Full Content is available to subscribers

Subscribe/Learn More  >

Establishing Stakeholder Needs for Medical Devices

[+] Author Affiliations
Vassilis Agouridas, Alison Marshall, Alison McKay, Alan de Pennington

University of Leeds, Leeds, UK

Paper No. DETC2006-99117, pp. 541-551; 11 pages
  • ASME 2006 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference
  • Volume 4a: 18th International Conference on Design Theory and Methodology
  • Philadelphia, Pennsylvania, USA, September 10–13, 2006
  • Conference Sponsors: Design Engineering Division and Computers and Information in Engineering Division
  • ISBN: 0-7918-4258-4 | eISBN: 0-7918-3784-X
  • Copyright © 2006 by ASME


Regulatory bodies require manufacturers of medical devices to use formally planned design processes that provide improved understanding of user and other stakeholder needs, and so enable traceability of designs (e.g. functional requirements and design parameters) to facilitate the control and reduction of risk. Current processes involve significant consultation with users, but are generally unstructured and hence the value of their input is not maximised. User needs and design requirements are not demonstrably aligned. This paper discusses the problem of establishing stakeholder needs from information that typically results from marketing activities and introduces the NASo technique as a means to address these problems. An application of the technique to establish stakeholder needs is demonstrated through a case study of hip joint surgical instruments. The case study showed that the rigour of the NASo technique enabled both the identification of needs, which would otherwise be overlooked, and their documentation in a traceable manner. This is necessary to support not only the derivation of design requirements that are aligned with stakeholder needs but also the prioritisation and quantification, where applicable, of such requirements. The business benefit stemming from this is the confidence gained in evaluating new product and/or service opportunities and in an improved capacity to respond to design changes.

Copyright © 2006 by ASME
Topics: Medical devices



Interactive Graphics


Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging and repositioning the boxes below.

Related eBook Content
Topic Collections

Sorry! You do not have access to this content. For assistance or to subscribe, please contact us:

  • TELEPHONE: 1-800-843-2763 (Toll-free in the USA)
  • EMAIL: asmedigitalcollection@asme.org
Sign In