Can Regulatory Efforts Motivate Innovation? The Case of Ventilator Innovations During COVID

In 2020, the United States Food and Drug Administration enacted the Emergency Use Authorization (EUA) to help respond to the COVID-19 pandemic. This regulatory pathway allowed for alternative uses of the existing medical devices and temporary authorization of new medical device designs, including ventilators. Given that regulation is often seen as a barrier to innovation, looking at ventilator innovation under the EUA is a good case study to explore if reducing regulatory barriers leads to increased or different forms of innovation. In this article, publicly available data are used to track the nature of innovation across all forms of ventilators submitted under the EUA pathway. We found that the EUA encouraged innovation in the ventilator industry, as indicated by new entrants to the medical device industry, a shift in the types of ventilators submitted for approval, and a wide variety of innovations. It also promoted new management practices to facilitate innovation, such as frugal design, a broader range of collaboration, and the use of open-source designs; these practices can be more widely used by industry to reduce costs, increase innovation, and serve traditionally underserved markets.