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Research Note
Effects of medical device legislation on innovation within Australian manufacturing companies
Alexander Svistounov
PhD Candidate
School of Mechanical Engineering
University of Adelaide
Adelaide SA, Australia
Colin Kestell
Senior Lecturer
School of Mechanical Engineering
University of Adelaide
Karen Adams
Lecturer
Research Education Programs
Graduate Centre
University of Adelaide
Kristin Munday
ESL Coordinator
Faculty of Engineering, Mathematical and Computer
University of Adelaide
Abstract
Unlike many other industries in Australia, manufacturers of medical devices must meet strict regulatory requirements to be permitted to supply their products on the consumer market. With the introduction of the Therapeutic Goods Act and Medical Device Regulations, Australian manufacturers became legally obligated to follow specific principles of quality systems implementation in design, manufacturing and product delivery processes. A survey was conducted to determine manufacturers' perceptions of the effects of the regulation on the product development practices within their companies.
Results of the survey showed that the majority of respondents are anticipating or have already experienced mostly positive effects of the legislation on quality, reliability and safety of products and legal security of their companies. However, the respondents estimate that the legislation will negatively affect the cost of innovation and delivery time of new products to the market.
Keywords
innovation, legislation, medical devices, rehabilitation equipment
Article Text
The Australian medical device (MD) industry is regulated by the Therapeutic Goods Act 1989 (TGA) (Office of Legislative Drafting, 1989) and Medical Device Regulations 2002 (MDR) (Office of Legislative Drafting, 2002). In addition to high risk medical devices, such as devices that are used for medical treatment and diagnosis of diseases, soon this legislation will also control the supply to the market of previously exempt low-risk medical devices including a broad range of rehabilitation equipment.
There is a clear need to ensure the quality and safety of medical equipment including low risk medical devices. However, despite the intended overall advantageous outcomes of the legislation, such as the increased safety of products and the removal or reduction of barriers in international trade, the imposition of compliance and aftermarket surveillance requirements may well stem innovation and place a substantial resource burden on small and medium enterprises (SMEs).
This could force some small Australian manufacturers to cease design, innovation and development of new products and to become suppliers for local or overseas larger manufacturers.
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, Mortimer D et al (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/devinfo3.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 and 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.
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