Adopting Agile in an FDA Regulated Environment

This paper is an experience report describing Abbott’s adoption of agile software development practices in its molecular diagnostics division. We will compare two medical device projects; one before agile and one after. Both of these projects required submission to the FDA (the U.S. Food and Drug Administration). We will describe the adoption of agile practices from realization of the need to the selection of a mentor to implementation and fine-tuning and finally to results and lessons learned. This experience has convinced us that an agile approach is the approach best suited to development of FDA-regulated medical devices.