Establishing stakeholder needs for medical devices

Proceedings of the ASME Design Engineering Technical Conference

Volumn 2006, Issue , 2006, Pages

  Agouridas, Vassilis ^a   Marshall, Alison ^a   McKay, Alison ^a   De Pennington, Alan ^a  

^a UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

Engineering design; Needs identification; Product design; Requirements engineering and management

Indexed keywords

HUMAN REHABILITATION EQUIPMENT; PRODUCT DESIGN; REGULATORY COMPLIANCE; RISK MANAGEMENT; SURGICAL EQUIPMENT;

ENGINEERING DESIGN; NEEDS IDENTIFICATION; REQUIREMENTS ENGINEERING AND MANAGEMENT;

REQUIREMENTS ENGINEERING;

EID: 33751371657     PISSN: None     EISSN: None     Source Type: Conference Proceeding    
DOI: None     Document Type: Conference Paper

References (54)

1. Kruger K., 2005, "The Medical Device Sector", in The Business of Healthcare Innovation edited by Burns L R, 2005, Cambridge University Press, UK.
2. European Council, 1993, Council Directive 93/92/EEc of 14 June 1993 concerning medical devices. Official Journal of the European Communities, No. L169, 12.7.93, pp. 1-43
3. US Food and Drug Administration, 1996, 21 CFR parts 808, 812, and 820, Medical device; current good manufacturing process (CGMP) final rule; quality system regulation. Federal Register, Vol.61, pp.52602-52662.
4. Agouridas V., Baxter J., McKay A., de Pennington A., 2001, "On defining product requirements: a case study in the UK health care sector", ASME 2001 Design Engineering Technical Conf, Pittsburgh, PA, USA, ETC2001/DTM21692.
5. Clarkson P. J., Buckle P., Coleman R., Stubbs D., Ward J., Jarrett J., Lane R. and Bound J., 2004, "Design for patient safety: a review of the effectiveness of design in the UK health service", Journal of Engineering Design, Taylor & Francis, Vol. 15, No.2, pp. 123-140.
6. Alexander K. and Clarkson P. J., 2002, "A validation model for the medical devices industry", Journal of Engineering Design, Taylor & Francis, Vol.13, No.3, pp.197-204.
7. Alexander K. and Clarkson P. J., 2002, "Good design practice for medical devices and equipment, Part I: a review of the current literature", Journal of Medical Engineering & Technology, Taylor & Francis, Vol.24, No.1, pp.5-13.
8. Alexander K. and Clarkson P. J., 2002, "Good design practice for medical devices and equipment, Part II: design for validation", Journal of Medical Engineering & Technology, Taylor & Francis, Vol.24, No.2, pp.53-62.
9. Shefelbine S., Clarkson P. J., Farmer R., Eason S, 2002, Good Design Practice for Medical Devices and Equipment: Requirements Capture. A Workbook. Engineering Design Centre, Cambridge University and Cambridge Consultants Ltd, UK.
10. Maruca R.F., 2000, "Mapping the World of Customer Satisfaction", Harvard Business School Publishing, Harvard Business Review, Vol. 78, No.3, p.30.
11. Dement C.W., 2003, "Strategic Management and Enterprise Engineering", notes for the Module of MECH5950, Keyworth Institute, School of Mechanical Engineering, University of Leeds, Leeds, UK.
12. Agouridas V., Winand R., McKay A., de Pennington A., 2006, "Early alignment of design requirements with stakeholder needs", to appear in the Proceedings of IMechE Part B, Journal of Engineering Manufacture, Professional Publishing, UK.
13. Morris L., Stauffer L. and Khadilkar D., 1996, "Eliciting and Managing Information for Product Definition", Elsevier Science, Computers and Industrial Engineering, Vol. 31, No. 3/4.
14. Davies A.M., 2003, "The Art of Requirements Triage", Computer, IEEE Computer Society, March 2003 p.42-49.
15. Higgins M., de Laat P.M.C, Gieles E.M., Gourts S.A., "Managing Requirements for Medical IT Products", IEEE Software Jan/Feb 2003 p.26-33.
16. Kendall J., 1995, "Using an industrial-design methodology to reduce the risk of medical product development", Medical Device & Diagnostic Industry, Vol.17, No.2, pp.94-102.
17. nd CDEN (Canadian Design Engineering Network) Conference, 18-20 July, Kananaskis, Alberta, Canada.
18. BS EN ISO 13485: 2003 Medical Devices - Quality management systems - Requirements for Regulatory Purposes.
19. Wilcox S. B., 2005, "Ethnographic Methods for New Product Development" in Designing usability into medical products edited Wiklund and Wilcox, Taylor and Francis.
20. Finkelstein A. and Finkelstein L., 1994, "Requirements engineering for instrument systems", Measurement and Control, Vol.27., pp.248-250.
21. Agouridas, V., McKay, A., and de Pennington, A. 2004, "Consumer Product Development: A systems engineering approach to the derivation of design requirements from stakeholder needs", Fourteenth Annual International Symposium of the International Council On Systems Engineering (INCOSE), Toulouse, France.
22. nd Edition, Open University Press, UK.
23. Gillham B., 2000, Case Study Research Methods, Real World Research., Continuum, London, UK.
