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    题名: 產業競爭優勢之提升: 以醫療器材產業為例
    The Enhancement of industrial competitive advantage: taking the medical equipment industry as an example
    作者: 葉家源
    Yeh, Chia-Yu
    贡献者: 羅明琇
    Lo, Ming-Shiow
    葉家源
    Yeh, Chia-Yu
    关键词: 產業競爭
    醫療
    批號
    條碼
    辨識系統
    PDA 掃描機
    medical equipment
    marketing
    regulations
    single identification system for medical equipment
    barcode and batch number traceability system
    PDA scanner
    日期: 2020
    上传时间: 2020-09-02 11:57:33 (UTC+8)
    摘要: 醫療器材是一個相當多元化而新興的產業，也是高度複雜而且跨領域整合的產業，其種類相當繁多而且相當廣泛，而且受到世界各國以嚴格的法規限制來做特許經營。然而，近幾年醫療器材已經接近以5%的幅度在成長。若要在此產業之中推廣醫療器材，首先產品要獲得醫療器材的許可認證，之後才會有機會銷售。一旦開始銷售，則必須完全依照法規的要求，開始做上市之後的監督工作，每一項產品必須要有正確的醫療器材單一識別系統(UDI)條碼，和批號來配合追蹤追溯系統，一旦有任何的市場狀況發生，則需要通報全國藥物不良反應通報中心，在必要時，需要做適度的回收工作。
    醫療器材的銷售通路及商業模式相當傳統化。但是一旦有機會切入市場，其行銷活動就比較不會受到大環境的影響。本研究提出一系列臺灣醫療器材產業，如何因應醫療器材單一識別系統(UDI)條碼追蹤追溯系統的注意事項。同時提出對已經在產業之中的業者，及對政府單位的建議。在研究之中所提出對於未來發展的方向為開發優質而標準化的商品、邁向高門檻及精密化的商業模式，發展多功能系統於一爐、微型化以及利用高科技來發展新的商品。本研究預計給予業者能夠認知到認證的取得並非長治久安及長銷的保證，同時本研究正確地引進醫療器材單一識別系統(UDI)條碼和批號，來配合追蹤追溯系統，培養異業能力的相互整合來創造附加價值。
    The Medical equipment is a diversified and emerging industry, as well as a highly complex technology integration industry. Not only that, but its variety is quite large and extensive, and it is subject to strict legal restrictions on franchising in various countries. However, in recent years, the international sales of medical equipment have almost been growing by 5%. Taiwan is also growing with an increase in exports ranging from 3-10%.To promote the medical equipment in this industry, first of all, products must obtain medical equipment license certification, and then only have the opportunity to sell. Once it starts to sell, it must follow the requirements of the regulations to start the post-marketing supervision work. Each product must have the correct medical equipment unique device identification system (UDI) barcode, and batch number tracking system, once there is any market To give back, you need to notify the National Adverse Drug Reaction Notification Center, and when necessary, you need to do a recycling and issue a notice.
    The sales channel of medical equipment is conservative, not only the channel is quite conservative, but also the developed business model is quite conservative. marketing will be less affected by the environment. This study proposes a series of considerations for how the Taiwan medical device industry is responding to the UDI barcode tracking system during the development process. new entrants and government units who want to enter the industry. In the research, it is proposed that the future development direction is to develop high-quality standardized products, toward a high-threshold precision business model, develop multi-functional systems in one machine, miniaturize, and develop new products using high technology. This research expects to give the practitioners the ability to recognize that the certification is only an admission ticket, not an amulet. At the same time, the medical equipment unique device identification system (UDI) barcode and batch number and the tracking and tracing system are correctly introduced to cultivate the integration of different industries To create added value.
    參考文獻: 一、中文部份
    1.許書銘，2000。產業國際競爭力之發展及其影響因素分析:國家競爭力觀點。博士論文，國立臺灣大學商學研究所，2000。
    2.許士軍、湯明哲、于卓民、洪明洲、蘇國賢，1995。我國國際競爭力評估之研究。行政院經濟建設委員會委託研究計畫，臺北。
    3.醫療器材藍皮書，2013。工業技術科技研究院產業經濟與趨勢研究中心。
    4.張慈映，2008。我國醫療器材產業回顧與展望，工研院生醫與生活組。
    5.王聰、宓現強、潘爾頓，2009。臺灣醫療器械監管法規系統概述。

    二、英文部份
    1.Hall, R.H. 1991. Organization, structures, Processes & outcomes, Englewood Cliffs, NJ: Prentice-Hall,275.
    2. Hammer, M.1997. Beyond Reengineering: How the Process Centered Organization Will Change Our Work and Our Lives, Harper Business Publishing ,4:46-47.
    3. Hammer, M. 2001.The Agenda: What Every Business Must Do to Dominate the Decade.Crown Business Publisher Inc.:40-42.
    4. Hammer, M. , Champ,J. 1993.Reengineering the Corporation A manifesto for business revaluation ,Harper Collins Publishers Inc.30-51.
    5. Hammer, M. 2005.The Strategic Power of Process .Harper Collins Publishers,10. James Champ.X-Engineering the Corporation.Business Plus Inc.2003:25-27.
    6.House,T.,Valery,k. 2003.Enterprise resource planning: Implementation procedures and critical success factors. European Journal of Operational Research.146 (2): 241-257.
    7.ISO 13485.2003. Medical Devices:Quality management systems-Requirements for regulatory purposes.
    8.ISO 14971.2000. Medical devices: Application of risk management to medical devices.
    9.Larry E.G. 1972. Evolution and Revolution as Organization Grow, Harvard Business Review.
    10. Ostroff,F. and Smith,D. 1992.The horizontal Organization.The Mckinsey Quarterly, (3):89-90.
    11. Page ,A.L.1991.PDMA new product development survey: Performance and Best practice, Paper presented at PDMA conference,Chicago,Nov.13.
    12. Porter, M. E. 1998. Clusters and the New Economics of Competition. Harvard Business Review , November–December.
    13.Wang, B. 2008.Evidence-based Medical Equipment Maintenance management, A Practicum for Biomedical Engineering & Technology Management Issues, Edited by Leslie Atles.
    描述: 碩士
    國立政治大學
    經營管理碩士學程(EMBA)
    107932403
    資料來源: http://thesis.lib.nccu.edu.tw/record/#G0107932403
    数据类型: thesis
    DOI: 10.6814/NCCU202001524
    显示于类别:[經營管理碩士學程EMBA] 學位論文

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