The Agile approach has become widely accepted over the past couple of decades. However, in the heavily regulated medical product development field, the validity of Agile practices long remained controversial. This question is no longer at issue—rather, the question now is how development teams (and companies) can be Agile and still satisfy their regulatory requirements.

Nancy Van Schooenderwoert will present highlights from several case studies that illustrate how Agile companies have found ingenious ways to maximize both quality and flexibility. These lessons apply to other industries where the presence of risk too often leads to paralysis. This presentation is based on the book Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies by Nancy Van Schooenderwoert and Brian Shoemaker.

About the Speaker:

Nancy is President and Principal Coach at Lean-Agile Partners. She was among the first to apply Agile methods to embedded systems development. As an engineer, manager, and consultant, she has led Agile change initiatives for software and hardware projects in safety-critical, highly regulated industries, including aerospace, factory automation, medical devices, defense systems, and financial services.

Nancy teaches modern Agile approaches like Mob Programming (now called Software Teaming), Agile Hardware, and Lean development methods, in addition to Scrum. She is past president of Agile New England (ANE) and has led numerous ANE events, including the Agile for Executives event series, Deep Agile and Mob Programming conferences. Nancy is a regular presenter at Agile-related conferences worldwide, and is co-author of the book Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies, published in 2021.