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Shelly has worked on complex human factors research problems for 10+ years in a variety of industries, with projects spanning the entire product lifecycle from inception to market. Her training in industrial and systems engineering has provided her the necessary skillset to evaluate both the human and technical components of systems to create intuitive, optimal solutions. Shelly has experience with both qualitative and quantitative research methods, specializing in formative and summative usability testing. Her work in community pharmacy health IT system development, in conjunction with electronic health record implementation, and device and software development in diabetes care has earned her multiple publications. Shelly has a MS and PhD in Industrial Engineering with a Human Factors research emphasis from Purdue University and a BS in Industrial Engineering from Clemson 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.