本論文探討醫療器材產業面對環境劇變的競爭，如何透過分析產品開發的程序與流程以及歷年既有的相關資料，以改善企業內部的產品開發管理模式，使企業有效的運用與整合內部的資源，以因應外在持續變化的競爭環境。
具體方法與成果是:
(1)分析產品開發專案的屬性，重新定義模組化產品開發流程，將開發專案流程解析成最小可應用的單元，以作為預估專案規劃、時間、成本及人力資源的基礎。
(2)分析專案產品營銷資料，用以制定專案營收追蹤的制度，作為調整專案執行順序、管理顧客需求與專案營銷，以及調整營業利潤公式之基礎。
本論文盼望以個案公司為例，有系統的整理醫療器材產業的產品開發與管理經驗，使產品開發流程能在滿足顧客需求與符合工程法規的前提下，縮短工程時間及最佳化資源的有效運用，以供後續相關研究之參考。

This essay examines the competition of the Medical Device Industry in this changing environment, and how a firm could adjust to the ever-changing market by managing and integrating their existing resources more effectively. Such goal can be achieved by reviewing their product development processes and archive data and improving their product development management.
Methodology and Result
1.Evaluate the characteristics of the product development projects and redefine the models of product development process. Dissect the process into smallest applicable components and use them as baseline for project planning and estimates of time, cost, and human resources.
2.Investigate the product sales records to establish a system to monitor project revenues, determine the priority of tasks in a project, manage customers’ demand and sales, and adjust the formula for calculating business profits.
This essay aims to use case studies to demonstrate and promote further studies of how a firm could organize its experience in product development and management to shorten the development cycle and optimize its resources in accord with consumer’s demand and manufacturing regulations.

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