Reducing waste in issue tracking for regulated software development

Abstract

Issue tracking in software development for the medical device industry is the process of converting issues into documentation and product to be delivered to such stakeholders as regulatory agencies, clinicians, and the medical device business itself. Issues track and document the concern, its resolution, and associated review. Issue tracking is essential to rigorously documenting, guiding, and exposing the story of the work completed as part of each issue. A significant amount of effort is spent in the issue tracking process and the problem of reducing waste in it is the focus of this thesis.The work described in this thesis makes contributions in the form of improved support for issue tracking and advances in theory for addressing sources of waste within the medical device industry. This thesis examines sources of waste identified by issue analysis and ethnography. It also describes novel capabilities developed into advisor agent software to address these sources of waste. Then it describes and evaluates the practical use and impact of targeted education and the advisor agent software capabilities for issue tracking over a number of months within the world's largest medical device manufacturer. Finally, evidence of significant improvements in the rate and nature of issue rejection are presented along with data showing greater improvements associated with use of the advisor agent.