UC San Diego

Chapter One examines how FDA regulation affects innovation and market concentration. I examine this question by exploiting FDA deregulation events that affected certain medical device types but not others. I collect comprehensive data on medical device innovation, device safety, firm entry, prices, and regulatory changes and enhance these data using text analysis methods. My analysis of these data reveals three key findings. First, deregulation events significantly increased the quantity and quality of new technologies in affected medical device types relative to controls. These increases are particularly strong among small and inexperienced firms. Second, these events increased firm entry and reduced prices for medical procedures that utilize affected medical device types. Finally, rates of serious injuries and deaths attributable to defective devices did not significantly increase following these events. Interestingly, deregulating certain device types was associated with reduced adverse event rates, possibly due to firms increasing their emphasis on product safety in response to increased litigation risk.

In Chapter Two, we analyze wartime prosthetic device patents to investigate how demand shocks and procurement environments can shape medical innovation. We use machine learning tools to develop new data describing the aspects of medical and mechanical innovations that are emphasized in patent documents. Our analysis of historical patents yields three primary facts. First, we find that the U.S. Civil War and World War I led to substantial increases in the quantity of prosthetic device patenting relative to patenting in other medical and mechanical technology classes. Second, we find that the Civil War led inventors to increase their focus on reducing cost, while World War I did not. The Civil War era emphasis on cost is consistent with a role for that period's cost-conscious procurement model. Third, we find that inventors emphasized dimensions of product quality (e.g., a prosthetic limb's comfort or facilitation of employment) that aligned with differences in buyers' preferences across wars. We conclude that procurement environments can significantly shape the dimensions of the technical frontier with which inventors engage.

In Chapter Three, we study how government price reforms affect innovation, market structure, and product quality within the health care sector. We exploit a Medicare payment reform that reduced expenditures on certain types of durable medical equipment (DME) by 66% while leaving other types unaffected. We find that manufacturers filed 29% fewer patents and introduced 22% fewer new models in DME types affected by the price reform relative to those that were unaffected. Additionally, patents filed after the price reform increasingly focused on "process" rather than "product" innovation, consistent with increased market demand for lower-cost products. The market structure was also affected, with 25% fewer manufacturers entering affected product markets and a 65% increase in outsourcing to foreign companies. The shift towards cost-cutting, both in patenting and supply chain restructuring, was associated with increased device repair rates among Medicare beneficiaries and reported adverse events. Firms that outsourced to foreign manufacturers experienced the highest increase in adverse events. While the Medicare price reform generated substantial savings, these gains were dampened by the adverse effects on innovation, market structure, and product quality in the long run. Our findings highlight the importance of considering long-run impacts when designing policy reforms.