Business Drivers That Influence Information Systems Development

By valid, we mean a sincere effort by both management and technical contributors to move the company through genuine change. We chose our cases based on several factors, chief of them being that we knew enough about the situation to say that it’s a valid use of Agile.

Uncover emerging trends and practices from the world’s most innovative software professionals. Specific companies and products are examined, and the actions their Agile change leaders took. This article is based on case studies from our new book Agile Methods for Safety-Critical Systems: Case Studies of Medical Product Companies. The FDA’s own Design Control Guidance, immediately after depicting development in a waterfall-like diagram, notes that “In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of product development.” This has been refuted by regulators and by industry people multiple times. One belief is that regulators (both FDA and in the EU) prefer stage-gate, waterfall-like product development. The question is no longer whether, but how Agile can work in medical product development - for our mix of technical, market, and regulatory constraints?ĭoubts persist, based on misinformation about Agile practices, regulations, or merely on a deep suspicion that work completed quickly must be taking unsafe shortcuts. The rise of home-use medical products has spurred use of Agile continuous delivery for mobile hardware platforms. Practices vary with the types of development work, from cloud-based continuous flow for data-intensive services (clinical trial data management) to a sprint-based flow for physical devices with embedded software.

We’ve noticed adoption of Agile methods steadily growing in medical product companies over the past ten years.

Business Drivers That Influence Information Systems Development