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Effects of medical device legislation on innovation within Australian manufacturing companies.


At this stage, it is not clear whether these negative effects will be minimised in the longer term when all medical device manufacturers have adapted to the legislation, or whether the TGA MD legislation will continue to have negative impact on some aspects of the innovation process within Australian MD manufacturing. The negative effects might be minimised or avoided by implementation and use of appropriate approaches developed to increase efficiency of the design and innovation process. A further, more comprehensive study could investigate the details of the current innovation and design processes used by these manufacturing companies and the possibilities for enhancing these processes, the companies' approaches to implementation and use of selected technical and management methods, and environmental factors (size of the company and complexity of the product). Methods and approaches for further study could be selected so as to include tools and methods for all stages of the new product development process, including the stages of conceptual development, innovation management, idea generation and evaluation, production, process planning and refining.

Received 8 February 2007 Accepted 25 September 2007

References

European Trend Chart on Innovation (2003a) 2003 European innovation scoreboard: Analysis of national performances. Tech. Rep. 2, ETCI, Brussels.

European Trend Chart on Innovation (2003b) 2003 European innovation scoreboard: National innovation system indicators. Tech. Rep. 5, ETCI, Brussels.

European Trend Chart on Innovation (2003c) 2003 European innovation scoreboard: Sectoral innovation scoreboards. Tech. Rep. 4, ETCI, Brussels.

Medical Devices Experts Group (2002) Report on the functioning of the medical device directive. Tech. Rep., MDEG, Brussels.

Office of Legislative Drafting (1989) Therapeutic Goods Act 1989. Attorney-General's Department, Canberra.

Office of Legislative Drafting (2002) Therapeutic Goods (Medical Devices) Regulations 2002. Attorney-General's Department, Canberra.

Peacock, S., D. Mortimer, A. Harris, R. Carter and J. Richardson (2001) An economic analysis of proposed changes to the conformity assessment of medical devices. Tech. rep., Centre for Health Program Evaluation, Melbourne.

Smith, K. (2002) What is the 'knowledge economy'; knowledge intensity and distributed knowledge bases. Tech. rep., INTECH Institute for New Technologies, The United Nations University, Amsterdam, Discussion Paper.

South Australia State Coroner (2000) Sandra Lee Rothwell Death State Coroner Inquest. Coroners Act, 27 January 2001, Number 45/200.

Terziovsky, M. (2002) The effects of continuous improvement and innovation management practice on small to medium enterprise (SME) performance. Tech. Rep., European Australian Cooperation Centre, Faculty of Economics and Commerce, The University of Melbourne, Melbourne.

Therapeutic Goods Administration (1998) Therapeutic goods (excluded goods) order no 1 of 1998. Commonwealth of Australia.

Therapeutic Goods Administration (2002) Information for manufacturers and suppliers of medical devices. Tech. Rep. Device Info 3, Commonwealth of Australia, Canberra. Retrieved at 08 February 2007, from http://www.tga.gov.au/devices/dev info3.htm

Therapeutic Goods Administration (2005) Recalls and alerts. Retrieved 09 March 2005, from http://www .tga.gov.au/recalls/index.htm.

Thumm N., Steg, H., Whitelegg, C. (2000) The impact of single market regulation on innovation: Regulatory reform and experiences of firms in the medical device industry. Tech. Rep. EUR 19734 EN, Joint Research Centre, European Commission, Seville.

ALEXANDER SVISTOUNOV

PhD Candidate

School of Mechanical Engineering

University of Adelaide

Adelaide SA, Australia

KAREN ADAMS

Lecturer Research

Education Programs Graduate Centre

University of Adelaide

Adelaide SA, Australia

COLIN KESTELL

Senior Lecturer

School of Mechanical Engineering

University of Adelaide

Adelaide SA, Australia

KRISTIN MUNDAY

ESL Coordinator

Faculty of Engineering, Mathematical and Computer

University of Adelaide

Adelaide SA, Australia

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COPYRIGHT 2007 eContent Management Pty Ltd. Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.

Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

NOTE: All illustrations and photos have been removed from this article.


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