Uncompromised Agile is Safer and Better for Regulated Medical Products – Nancy Van Schooenderwoert


Domain-Driven Design Europe 2019

Uncompromised Agile is Safer and Better for Regulated Medical Products (Talk)

As a software tech lead building many safety-critical products, I
immediately saw the “other” benefits of Agile – the way that speed to
market is merely a side effect of doing the deeper engineering work more
thoroughly (while avoiding gold-plating and blind alleys, etc.!)

Now, as someone coaching teams and managers in medical and other
safety-critical work, there is good news: Regulatory bodies in both the
EU and USA are able to recognize this same insight. It’s built into
their operating rules in many ways. If you are starting to work with a
medical device company in any role, this session will explore some key
things you need to know for helping them move to Agile practices:

• Agile is preferred by regulatory bodies for risk mitigation, done
• Every Agile Demo can be a regulatory formal design review with just
minimal added steps
• Documentation is streamlined by the Agile practices we all know, but
there are a few further tips to be aware of when Agile companies submit
documentation to regulators
• Examples will be given of Agile medical device companies using all
these ideas


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 professional group.

Currently based in greater Boston, USA.


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