The Association for the Advancement of Medical Instrumentation (AAMI) will hold a new 2-day course September 22-23, 2016, at AAMI headquarters in Arlington, VA.
AAMI’s strategic plan includes a goal to advance a systems approach for medical devices and related data. This new course will help build competencies among medical device manufacturers and offers an educational opportunity to support a systems approach to medical device design and development.
For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems. This course goes beyond small-team and software-only applications and demonstrates how Agile practices can be used in the development of medical device systems.
Course Learning Objectives:
This course focuses on the application of Agile principles and practices in the development of large systems – systems built by large teams and/or systems that include more than software.
Topics include:
- Interpreting the Agile Manifesto Principles in a System Engineering perspective
- Lean Agile Principles
- Systems Engineering Process Model
- Product Development Lifecycle Models
- Aligning Agile with Phase-Gate Models
- Agile Adoption Moels and Team Structure
- Stakeholder Expectations, Requirements Definitions, and Agile Stories
- Verification and Validation
- Agile Practices applied to Hardware & Mechanical
- Backlogs for Feasibility, Spikes, Enablers
- Release/Increment Planning
- Satisfying the Quality Management System
- Safety Risk Management, Hazard Analysis
Trainers
- Kelly Weyrauch, Owner, Agile Quality Systems LLC
- Chris Unger, Chief Systems Engineer, GE Healthcare
Format
The workshop format will consist of lecture, with multiple interactive in-class exercises.
Target Audience
Instruction is targeted to Systems Engineers, Software/Mechanical/Electrical Developers and Testers, Program Managers, Architects, and leaders of organizations developing complex healthcare products, whether those are large Healthcare IT systems, electro-mechanical systems with or without embedded software, or complex systems with multiple hardware and software subsystems.
Because this is an advanced course on the application of Agile, attendees should have a basic knowledge of Agile principles and practices, such as might come from Agile/Scrum training, or having attended the AAMI course related to AAMI TIR45:2012,“Effective Application of Agile Practices in the Development of Medical Device Software.”
Registration Fees
- AAMI Member $2035
- AAMI Non-Member $2335
- Government Employees $735
Materials: Include electronic versions of the course PowerPoint presentations and case studies, relevant standards and technical information reports, pertinent FDA documents, and additional references. Complimentary Wi-Fi Internet access will be available in the meeting area.
Meals: Include continental breakfast, lunch, and refreshments.
