Many organizations that provide regulated, high-assurance, safety-critical software and hardware development struggle to understand how Agile methods work there. High-assurance products are ones that may risk human life, prosperity and health. Product development challenges include audits, regulatory documentation, risk management, safety, security, and traceability. You do not have to retreat to waterfall methods when building safety-critical applications. Agile and Lean principles apply here 100%.
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 Bostons 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.
