  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.
