Instructor

Katherine Stephenson LinkedIn

"When you design a medical device, the 'how' is as critical as the 'what.' Design controls ensure a design process is efficient, thorough, and easily communicated to your team and the different authorities tasked with ensuring the safety and efficacy of your final product."

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KATE J. STEPHENSON, Ph.D. is the founder and principal of Dyad Engineering, LLC, a consulting firm specializing in design and engineering strategy for new life science ventures. A resident of the Silicon Valley startup ecosystem for 20-plus years, she has worked on over 60 different early-stage products in medical devices, diagnostics, and drug delivery. She earned her doctorate in Mechanical Engineering from Stanford University and has deep expertise in the design and manufacturing of hardware. A peer reviewer for both the National Institute of Health and the National Science Foundation Small Business Innovation Research grants, she is also an evaluator for Federal Innovation initiatives, and a subject matter expert for investment due diligence.

Associated Program(s)

Medical Device Quality and Design Regulatory Affairs

Design Control for Medical Devices