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.本研究针对医疗系统敏捷软件开发流程中，从业者将合规监管要求与关键安全需求纳入开发流程的实践做法开展实证调研。本研究通过专业专家网络的滚雪球抽样法，招募了来自英国、印度与尼日利亚的30名资深敏捷从业者开展访谈。 本研究采用扎根理论（Grounded Theory）指导下的分析方法对采集数据进行处理，具体包含开放编码、持续比较法、备忘录编写与理论饱和检验。本研究共识别出涵盖角色、仪式与软件制品（Artefacts）在内的31项实践，并构建了一款面向医疗软件开发的新型实践导向流程模型。研究团队识别出多项既往未被提及的新型活动与软件制品，包括风险导向测试、合规评审、误用场景待办清单、合规项更新、临床系统测试、安全相关临床待办清单、合规待办清单、内部临床演示，以及一款未在既往敏捷软件开发流程中出现的新型合规评审仪式。 本研究通过尼日利亚某加拿大资助医疗软件项目的在岗敏捷从业者完成了模型验证工作。