RETRACTED ARTICLE: Seasonal and Secular Periodicities Identified in the Dynamics of US FDA Medical Devices (1976–2020): Portends Intrinsic Industrial Transformation and Independence of Certain Crises

被引:0
作者
Iraj Daizadeh
机构
[1] Takeda Pharmaceuticals,
来源
Therapeutic Innovation & Regulatory Science | 2022年 / 56卷
关键词
Business cycles; Medical devices; FDA policy; Regulatory science; Economic dynamics;
D O I
暂无
中图分类号
学科分类号
摘要
The US Food and Drug Administration (FDA) regulates medical devices (MD), which are predicated on a concoction of economic and policy forces (e.g., supply/demand, crises, patents), under primarily two administrative circuits: premarketing notifications (PMN) and Approvals (PMAs). This work considers the dynamics of FDA PMNs and PMAs applications as an proxy metric for the evolution of the MD industry, and specifically seeks to test the existence [and, if so, identify the length scale(s)] of economic/business cycles. Beyond summary statistics, the monthly (May, 1976 to December, 2020) number of observed FDA MD Applications are investigated via an assortment of time series techniques (including: discrete wavelet transform, running moving average filter, complete ensemble empirical mode with adaptive noise decomposition, and Seasonal Trend Loess decomposition) to exhaustively seek and find such periodicities. This work finds that from 1976 to 2020, the dynamics of MD applications are (1) non-normal, non-stationary (fractional order of integration < 1), non-linear, and strongly persistent (Hurst > 0.5); (2) regular (non-variance), with latent periodicities following seasonal, 1-year (short-term), 5–6 year (Juglar; mid-term), and a single 24-year (Kuznets; medium-term) period (when considering the total number of MD applications); (3) evolving independently of any specific exogenous factor (such as the COVID-19 crisis); (4) comprised of two inversely opposing processes (PMNs and PMAs) suggesting an intrinsic structural industrial transformation occurring within the MD industry; and, (6) predicted to continue its decline (as a totality) into the mid-2020s until recovery. Ramifications of these findings are discussed.
引用
收藏
页码:104 / 116
页数:12
相关论文
共 19 条
  • [1] Kitchin J(1923)Cycles and trends in economic factors Rev Econ Stat. 5 10-16
  • [2] Abramovitz M(1968)The Passing of Kuznets Cycle Economica 35 349-367
  • [3] Kondratieff ND(1935)The long waves of economic life Rev Econ Stat 17 105-115
  • [4] Stolper WF(2002)Structural change: an R package for testing for structural change in linear regression models J Stat Softw 7 1-38
  • [5] Zeileis A(2003)Testing and dating of structural changes in practice Comput Stat Data Anal 44 109-123
  • [6] Leisch F(2006)Implementing a class of structural change tests: an econometric computing approach Comput Stat Data Anal 50 2987-3008
  • [7] Hornik K(2008)Automatic time series forecasting: the forecast package for R J Stat Softw 26 1-22
  • [8] Kleiber C(2021)US FDA Drug Approvals are persistent and polycyclic: insights into economic cycles, innovation dynamics, and National Policy Ther Innov Regul Sci 55 743-754
  • [9] Zeileis A(2021)Has the COVID-19 crisis affected the growth of United States Food and Drug Administration drug approvals? The answer is not yet! A time series (forecasting) study Ther Innov Regul Sci 55 553-557
  • [10] Kleiber C(2020)Investigating Rates of Food and Drug Administration approvals and guidances in drug development: A structural breakpoint/cointegration timeseries analysis Ther Innov Regul Sci 54 1056-1067