Abstract

Innovation in the medical device industry is crucial to continuously improve the health and wellbeing of society. The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of medical devices on the market while balancing the need for continuous innovation. One way the FDA has tried to support innovation is through the development of the 510(k) pathway, which does not require clinical testing as the safety of the device is determined based on a predicate device. Many companies choose to develop products that can obtain approval through the 510(k) pathway. While the 510(k) pathway is shorter, it does not allow for the type of rapid innovation and approval needed during a public health emergency. The FDA has an alternate path, the Emergency Use Authorization (EUA), that authorizes the use of certain devices during pandemics such as COVID-19.

The goal of this thesis was to identify the ways in which the COVID-19 EUA encouraged innovation in the ventilator industry. The EUA provides an opportunity for new devices, technologies, and players to enter the industry that would otherwise face regulatory barriers. This study was completed using publicly available data to identify historical patterns in the ventilator industry, changes in the industry from the 510(k) to the EUA, and innovation in ventilator development. The analysis showed that there were new entrants to the ventilator market and companies took multiple approaches to innovative solutions, from manufacturing to product design. Based on my findings, I conclude with a number of policy recommendations.

Library of Congress Subject Headings

Respirators (Medical equipment)--Technological innovations--United States; COVID-19 (Disease)--Government policy--United States; United States--Food and Drug Administration

Publication Date

12-23-2020

Document Type

Thesis

Student Type

Graduate

Degree Name

Science, Technology and Public Policy (MS)

Department, Program, or Center

Public Policy (CLA)

Advisor

Sandra Rothenberg

Advisor/Committee Member

Marcos Esterman

Advisor/Committee Member

Ezekiel Leo

Campus

RIT – Main Campus

Plan Codes

STPP-MS

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