人口結構高齡化與先進國家對生活品質的高要求趨勢下,造就醫療與照護相關產業的商機。台灣製造業的產業鏈具有舉世矚目的產品開發和製造能力,醫療器材相關產業則成為各家廠商爭相投入的重點領域,對於欲進入此產業的企業來說,如何有效掌握本身的競爭優勢,進一步創造利潤價值遂成為一個重要的課題。 本研究透過個案研究的方式,以文件資料、檔案紀錄、個案公司成員訪談及直接觀察等方式取得研究資料,目的是以資源基礎觀點探討個案公司在產品實現過程中所運用之資源有何特性?又是如何透過組織運作規劃來進一步創造持續性的競爭優勢。 本研究個案公司經鑑別,在其產品實現流程中有18項具價值性資源,其中在產品設計開發的專案管理部分(專案機會啟動評估機制、產品設計規劃及跨功能開發專案管理制度)具有相對持續性(長期)的競爭優勢。同時,持續將產品開發的成功所帶來的利潤投入創新(包括產品與技術提升)與先進設備引進因而讓企業資源在資產與能力部份都不斷累積而持續擁有競爭優勢。 另一方面,透過強調PDCA(Plan-Do-Check-Action)循環與持續改善的國際標準化組織之品質管理系統精神,不斷地透過協調與整合、學習和重配置與變形的過程,將個人能力轉換成不易移動與模仿的組織能力,建構持續性競爭優勢。;Due to the trend of aged society and high demand on the quality of life in advanced countries, business opportunities in medical and healthcare industries are flourishing. Based on the world-renowned product development and manufacturing capabilities, Taiwan′s manufacturers aim to invest in the medical device industries. How to creating profits with own resource has become an important topic for these manufacturers. The purpose of this study is to use secondary data analysis, interviewing the case members and direct observation to identify the characteristics of the resources used in product realization process of the case corporation, and study how these resources create the sustainable competitive advantage through the organization operation planning. Eighteen valued resources are identified through the product realization process. Three of them (project kick-off evaluation mechanism, product design planning and cross-functional project management system) are reckon as factors that bring sustainable competitive advantage. Continuous investment in product and technology innovation with the profit made from successful product launch also allows corporate to accumulate resource and competitive advantage. The main spirits of QMS (Quality Management System) of ISO (International Organization of Standardization) emphasize on PDCA (Plan-Do-Check-Action) and continuous Improvement. Following this spirit, the case corporation turns personal abilities into organization capability by the coordination, integration, learning and reconfiguration of process, and establishes sustainable competitive advantage.