12 - 13 February, 2019 | Meliá, Berlin, Germany

Post-Conference Training Day

Advanced How-To Topics

Your company has accepted the concepts of Agile and you’ve started several projects which use the approach. You’re making good progress, but you want guidance on getting the most out of this new method. In particular, you’re looking for how to document your project, how to address risk management, and how to work in human factors engineering (none of which classically seems to fit the Agile mindset). Picking up the thread from the introductory course, this session explores topics essential to any regulated medical product company applying an Agile approach for development.

The course will cover these topic areas:
  • Lean flow - exercises using a medical product example
  • Understand lean cycle time and lead time metrics and use them to predict completion times – even for tasks difficult to estimate
  • Learn how to apply lean metrics to a real medical device project
  • You’ll have an alternative to offer your managers when you are being pressured to maximise utilisation of your staff

Dive into documentation - more specific how-to
  • Learn techniques based on “thinking from the end result” to define your work so that tests and requirements are paired from the start
  • Be able to substitute automatically-generated info for much of the manual documents you now create
  • Be able to use your Agile Demo meetings as complete design review meetings per FDA / European regulatory needs

Fitting risk management into the Agile approach
  • Recognize how Agile inherently minimises several types of risk
  • Understand the cadence of iterative risk management
  • Be able to apply classical risk management tools (FTA, FMEA) in an Agile context

Where does Human Factors Engineering come in?
  • Recognise how Human Factors Engineering goes beyond User Experience design
  • Grasp how Human Factors Engineering fits with Agile
  • Understand how to conduct Human Factors exploration in parallel with development
  • Recognise the value of sprint demo sessions for learning human factors issues

Agile Leadership and the organization
  • You will learn how to stop being the “process police” and instead guide self-managing teams
  • Understand the deeper cultural and psychological aspects of the change to team-based work
  • You’ll learn ways to help your teams become self-organising, and why such teams are a great antidote to being blind-sided on project status 


Individuals with business, technical or medical domain expertise will all benefit from the discussions in this course - which will include several hands-on exercises to help apply the techniques we describe.

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

This will be an advanced course, and makes an assumption that attendees have either attended our introductory course, or have been involved in their company’s Agile adoption program for at least 6 months.

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Brian Shoemaker

Principle Consultant
ShoeBar Associates

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Nancy Van Schooenderwoert

President and Principal Coach
Lean-Agile Partners