Pre-Conference Workshop or Training Day
9:30 am - 11:30 am Applying Model-Based Design and Verification for Medical Device Software Development
Complexity is one of the dominant challenges in embedded software and systems engineering. In this workshop, you’ll see how incremental modeling and simulation of various aspects of a software development process from requirements to embedded implementation and testing can help medical device systems and software engineers gain confidence in their designs throughout the development workflow. The process is based on simulation-based testing and verification plus the use of formal methods on both the model and the code. Highlights include:
- Overview of Model-Based Design workflow using FDA’s Infusion Pump reference design as a system case study for software and pump modeling
- Automating simulation testing, including functional testing of the model and equivalence testing of the generated code
- Uncovering hard-to-find design errors such as dead logic, divide by zero, and integer overflows
- Checking the build quality of integrated code, generated and/or hand-coded
Christian GußSenior Field Application Engineer
11:30 am - 1:30 pm Map the Key Challenges During the Development Cycle to Decrease Your Time to Market
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.
- 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 AlonsoSoftware Development Manager
1:30 pm - 2:30 pm Networking Lunch
2:30 pm - 5:30 pm Ensure Product Quality by Implementing Effective Root Cause Analysis Techniques
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.
- 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 MollDirector of Quality and Regulatory
9:30 am - 5:00 pm Introduction to Agile Adoption for Regulated Medical Software: Business and Regulatory Impacts (Beginners Course)
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 ShoemakerPrinciple Consultant
Nancy Van SchooenderwoertPresident and Principal Coach