Why we wrote this book

In the years of teaching our introductory course on Agile methods for Medical Device companies, we saw several strong areas of interest by our attendees that were not addressed, or sometimes even dismissed, by other Agile training.  Topics like risk management, regulatory documentation, traceability, and hardware-software co-design are better served by the incremental approach of Agile teams.  It is our firm belief that Agile methods do not need to be watered down or compromised when building safety-critical products.  Our courses explain why, and we hope our book will reach even more people.

Nancy Van Schooenderwoert

Nancy Van Schooenderwoert is President and Principal Coach at Lean-Agile Partners. Nancy was among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. She has led Agile change initiatives beyond software development in safety-critical, highly regulated industries, and teaches modern Agile approaches like Mob Programming, Agile Hardware, and Lean development methods.
Initially working as an electronics designer and software engineer in flight simulation, she later focused on software engineering. Nancy has worked coaching Agile teams in the USA, UK, and Germany. Her coaching extended to their work with their teams in Japan, India, China and other countries.
Nancy's experience spans embedded software and hardware development for applications in aerospace, factory automation, medical devices, defense systems, and financial services. Her coaching practice spans delivery teams to middle and upper managers. She is a regular presenter at Agile-related conferences worldwide. She is a founder and past president of Greater Boston’s premier Agile user group, Agile New England.

Brian Shoemaker

As Principal at Shoebar Associates, Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including Agile methodology), and evaluated 21 CFR Part 11 compliance.
Brian’s strengths include:
  • Application of software development life-cycle and quality systems in FDA-regulated environment.
  • Direct experience applying Electronic Records and Signatures rule (21 CFR Part 11)
  • Multidisciplinary team leadership: coordinating work, obtaining consensus, managing by influence
  • Applied knowledge of quality system components, SOP design, and auditing.
Much of Brian’s activity has been in validation and software quality for medical devices, but some of his projects have been for companies in clinical trial data managements. His clients have been in fields as diverse as medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants. He has worked with companies in Germany and Switzerland as well as the U.S.