| Abstract: | 在現今高度競爭激烈及全球化的趨勢下，新產品開發(New Product Development, NPD)儼然成為企業突破傳統窼臼、創造新利基的一種方式；以醫療器材製造業而言，由於醫學的日新月異、社會老年化的來臨及健康管理的日漸普及促使醫療器材業者紛紛投入新產品開發。然而醫療器材新產品開發的高研發門檻、廣泛的技術應用及醫療法令等種種限制，導致醫療器材之新產品開發常常功敗垂成。以台灣地區而言，醫療器材新產品開發正如雨後春筍般的蓬勃發展，故本研究提出一個可行的方案來解決醫療器製造商在新產品開發階段中所遭遇的問題如(1)顧客的需求的失焦 (2)產品規格定義的不穩定性 (3)新產品開發任務的執行不力 (4) 新產品開發專案團隊的效率不彰及(5)不完善的新產品上市. 本研究利用同步工程方法論(Concurrent Engineering, CE)建構在屬性導向模式(Attribute-driven design, ADS)並結合新產品開發流程及IDEF3方法來研究ODM或OEM醫療器材製造商在新產品開發時，訂定新產品之各項屬性，以期引導新產品開發團隊解決在新產品開發流程所面臨的困境; 如資源管理上的困難、團隊的目標分岐及開發時程的不確定性.來整合並管控新產品開發團隊，使新產品達到顧客需求、縮短開發時程之目標，最後以目前某醫療器材製造商之新產品開發為例來驗証其方法及流程之可行性。 Nowadays, companies must confront high levels of competition and extensive globalization. New product development (NPD) is a way to boost up enterprises and achieve optimum benefits. In the medical device industry, there have been rapid advancements in technology and medical practices, as well as ageing of the population, increases in the number of diseased individuals, and increasing respect for health-care management. The medical device industry is now faced with stiff competition in the development of novel medical devices. In Taiwan, the design of new medical devices is just starting to be competitive. However, designing new medical devices requires diversification, complexity and consistency. The basic theories and technical applications of medical devices span the fields of medical science, biotechnology, physiology, material science, mechanical engineering, electronics engineering and electrical engineering. Also, medical devices help in the diagnosis, treatment and prevention of human disease, and/or affect the structure and function of the human body. As a result, this dissertation attempts to provide a method by which one can figure out the problem as such as (1) failure to address customer wants and needs; (2) Unstable product definition; (3) Poor quality execution of key NPD tasks; (4) A poorly-structured, ineffectual project team and (5) Premature product launches. This dissertation applies concurrent engineering (CE) methodology by attribute-driven design (ADS). Then, the method combines new product development (NPD) and integrated computer-aided manufacturing (ICAM) DEFinition (IDEF3). The proposed method first defines product attributes in an NPD project for ODM or OEM medical device manufacturers. The study addresses the difficult scenario that occurs when the NPD team faces problems during the NPD process, like problems with resource management, target inconsistencies, and uncertainties in the development schedule. The dissertation also utilizes the proposed method to integrate and monitor the NPD team, as it strives to fulfill goals, like meeting customer requirements and reducing the time to market. Finally, this dissertation applies the model to a specific new device case, so as to verify that the method is both effective and efficient. |
