PROMOTING BREAKTHROUGH MEDICAL INNOVATION: INSIGHTS FROM AN ANALYSIS OF RECENT TRANSFORMATIVE DRUGS, BIOLOGICS AND MEDICAL DEVICES

Abstract

Given the recent concern from multiple healthcare stakeholders that the pipeline of medical innovation is slowing, this thesis provides insights on how to spur breakthrough medical innovation in present day. The findings and recommendations are derived from one of the largest collections of interview transcripts from biomedical innovators (n=143) responsible for developing critical devices, drugs and diagnostics used in medicine today. An exemplary case (coronary artery stent) was selected for an in-depth analysis, which included a detailed recounting of stent development and an exhaustive analysis of the patent literature. External factors either catalyzed (e.g., supportive institutions, strong underlying science and collaboration) or hindered (e.g., technology transfer challenges, lack of funding and onerous conflict of interest rules) the development process. Strategies aimed towards promoting transformative medical innovation should focus on institutional-level policies targeting early stages of innovation. This includes providing individuals with unique expertise with the capacity to pursue innovative work. Technology transfer processes should be simplified to enable collaboration for individuals between institutions with disparate expertise. Policymakers should continue to support basic science research, which underlies future innovations. In contrast, policies that increase reimbursement or reduce taxes for industry or extend patent terms are less likely to impact transformative innovation.