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生产救命和改善生活的产品 每年为数以百万计的患者提供创新。虽然研究显示医疗器械公司在以下方面的支出减少 研究和开发(R&D)当他们遇到经济困难时，研究尚未确定如何 研发的减少影响了患者获得新的、具有临床价值的技术。这在一定程度上是由于 缺乏直接描述救命和改善生命的医疗发展的坚定措施 设备。为了解决这些差距，在这项研究中，我将1)生成新的公司级别的衡量标准，以衡量 设备行业的创新和2)决定公司财务变化对其生产的影响 具有临床价值的技术。为了衡量临床价值，我将使用成本效益的概念 分析文献，检查公司如何开发延长和改善患者生活的设备。海流 临床价值的标准衡量标准是增量质量调整寿命年(QALY)和增量成本 有效率(ICER)。QALY衡量患者的额外生命年数，以 这些额外的生命年数，而ICER将这些健康收益与治疗成本进行比较。我的学习将会 还要开发新的“引文加权”方法来衡量公司层面的临床价值。美国的食品和药品 美国食品和药物管理局(FDA)根据新设备是否至少同样安全和 作为引用的预先存在的装置有效。我提出的引文加权指标将考虑QALY和 一家公司的设备的ICER以及后来的设备的QALY和ICER，这些设备在 他们的FDA申请。在创建了新的临床创新的“引文加权”衡量标准后，我将 通过研究企业财务的随机“冲击”如何影响其创新设备的生产 自然实验：波多黎各的飓风。许多设备公司都有分散的生产设施 横跨波多黎各。因此，飓风创造了一个自然的实验，在这个实验中，一些公司随机体验 与其他公司相比，由于生产设施的位置，生产成本增加得更多。vbl.使用 这项自然的实验将使我能够对公司财务状况的变化做出因果估计 影响他们开发具有临床价值的设备。AHRQ宣称的任务之一是“提供证据 使卫生保健更安全、更高质量、更容易获得、更公平和负担得起。医疗器械政策 涉及到这些目标之间的根本权衡。政府可以征税或制定更多法规 关于公司促进更高质量或更好的安全性，但这些政策可能会减少患者获得 未来的救生和改善生活的创新通过增加制造商的成本和减缓 新设备的开发。我的研究估计了经济负担和临床之间的权衡 创新，从而使政策制定者能够评估政策如何影响子孙后代的生活- 救生和改善生活的设备。

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.