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研发流程管理方法在医疗器械企业中的应用研究

发布时间:2018-10-13 07:21
【摘要】:科学技术的高速发展以及经济全球化的趋势,再加上信息技术的爆发式增长,带动了一大批中国高科技企业的萌芽和生长。而医疗器械作为高科技产品的代表,其产业发展受到了企业家的重点关注和国家的大力支持。现代企业之间的竞争,已经不再是单方面技术水平的竞争,而是企业综合业务管理水平的竞争。企业研发流程管理作为目前先进的产品研发管理方法,已经在众多高科技企业中实施并取得了成功。我国企业产品研发流程管理还处于起步阶段,大多数企业进行的流程管理,只是一种方法的套用,流程管理的思想还没有真正形成。如何应用研发流程管理方法提高医疗器械产品开发效率就成了企业急需解决的一个难题。本文首先是回顾了几个成熟的流程管理理论——门径管理、敏捷管理、六西格玛管理和并行工程理论,再总结了企业流程管理实施的一般方法。结合AA公司DR(Digital Radiography)产品研发项目流程管理的实例,分析和总结了研发流程管理在AA公司前半程项目实施中所取得的成果和存在的问题。结合门径管理方法、并行工程理论及项目管理方法,对项目中所出现的项目延期,费用超支和质量不达标等做了充分的分析和研究,并针对问题提出研发流程管理方法的优化建议。将这些优化建议实施到后期的项目研发过程中去,通过实际的企业产品研发过程实践和检验优化后的管理方法的有效性。本文结合门径管理、敏捷管理、并行工程和现代项目管理知识理论,以及AA公司DR产品完整的开发过程的研究。得出以下一些方法对于改善医疗器械企业产品研发流程管理效率有很好的效果:从公司层面加强对流程管理人员的层级培养;公司战略目标落实到产品研发项目中去,从流程本身出发,建立更加完善的研发流程管理系统和其他流程支持系统;为项目成员制定流程绩效目标和评估制度;建立流程化模式的项目团队,增强团队沟通协作能力;运用信息系统加强流程的管控,通过IT系统对各个产品的开发进行项目管理。
[Abstract]:The rapid development of science and technology and the trend of economic globalization, coupled with the explosive growth of information technology, have led to the germination and growth of a large number of high-tech enterprises in China. As a representative of high-tech products, medical device industry development has been the focus of attention of entrepreneurs and strong support of the country. The competition among modern enterprises is no longer the competition of unilateral technology level, but the competition of enterprise's comprehensive business management level. Enterprise R & D process management, as an advanced product R & D management method, has been successfully implemented in many high-tech enterprises. The process management of product research and development in our country is still in its infancy. The process management carried out by most enterprises is just the application of one method, and the thought of process management has not really formed yet. How to apply the method of R & D process management to improve the efficiency of medical device development has become a difficult problem that enterprises urgently need to solve. This paper first reviews several mature theories of process management, such as door management, agile management, six Sigma management and concurrent engineering, and then summarizes the general methods of implementing enterprise process management. This paper analyzes and summarizes the achievements and existing problems of R & D process management in the first half of the project implementation of AA Company, based on the example of DR (Digital Radiography) product R & D project process management of AA Company. Combined with the door diameter management method, concurrent engineering theory and project management method, the project delay, cost overrun and substandard quality in the project are fully analyzed and studied. And put forward the research and development process management method optimization suggestions. These optimization suggestions are put into practice in the later stage of the project research and development, and the effectiveness of the optimized management method is tested through the practice of the enterprise product development process and the test of the effectiveness of the optimized management method. This paper combines the knowledge theory of door path management, agile management, concurrent engineering and modern project management, as well as the complete development process of DR products of AA Company. It is concluded that the following methods have good effect on improving the efficiency of product development process management in medical device enterprises: strengthen the hierarchical training of process managers at the company level; implement the strategic objectives of the company in the product development projects. From the process itself, establish a more perfect R & D process management system and other process support systems; establish process performance goals and evaluation system for project members; establish a process-based project team to enhance team communication and collaboration; Use information system to strengthen the control of the process, through the IT system for the development of each product project management.
【学位授予单位】:复旦大学
【学位级别】:硕士
【学位授予年份】:2013
【分类号】:F273.2;F426.4

【共引文献】

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