Kesselheim Aaron S, Xu Shuai, Avorn Jerry
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.
PLoS One. 2014 Feb 12;9(2):e88664. doi: 10.1371/journal.pone.0088664. eCollection 2014.
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.
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.
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.
医疗设备创新仍未得到充分理解，政策制定者对于如何激励早期研发存在分歧。我们试图通过对一种关键医疗设备——冠状动脉支架的研发进行深入案例研究，来阐明变革性医疗保健创新的组成部分。
我们对那些其工作对冠状动脉支架研发有贡献的创新者进行了半结构化访谈，这些创新者是我们基于对监管、专利和医学文献的回顾而确定的。对每位参与者的半结构化访谈涵盖了受访者个人在冠状动脉支架研发中的参与情况、机构和其他个人在研发过程中的作用、资金与知识产权在受访者贡献中的相互作用，以及最后对从该经历中获得的经验教训的反思。使用标准编码技术和定性数据分析的持续比较方法对访谈记录进行了分析。
我们发现首批冠状动脉支架来自三个团队：胡利奥·帕尔马兹和理查德·沙茨、切萨雷·詹图尔科和加里·鲁宾，以及乌尔里希·西格瓦特。首先，这些个体医生发明家在临床实践中看到了对冠状动脉支架的需求。作为回应，他们在学术医疗中心的支持下开发了原型，从而开展了早期验证研究。随后大公司在工程支持下进入。一旦技术传播开来，专利就变得至关重要。冠状动脉支架的案例表明，创新政策应侧重于支持学术中心的早期医生发明家。
