Investigating the Capability of Agile Processes to Support Medical Devices Regulations: The Case of XP, Scrum, and FDD with EU MDR Regulations

Abstract

Nowadays, medical devices rely on software whether completely such as mobile medical applications or as embedded software into medical chips such as tele surgery systems. Medical device software usually developed by using traditional development methods such as V-model and Waterfall model as these methods are straightforward and has the ability to comply with regulatory requirements such as documentation that ensures traceability. However, these methods could take a long time, could be costly, and these are inappropriate in case of requirements changing. In contrast, agile processes have several benefits such as producing a product of a high-quality with low cost and in short period with the capability to embrace change during development. Therefore, companies that develop medical device software can benefit from adopting agile practices. While the adoption rate of agile practices in software development in different industries is increasing, healthcare industries still have a low rate of agile adoption. This due to the gaps between agile practices and the stringent requirements of healthcare regulations such as documentation, traceability, and formality. The main question of this research is how capable are Agile processes can be in dealing with MDR requirements? This paper will investigate the capability of agile processes to support European Medical Device Regulation (MDR) requirements by extracting the MDR requirements that are related to software development life cycle. Then investigating the robustness of agile processes, to support MDR regulations. These objectives will be conducting by comparing and analysing the most popular agile processes (XP, Scrum, and FDD) to identify the gaps between MDR requirements and agile processes. The analysis revealed that XP is inappropriate for MDR requirements since it lacks the fixed up-front planning and also have insufficient documentations for treatability, Scrum has a model status report can be used for traceability but also it has insufficient documentation for MDR, and FDD is the closest agile practices to satisfy MDR requirements because it has a develop overall model phase which can be considered as semi-fixed up-front planning as well as has more documentations than the XP for traceability purposes such as UML modelling.