Design an AI-enabled software as a medical device that offers cutting-edge capabilities and earns the trust of healthcare professionals, ultimately improving patient care.
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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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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.