An Agile Implementation within a Medical Device Software Organisation

Abstract

Abstract. Three surveys conducted over a 6 year period revealed that medical device software organisations have difficulties in the area of requirements management, namely accommodating changes in requirements. Medical device software is traditionally developed in accordance with a plan driven software development lifecycle (SDLC). These SDLCs are rigid and inflexible to changes once the requirements management stage has been completed. Agile methods are gaining momentum in non-regulated industries but as of yet, the adoption of these methods in regulated industries such as the medical device software domain remains low. This study presents an implementation of agile methods within a medical device software development organisation based in Ireland. This implementation involved integrating agile practices with a traditional plan driven SDLC. Upon completing this implementation within a medical device software development project, the organisation identified cost savings and a reduction in the rework required when introducing a change in requirements.

Safety-Critical Systems and Agile Development: A Mapping Study

“…Teams are self-organized and empowered to manage daily tasks of producing software on their own [SW13], [MMC14]. Rely on collective code ownership [WBHV06] to allow the whole team to help and keep track of who did what [NHR13].…”

“…A team of peers with assigned roles performs code reviews [GEI + 11], [FSOO13] or more formal technical reviews [AETO15]. Acceptance and unit testing Do unit tests [WBHV06], [RHJS09] and acceptance tests [WBHV06], [MMC14], [PGC + 11], [GŁ13] once a number of iterations have been completed [MMC12]. Apply Test driven development (TDD) to establish high test coverage [JLP12], [WBHV06], [MMC14], [HWS17], [WW16], [Wol12], [HHS + 16], [CWR10], [RR08] and increased regression testing [McM16].…”

Effective Implementation of Agile Software Development with a Framework, Metric Tool, and in Association with Cloud and Lean Kanban

“…Several adopters experienced enrichments in competence, superiority, work inspiration, and consumer satisfaction. User involvement is given high priority in the working style of agile, drawing user's right in to the heart the development process [11]. While transferring to agile methodology from the traditional pattern it produced the benefits above expectations which replicated in the decrease in fault rate as well as producing high quality software.…”

Mobile medical app development with a focus on traceability

“…improve the product quality by reducing the number of errors that are made, while at the same time, supporting the achievement of delivery dates, budget constraints, and in the case of MD software development, the achievement of the primary goals of creating safe and effective MDs. Medical device software developers typically develop software in accordance with a plan-driven sequential SDLC, such as the V-model or waterfall,29 as it is a tried and trusted life cycle approach within the industry for producing the deliverables demanded by the regulatory authorities 30,31. However, participants agreed that this is a timeconsuming, resource-intensive, and rigid plan-driven approach that is not well suited for developing MMAs in a timely manner.The group discussion identified several concerns with adopting either a waterfall or V-model SDLC adoption, such as: there is no focus upon iterations, consequently, making it difficult to deliver frequent releases and to change incorrect decisions in a timely manner; they do not embrace change easily, thus, any changes introduced once the project has started can create financial overruns; they do not include a prototyping practice, therefore making it more difficult to engage users in the development process; a large amount of time is spent producing and verifying documentation, therefore leaving less time for the development and testing; there is a sign-off process after every software development phase, hence, bringing an inflexibility in terms of incorporating changes post sign-off.In traditional MD development, there is a heavy emphasis on documentation and sign-off before proceeding to the next stage.…”