The Value of Innovation in the Medical Device Industry

摘要 美国依靠价值1710亿美元的医疗器械行业来生产挽救生命和改善生活的产品。 每年为数百万患者提供创新。虽然研究表明医疗设备公司在医疗设备上的支出减少， 研究和开发（R&D）当他们遇到财政困难，研究还没有建立如何 这些研发的减少影响了患者获得新的和有临床价值的技术。部分原因 缺乏公司一级的措施，直接描述拯救生命和改善生活的医疗发展， 装置.为了解决这些差距，在这项研究中，我将1）产生新的公司层面的临床价值的措施， 设备行业的创新; 2）确定公司财务变化对其生产的影响 有临床价值的技术为了衡量临床价值，我将使用成本效益的概念 分析文献，研究公司如何开发延长和改善患者生命的设备。当前 临床价值的标准衡量标准是增量质量调整生命年（QHLS）和增量成本 有效性比率（ICER）。生活质量指数衡量的是患者的额外寿命， 这些额外的生命年数，而ICER将这些健康收益与治疗费用进行比较。我的研究将 还开发了新的“引用加权”措施的公司层面的临床价值。美国食品和药物 美国食品药品监督管理局（FDA）批准大多数医疗设备的基础上，一个新的设备是否至少是安全的， 与所引用的现有器械一样有效。我提出的引用加权措施将考虑QQs和 公司设备的ICER以及引用给定公司设备的后续设备的QER和ICER， FDA申请。在创建了我的新的“引用加权”临床创新措施后，我将 确定如何随机“冲击”公司的财务影响他们的生产创新设备，通过检查一个 自然实验：波多黎各的飓风。许多设备公司的生产设施分散在 横跨波多黎各。因此，飓风创造了一个自然实验，其中一些公司随机经历 与其他公司相比，由于生产设施的位置，生产成本增加较多。使用 这个自然实验将使我能够对公司财务状况的变化做出因果估计， 影响他们开发有临床价值的设备。AHRQ宣称的部分使命是“提供证据 使卫生保健更安全、更高质量、更容易获得、公平和负担得起”。医疗器械政策 涉及这些目标之间的基本权衡。政府可以征税或制定更多的法规 公司促进更高的质量或改善安全性，但这些政策可能会减少患者获得 通过增加制造商的成本和减缓 开发新设备。我的研究估计了经济负担和临床 创新，从而使决策者能够评估政策如何影响后代的生活- 拯救和改善生活的设备。

Abstract The United States relies on the $171 billion medical device industry to produce life-saving and life-improving innovations for millions of patients every year. While research shows medical device firms spend less on research and development (R&D) when they experience financial hardship, research has not established how those reductions in R&D affect patients’ access to new and clinically valuable technologies. This is due in part to a lack of firm-level measures that directly describe the development of life-saving and life-improving medical devices. To address these gaps, in this study I will 1) generate new firm-level measures of the clinical value of innovation in the device industry and 2) determine the effect of a change in a firm’s finances on their production of clinically valuable technology. To measure clinical value, I will use concepts from the cost-effectiveness analysis literature to examine how firms develop devices that extend and improve patients’ lives. The current standard measures of clinical value are incremental quality-adjusted life years (QALYs) and incremental cost effectiveness ratios (ICERs). QALYs measure a patient’s additional years of life weighted by the quality of those additional years of life, while ICERs compare those health gains to the cost of treatment. My study will also develop new “citation-weighted” measures of firm-level clinical value. The US Food and Drug Administration (FDA) approves most medical devices based on whether a new device is at least as safe and effective as a cited pre-existing device. My proposed citation-weighted measures will consider the QALYs and ICERs for a firm’s devices as well as the QALYs and ICERs of later devices that cite the given firm’s devices in their FDA applications. After creating my new “citation-weighted” measures of clinical innovation, I will determine how random “shocks” to firms’ finances affect their production of innovative devices by examining a natural experiment: hurricanes in Puerto Rico. Many device companies have production facilities spread out across Puerto Rico. Thus, hurricanes create a natural experiment in which some firms randomly experience larger increases in production costs compared to other firms due to the location of production facilities. Using this natural experiment will allow me to produce causal estimates of how changes in firms’ financial status affect their development of clinically valuable devices. Part of AHRQ’s stated mission is “to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable”. Medical device policy involves a fundamental trade-off between these goals. Governments can levy taxes or place more regulations on firms to promote higher quality or improved safety, but these policies may decrease patients’ access to future life-saving and life-improving innovations by increasing costs for manufacturers and slowing the development of new devices. My study estimates the trade-off between financial burden and clinical innovation, thereby allowing policymakers to evaluate how policies affect future generations’ access to life- saving and life-improving devices.