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首页> 外文期刊>Journal of Technology Management & Innovation >Spinning Out of Control? How Academic Spinoff Formation Overlooks Medical Device Regulations
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Spinning Out of Control? How Academic Spinoff Formation Overlooks Medical Device Regulations

机译：旋转失控？学术衍生组织如何忽视医疗器械法规

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This paper investigates the impact of the medical device regulatory framework on the academic spino? formation process and contributes to knowledge in the domain by expanding and deepening our understanding of its underlying routines and capabilities. A detailed case study focusing on academic spinoff formation in the Irish medical device industry was conducted and found that the consideration given to the medical device regulatory framework significantly lags behind that given to other commercialisation activities. This trend has potential to both significantly delay spinoff formation and negatively impact its potential success and survival. Findings indicate that incorporating expert regulatory knowledge earlier within the process may enhance the spinoff activities within universities, particularly funding, research and capital investment.
机译：本文研究了医疗器械监管框架对学术界的影响。形成过程，并通过扩展和加深我们对其基础例程和功能的理解来为该领域的知识做出贡献。进行了针对爱尔兰医疗器械行业学术衍生品形成的详细案例研究，发现对医疗器械监管框架的考虑大大落后于对其他商业化活动的考虑。这种趋势可能会大大延迟衍生产品的形成，并对其潜在的成功和生存产生负面影响。研究结果表明，在此过程的早期融入专家监管知识可能会增强大学内部的衍生活动，特别是资金，研究和资本投资。

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