OBJECTIVES:Medical device companies are under growing pressure to provide health-economic evaluations of their products. Cost-effectiveness analyses are commonly undertaken as a one-off exercise at the late stage of development of new technologies; however, the benefits of an iterative use of economic evaluation during the development process of new products have been acknowledged in the literature. Furthermore, the use of Bayesian methods within health technology assessment has been shown to be of particular value in the dynamic framework of technology appraisal when new information becomes available in the life cycle of technologies. METHODS:In this study, we set out a methodology to adapt these methods for their application to directly support investment decisions in a commercial setting from early stages of the development of new medical devices. RESULTS AND CONCLUSIONS:Starting with relatively simple analysis from the very early development phase and proceeding to greater depth of analysis at later stages, a Bayesian approach facilitates the incorporation of all available evidence and would help companies to make better informed choices at each decision point.

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目标:医疗器械公司面临越来越大的压力,要求对其产品进行健康经济评估。在新技术开发的后期,成本效益分析通常是一次性的活动;但是,文献已经认识到在新产品开发过程中反复使用经济评估的好处。此外,当在技术生命周期中可获得新信息时,在健康技术评估中使用贝叶斯方法已被证明在技术评估的动态框架中具有特殊价值。
方法:在这项研究中,我们提出了一种方法,以适应这些方法的应用,以从新医疗器械开发的早期阶段就直接支持商业环境中的投资决策。
结果与结论:贝叶斯方法从很早的开发阶段开始就进行相对简单的分析,然后在以后的阶段进行更深入的分析,这有助于整合所有可用的证据,并有助于公司在每个决策点做出更明智的选择。

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