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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Shelly Holbrook
Director
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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Bold facts
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Something unique about you summed up in one sentence
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Your favorite part of working at Bold Insight
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In your spare time (or if you had spare time), you would absolutely do this:
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You cannot start the day without doing this…
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Your ultimate celebrity dinner party guest list would include:
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Long-term personal or professional goal?
- Human factors testing for OTC drugs and non-prescription medical devices
- What the history of human factors tells us about the future of our industry
- Unlocking the power of user-centric design for business success
- Bold Insight to present on IFU design, digital telemetry, and other human factors topics at HFES Healthcare Symposium
- Improve medical device safety with these packaging design tips
- Bold Insight to present on global medical device testing, in-person research logistics during COVID at HFES Health Care Symposium
- Working from home: Tips for designing your workspace from an ergonomics expert
Read our team’s latest bold insights
What the history of human factors tells us about the future of our industry
Look back at the rich history of human factors engineering, from its roots in anthropometry to the advanced field of ergonomics and beyond. These developments have shaped technologies and design, enhancing everyday life by making experiences safer and more intuitive.
Mastering the balance between moderation and facilitation in UX research
Moderation and facilitation exist on a continuum. Discover how building skills in both areas allows you to adapt to various research methods and project needs.
The FDA’s PCCP: A game changer for AI-enabled medical device software
Learn how incorporating human factors principles in developing the PCCP approach can improve the chances of successfully implementing a PCCP.