24. Rosenman M. A. and Gero J. S., 1998, "Purpose and function in design: from the socio-cultural to the techno-physical" Design Studies, Vol.19, No.2, pp.161-186.
25. Bucciarelli L. L., 1994, Designing Engineers, Massachusetts Institute of Technology, Boston, USA.
26. Jenkins M., 1985, Research Methodologies and MIS Research, pp. 103-117, Editors: Mumford,E.; Hirschheim,R., North-Holland, Amsterdam.
27. Reich Y., 1995, "The Study of Design Research Methodology" Transactions of the ASME, Journal of Mechanical Design, Vol.117, pp.211-214.
28. Konda S., Monarch I., Sargent P., and Subrahmanian E., 1992, "Shared Memory in Design: A Unifying Theme for Research and Practice", Research in Engineering Design, Vol.4, No.1, pp.23-42.
29. Antonsson E. K., 1987, "Development and Testing of Hypotheses in Engineering Design Research", ASME Journal of Mechanisms, Transmissions, and Automation in Design, Vol. 109, pp.153-154.
30. Bruce M., Wooton A. and Cooper R., 2000, Creative Product Design: A Practical Guide to Requirements Capture Management, John Wiley & Sons, Inc., New York, USA.
31. Yan W., Chen C.H. and Khoo L.P., 2002, "An Integrated Approach to the Elicitation of Customer Requirements for Engineering Design Using Picture Sorts and Fuzzy Evaluation", Cambridge University Press, Artificial Intelligence for Engineering Design, Analysis and Manufacturing (AI EDAM), Vol. 16, pp.59-71.
32. Chen C.H., Khoo L.P. and Yan W., 2002, "A Strategy for Acquiring Requirement Patterns Using Laddering Technique and ART2 Neural Network", Elsevier Science Ltd, Advanced Engineering Informatics, Vol. 16, pp.229-240.
33. Buren J.V. and Cook D.A., 1998, "Experiences in the Adoption of Requirements Engineering Technologies", A DoD Publication, CrossTalk-The Journal of Defense Software Engineering, pp.3-10.
34. Young R.R., 2001, Effective Requirements Practices, Addison Wesley, Boston, MA, USA.
35. Kaulio M.A., Karlsson R.P. and Klemets M., 1997, "Design and Implementation of New Processes for Customer Requirements Management: A Practice-Centered Approach", Chalmers Tekniska Hogskola, Doktorsavhandlingar Vid Chalmers Tekniska Hogskola N1358, pp.6(1)-6(28).
36. Fung R.Y.K., Popplewell K. and Xie J., 1998, "An Intelligent Hybrid System for Customer Requirements Analysis and Product Attribute Targets Determination", Taylor & Francis Ltd, International Journal of Production Research, Vol. 36, No.1, pp. 13-34.
37. Bodice M.T., Leifer L.J. and Fruchter R., 2000, "Analyzing Requirements - Evolution in Engineering Design Using the Method of Problem-Reduction", Technomic Publishing Co., Inc., Concurrent Engineering: Research and Applications, Vol. 8, No.2, pp.104-114.
38. Agouridas V., 2003, "The derivation of design from stakeholder needs", PhD Thesis, School of Mechanical Engineering, University of Leeds, UK.
39. th Edition., Prentice Hall, New Jersey, USA.
40. Suh N.P., 2001, Axiomatic Design - Advances and Applications, Oxford University Press, New York, USA.
41. Boardman J.T. and Cole A.J, 1996, "Integrated process improvement in design and manufacture using a systems approach", IEE Proc. D, Control Theory Appl., Vol. 143, No. 2, pp. 171-185.
42. Checkland P, 1981, Systems thinking, systems practice, Wiley, Chichester, UK.
43. Larsen R.F. and Buede D.M., 2002, "Theoretical Framework for the Continuous Early Validation (CEaVa) Method", Wiley InterScience, Systems Engineering - The Journal of The International Council on Systems Engineering, Vol.5, No.3, pp. 223-241.
44. Buede D.M., 2000, The Engineering Design of Systems: Models and Methods, John Wiley & Sons, Inc., New York, USA.
45. th Edition, Upper Saddle River, New Jersey, USA.
46. The Chartered Institute of Marketing, http://www.cim.co.uk, Accessed in November 2005.
47. Vollerthun A., 2002, "Design-to-Market: Integrating Conceptual Design and Marketing", Wiley InterScience, Systems Engineering - The Journal of The International Council on Systems Engineering, Vol. 5, No.4, pp.315-326.
48. Virtual Hospital - a digital library of health information, The University of Iowa, http://www.vh.org/adult/patient/orthopaedics/hipreplace/, accessed in November 2005.
49. Stone M.H., McDonald D. and Husby O.S., 2003, "CHARNLEY - Surgical Technique", DePuy International Ltd, http://www.depuy.com, accessed in June 2003.
50. Senge P. M., 1992, The Fifth Discipline: The Art and Practice of the Learning Organisation, Century Business, London.
51. Flood R. L., 1999, Rethinking the fifth discipline: Learning within the unknowable, Routledge, Taylor & Francis Group, London, UK.
52. Sage, A.P. 1992, Systems Engineering, John Wiley & Sons, Inc., New York, USA Sage
53. th Edition, Financial Times Management, London, UK.
54. Vermaas P. E. and Houkes W., 2006, "Technical functions: a drawbridge between the intentional and structural natures of technical artefacts", Studies in History and Philosophy of Science, Vol.37, pp. 5-18.