MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software

Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers

On the real world practice of Behaviour Driven Development

Surveys of industry practice over the last decade suggest that Behaviour Driven Development is a popular Agile practice. For example, 19% of respondents to the 14th State of Agile annual survey reported using BDD, placing it in the top 13 practices reported. As well as potential benefits, the adoption of BDD necessarily involves an additional cost of writing and maintaining Gherkin features and scenarios, and (if used for acceptance testing,) the associated step functions. Yet there is a lack of published literature exploring how BDD is used in practice and the challenges experienced by real world software development efforts. This gap is significant because without understanding current real world practice, it is hard to identify opportunities to address and mitigate challenges. In order to address this research gap concerning the challenges of using BDD, this thesis reports on a research project which explored: (a) the challenges of applying agile and undertaking requirements engineering in a real world context; (b) the challenges of applying BDD specifically and (c) the application of BDD in open-source projects to understand challenges in this different context. For this purpose, we progressively conducted two case studies, two series of interviews, four iterations of action research, and an empirical study. The first case study was conducted in an avionics company to discover the challenges of using an agile process in a large scale safety critical project environment. Since requirements management was found to be one of the biggest challenges during the case study, we decided to investigate BDD because of its reputation for requirements management. The second case study was conducted in the company with an aim to discover the challenges of using BDD in real life. The case study was complemented with an empirical study of the practice of BDD in open source projects, taking a study sample from the GitHub open source collaboration site. As a result of this Ph.D research, we were able to discover: (i) challenges of using an agile process in a large scale safety-critical organisation, (ii) current state of BDD in practice, (iii) technical limitations of Gherkin (i.e., the language for writing requirements in BDD), (iv) challenges of using BDD in a real project, (v) bad smells in the Gherkin specifications of open source projects on GitHub. We also presented a brief comparison between the theoretical description of BDD and BDD in practice. This research, therefore, presents the results of lessons learned from BDD in practice, and serves as a guide for software practitioners planning on using BDD in their projects