Making Sense of the Gaps: Bridging FDA Guidance and Real-World Complexity in OTC SaMD Self-Selection Testing
An oral presentation given at the 2026 HFES International Symposium on Human Factors and Ergonomics in Health Care on Wednesday, March 25, 2026.
Presented by Agatha Kalinchenko, MD and Natalie Stepien-Bernabe, PhD
About the Authors
Agatha Kalinchenko, PhD is a physician with a master’s degree in psychology who transitioned her clinical and psychological expertise into the fields of user experience and human factors. Currently a senior consultant at Sage Research + Design, she utilizes her multidisciplinary background to improve medical device safety and patient satisfaction through strategic design.
Natalie Stepien-Bernabe, PhD is a Human Factors Managing Scientist at Sage Research + Design, applying her expertise in experimental psychology and research methods to develop safe, effective medical products and guide companies through the complexities of medical device regulatory submissions. With an extensive background in user experience research, she ensures design decisions reflect real user needs while advancing usability across the product lifecycle.
