Agile – Is it Suitable for Medical Device Software Development?

Abstract

Abstract. Medical device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the medical device industry. However, there are some concerns with using agile for medical device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional medical device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the medical device software industry.

Scrum for safety: an agile methodology for safety-critical software systems

“…Testing is yet another aspect that seriously limits the adoption of agile methods in the safety critical context, since incorporating verification techniques is challenging, and these activities are work intensive (Paige et al, 2008). Indeed, while test-driven development is widely used in the agile community (Nerur et al, 2005), in safety-critical software development, instead, testing is done only in the final phases (McCaffery et al, 2016). Moreover, some standards, such as the CENELEC EN50128 (Comité européen de normalisation en électronique et en électrotechnique, 2011), mandate that the testers must be responsible for specifying the test and that developers and testers must be separate persons (Jonsson et al, 2012).…”

“…Nevertheless, more recent results questioned this conclusion, identifying four main challenges inherently arising while adopting agile methods in the safety-critical context, i.e. : (i) documentation, since it is not essential in agile software development; (ii) requirements, since traditional safety-critical development processes discourage requirement changes (Notander et al, 2013); (iii) project life-cycle, since safetycritical projects are developed neither iteratively nor incrementally (Ge et al, 2010), and (iv) testing, which, in the safety-critical context, is done only at final stages of the development (McCaffery et al, 2016).…”

A Method to the Specification of Safety Requirements in Agile Contexts

“…For instance, Guo and Hirschmann (2012) describes an agile safety life cycle and proposes that software aspects of system safety validation should be considered throughout Sprint Review and Retrospective, for facilitating stakeholder involvement and continuous improvement of products. Besides that, in McCaffery et al (2016), it is proposed to integrate agile practices into the MDevSPICE framework, amongst them iterative testing and TDD to assure that all safety implications are reflected in test cases. Therefore, according to authors of Hanssen et al (2016) and McBride and Lepmets (2016), it is needed to incorporate safety validation practices into agile methods, since these are fundamental for safety-critical systems development (HANSSEN et al, 2016;MCBRIDE;.…”