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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Kaitlin Stinson
Director
Kaitlin brings to Bold Insight over 14 years of experience as a human factors engineer at medical device manufacturers. She has extensive experience in diabetes care products, software as medical device (SaMD), and complex drug delivery systems. Kaitlin has a passion for meeting design control and regulatory requirements while executing agile human factors programs of research. She has a BS in Psychology from Ball State University and an MS in Human Factors from Bentley University.
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- Integrating FDA's new cybersecurity guidance into medical device human factors engineering processes
- Bold Insight and Eli Lilly and Company co-publish journal article on novel assessment tool to enhance medical device usability
- Bold Insight to launch AI research project at the 2024 HFES Health Care Symposium
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