Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.

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...

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Main Authors: Aaron S Kesselheim, Shuai Xu, Jerry Avorn
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2014-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC3922977?pdf=render
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author Aaron S Kesselheim
Shuai Xu
Jerry Avorn
author_facet Aaron S Kesselheim
Shuai Xu
Jerry Avorn
author_sort Aaron S Kesselheim
collection DOAJ
description 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.
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spelling doaj.art-705a02a524b84669a31a9f2e4f00bf182022-12-22T01:59:59ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0192e8866410.1371/journal.pone.0088664Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.Aaron S KesselheimShuai XuJerry AvornMedical 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.http://europepmc.org/articles/PMC3922977?pdf=render
spellingShingle Aaron S Kesselheim
Shuai Xu
Jerry Avorn
Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
PLoS ONE
title Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
title_full Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
title_fullStr Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
title_full_unstemmed Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
title_short Clinicians' contributions to the development of coronary artery stents: a qualitative study of transformative device innovation.
title_sort clinicians contributions to the development of coronary artery stents a qualitative study of transformative device innovation
url http://europepmc.org/articles/PMC3922977?pdf=render
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