Technological Innovation Comparing Development of Drugs, Devices, and Procedures in Medicine, Background Paper (1989) / Chapter Skim
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1. Introduction: An Initial Conceptualization of the Development Process
1. Introduction: An Initial Conceptualization of the Development Process
Pages 1-7
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For example, making a quantum leap through time from Paleolithic tools to the emergence of modern technology during the Enlightenment, the development and large-scale introduction of John Kay's shuttles transformed the textile industry fundamentally and, together with James Watt's steam engine some decades later, was one of the major shaping forces in the industrial revolution (52~. Since then, technological change has had enormous economic consequences; in modern industrialized societies it has become the critical factor in long-term economic growth (123~.
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In medicine, this translation process can be categorized into three components: the development of new drugs and biologicals, that of medical devices, and that of clinical procedures. 3 Rosenberg: "In a fundamental sense, the history of technical progress is inseparable from the history of civilization itself, dealing as it does with human efforts to raise productivity under an extremely diverse range of environmental conditions"~123~.
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Health care technology development then can be defined as a multi-stage process through which a new biological or chemical agent, medical device prototype, or clinical procedure is modified and tested until it is ready for regular production and utilization in the health care market. This development process can be divided into two closely related series of activities: J
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The following major differences can be discerned: 4 Within the development process, clinical investigation is essentially initiated with the first testing of a potential innovation in humans. In the development process of drugs and biologics these initial studies in humans have been designated so-called Phase ~ studies, which are generally followed by Phase IT and Phase TIT clinical studies before a `drug or biological can be marketed.
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cat . These idiosyncrasies of the health care market have prompted government intervention in the development process.
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These policies are providing strong incentives to evaluate the risks, costs, and benefits of a new technology during its development. A conceptual framework thus also should take into account another central characteristic of the development process: the extremely diverse and complex institutional structure within which development decision making takes placed.
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3. What are the implications of these evaluative strategies for the effectiveness and efficiency of the process by which research findings are translated into clinical practice?
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