title: Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
abstract: BACKGROUND
  Medical device innovation remains poorly understood, and policymakers disagree over how to incentivize early development. We sought to elucidate the components of transformative health care innovation by conducting an in-depth case study of development of a key medical device: coronary artery stents.
  
  
  RESULTS
  We conducted semi-structured interviews with the innovators whose work contributed to the development of coronary artery stents who we identified based on a review of the regulatory, patent, and medical literature. Semi-structured interviews with each participant covered the interviewee's personal involvement in coronary artery stent development, the roles of institutions and other individuals in the development process, the interplay of funding and intellectual property in the interviewee's contribution, and finally reflections on lessons arising from the experience. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis.
  
  
  CONCLUSIONS
  We found that the first coronary artery stents emerged from three teams: Julio Palmaz and Richard Schatz, Cesare Gianturco and Gary Roubin, and Ulrich Sigwart. First, these individual physician-inventors saw the need for coronary artery stents in their clinical practice. In response, they developed prototypes with the support of academic medical centers leading to early validation studies. Larger companies entered afterwards with engineering support. Patents became paramount once the technology diffused. The case of coronary stents suggests that innovation policy should focus on supporting early physician-inventors at academic centers.
authors.affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
authors.affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Shuai
authors.initials: S
authors.lastname: Xu
authors.affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Jerry
authors.initials: J
authors.lastname: Avorn
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D002309:Cardiology / Q000266:history* / Q000379:methods; D003324:Coronary Artery Disease / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology; D006291:Health Policy; D049673:History, 20th Century; D006801:Humans; D018973:Intellectual Property; D062069:Inventions; D062068:Inventors; D010820:Physicians; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration