Medical devices are critical to the delivery of health care, but malfunctioning products can pose a threat to patients, necessitating product recalls. In addition to the direct effects of medical device recalls, such as public health protection and negative reputational and financial consequences for the recalling firm, there may be spillover effects on product development. In particular, the vacuum left by the recalled product and its reputational damage may incentivize competing firms to introduce new medical devices to the market. This study examines the impact of serious medical device recalls on subsequent new product development by competitors, as measured by new medical device submissions to the FDA. We compile data from three regulatory databases representing 11,724 new product submissions and 2,647 recalls for 7,208 unique medical device firms over a 17-year period. Using a fixed effect model and institutional features of the FDA’s clearance process, we find that serious recalls increase other firms’ new product submissions in the affected product market. We estimate that a single recall in a product market increases subsequent submissions by approximately eight percent. Moreover, we find that this relationship is attenuated in markets with more competitors. Our results indicate that firms may currently undervalue actions to avoid product recalls, and that the medical device market may be improved by regulatory efforts to enhance transparency in the recall process.
Ansprechperson: Elisabeth Hofmeister
Eintragung in den Einladungsverteiler und mehr Informationen auf der Seminarseite.
