Applying HFE Expertise Early in the Medical Product Development Process

Michael Wiklund and Tess Forton are the HFE specialists hosting the webinar and have worked on various medical technologies, including medical devices, combination products and in-vitro-diagnostic devices. They have witnessed firsthand how early user research mines findings that prove crucial to producing successful, final products that will cater to user needs and preferences from a functional and experiential standpoint. Forton and Wiklund will walk you through examples of productive user research and outline cases where early research was skipped or limited in ways that compromised the final product or considerably delayed its launch.

Learn how various user research methods may be applied when a manufacturer is looking for promising ideas for a new product, or a manufacturer has a product idea that needs further development based on field research and user input. The UL experts comment on the value of such methods as unobtrusive observations of people engaged in pertinent activities, individual and group interviews, diary studies, participatory design sessions and the like. Forton and Wiklund emphasize how this familiar kind of research can be adjusted to glean results from a world affected by recent global events, making in-person research a lot more difficult if not prohibited altogether.

Better understand the value and impact of implementing early research and how to optimize the planning and execution thereof to guide the subsequent product design.

About the presenters:

Michael Wiklund, MS, CHFP, general manager, Emergo by UL

General Manager of Emergo by UL, Human Factors Research and Design team, Michael Wiklund, is a board-certified human factors professional. He is also recognized as a Professor of the Practice at Tufts University, where he has taught on human factors for over 30 years and focused the human factors program on the application of human factors engineering knowledge to medical technology. Wiklund has contributed to several standards on human factors, including IEC 62366-1 and AAMI HE75. He has published multiple books on human factors including “Designing for Safe Use,” “User Interface Requirements for Medical Devices,” “Usability Testing of Medical Devices”  and “Medical Device Use Error: Root Cause Analysis.” 

Tess Forton, BS, senior user researcher, Emergo by UL

Tess Forton is a senior user researcher on the Emergo by UL team for Human Factors Research and Design. Forton routinely leads human factors activities for medical device and pharmaceutical companies, with a strong focus on conducting early-stage user research. She is skilled in using a diverse array of user research methods, such as field observations, focus groups and diary studies to uncover user needs and guide product development decisions. Forton has a particular interest in Software as a Medical Device (SaMD) and the interplay of healthcare and human behavior. She has expertise in developing digital mental healthcare solutions and holds a Bachelor of Science in Psychology from Northeastern University.