News and Events:
Our Case Studies Book is Published!
Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies is a new book of case studies in the use of Agile Methods for regulated medical product development. This is a follow-up to our earlier book Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples.
We just had to do this book! There are so many inspiring, creative stories of real teams in real companies using the Agile and Lean principles to make a vital difference. These cases are known only to limited groups – those directly involved and attendees at smaller industry conferences. They deserve a bigger audience. This book names the companies and products involved; they deserve to be known.
Webinar: Agile in Medical Product Companies
Join us for a lively discussion on how Agile principles are in use right now. Safety-critical medical product development can be fully-agile and fully-compliant with regulatory needs. Hear about real-world examples!
The discussion will focus on our recently published book Agile Methods for Safety - Critical Systems: Case Studies of Medical Product Companies, where they present seven case studies, from medical software development. Join us for a free-flowing conversation on what lean-agile is and where it’s headed, both in industry and practice. Introductory Book Available
Agile Methods for safety-Critical Systems: A Primer Using Medical Device Examples This book, packed with real-world insights and direct experiences, is for managers who want the benefits of Agile but also must address regulatory compliance, integration of software with other disciplines, and product safety. In it, we combine our understanding of Agile development, hardware/software integration, and regulatory requirements. We know that Agile is simple but not easy; leadership is crucial to make this change spread. We aim to show how you can navigate the transition. For more information click here. To order, go to the Amazon page. A copy of this book is included with our course "Agile Introduction for Regulated Medical Software". More details here. We are a Specialist Collaborator with
Affiliated Associations
 We're an active supporter of Agile Alliance and Agile New England!
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Our Mission1. To bring state of the art Agile methods to safety-critical product development - in medical devices, industrial controls, aerospace.
2. To support teams and managers in applying Lean-Agile principles to software, hardware, embedded systems, and other disciplines in all types of companies. 
Nancy Van Schooenderwoert, founder of Lean-Agile Partners offers Agile coaching, training, and consulting worldwide. 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 beyond software development in safety-critical, highly regulated industries, and teaches modern Agile approaches like Mob Programming, Agile Hardware, and Lean development methods. (More...)
What We DoWe tailor Lean-Agile methods through hands-on, practical coaching to create real behavioral change that goes to the bottom line. This achieves measurable product quality and predictable time to market. We have demonstrated success in safety critical, regulated industries such as medical, aerospace, and industrial controls; as well as financial services and consumer products.
Keynoting at QA&Test Embedded 2021
October 20-21 Online
Keynote presentation: "Medical Device Innovation Through Agile"
Presenters: Nancy V. And Brian Shoemaker 
Innovation is central to survival in the medical device industry, where new concepts and new designs are appearing every day. We’ve interviewed key actors at several companies doing development in medical devices and clinical trial data management software – companies which had successfully implemented an Agile approach. We found that a common set of principles surfaces in these cases, although their application is different in each situation. More info here
SDMD Global 2021 Online
Master Class: 21st Century Agility in Regulated Med Tech Work
Feb 2-4, 2021 From this workshop, participants will learn real-world examples of:
SDMD Boston 2018Jan 22-24, 2018
Nancy Van Schooennderwoert and Brian Shoemaker gave a 2 hour workshop An Incremental Approach to Risk and Quality Management in Medical Device Software Design 
SDMD 2017 Conf.
Software Design for Medical Devices Europe, 22-23. February 2017, in Munich
Course: Introduction to Agile Adoption for Regulated Medical Software: Business and Regulatory Impacts
Nancy Van Schoenderwoert and Brian Shoemaker will present this full-day workshop on Feb 24th, designed for managers, technical leaders, and regulatory affairs professionals who want to understand the benefits and pitfalls of adopting Agile practices in an FDA-regulated company. 
26. - 28. October 2015
Park Plaza Hotel, Boston MA Nancy Van Schooenderwoert and Brian Shoemaker will present Agile is More Than Software! Trying to understand the “Agile method” as just another software development lifecycle, with specific rules and a fixed outline, is mistaken, and seriously limits the benefits that Agile can bring. Successful Agile implementations include development, operations and business functions right from the outset. Anything less just creates another process island and cross function friction. |
Lean-Agile Practices for Hardware & Software Products, and Regulated Industries
When Safety, Quality and Product Value are Critical
