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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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Regulations and guidance for human factors research and medtech have evolved, but the goals remain unchanged. The right research partner makes navigating FDA rules simple.
Instead of a top-down, one-size-fits-all approach to research, collaboration between manufacturers and human factors research teams can create trusted partnerships and a focus on designing valuable products.
To boost adoption of IoT devices, medical device manufacturers should consider four key questions to gain insights into user contexts and perceptions.
With a few considerations and thoughtful planning, research that includes the a11y community can effectively collect data while ensuring a respectful participant experience to help design products that meet the needs of all users.