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

Martin Mc Hugh, Oisin Cawley, Fergal McCaffcry, Ita Richardson, Xiaofeng Wang

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

Abstract

Through the use of semi structured interviews with medical device software organizations it emerged that medica device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC) particularly in the area of requirements management. To attemp to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software.

Original languageEnglish
Title of host publication2013 5th International Workshop on Software Engineering in Health Care, SEHC 2013 - Proceedings
Pages12-19
Number of pages8
DOIs
Publication statusPublished - 2013
Event2013 5th International Workshop onSoftware Engineering in Health Care, SEHC 2013 - San Francisco, CA, United States
Duration: 20 May 201321 May 2013

Publication series

Name2013 5th International Workshop on Software Engineering in Health Care, SEHC 2013 - Proceedings

Conference

Conference2013 5th International Workshop onSoftware Engineering in Health Care, SEHC 2013
Country/TerritoryUnited States
CitySan Francisco, CA
Period20/05/1321/05/13

Keywords

  • A V-Model
  • Agile
  • FDA
  • Medical Device Software
  • Model
  • Safety Critical
  • V

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