Medical Devices: Crossing the Abyss from Development to Design Lock

Event description

Presenter: Diane Earp, MSHS, SBB(ASCP)

Medical devices face a critical inflection point between early research and development and full product commercialization.

Join this Catalyze webinar to explore what it takes to successfully cross the "abyss" from prototype development to design lock. This session will examine the technical, regulatory, and strategic milestones that shape this transition, helping innovators understand how to move from iterative development to a finalized product ready for commercialization while avoiding the costly traps that can result in significant delays or failure to launch.

Presenter Diane Earp, who brings 20+ years of experience in regulatory affairs and quality assurance, will share insights drawn from her work across U.S. and international regulatory environments supporting drug, biologic, and medical device development, testing and validation, manufacturing, and commercialization. Designed for early-stage medical device innovators, academic investigators, and startup teams, this webinar will provide actionable guidance for navigating one of the most challenging and consequential stages of in vitro diagnostic and therapeutic medical device development.

Webinar presented on June 12, 2026 to an invited audience.

This video is provided for educational purposes only.

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This research was, in part, funded by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.