Post Conference Training Day

9:00 AM - 4:30 PM Agile Adoption and Development for the Regulated Medical Software Industry: A Cross-Business Impact Analysis

Brian Shoemaker, Principal Consultant, Shoebar Associates Nancy Van Schooenderwoert, Principal Consultant, Lean Agile Partners
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.

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Brian Shoemaker

Principal Consultant
Shoebar Associates
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Nancy Van Schooenderwoert

Principal Consultant
Lean Agile Partners