Nancy Van Schooenderwoert

Principal Consultant
Lean Agile Partners
Nancy Van Schooenderwoert does Agile Enterprise coaching— everything from launching new agile technical teams to advising executives on how to take Agile and Lean principles far beyond software development in their drive to deliver more customer value faster. She works with large and small companies. Nancy pioneered agile practices for embedded software development beginning in 1998. Her background in electronics and software development for avionics, factory automation, medical, and defense systems brings a unique perspective to her coaching practice.
Nancy holds a Scrum Master certification, has edited a column for the Agile Times, and served on the IEEE 1648 committee to define a standard for customers of agile teams. She has been a regular presenter at various Agile-related conferences since 2003. Her work in applying Agile methods to embedded systems has been referenced by Jim Shore and Mary Poppendieck in their books. She is a founder and past president of Agile New England, Boston's largest Agile

9:00 AM Agile Adoption and Development for the Regulated Medical Software Industry: A Cross-Business Impact Analysis

The Agile approach is well established in other industries, and the continued adoption of Agile in medical device development has been driving industry innovation. Agile’s goal is not just to speed up your development timeline, but also to increase your quality. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met with this change in approach.

Regulatory structure and initiatives are changing, both in the EU and in the US; and this course material will take those changes into account.

By walking through a safety critical project, Nancy Van Schooenderwoert and Brian Shoemaker will delve into several key areas for applying Agile in the medical device context, with new focus areas including:
* Impact of new regulatory developments and understanding the REAL requirements
* Agile as a mindset to foster team involvement and innovation
* Understanding the relationship between hardware and software development with an agile approach
* Documentation: how to be Agile and still be compliant
* Chart your path with Impact and Story Mapping methodologies
* Agile across the functions – creating an agile team not just agile software
* Incremental risk mitigation, including cybersecurity risks
* Scaling your approach - applying Agile to any scale of organizations or project
* Metrics - how to use them and what to avoid

Rather than focusing on any methodology class (Scrum, Kanban, Crystal, XP), this course aims to build understanding of the fundamentals which underlie all methods, so that teams can determine their own blend based on what works in their context, and address the issues which inevitably come up in Agile adoption. Practical illustrations will be demonstrated by use of specific tools, but the tools themselves are not the focus.

Who should attend?
* Regulatory and quality assurance specialists
* Project managers and program managers
* Functional managers - Software, Test, Hardware
* Other development specialists (mechanical, engineering, other)
* Software Developers
* Business Analysts, requirements analysts
* Product managers
* Portfolio Managers

This will be an introductory course, and makes no assumptions about previous knowledge or experience with the Agile approach.