中文摘要
本文以 Y 公司新研发的红外生物效应治疗仪项目为例，对医疗器械创新技术
项目开发进行了研究。本论文共分为四章，首先简要介绍了红外生物效应治疗仪
器的研究背景和项目开发的相关理论；其次运用 SWOT、波特五力分析法对 Y 公司
内部资源和外部环境进行了系统分析，提出了其新产品开发的方向和重点；再次
根据市场细分理论，在确定新产品市场目标、产能、定位的基础上，给出了该项
目开发的具体框架和资金运作方案；之后，对本项目在新产品开发过程中存在的
风险进行了分析和评估，并结合企业现实情况提出了风险的控制措施；最后进行
了总结，认为红外生物效应治疗仪项目具有很强的可行性，并且在细分市场定位
得当后能够有效地吸收空白市场份额
关键字：医疗器械；红外生物效应治疗仪；项目开发；波特五力模型
Abstract
Take the new infrared biological effect therapeutic project of Y Company for
example; this paper promotes the study of medical device innovation technology project
development. This paper is divided into four chapters. Firstly, I briefly introduce the
background of infrared therapy instrument project and the development of related
theories. Secondly, I systematically analyze the external situations and internal
resources of Y Company with SWOT and Porter five strength analyzing method and put
forward the direction and key point of Y company’s new project. Thirdly, based on the
market division theory, I confirm the market target, capacity and position of the new
product, and come out the framework and capital operation scheme of the project.
Fourthly I evaluate the risk in the project development, and give out the risk controlling
strategy concerning the reality of the company. Finally, the paper comes to the
conclusion that the project is of great feasibility and can absorb the blank market share
if it’s well located.
Keyword:Medical Device;Biological Effect Therapeutic Product; Project Development;
Porter Five Strength Model