Why did the number of US FDA medical device guidelines begin to rise in the mid-2010s? A perspective.

AREAS COVERED: An initial investigation of US medical device guidelines is presented, with the aid of those of medicines as qualitative comparator. Since the first recorded FDA medical device guideline (February 1975) until the mid-2010s, the number of medical device guidelines has been basically stable, then rapidly rose. EXPERT OPINION: The rise of the COVID-19 pandemic and digital health technologies explains 50% of the upward momentum in guidelines since the mid-2010s. Concomitantly, medical device and medicinal guidelines became moderately correlated. This perspective posits that this trend will continue irrespective of the ebbing pandemic as it is embedded in the concept of 'innovation saltus' - i.e. discrete periods of elevated innovation. A key aspiration of this work is to inspire additional research into this interesting area of regulatory science; namely, examination of guidelines (as proxy measures of regulations) and their influence on innovation.

Singular secular Kuznets-like period realized amid industrial transformation in US FDA medical devices: a perspective on growth from 1976 to 2020.

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: 1992-2019; 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 that MD innovation is driven by a singular secular Kuznets-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.

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

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.

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.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19; HCoV-19; COVID-19) has affected all daily activities. Has it also affected the number of United States (FDA) drug approvals over time? The short answer from empirical time series forecasting is not yet. Care should be taken as the crisis continues through maintaining the scientific, economic, political, and social supportive structures to sustain momentum. This conclusion is based on analyzing the results of (non-overlapping) forecasting routines (viz., complex exponential smoothing, auto-regressive fractionally integrated moving average, extreme learning machine, and multi-layer perceptron) performed on longitudinal (1939-present) FDA (CDER) drug approvals taking into regard pre- and extant-COVID-19 eras. This is an initial study and there are caveats with the approach, and as such, all data and programs are provided to support replication of the results and furthering of the investigation.