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

Nancy Van Schooenderwoert


President and Principal Coach
Lean-Agile Partners


9:30 AM Introduction to Agile Adoption for Regulated Medical Software: Business and Regulatory Impacts (Beginners Course)

How-To Topics
 
The Agile approach is well established in other industries; adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. 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, including:
 
-          Countering the village rumors
-          Understanding the REAL regulatory requirements
-          Agile is a mindset, not a canned method
-          Fitting together hardware and software development, and being Agile in both
-          Applying Impact Mapping and Story Mapping practices to chart the way
-          Bringing everyone on board, not just software
-          Applying Agile to larger scale organizations / projects
-          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 specialists
  • Functional managers - Software, Test, Hardware
  • Other development specialists (mechanical, engineering, other)
  • Project managers (especially for cross-functional teams)
  • 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.
 

2:40 PM Agile Requires Leadership

  • Discover how peer learning collaboration may be utilised to make every function agile
  • Future Leaders: Learn how agile teams are a training ground for future leaders
  •  Which scaling framework should you use in your company? (Hint it’s a trick question!)

8:30 AM Advanced Agile Adoption for Regulated Medical Software

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.



Check out the incredible speaker line-up to see who will be joining Nancy.

Download The Latest Agenda