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The FDA reached out to the Human Factors and Ergonomics Society (HFES) to assemble a team of experts.
The objective was to provide a training course for the Division of Medication Error Prevention and Analysis (DMEPA) from the Center for Drug Evaluation and Research (CDER) that would offer deeper knowledge of and appreciation for the scientific roots of human factors (HF) research and user-centered design.
Three experts were chosen by HFES to design and deliver the two-day training, including Korey Johnson (Bold Insight), Dr. Anthony Andre, and Michael Wiklund. The team covered topics ranging from the history and origin of HF as a practice to user-centered design principles.
A series of modules included the science behind HF, such as human perception, cognition, memory, and learning, as well as best practices in root cause analysis and dealing with the biases associated with subjective data.
The team provided the FDA with the scientific underpinnings of HF – 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.