An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

McHugh, Martin; Cawley, Oisín; McCaffery, Fergal; Richardson, Ita; Wang, Xiaofeng

doi:10.1109/sehc.2013.6602471

Cited by 57 publications

(49 citation statements)

References 23 publications

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“…McHugh et al mention that "for agile methods to succeed, an organisation must be structured in a way to accommodate agile methods" [3]. McHugh, Cawley, McCaffery, Richardson and Wang summarize that there is evidence of gaining significant organisational benefits upon the adoption of an agile method for managing and performing software development projects [4]. While there is sufficient of scientific literature on organisational requirements for optimal agile adoption, there is no literature elaborating this knowledge about pharmaceutical companies.…”

Section: Introductionmentioning

confidence: 99%

An Insight into the Difficulties of Software Development Projects in the Pharmaceutical Industry

Hajou¹,

Batenburg²,

Jansen³

2015

LNSE

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Abstract-Software development projects in the pharmaceutical industry are highly regulated as software failures can have a direct impact on the quality of medicinal product and therefore patient safety. Regulation is imposed from a governmental level but is also employed in the form of comprehensive industry standards. The strive for regulatory compliancy is a direct cause for high overhead in software development projects, which leads to the procrastination of innovation. 14 interviews have been conducted with domain experts in a quest to understand and validate the difficulties of software development projects in the context of the pharmaceutical industry. The interviews focussed on the difficulties of software development projects in the pharmaceutical context and the lack of adoption of agile methods, as these have proven to reduce overhead of software development projects in other industries. The collected information is disclosed for the purpose of advancing the research area which is characterised to be minimally researched. IndexTerms-Agile pharmaceutical industry, problem-centered interviewing, regulatory compliance, software development.

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Section: Introductionmentioning

confidence: 99%

An Insight into the Difficulties of Software Development Projects in the Pharmaceutical Industry

Hajou¹,

Batenburg²,

Jansen³

2015

LNSE

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“…Simply, with the diversification of the software market and the vast ranges of complexity and volatility of the software engineering/development task there can be no one-size-fits-all process model. Practically, this means that organisations and practitioners adopt and adapt models as their needs change (see, for instance, [21], [8]). …”

Section: Introductionmentioning

confidence: 99%

Towards a Design-Theoretic Characterisation of Software Development Process Models

Hall

Rapanotti

2015

2015 IEEE/ACM 4th SEMAT Workshop on a General Theory of Software Engineering

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Abstract-Context: Effective assessment, comparison, selection and adaptation of software development processes remain an acute problem in Software Engineering practice. The quest for a unified theory which might serve this purpose is ongoing.Objective: To take a first step towards such a theory, with focus on characterising and comparing features of software development process models.Method: We consider a theory of design as problem solving and investigate how it can be applied to characterise and explicate specific process features in well known process models from the literature. The intention is to characterise emerging trade-offs between resource expenditure and risk mitigation, which result from the interplay between process efforts into problem and solution exploration vs stakeholder validation. The analysis, at this point performed, is purely qualitative, and the treatment of resource expenditure and risk quite abstract.Results: We provide an initial characterisation and comparison of features found in a wide range of process models from the literature, within a design theoretic framework using a single building blockthe Problem Oriented Engineering (POE) Process Pattern -that allows the characterisation of information flow, the relationship between actors, resource usage and developmental risk.Conclusions: The initial characterisation identifies repeated structure in diverse processes, which allows basic process comparison across models. The interpretations are modular, allowing the possibility of relationships between different process models to be explored. As such, the theory allows for a unified means to characterise and compare systematically key features of different process models. In being of an exploratory nature, the work has a number of limitations, which should be addressed by further research

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“…As a result, research was conducted into the use of agile approaches in this domain. A comprehensive mapping study [10] was performed to identify where agile practices have been used in regulated domains. This mapping study revealed that despite the widespread adoption of agile methods in non-regulated domains there is still a low rate of adoption among software development organizations in regulated domains.…”

Section: Introductionmentioning

confidence: 99%

Adopting Agile Practices when Developing Medical Device Software

McHugh¹,

McCaffery²,

Coady³

2015

J Comput Eng Inf Technol

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Abstract-Agile methods are gaining momentum amongst the developers of non-safety critical software. They offer the ability to improve development time, increase quality and reduce development costs. Despite this, the rate of adoption of agile methods within safety critical domains remains low. On face value agile methods appear to be contradictory to regulatory requirements. However while they may appear contradictory, they align on key values such as the development of the highest quality software. To demonstrate that agile methods could in fact be adopted when developing regulatory compliant software they were implemented on a medical device software development project. This implementation showed that not only can agile methods be successfully followed, but it also revealed that benefits were acquired. For example, the medical device software development project was completed 7% faster when following agile methods, when compared to if it had been completed in accordance with a plan-driven approach. While this implementation is confined to a single project, within a single organization it does strengthen the belief that adopting agile methods within regulated domains can reap the same benefits as those acquired in non-safety critical domains.

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An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

Cited by 57 publications

References 23 publications

An Insight into the Difficulties of Software Development Projects in the Pharmaceutical Industry

An Insight into the Difficulties of Software Development Projects in the Pharmaceutical Industry

Towards a Design-Theoretic Characterisation of Software Development Process Models

Adopting Agile Practices when Developing Medical Device Software

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