Case Study: Making Agile Work for the Regulators
Historically, highly-regulated industries (e.g. banking, medical, military) have had to rely on waterfall-based processes to meet the expectations of regulators. This presentation examines the case of a medical company using agile methodologies to satisfy the demands of customers who must satisfy software validation requirements set forth by the US FDA. As the lead executive in charge of software development at my company, I can share first-hand knowledge on how implementing agile has worked in this context.
Outline/structure of the Session
- Introduction and Context
- Creating a Process Framework
- How it worked in practice
- What we missed and what we learned
- Advice for those venturing into this at your company
- Common process frameworks to choose from
- Challenges with meeting expectations of regulators
- Startup considerations for implementing agile methods
Company leaders who are concerned about the effectiveness of agile processes meeting their business goals, especially in highly-regulated industries.