Representatives from the Human Factors and Ergonomics Society (HFES) provided a two-day training course on human factors science, user-centered design principles, and root cause analysis on September 25-26, 2018 at the Food and Drug Administration’s (FDA) White Oak Campus in Silver Spring, Maryland. This course was attended by representatives of the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER). Korey Johnson, Managing Director of Bold Insight, along with Dr. Anthony Andre, and Michael Wiklund were the three experts selected by HFES to provide this training course.

The training was intended to provide attendees with deeper knowledge of and appreciation for the scientific roots of human factors research and user-centered design. Training drew on seminal research and literature from the fields of psychology, engineering, and product design, and leveraged a wide range of practical examples of both good and bad application of human factors science.

“There are many reviewers within CDER tasked with assessing the extent to which submissions adequately support a decision indicating that a product can be used safely and effectively. Many of those reviewers have abundant experience assessing human factors and user-centered design related shortcomings. With this training we hoped to provide a bit more of the scientific underpinnings of our practice – on one hand to amplify instances where requests for additional research are warranted, and on the other hand to provide the scientific context for when that additional research may not be warranted,” said Johnson.

For more information about the Human Factors and Ergonomics Society (HFES), visit hfes.org.

Connect with Korey Johnson on Linked In, Twitter, or email.

Bold Insight is a user experience (UX) research agency based in Chicago. Our team offers clients the expertise and professionalism of a large agency, with the imagination and agility of a startup; specializing in medical device research, human factors validation, and large-scale global testing. https://boldinsight.com/medical-devices