An Agile-Based Framework for Addressing Defects in Medical Device Software Development

Abstract

Defects in Medical Device Software (MDS) have the potential to cause harm to both patients AQ1 and caregivers. Research has revealed that defect prevention is often neglected or inadequately implemented in many software development projects. In MDS development, the focus is on defect identification in later stages, typically during coding and testing stages. A recent survey revealed that although MDS development organisations plan to be proactive in defect management by preventing them in early development stages, in practice, they emphasise defect identification in later stages. This approach potentially leads to costly rework and increased risk of defects slipping into the final software release. When using the V-Model, a commonly adopted methodology for safety-critical software development, defect prevention occurs in the early stages on the left side, while defect identification occurs in the later stages on the right side. Studies have revealed that many defects that occur in software can be traced back to the early stages of the development lifecycle. Agile practices provide the potential to prevent defects in the early development stages and identify those that may slip into the later stages. This paper presents an Agile-based Defect Addressing Framework (AbDAF) that is designed to assist MDS development organisations to address defects during the development lifecycle. This framework uses agile practices to address defects by preventing them early on and identifying those that may arise in later stages of development