FMEA is a commonly used technique by engineers in the medical device industry to analyze different failure modes, their causes and effects. When used correctly, it is highly effective in identifying and implementing appropriate control measures to improve product quality and reliability.
However, FMEAs are also overused in the industry; often almost exclusively for risk analysis. The main problem with this approach is that system level hazards and hazardous situations cannot be easily linked to individual failure modes identified in an FMEA. Further, harm can occur even when a medical device is operating in the normal mode.
In this episode, Roger Hill discusses some of the common challenges in using FMEAs and shares best practices based on over 30 years of industry experience.
About Roger Hill
Roger Hill is is a Mechanical Engineer with extensive experience in design, development, manufacturing and ongoing sustainability of medical devices. He started his career in the defense industry and later moved to the medical device industry in the early 1990s. His expertise includes design controls, verification and validation of hardware, manufacturing operations and process validation. He also mentors and teaches classes for biomedical and mechanical engineering students at the University of Texas at Dallas.
About Let’s Talk Risk with Dr. Naveen Agarwal
Let’s Talk Risk with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
Best practices for using FMEAs for medical devices