Requirements capture for medical device design

J. Ward, S. Shefelbine, P. J. Clarkson

Research output: Chapter in Book/Conference proceedings/Edited volumeConference contributionScientificpeer-review

13 Citations (Scopus)


There are many examples from the medical device design industry where poor requirements capture practice has led to post-market problems, including patient morbidity and mortality. There is a clear need to improve this process. The purpose of this paper is to present the results of several years of study by five researchers into the requirements capture process in this area of industry and to highlight the need by industry for further guidance. Various research methods were used to investigate the requirements capture problem and to develop and evaluate a workbook which provides guidance for designers. The workbook consists of a package of methods: a functional analysis approach, a matrix-based checklist and advice on regulatory requirements. It has been refined over the years and is now published [1] The matrix also forms part of a publication for the UK Department for Trade and Industry [2], and a web version is under development.

Original languageEnglish
Title of host publicationProceedings of ICED 03, the 14th International Conference on Engineering Design
EditorsAnders Folkeson, Margareta Norell, Ulf Sellgren, Klas Gralen
PublisherDesign Society
ISBN (Electronic)1904670008
Publication statusPublished - 2003
Externally publishedYes
Event14th International Conference on Engineering Design, ICED 2003 - Stockholm, Sweden
Duration: 19 Aug 200321 Aug 2003

Publication series

NameProceedings of the International Conference on Engineering Design, ICED
VolumeDS 31
ISSN (Print)2220-4334
ISSN (Electronic)2220-4342


Conference14th International Conference on Engineering Design, ICED 2003


  • Best practice
  • Introduction of methods
  • Medical devices
  • Requirements capture


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