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The Essential Elements of Human Factors Engineering in the Product Development Process

Upcoming Virtual Courses

Overview

This course offers a concise overview of Human Factors (HF) in medical device design, focusing on its integration across all stages of product development, from concept to post-market surveillance (PMS). Participants will explore the essentials of Human Factors Engineering (HFE), including its role, key deliverables, regulatory standards, and the return on investment (ROI) in product development. The course also covers formative evaluation methods, such as task analysis and usability testing, which are crucial for shaping product usability. Finally, the course highlights Human Factors Validation Testing (HFVT) as part of design validation, emphasizing regulatory compliance and best practices. The key takeaway is a solid understanding of HF deliverables necessary for regulatory approval and effective product development.

Objectives

Over the course of (4) hours, the attendee will be able to:

  • Identify the role of Human Factors Engineering (HFE) in medical device design and articulate its impact on product usability and regulatory compliance.
  • Apply formative evaluation methods, including task analysis and usability testing, to improve product design and document these efforts within the usability engineering file.
  • Execute Human Factors Validation Testing (HFVT) as part of design validation and ensure compliance with regulatory requirements by avoiding common submission errors.

Who Should Attend?

  • Human Factors Engineers
  • Quality Engineers
  • Systems Engineers
  • Regulatory 
  • Usability 
  • Interaction Designers
  • Project Managers

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Faculty

Tressa J. Daniels

Tressa has shared her 24 years of experience in Human Factors Engineering in both regulated and non-regulated industries.  Currently Tressa is the Sr. Director, Global Human Factors and Usability Engineering at Teleflex.   She contributes to industry by teaching the AAMI Human Factors in Medical Device Design course, serving on the AAMI Human Factors Engineering Standards Committee as well as hosting regular webinars for both AAMI and outside the US organizations focused on medical device design and development.    Tressa holds a Master’s in Human Factors Engineering and Applied Experimental Psychology and a Bachelor’s degree in psychology and is based in San Diego California.