Join us for the next event in our Institute's fall 2025 Speaker Series featuring Kayvan Hedayat, Senior Director, New Product Development, CooperSurgical. 

This event is sponsored by the Institute for Integrative and Innovative Research (I³R). 

To join via zoom remotely:

Please click the link below to join the webinar: https://uark.zoom.us/j/82305680047?pwd=bbBQ990IAcABxpaYbZPOaNUgCIlzrB.1

From Concept to Compliance: Building Predictable Pathways for Development in Regulated Environments

Successful technology deployment in regulated environments demands predictable and robust product development to minimize implementation lead time and ensure optimal performance at a reasonable investment. Organizations often strive to differentiate or “innovate” and grow while navigating stringent regulatory requirements and diverse stakeholder expectations. 

This presentation outlines the FDA’s waterfall process for the design and development of medical devices, highlighting how it differs from other regulated sectors. It explores common pitfalls, shares real-world lessons learned from medical device and other industries, and incorporates industry perspectives to support predictable and timely outcomes. Tools and practices used throughout each development phase—from capturing “User Needs” and the “Voice of the Customer” to product launch and “Manufacturing Transfer”—are discussed to ensure traceability and regulatory compliance. The concept of Robust Design Validation methodologies is examined, particularly as they apply to technology transfer and product development.