Using Agile Practices to Address Defects in Medical Device Software Development: A Survey of Medical Device Software Organisations in Ireland

Agile Practices are widely used in the noncritical software development domain and are advocated to reduce defects. However, there is limited evidence in the existing literature about their exclusive implementation in Medical Device Software (MDS) development. Prior research has shown that agile practices are often integrated into traditional approaches for specific purposes, but there is little evidence in the existing literature about using agile practices specifically for addressing defects in MDS development. Through a survey of MDS organisations in Ireland, this study investigated the use of agile practices for addressing defects. The findings revealed that organisations implement agile practices for addressing defects, but prioritise identifying defects during coding and testing phases, primarily using code review, unit testing, integration testing, and coding standards. Defect identification usually occurs in the later part of the software development cycle. However, addressing defects late in the software development cycle can lead to costly rework and potential catastrophes when defects slip into the final product. We argue that in MDS development, both defect prevention and identification should be prioritised and implemented to manage defects more effectively and comprehensively. This approach could help to avoid costly rework and potential consequences arising due to defects that occur later. Agile practices can help in preventing defects early in the software development process and identifying those that slip to later stages, thereby ensuring overall software quality.