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

In general, the outcomes of the study suggest that the hypothesis that TGA legislation affects new product development processes within the Australian medical device industry is correct. From the manufacturers' point of view the legislation had mostly positive effects and performed its main function of ensuring quality, safety and the reliability of medical devices sold in Australia. However, the study also provided indications that, from the manufacturers' perspective, the legislation had negative effects on some aspect of the design and innovation processes within manufacturing companies and particularly with respect to the innovation cost and time of delivery of new products to market.

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

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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 FIGURE 1: EFFECTS OF THE TGA MD LEGISLATION: VARIABLES WERE MEASURED ON THE SCALE FROM -1 (NEGATIVE EFFECT) TO +1 (POSITIVE EFFECT) Variable Mean Quality of products 0.44 Innovation cost -0.44 Reliability and safety 0.44 Novelty of products 0 Business success 0.31 Frequency of new product development -0.25 Legal security 0.38 Delivery time of new products -0.38