标题： 美国食品药品监督管理局医疗器械在工业转型中的奇异长期周期：1976年至2020年创新的视角 显示英文标题

标题： Singular Secular Kuznets-like Period Realized Amid Industrial Transformation in US FDA Medical Devices: A Perspective on Innovation from 1976 to 2020

摘要： 简介：自成立以来，美国食品药品监督管理局（FDA）一直保持着对受监管医疗器械（MDs）的详实记录。 基于这些数据，我们能否深入了解该行业的创新动态，包括产业转型的潜力？ 涵盖领域：使用上市前通知（PMNs）和批准（PMAs）数据表明，从1976年到2020年，总复合（PMN + PMA）指标经历了一个长期周期：20.5年（申请峰值到峰值：1992-2012；低谷：2002）和26.5年（注册峰值到峰值：1992至2019；低谷：2003），峰值到低谷的相对百分比差异分别为24%和28%。 重要的是，PMNs和PMAs各自呈现出相反的结构。 专家观点：证据表明：医疗器械（MD）创新是由一个单一的长期库兹涅茨式周期现象驱动的（独立于经济危机），这种现象源于从简单（PMNs）到复杂（PMAs）医疗器械的根本性转变。 值得注意的是，尽管新冠疫情可能不会影响主导动态，但预期且显著（约25%）的医疗器械创新下降可能会通过医疗器械利益相关者的关注措施得到缓解。 这种方法的局限性和进一步思考完善了这一观点。 显示英文摘要

摘要： Introduction: Since inception, the United States (US) Food and Drug Administration (FDA) has kept a robust record of regulated medical devices (MDs). Based on these data, can we gain insight into the innovation dynamics of the industry, including the potential for industrial transformation? Areas Covered: Using Premarket Notifications (PMNs) and Approvals (PMAs) data, it is shown that from 1976 to 2020 the total composite (PMN + PMA) metric follows a single secular period: 20.5 years (applications peak-to-peak: 1992-2012; trough: 2002) and 26.5 years (registrations peak to peak: 1992 to 2019; trough: 2003), with a peak to trough relative percentage difference of 24% and 28%, respectively. Importantly, PMNs and PMAs independently present as an inverse structure. Expert Opinion: The evidence suggests: MD innovation is driven by a singular secular Kutnets-like cyclic phenomenon (independent of economic crises) derived from a fundamental shift from simple (PMNs) to complex (PMAs) MDs. Portentously, while the COVID-19 crisis may not affect the overriding dynamic, the anticipated yet significant (~25%) MD innovation drop may be potentially attenuated with attentive measures by MD stakeholders. Limitations of this approach and further thoughts complete this perspective.