Keys to classifying failures for quality engineers


Medical device failures are a common-and costly-occurrence. They can lead to a product recall, affect the product development cycle, and result in extra expenses for manufacturers. The reasons devices fail can be complex, making it difficult for quality engineers to classify the problem.
 
What can quality engineers do to remedy this problem? Consider these factors:
 
  • Understand why failures occur: Most device failures are caused by a misunderstanding of how a material’s properties, processing, and environment work together. In many cases, failures can result from a combination of wrong material selection, poor chemical resistance, high-stress design, or inconsistencies in manufacturing processes.
  • Collaborate with your supplier: Working with material suppliers on material selection, testing, part and tooling design review, and secondary operations can give quality engineers access to knowledge and resources they may not otherwise have.
  • Test your materials: Find a testing method that helps you choose the best plastic for your project. Eastman’s 4-step test for chemical resistance, for example, helps predict the reliability of a material after exposure to harsh cleaners and drugs commonly used in hospital settings.
 
Understanding the root causes of failures and working with industry experts to make better material choices can help quality engineers improve device design, have a more successful product launch, and save on costs.