Challenges Experienced by Medical Device Software Organisations while following a Plan-driven SDLC

Medical device software organisations face challenges not faced by generic software development organisations. These challenges include the adherence to regulatory controls. Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable. To produce this, regulatory bodies require a number of deliverables which must be achieved. However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle. By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software. The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome. The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews

Integrating Agile Practices with a Medical Device SDLC.

The rate at which agile software development practices are being adopted is growing rapidly. Agile software development practices and methodologies appear to offer the silver bullet which can solve the problems associated with following plan driven software development lifecycles. Agile software development practices offer the possibility of achieving lower development costs, increased efficiency and improved software quality. However, there is currently a low rate of publicly available information that suggests there is widespread adoption of agile practices within the medical device software domain. This is largely due to the fact that software developed for medical devices includes challenges not faced when developing non safety critical software. As a result of these challenges, medical device software is typically developed using plan driven software development lifecycles. However, such lifecycles are quite rigid and cannot accommodate changes easily. Previous research has revealed that medical device software development projects can benefit from adopting agile practices whilst still maintaining the discipline associated with following plan driven development lifecycles. This paper outlines the challenges faced by developers when developing medical device software and how shortcomings in both agile and plan driven approaches can be resolved by following a mixed method approach to medical device software developmen

Large-Scale Agile Project Management in Safety-Critical Industries: A Case Study on Challenges and Solutions

While agile project management offers benefits such as faster time to market and improved collaboration, scaling it to larger projects presents challenges, particularly in safety-critical industries. This research provides insights into the resistance to agile adoption due to regulatory constraints and other barriers. The findings contribute to information systems literature by identifying four challenges (organizational, technological, behavioral, regulatory) and complementing solutions to show how large-scale agile can work in safety-critical industries