2007
DOI: 10.5172/impp.2007.9.3-4.343
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Effects of medical device legislation on innovation within Australian manufacturing companies

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“…Research on medical devices mainly takes a micro perspective and examines the technological innovation and enterprise efficiency of medical device companies using tools such as case analysis, data envelopment analysis (DEA), and questionnaire survey (10)(11)(12)(13). Some studies have also been conducted from the perspective of the industry by investigating the current regulation status, innovation, regulation mechanisms, technical standards, and industry development of medical devices (14)(15)(16)(17)(18)(19)(20).…”
Section: Theoretical Basismentioning
confidence: 99%
“…Research on medical devices mainly takes a micro perspective and examines the technological innovation and enterprise efficiency of medical device companies using tools such as case analysis, data envelopment analysis (DEA), and questionnaire survey (10)(11)(12)(13). Some studies have also been conducted from the perspective of the industry by investigating the current regulation status, innovation, regulation mechanisms, technical standards, and industry development of medical devices (14)(15)(16)(17)(18)(19)(20).…”
Section: Theoretical Basismentioning
confidence: 99%
“…More recently, anticipated drug-safety regulations from the FDA could double the annual cost of clinical testing, reducing research and development (R & D) investment that leads to breakthrough therapies (Shelby, Califf, and Schulman 2006). Medical device manufacturers surveyed in Australia expect that planned regulations relating to product quality will increase costs and the delivery time of new products to the market (Svistounov et al 2007).…”
Section: Hypothesis 1ementioning
confidence: 99%