Impacting Patient Outcomes Beyond the Minimum Requirements Set by Regulatory Standards for Medical Devices

“Device design” issues have been a leading cause of Class I medical device recalls in recent years, highlighting a system-level gap despite established FDA Human Factors (HF) standards. This study analyzes recall patterns to identify recurring usability failures and limitations in current HF practices. It proposes a proactive, Closed-Looped Post-Market Surveillance approach to detect use-related issues earlier, strengthen design risk controls, and reduce patient harm. The study also emphasizes collaboration between device manufacturers and healthcare providers to enable continuous real-world feedback and improve patient safety beyond regulatory compliance.