When it just *has* to work: Agile Development in Safety-Critical Environments
Traditional thinking holds that the more critical the application, the more tightly its development must be planned, staged, and controlled. The truth is that a flexible culture is stronger, safer, and more robust. FDA regulatory standards are designed to support a learning organization – fully compatible with Agile! This session gives you practical tips for moving your customers and auditors to a flexible agile approach to planning, team interactions, and risk management. When the culture shifts, the result is not just that teams achieve their goals sooner, but safety is greatly enhanced.
The presentation will be interspersed with audience interaction, to permit discussion of concerns and current problems in regulated environments. By the end of the talk, attendees will have a clear vision for developing their own action plan to change the development culture.
- Get ammunition for conversations with managers, to show why incremental design is safer than up-front design
- See examples of how several medical device companies are already reaping increased ROI from using agile team discipline
- Understand how the traditional method of hazard analysis is more dangerous than the agile approach
- Be able to explain to your customers (internal and external) the benefit - to them - of working collaboratively with you
- Grasp how the regulatory requirement for separate reporting chains for development and QA need not prevent Agile collaboration