Human Factors Engineering

Gaining Maximum Benefit from Human Factors Engineering

Twenty years after FDA first called upon manufacturers to apply human factors engineering (HFE) in medical product development, HFE has become a relatively mainstream activity. Few companies are just discovering it for the first time, as was the case as recently as 5 years ago. By now, most companies have figured out the basics of what they need to do and how to do it.

Now, the challenge for manufacturers is to apply HFE efficiently and effectively.

This seminar will help guide you toward a better HFE approach with answers to these questions:

  • Is there value in establishing an in-house HFE team? Does the answer depend on company location, size, and both the number and type of products?
  • Should in-house HFE teams conduct summative usability tests or engage consultants to run them?
  • Is it worth investing much into learning tools (e.g., user manual, quick reference guide, “Get Started” guide, online simulations)?
  • How many rounds of formative usability testing is enough?
  • Should we build our own usability test laboratory or rent?
  • Where should an HFE team reside in the organizational hierarchy?
  • How much user research is necessary when developing a global product?

Who should attend
Anyone involved in the planning, execution and/or management of HFE work including user research, hazard and task analysis, use-related risk analysis, user interface design, usability testing, and associated quality management and clinical affairs tasks. The seminar will NOT be Human Factors Engineering 101. Rather, it is direct toward individuals who already know HFE and seek to refine their practices.

About the presenter
Michael Wiklund serves as general manager of UL's human factors engineering practice. He has a total of over 30 years of experience in the field. Michael has authored many books on human factors engineering,  In 2018, AAMI will publish his latest book titled, Writing Human Factors Plans & Reports for Medical Technology Development. He has also contributed extensively to the current AAMI and IEC standards and guidelines on human factors engineering. As Professor of the Practice at Tufts University, he teaches courses on applying human factors to medical technology to meet regulatory and commercial imperatives.




12.00 – 12.30                 Sandwich and networking

12.30 – 12.35                 Welcome by Medicoindustrien

12.35 – 14.00                 HFE implementation models

  • HFE practice models
  • Benefits and costs of an in-house HFE practice
  • Positioning an HFE practice within an organization
  • Outsourcing for certain HFE services
  • Value of an HFE procedure – a component of a quality management program

14.00 – 14.20                 Coffee break

14.20 – 15.40                 Practical considerations

  • Deciding how much user research is enough
  • How to conduct user research when a product will be sold worldwide
  • Scaling the application of HFE to learning tools (e.g. user manuals, quick reference guides)
  • Building versus renting a usability test laboratory
  • Optimal amount of formative evaluation

15.40 – 15.50                 Wrap up

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bm@medicoindustrien.dks billede
Berit Munkebo