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将矫形技术转化为临床实践:挑战与解决方案。

Translating Orthopaedic Technologies Into Clinical Practice: Challenges and Solutions.

机构信息

From the Department of Biomechanics, Hospital for Special Surgery, New York, NY (Dr. Maher), Hennepin County Medical Center, Minneapolis, MN (Dr. Kyle), and the Mayo Clinic, Rochester, MN (Dr. Morrey and Dr. Yaszemski), and the University of Texas Health Research, San Antonio, TX (Dr. Morrey).

出版信息

J Am Acad Orthop Surg. 2019 Jan 1;27(1):e9-e16. doi: 10.5435/JAAOS-D-17-00851.

Abstract

Despite the wealth of innovation in the orthopaedic sciences, few technologies translate to clinical use. By way of a 2-day symposium titled "AAOS/ORS Translating Orthopaedic Technologies into Clinical Practice: Pathways from Novel Idea to Improvements in Standard of Care Research Symposium," key components of successful commercialization strategies were identified as a passionate entrepreneur working on a concept aimed at improving patient outcomes and decreasing the cost and burden of disease; a de-risking strategy that has due recognition of the regulatory approval process and associated costs while maximizing the use of institutional, state, and federal resources; and a well thought-out and prepared legal plan and high quality, protected intellectual property. Challenges were identified as a lack of education on the scale-up and commercialization processes; few opportunities to network, get feedback, and obtain funding for early stage ideas; disconnect between the intellectual property and the business model; and poor adoption of new technologies caused in part by un-optimized clinical trials. By leveraging the network of professional orthopaedic societies, there exists an opportunity to create an enlightened community of musculoskeletal entrepreneurs who are positioned to develop and commercialize technologies and transform patient care.

摘要

尽管矫形科学领域有丰富的创新,但很少有技术能够转化为临床应用。通过为期两天的题为“矫形外科医师学会/骨科研究学会将矫形技术转化为临床实践:从新颖理念到改善护理标准的研究研讨会”的专题研讨会,确定了成功商业化策略的关键组成部分,包括:一位充满激情的创业者,致力于开发旨在改善患者治疗效果、降低疾病成本和负担的概念;一项风险降低策略,该策略充分认识到监管审批程序和相关成本,同时最大限度地利用机构、州和联邦资源;以及深思熟虑和精心准备的法律计划以及高质量的受保护知识产权。研讨会还确定了一些挑战,包括:缺乏关于规模化和商业化过程的教育;很少有机会进行网络交流、获得反馈和为早期创意获得资金;知识产权和商业模式之间脱节;以及部分由于临床试验优化不足导致新技术采用率低。通过利用专业矫形协会的网络,有机会创建一个有见识的肌肉骨骼创业社区,使他们能够开发和商业化技术,从而改变患者的护理方式。

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