless modality with its advancements in throughput and latency performance that can benefit existing and new use cases in healthcare applications. However, there are no standardized evaluation methods for assessing the impact of 5G communication failures on medical device functions. This gap has been acknowledged by industry stakeholders in both the medical device and telecommunication fields. To help address this issue, we propose in this paper a testing framework for evaluating 5G-enabled medical devices, which incorporates a comprehensive analysis of potential 5G failure modes along with a prioritization approach to focus network failure tests specifically on those most pertinent to the device under test. We outline the implementation of the testing framework using a graph database methodology and demonstrate representative test cases to validate the feasibility of the framework. The outcome is a flexible method that could be used by medical device developers, network operators, test lab engineers, and regulators for assessing the use of 5G connectivity in medical device functions.