开发一种SIBS套路来治疗玻璃眼
1InnFocus, Inc., a Santen Company, Miami, Florida, and Department of Biomedical Engineering, University of Miami, Miami, Florida.
概括
开发用于医疗器械的新型生物材料,比如Poly ((styrene-block-isobutylene-block-Styrene) 对于玻璃眼的微型治疗,为导航FDA批准和业务发展的初创企业提供了宝贵的教训.
科学领域:
- 生物材料科学 生物材料科学
- 医疗设备创新 医疗设备创新
- 眼科医生 眼科 眼科
背景情况:
- 制药和医疗器械初创企业在将创新推向市场方面面临着独特的挑战.
- 获得食品和药物管理局 (FDA) 的批准需要在复杂的科学,监管和商业环境中进行导航.
- 从早期公司学习的经验教训对于创业成功至关重要.
研究的目的:
- 为医疗器械行业的企业家提供见解和建议.
- 详细介绍开发一种基于生物材料的新型医疗器械的旅程,从概念到收购.
- 突出技术,科学,监管和商业发展方面的关键决策和经验教训.
主要方法:
- 基于聚乙烯块-异布乙烯块-乙烯) 的微型猎物开发过程的审查.
- 讨论科学,工程和生物材料方面的考虑.
- 对监管途径和业务战略进行分析,从而获得市场认可和公司收购.
主要成果:
- 成功开发了一种用于治疗玻璃眼的Poly ((styrene-block-isobutylene-block-Styrene) 微型治疗方法.
- 2004年成立InnFocus, Inc.,专注于这种创新的设备.
- 2016年,Santen制药公司收购了InnFocus,证明了成功的商业化.
结论:
- 新型生物材料和医疗器械的开发需要一个多学科的方法,整合科学,工程和商业敏.
- 整个创新生命周期的战略决策对于获得FDA批准和成功进入市场至关重要.
- 对于医疗技术行业的初创企业来说,InnFocus,Inc.的案例提供了一个有价值的模型.
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