This webcast will demonstrate the unique benefits of applying human factors methods and solutions to clinical and IDE trials. You will learn specific human factors techniques for risk analyses, training, instructions, interaction videos, and checklists.
Most pharmaceutical and medical technology sponsors do not focus on labeling, training, or instructions for use until the commercial phase of product development. However, these critical elements can significantly affect the success of a clinical trial. Clinical research and human factors are often treated as separate disciplines. Even the most promising product cannot demonstrate safety or effectiveness if it is not used correctly during an IDE study or clinical trial.
This webcast explores how human factors science, methods, and tools can strengthen clinical trials by reducing use errors among research staff and study participants. By addressing human factors early, organizations can improve data quality and minimize confounding factors that may affect study outcomes. Examples include use-related risk analyses, staff and participant training programs, instructions for use, interaction videos, checklists, and other human factors solutions designed to support successful clinical research.
Upon completion of this webcast, attendees will understand:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].



Director, Interface Analysis Associates, LLC
Anthony Andre, PhD, CPE, is a world-recognized thought leader in healthcare human factors. He is director of Interface Analysis Associates LLC, a leading healthcare human factors consultancy in business since 1993. He is a recently retired professor of human factors/ergonomics at San Jose State University, the founding chair of the International Symposium on Human Factors and Ergonomics in Healthcare and the founding editor-in-chief of the journal “Human Factors in Healthcare.” Andre and his staff have been at the forefront of the combination drug product and medical device Human Factors movement, having managed and executed hundreds of HF validation programs for pharma, biotech, and medical device sponsors all over the world. Andre has provided human factors training to the FDA reviewers, and for 10 years moderated an annual FDA-Industry human factors workshop.
Human Factors Engineer, Interface Analysis Associates
Margot earned a Master of Science in Human Factors and Ergonomics from San Jose State University in May 2022. She joined Interface Analysis Associates in January 2022, focusing on usability research and applying perceptual, cognitive, and ergonomic principles to the design and evaluation of medical devices and digital health systems. Before transitioning to human factors, Margot specialized in developing, optimizing, and validating analytical methodologies for oncology pharmaceuticals. She also trained analysts in cGMP laboratory practices. Margot holds a Bachelor of Arts in Biochemistry from Wellesley College and has been an active member of the Human Factors and Ergonomics Society since 2020.