Developing a Tailored Agile Process Model for Medical Software

This research empirically investigates the practices practitioners use to incorporate regulatory compliance and safety-critical requirements in agile software development processes for medical systems. We employed interviews with 30 experienced agile practitioners in the UK, India, and Nigeria recruited through snowball sampling from a network of professional specialists.
The data were analysed using techniques informed by grounded theory, which involved open-coding, constant comparison, memoing and theoretical saturation. The study identified 31 practices including roles, ceremonies, and artefacts, and developed a novel, practice-based process model for developing healthcare software. We identified novel activities and artefacts, including risk-based testing, compliance reviews, misuse backlog, updates in compliance items, clinical systems testing, safety clinical backlog, compliance backlog, internal clinical demoing, and a new compliance review ceremony not previously identified in agile software development processes. Model validation was conducted with agile practitioners engaged on a Canadian funded medical software project in Nigeria.