Document Type
Conference Paper
Rights
Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence
Disciplines
Computer Sciences
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.
DOI
https://doi.org/10.1007/978-3-319-13036-1_17
Recommended Citation
Mc Hugh, M., Mc Caffery, F., & Coady, G. (2014). An Agile Implementation within a Medical Device Software Organisation. The 14th International SPICE Conference Process Improvement and Capability dEtermination. doi:10.1007/978-3-319-13036-1_17
Publication Details
The 14th International SPICE Conference Process Improvement and Capability dEtermination.