The Vital Role of Failure Analysis in Medical Device Electronics

Failure analysis plays a crucial role in the development and maintenance of medical device electronics. It involves investigating and understanding the reasons behind the failure of electronic components or systems. Failure analysis in medical device electronics is a systematic process that not only helps ensure the safety and reliability of the devices but also contributes to compliance with regulations, product improvement, cost reduction, and overall quality management. 

As the medical industry continues to evolve, embracing improved tools and products, research and development (R&D) become more sophisticated. As manufacturing processes become more intricate, challenges increase. Identifying and fixing failures becomes more complex. Our experienced engineers and scientists have advanced tools to thoroughly analyze failures in a wide range of electronic devices.

SIMS Machine

An Investigation into Catheter Issues

We were tasked with investigating a catheter due to reported electrical opens by customers. After conducting usage tests, a 10% failure rate was observed, mainly concentrated at the catheter tip. Subsequent investigation revealed that the electrical opens were indeed at the catheter tip, and X-ray imaging confirmed a break in the electrical traces on the Flex circuit. Further analysis through cross-sectional examination verified a flex crack. The root cause of the failure was pinpointed to the electronic joint at the catheter tip, where fatigue cracks caused breaks in signal line interconnects. Identifying this root cause enabled product redesign to alleviate stress and bending of the flex circuit, preventing fatigue cracking and subsequent failures.

An Investigation into Catheter Issues

EAG has a skilled team of engineers specializing in failure analysis. Our diverse backgrounds cover industries like semiconductor, medical devices, aerospace, military, automotive, laser, solar, and manufacturing. We work with innovative companies daily, tackling the latest technological challenges and improving our problem-solving skills.

EAG is a leading provider with labs worldwide and an extensive breadth of services. Contact us to learn how we can assist you further.

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