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

Pre-Conference Workshop or Training Day

9:30 am - 12:00 pm Map the Key Challenges During the Development Cycle to Decrease Your Time to Market

Ramon Alonso - Software Development Manager, Kiro Grifols
Delivering a medical device to the market is a complex challenge, where too often the simplest development may transform into an endless resource drain on a medical device team. From identifying the market need to device validation and post-production activities, the checklist of milestones to be accomplished can become daunting.
Overcome the principle challenges faced during and post development of a medical device by utilising the tips and tricks used in real-life examples, to ensure you maintain regulatory compliance and end-user expectations throughout your agile development. Combat challenges in risk management, architectural design, verification and validation, effective documentation and preparing yourself for post-release life, by learning from example and employing methods with peer-proven success.

Session Objectives:
  • Maximise the efficiency of your development activities as per the FDA Design Controls using real-life case studies
  •  Understand the power of standard operating procedures  beyond
  •  Delivering you medical device is just the beginning:  Prepare yourself for post-commercial life by learning from real-life examples
  • Benchmark your own practices against the KIRO Link Project 

Ramon Alonso

Software Development Manager
Kiro Grifols

1:00 pm - 4:30 pm Ensure Product Quality by Implementing Effective Root Cause Analysis Techniques

Jan Van Moll - Director of Quality and Regulatory, Philips
Bad product quality can haunt companies long after release. Root cause analysis (RCA) on product quality issues is an indispensable step to avoid and prevent these from recurring. Unfortunately the medical device industry is struggling to conduct successful RCA both on product products as well as process issues. Though being crucial to processes like CAPAs, companies fail to unlock the full potential of RCA techniques by limiting themselves to the usage of ‘quick and easy’ techniques only. This workshop session is aimed at providing the primary training necessary to produce adequate problem statements, and demonstrate the power of several successful, but rarely used RCA techniques. This interactive workshop will challenge the participant to re-evaluate their RCA approaches in their own domain by completing hands-on group exercises, complimented with real-life RCA case studies from the regulated device industries.
Session Objectives:
  • Apply successful RCA tools and write effective problem statements by taking part in interactive group activities
  • Understand the importance of adequate problem statements to RCA
  • Gain hands-on experience writing effective problem statements
  • Boost your product quality by applying powerful RCA techniques
  • Explore the importance of proper RCA with respect to CAPA and successful problem solving

Jan Van Moll

Director of Quality and Regulatory

9:30 am - 5:00 pm Introduction to Agile Adoption for Regulated Medical Software: Business and Regulatory Impacts (Beginners Course)

Brian Shoemaker - Principle Consultant, ShoeBar Associates
Nancy Van Schooenderwoert - President and Principal Coach, Lean-Agile Partners
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.

Brian Shoemaker

Principle Consultant
ShoeBar Associates


Nancy Van Schooenderwoert

President and Principal Coach
Lean-Agile Partners