Imagine: You’re interviewing a 9-year-old to get feedback on a new level of a popular children’s game. During the warmup part of the session, she was chatty and smiling and made a lot of eye contact, but now something has changed. She’s nervous and is struggling to...
Korey has over 15 years of experience in UX and HF research. With a background in both automotive UX (improving the design of vehicle cockpits and in-vehicle systems) and, over the past 10+ years, a strong focus on medical device human factors, he offers clients cross-industry expertise with a critical understanding of working with regulated spaces. Korey has a passion for making medical devices safer and more effective through the application of HFE/UE, and also for establishing and maintaining an organizational culture that supports the development of expert HF practitioners – both of which are central to the mission of Bold Insight.
During graduate school he applied the principles of human factors engineering to the problem of user authentication, creating a novel graphical authentication mechanism for which he holds a patent. Korey is a contributing author to industry standards, regularly speaks at national and international conferences, and has an MS in Human Factors Psychology from the University of Idaho.
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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.
A successful global project starts with understanding and planning for logistical challenges.
Prepare for a successful global study by allocating additional time to strategize localization and translation.
Understanding and accounting for common challenges is the first step in collecting high quality data during global research.
Conducting research to inform development of safe and effective medical devices is essential and with modifications and precautions, in-person research can be conducted safely and effectively.
Human factors research in the support of medical and drug delivery device commercialization is essential and we should be planning on a return to in-person research as soon as is possible by applying all available and practical protective measures.
HFES healthcare symposium provides insight on FDA and regulatory perspectives, use of technology in research, interesting research methods employed, and cross-industry collaboration.
A stronger recruiting strategy that includes relationships with patient support groups and clinical treatment centers can provide better access to difficult-to-reach patient populations. Being intentional about how you plan the logistics of your human factors and user research can mitigate risks to validity introduced by biases.
Finding efficient ways to leverage post-market surveillance data to inform product development at an institutional level will be key for SaMD manufacturers seeking FDA precertification.
Healthcare symposium provides clarity for interpretation of FDA guidance documents related to human factors engineering.
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