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Jim Kershner
Director
Jim has 20+ years of medical device product development experience, ranging from orthopedic implants and surgical instruments, to endovascular products, to drug delivery systems. Jim conducts and manages both UX and human factors projects in the healthcare space. Jim has a BS in Physics from Appalachian State University and an MEngSc in Biomedical Engineering from the University of New South Wales.



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- Bold Insight presents with Stryker, Genentech, and AbbVie at the HFES Healthcare Symposium
- Human factors optimization: How to leverage HF researchers in your medtech team
- Bold Insight featured in Packaging Digest on when to finalize design elements of your medical device packaging
- What medtech design teams need to know about AI regulations
- 3 crucial aspects of submitting a successful human factors engineering package to the FDA
- Bold Insight to present on IFU design, digital telemetry, and other human factors topics at HFES Healthcare Symposium
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3 crucial aspects of submitting a successful human factors engineering package to the FDA
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.