Avoiding Common Mistakes in Medical Device Human Factors

Duration: 60 Minutes
With the recent finalization of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, device developers have a clearer picture of the expectations for human factors testing on devices for which they seek clearance or approval. However, attempting to meet the FDA expectations using the guidance alone often results in limited understanding and poor execution of human factors studies. This course highlights common mistakes made by medical device companies and human factors consultants when incorporating human factors into development processes and discusses solutions to avoid these issues. Topics will focus on meeting the FDA human factors requirements for 510(k) and PMA submissions.
Medical Device Human Factors
Instructor: Natalie Abts
Product ID: 501849
Objectives of the Presentation
  • FDA expectations for human factors in regards to 510(k) and PMA submissions
  • What can derail a successful submission
  • Preventing mistakes with conducting human factors
  • Types of human factors studies during different stages of the development process
  • Evaluating different product components
  • Incorporating user feedback
  • Utilizing a pre-submission
  • Conducting a successful validation test
Why Should you Attend
This session provides insights on the FDA human factors requirements that go beyond what is available in the guidance document. Attendees will hear from a human factors consultant experienced in collaborating with medical device developers on FDA submissions.

Areas Covered
  • 510(k) and PMA human factors expectations
  • FDA human factors guidance
  • User testing
  • Human factors protocols
  • Risk analysis and critical task selection
  • Instructional materials, labeling and training
  • Formative and summative methods
  • FDA pre-submission
  • Validation studies
Who will Benefit
  • Medical device manufacturers
  • Usability/human factors engineers
  • Design and development engineers
  • Quality control personnel
  • Risk managers
  • Regulatory personnel
Topic Background
The FDA draft guidance on human factors became available in 2011 and was finalized in 2016. Before this, best practices for conducting human factors testing on devices for FDA submission were less defined and did not ensure thorough usability testing. The medical device industry has been going through a learning process since the draft guidance was produced and the final guidance that was made available earlier this year clarified certain items and expectations. However, using this document alone to guide human factors is not advisable and will not result in successful outcomes in most instances. This course will showcase the speaker’s expertise in this area based on industry experience to demonstrate to the audience how they can successfully conduct human factors testing and avoid common mistakes.
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Instructor Profile:
Natalie is the Program Manager for the Usability Services division of the National Center for Human Factors in Healthcare. She oversees the technical and quality aspects of usability projects conducted both for the medical device industry and within MedStar Health. She is involved in all aspects of planning and executing usability tests, and also leads an initiative to incorporate usability testing in medical device procurement. She has a special interest in ensuring that safe and effective products are brought to market through successful FDA submission. Natalie holds a master's degree in industrial engineering, with a focus on human factors and ergonomics, from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh. Some of her previous work involved research on primary care redesign for the aging population and implementation of process improvement efforts in the ambulatory care setting.
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