论文标题
在美国FDA医疗设备的工业转型中，奇异的世俗库兹尼茨时期实现了：1976年至2020年创新的观点
Singular Secular Kuznets-like Period Realized Amid Industrial Transformation in US FDA Medical Devices: A Perspective on Innovation from 1976 to 2020
论文作者
论文摘要
简介：自成立以来，美国（美国）食品药品监督管理局（FDA）一直保持着受监管的医疗设备（MDS）的记录。基于这些数据，我们是否可以深入了解行业的创新动态，包括工业转型的潜力？涵盖的区域：使用前市场通知（PMN）和批准（PMA）数据，这表明，从1976年到2020年，总复合材料（PMN + PMA）指标遵循单个世俗期：20。5年（申请峰值峰值：1992 - 2012年峰值：1992-2012; 2012; FORGH：2002）和26.5岁以下（注册到26.5岁以上的峰值：1992年峰值到2019年的峰值；分别为24％和28％。重要的是，PMN和PMA独立存在作为逆结构。专家意见：证据表明：MD创新是由奇异的世俗库特尼茨式循环现象（独立于经济危机）驱动的，该危机是从从简单（PMN）到复杂（PMAS）MDS的基本转变造成的。有效的是，尽管Covid-19危机可能不会影响压倒性的动态，但预期但显着的（约25％）MD创新下降可能会受到MD利益相关者的细心措施的潜在减弱。这种方法的局限性和进一步的思想完成了这一观点。
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.
