Human factors and risk create a lot of confusion in the medical device industry. What do you need to do from a design control perspective?

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Mary Beth Privitera, Principal – human factors at HS Design and AAMI Human Engineering Committee co-chair discusses the similarities and differences between human factors vs. design validation. The in-depth podcast with Greenlight Guru includes:

  • What constitutes human factors validation? It involves an international standard and FDA guidance on rules that medical device professionals need to follow.
  • Design validation focuses more on what’s expected during the audit of a human factors file, if you have a product that is a high risk for harm or injury.
  • Most companies don’t know how to intertwine human factors within design and development practices. Use common sense to make a good product design.
  • FDA helps developers understand what they need to do and document early on during the design process to avoid validation issues with a product later on.
  • Past sales criteria is a major difference between design and human factors validation because it’s difficult to define and measure ease of use.
  • Understand all elements that could impact a product’s design. Study your users and use environment before identifying and fixing design issues.
  • A task analysis identifies each step users need to take and serves as evidence that you considered their needs and made necessary compromises.
  • Mary Beth busts myths related to human factors and design validation, such as needing three people to evaluate and provide feedback on your product’s design.