Reliability Engineering in Medical Device Development: A Systematic Review

Abstract

The integration of reliability engineering into medical device development is critical for ensuring patient safety, regulatory compliance, and the overall success of innovative healthcare technologies. This systematic review examines the evolution, methodologies, and application of reliability engineering practices within the context of medical device development. Our analysis identifies key trends in design improvements, failure mode effects, and reliability prediction models that have emerged over the past two decades. Through a rigorous screening of peerreviewed literature, industry reports, and technical standards, we have distilled insights into common reliability metrics such as mean time between failures, failure rate distributions, and risk-based maintenance protocols. The review highlights both the advancements and challenges inherent in applying reliability engineering principles to the medical device industry, noting significant gaps in standardization and the need for real-time monitoring systems. In conclusion, this study underscores the importance of an integrated approach that combines traditional reliability analysis with emerging techniques, such as machine learning and real-world evidence analytics, to enhance device safety and performance. These insights provide guidance for manufacturers, engineers, and regulators aiming to improve the robustness and dependability of medical devices in a rapidly evolving technological landscape.