Applying Human Factors and Usability Engineering Throughout the Medical Device Development Lifecycle

Duration: 90 Minutes
For medical device manufacturers, human factors engineering has gradually become part of the standard expectations for products on an FDA approval pathway. Though it is possible to execute successful studies that only meet the FDA's minimum standards for human factors, this strategy does not necessarily result in products that have been optimized for safety and usability. Incorporating a more robust approach that considers human factors concepts throughout the entire development process is much more useful, and typically results in better designs and lower costs. This course describes the benefits of incorporating human factors throughout product development lifecycle, and provides guidance on how to effectively accomplish this.
Human Factors Engineering Design of Medical Devices
Instructor: Natalie Abts
Product ID: 505949
Objectives of the Presentation
  • Identifying human factors activities at all stages of development
  • How to properly execute different types of human factors tasks
  • When to employ different techniques to assess a device
  • When and how to consult different types of experts for feedback (e.g. device users, human factors specialists, subject matter experts)
  • How early-stage activities contribute to meeting FDA expectations
  • How to translate feedback and results into design inputs
Why Should you Attend
This session will describe techniques that, when applied appropriately, can greatly impact product safety and usability. Product developers looking to maximize safety, usability, and satisfaction with their products, as well as human factors engineers who want to help developers to accomplish this, will benefit from this course.

Areas Covered
  • Major stages of the product development lifecycle from a usability perspective
  • Key human factors activities that provide that most value at each stage of development
  • Conducting human factors assessments in the intended use environment
  • The systems perspective to identifying usability inputs
  • Heuristic evaluations and usage risk analysis
  • Executing effective user testing
  • Details of a proper human factors validation test
  • Post-market monitoring and data collectionv
  • Examples of successful execution of human factors activities in each stage
Who will Benefit
  • Medical device manufacturers
  • Usability/human factors engineers
  • Design and development engineers
  • Industrial designers
  • Risk managers and project managers
  • Quality Engineers
  • Quality Managers
  • Regulatory Specialists
  • Regulatory Managers
  • Compliance Specialists
  • Engineers involved in managing Design Changes
  • Engineers involved in developing Field Modifications
Topic Background
Human factors have slowly become an integral part of medical device development. Prior to the release of the draft guidance for applying human factors and usability engineering to medical devices in 2011, the FDA's perspective on these topics was vague, and device companies were not expected to follow strict procedures. The final guidance release in 2016 provides even more detail about expectations, but still keeps requirements somewhat minimal. When device developers are new to the process, they may fail to see the benefit of going above and beyond to conduct activities that the FDA does not necessarily require. This course will describe why these activities are vital to device success, and provide a primer for developing a robust human factors process that accounts for all stages of development.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
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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