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.
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The panelists:

Nancy Van Schooenderwoert
ANE Founder and Past President

Nancy Van Schooenderwoert is an independent Agile Coach and past president of Agile New England. As an electronics & software engineer for medical, aerospace, Industrial applications she was among the first to apply Agile methods to embedded systems work. Co-author of book series “Agile Methods for Safety-Critical Systems”, coaching Agile teams and managers since 1998. https://leanagilepartners.com.

Mike Dwyer
ANE Founder

Mike Dwyer has been active in the Agile/ Scrum communities for 20+ years as a practitioner, coach and teacher. Currently, he is curious about the power of the followers who make up the majority of team and Agile organizations.

Damon Poole
Past ANE President

Damon is an Enterprise Agile Coach, Coaching and Agile instructor, and the co-author of Professional Coaching for Agilists (Addison-Wesley). He has coached and trained thousands of people and presented at a wide variety of conferences and meetups. He has also co-created a series of popular Agile games including Heroes of Agility.

Johanna Rothman
Longtime, Frequent Speaker

Johanna Rothman, known as the “Pragmatic Manager,” offers frank advice
for your complex problems. She helps leaders and teams learn to see
practical alternatives that help them achieve more agility in their
work. With that knowledge, they can choose what—and how—to adapt their
product development. See her writing and other resources at jrothman.com
and createadaptablelife.com.

Chet Hendrickson
Agile Expert

Chet Hendrickson has been involved with Agile Software Development since 1996, when as a member of Chrysler’s C3 project he helped develop Extreme Programming. Chet is the first signatory to the Agile Manifesto.

• Much longer cycle times
• Deeper specialization of team members, which limits task sharing
• Much higher costs for rework (refactoring)

Separate engineering teams do add complexity to communications patterns. Still, for this issue and for cycle time and rework, real teams have found ways to get the benefits of Agile practices, and additional benefits they didn’t expect!

Nancy will show examples of varying degrees of collaboration between software and other disciplines, from industry and from her own experience as an electronics designer and software engineer. She will make recommendations based on Agile and Lean concepts, and on her 15 years’ work as an independent Agile coach.

About the Speaker

Nancy van Schooenderwoert 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, Agile Hardware, and Lean development methods, in addition to Scrum. She is a former president of Agile New England, and has led numerous ANE events, including the Agile for Executives event series, and Deep Agile and Mob Programming conferences. She is a regular presenter at Agile-related conferences worldwide, and is currently helping executives build a peer-to-peer learning network.

We will share how tools like Story Mapping and Impact Mapping are integrated into product development. We explain how to use safety stories, integrate traceability using your story map, and specify tests to address safety and hazard mitigation requirements. We share how to proactively conduct incremental hazard analysis and mitigation and formal design review to satisfy regulatory requirements. And we’ll explain how stakeholders;€” including marketing, engineering, and service can share a coherent vision early in development to support the special demands of the high-assurance products.

The lessons learned from our medical example apply to all types of high-assurance software and hardware development projects. Join us as we show how you can use a lean process to develop these types of products, which are so important for health and safety in modern life. Using actual medical device examples, we show how to create thin vertical slices of organizational activity to deliver fully compliant, high quality, high-assurance, customer value on time.

About the speakers:

Nancy Van Schooenderwoert was among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. Beginning in 1998 she has led Agile change initiatives beyond software development in safety-critical, highly regulated industries, and coached clients in the art of Agile technical and management leadership. A contributor to Agile Times and Cutter IT Journal, she also served on IEEE 1648 Agile Customers committee. She speaks at numerous software conferences worldwide, and is past president of Greater Boston€™s premier Agile user group, Agile New England. Nancy is founder and President of Lean-Agile Partners, Inc.

Brian Shoemaker consults for healthcare products companies in 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. He has had clients in clinical diagnostics, 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. Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.