After collaborating for 10 years via custom workshops, training, and worldwide presentations on the power of Agile methodology, Nancy Van Schooenderwoert, principal of Lean-Agile Partners, Lexington, MA, and Brian Shoemaker, principal of ShoeBar Associates, Dedham, MA, have co-authored a book for the medical device industry titled, Agile Methods for Safety Critical Systems.

“We recognize that the transition to Agile can require challenging mindset changes not only in the software group, but also among management, quality, regulatory, and marketing. Changes of this scale are best accomplished in small steps such as coaching with an Agile specialist. Nancy and I thought that writing a book would put it in the hands of those who need it most but are not ready to commit to coaching,” Dr. Shoemaker explains.

The Agile approach is well established in other industries, and adoption of Agile in medical device development has been increasing in the past seven years. Experience is showing that both quality and safety are improved when the development team is Agile, and that regulatory requirements can still be met.

“Using examples around safety critical medical devices, the authors reveal counter-intuitive means of moving beyond older software methods to be able to consistently produce previously unachievable levels of quality, while simultaneously increasing the speed of production! If that seems impossible, you need to pick up this book!” says Jack Lewin MD, Founder and Principal, Lewin and Associates LLC.