Publications by authors named "I Daizadeh"

Purpose: Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how?

Methods: Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines) and innovation (corresponding FDA-registrations) from 1976-2020 are used to determine interdependence, a concept relying on strong correlation and reciprocal causality (estimated via variable lag transfer entropy and wavelet coherence).

Results: Based on the observed interdependence, a mapping of regulation onto innovation is conducted and finds that regulation seems to accelerate then supports innovation until on or around 2015; at which time, an inverted U-curve emerged.

Conclusions: If empirically evidentiary, an important innovation-regulation nexus in the US has been reached; and, as such, stakeholders should (re)consider the complexity of the regulatory landscape to enhance US medical product innovation.

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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.

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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.

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