As the field of human factors continues to evolve, so must our approaches to testing and study design. While the FDA’s 2013 guidance laid the groundwork for study design and methodology, recent discussions and conference presentations have prompted a shift in how we approach OTC HF testing, leading to more comprehensive and realistic assessments of these products.
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Christina Ambrose
Director
With a background in interdisciplinary social sciences, Christina has been trained in various qualitative research methods. Her human factors expertise includes consulting on products from early-stage exploratory research through end stage validation studies, and she has supported several successful submissions. She collaborates with clients to design programs of research and decide on optimal methodologies, while supervising individual research projects involving medical devices and digital health management platforms. Christina holds a BA in Comparative Human Development and an MA in the Social Sciences from the University of Chicago.
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