Wednesday, June 17, 2009

[AgileScotland] When it just *has* to work: Agile Development in Safety-Critical Environments

Hi Everyone,

Nancy Van Schooenderwoert, a very experienced Agile coach with a very long name, is in Edinburgh next Friday afternoon, the 26th. She's presenting a one-off session, running from 3-5, about Agile in Safety-Critical Environments to the agile team at
Toshiba Medical Visualizaton Systems (they're one of Scotland's agile success stories). You can see details of Nancy's talk, below.

The folk at Toshiba have very kindly set aside a few spaces for the general public.  If you are interested then get back to me - and I'll let you know if you've got a spot early next week.  I'm sorry, but I'm going to have to turn some of you away.  If you are particularly interested in safety-critical code then let me know and I'll prioritize you.


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.

Learning outcomes

   * 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

Who Should Attend
Key attendees are described here as "Personas"

Patricia - a seasoned project manager. She prefers agile development to her old attempts to force teams to conform to an overly prescriptive plan. But, her stakeholders still ask for the same predictability and schedule commitments. And the regulatory documentation needs seem to force a "big design up front" approach so she ends up with a mix of agile and waterfall practices that is only marginally better than waterfall.

Don - the product Quality Assurance representative. Don is responsible for quality concerns of the overall product, only part of which is the embedded software. In particular, Don has to make sure all the requirements of the regulatory agencies (in his world, the FDA) have been fulfilled, and wants to be sure the Agile approach will result in the kind of information he needs to provide.