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課程大綱及進度表 開課系所 醫工所 開課學年 博 Senior undergraduate students, Graduate students 開課學期 第學期 課程名稱(中文) 課程名稱（英文） 課程碼 分班碼 先修科目或先備能力 學分數 開課教師 e-mail fcsu@.tw 電話 Office Hours 2:10-05:00 PM Wednesday 醫技醫工館 5725 課程概述 課程 STB fellows授課主講並分享其受訓經驗，協助學員參與校內外醫療器材相關之產品創業競賽。此課程著重「醫療產品」從醫療需求到產品概念之醫療器材研發過程之學習與實作為主，深入探討中所遭遇到的問題，進而提出解決方案，並設計出創新之醫療器材臨床治療為主。 教學目標 課程內容教學目標，培育跨生醫工程領域之研發或管理人才基礎專業課程：介紹醫療器材設計，療所面臨之臨床問題。介紹醫療器材、技術、新進醫療器材之研究現況，以及未來發展方向。醫產品討論會(Unmet Clinical Need Forum)為主。biodesign的整個過程。 實作課程：醫療產品雛型製造和測試提供課prototype製造材料及輔助任何原創新觀念設計、雛形試作檢視理念及腦力激盪。實作課程期間臨床醫親自參與問題之發掘、討論提出臨床解決方案，再經由原型製作過程，加以修改、驗證 授課課程大綱明細 Semester (Winter) IMPLEMENT Stage 5 Development Strategy and Planning 5.1 Intellectual Property Strategy 5.2 Research and Development Strategy 5.3 Clinical Strategy 5.4 Regulatory Strategy 5.5 Quality and Process Management 5.6 Reimbursement Strategy 5.7 Marketing and Stakeholder Strategy 5.8 Sales and Distribution Strategy 5.9 Competitive Advantage and Business Strategy Case Study: Stage 5 Stage 6 Integration 6.1 Operating Plan and Financial Model 6.2 Business Plan Development 6.3 Funding Sources 6.4 Licensing and Alternate Pathways Case Study: Stage 6 參考書目 Lecture Notes/Power-point slides Textbook: Zenios, S., Makower, J. Yock, P. “Biodesign: The Process of Innovating Medical Technologies, 1st Ed, The Edinburgh Building, Cambridge, UK, 2010. 課程要求 assigned readings of the textbook, followed by turning in homework on time. To deliver oral presentation of a team project for midterm and final examinations. To submit a provisional patent related to medical device prior to filing an official patent when it is applicable. To submit or join a domestic or international medical device award competition or conference. 評量方式 proposal submission of a medical device design award competition 課程網址 Moodle數位學習平台 助教資訊 陳星杰Ph.D. ( coordinator)Assistant Research ProfessorMedical Device Innovation Center (MDIC) .tw/~mdic/index_ch.html 06-2353535-ext 3404