4 Most Common Reasons For Medical Device Material Failures

In 2021, the FDA received reports of medical device failures, with a staggering 36% attributed to materials-related issues. This alarming statistic highlights the need for companies to address this problem promptly. Additionally, an additional 4% of failures were caused by electronic failures stemming from materials.

Material failures in medical devices can have severe consequences for companies, including financial losses from warranty claims, inventory loss, damage to reputation, and even product recalls. To mitigate these risks, it is crucial for companies to understand the four primary causes of material failure: improper materials selection, in-service degradation, reagent or raw material stability issues, and manufacturing process incompatibility.

To prevent material failures, companies must adopt a proactive design framework that encompasses meticulous materials analysis, selection, process engineering, and comprehensive medical device testing. By implementing this framework, companies can identify potential issues early on and make informed decisions regarding materials selection. This approach will help ensure that the chosen materials are compatible with the device's intended use and can withstand the rigors of the medical environment.

The high percentage of materials-related failures in medical devices necessitates immediate action from companies. By implementing a proactive design framework that includes careful materials analysis, selection, process engineering, and comprehensive testing, companies can significantly reduce the risk of material failures and the associated costs. Prioritizing these measures is crucial for safeguarding patients' well-being and maintaining a company's reputation in the highly regulated medical device industry.