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, often with UL's help.
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. This 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, which includes staff working in Europe, the USA and Asia. A certified human factors professional, he has a total of over 30 years of experience in the field, much of it focused on medical technology development. Michael has authored many books on human factors engineering, the latest being the second edition of Usability Testing of Medical Devices and Medical Device Use Error - Root Cause Analysis. In early 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.
We are inviting you to attend the seminar in person and are extending a special discount off registration for non-members.
Date: May 31st, 2018
Time: 12:00 - 16:00
Discounted Non-Member Price: Dkr 1.565.
Location: Medicoindustrien, Forskerparken Scion DTU, Agern Allé 13, DK-2970 Hørsholm
Please reference "UL" when registering to receive this discount.
Click here to view the agenda and register: https://medicoindustrien.dk/events/184
If you are unable to attend the seminar and would like to learn more about Human Factors Engineering, visit HFE page, which also has links to resources such as white papers or contact us at: [email protected]