III类医疗器械研发项目的全生命周期管理研究

发布时间：2018-04-15 05:26

本文选题：III类医疗器械 + 人工角膜　；参考：《青岛科技大学》2017年硕士论文

【摘要】：医疗器械行业是我国医疗卫生产业的重要构成部分,随着经济水平的提高和科学技术的进步,在政府的大力支持下,这一行业的落后局面正在得到改变,尤其是知识和资金密集型的III类医疗器械行业更是获得了前所未有的发展,正在逐渐打破美日欧等国家垄断的局面。由于III类医疗器械行业发展的水平也是我国综合实力的体现,因此大力发展医疗器械行业(尤其是III类医疗器械)势在必行。我国III类医疗器械研发项目具有安全性和法规要求严格、专业要求高、复杂程度高、研发周期长、失败风险高等特点,同时在管理方面又存在项目立项决策不科学、项目管理团队水平较低、缺乏有效的激励机制、忽视项目全生命周期管理等不足,加之行业发展的紧迫性要求更高的成果转化率和更快的转化速度,因此,将全生命周期管理的理念引入III类医疗器械研发项目管理中变得越来越迫切。本文在项目管理理论、医疗器械研发、项目全生命周期理论研究的基础上,建立起III类医疗器械研发项目的全生命周期模型,并将生命周期划分为四个阶段,即立项阶段、产品设计研发阶段、验证阶段、注册报批阶段;八个子过程:新产品开发建议书、设计开发输入、设计开发输出、小试、中试、临床试验、报批准备以及获得许可。本文对每个阶段的工作范围、工作目标、工作内容都做了详细分解,明确了每个阶段的交付成果。在案例研究部分,以A公司人工角膜研发项目作为研究对象,基于全生命周期模型对人工角膜研发项目的范围、利益相关者的管理以及风险管理进行了分析,并对项目的组织结构、WBS、责任分配矩阵进行了设计,验证了全生命周期模型的有效性,为其他同类医疗器械研发项目的组织实施提供了管理框架。本文最后结合A公司的项目进展情况,总结了实施全生命周期管理取得的成效,可以为III类医疗器械研发项目管理提供参考。
[Abstract]:The medical device industry is an important component of the medical and health industry in China. With the improvement of economic level and the progress of science and technology, with the support of the government, the backward situation of this industry is being changed.Especially, the knowledge and capital intensive III medical device industry has gained unprecedented development, and is gradually breaking the monopoly situation of America, Japan, Europe and other countries.Since the development level of III medical device industry is also the embodiment of our country's comprehensive strength, it is imperative to vigorously develop medical device industry (especially III medical device).The III medical device R & D project in China has the characteristics of strict safety and regulations, high professional requirements, high complexity, long R & D cycle, high risk of failure, etc. At the same time, there are unscientific project decision making in the field of management.The low level of project management team, the lack of effective incentive mechanism, the neglect of project life cycle management and other deficiencies, coupled with the urgency of industry development requires a higher conversion rate of results and faster transformation speed, so,It is more and more urgent to introduce the concept of whole life cycle management into III medical device R & D project management.Based on the research of project management theory, medical device R & D and project life cycle theory, this paper establishes the whole life cycle model of III medical device R & D project, and divides the life cycle into four stages, I. e.Product design development phase, verification phase, registration and approval phase; eight sub-processes: new product development proposal, design development input, design development output, pilot, pilot, clinical trial, approval preparation and licensing.In this paper, the scope, objectives and contents of each stage are analyzed in detail, and the deliverables of each stage are defined.In the part of case study, the scope, stakeholder management and risk management of corneal prosthesis R & D project are analyzed based on the whole life cycle model.The organizational structure of the project, WBSand the responsibility allocation matrix are designed to verify the validity of the whole life cycle model and provide a management framework for the organization and implementation of other similar medical device R & D projects.Finally, combined with the project progress of A Company, this paper summarizes the effect of implementing the whole life cycle management, which can provide a reference for the R & D project management of III medical devices.
【学位授予单位】：青岛科技大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F426.4

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