Pediatric Medical Device Consortia: A Novel Pathway for Pediatric Device Development for Pediatric Urologists and Other Pediatric Specialists.
Pediatric Medical Device Consortia: A Novel Pathway for Pediatric Device Development for Pediatric Urologists and Other Pediatric Specialists.
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DOI：
10.1016/j.urpr.2014.11.002
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发表时间：
2015-07-01
期刊：
影响因子：
0.8
通讯作者：
Koh, Chester J
中科院分区：
文献类型：
--
作者：
Grant, Matthew;Stanasel, Irina;Koh, Chester J
引言：目前存在着对专门为儿童设计的医疗器械的巨大需求。这一差距很可能是经济、临床和监管挑战以及缺乏将儿科器械想法与合格个人/项目和行业合作伙伴结合起来的既定机制造成的。我们描述了我们组建儿科医疗器械联盟的经验，该联盟起源于一所大学附属儿童医院的儿科泌尿科和技术转移办公室。方法：我们回顾了2011年3月至2013年6月在一所大学附属儿童医院儿科医疗器械联盟的发展历史，重点是联盟的组织方面。结果：在大学种子基金的帮助下，成立了一个儿科医疗器械联盟，以鼓励多个校区的教师合作。该联盟继续作为儿科器械项目的资源取得进展，并于2013年成为美国食品药品监督管理局支持的儿科器械联盟。这使得该财团通过P50 PDC Grant Program.CONCLUSIONS扩大其活动：儿科泌尿科医生可以在组织儿科设备财团中发挥重要作用。联盟可以将联合收割机学术中心与当地的商业、投资、高等教育和慈善团体结合起来，快速推进儿科医疗器械项目。儿科器械项目需要新的方法来克服当前的商业化障碍，包括在学术环境中的长期停留。
INTRODUCTION: A great need currently exists for medical devices designed specifically for children. This gap is most likely a result of economic, clinical and regulatory challenges as well as a lack ofestablished mechanisms for joining pediatric device ideas with qualified individuals/programs and industry partners. We describe our experience with forming a pediatric medical device consortium that originated from the pediatric urology division and the technology transfer office of a university affiliated children's hospital.METHODS: We reviewed the developmental history of a pediatric medical device consortium at auniversity affiliated children's hospital from March 2011 to June 2013 with emphasis on the organizational aspects of the consortium.RESULTS: A pediatric medical device consortium was formed with the assistance of university seed funding to encourage faculty collaboration across multiple campuses. The consortium continued its progress as a resource for pediatric device projects to become a Food and Drug Administration supported pediatric device consortium in 2013. This allows the consortium to expand its activities through the P50 PDC Grant Program.CONCLUSIONS: Pediatric urologists can have a major role in organizing pediatric device consortia. Consortia can combine academic centers with the local business, investment, higher education and philanthropic communities to rapidly advance pediatric medical device projects. Novel approaches are necessary for pediatric device projects to overcome current barriers to commercialization, including an extended stay in the academic setting.