中正大學課程大綱
課程名稱(中文): 醫療電子臨床導入 開課單位: 資訊工程研究所(Graduate Institute of Computer Science and Information Engineering)
課程名稱(英文) Clinical Applications of Medical Electronic Devices 課程代碼 4105597_01
授課教師: 劉偉名 學分數 3
必/選修 選修 開課年級 研究所(開放大三以上選修)
先修科目或先備能力:
數位信號處理
課程概述:
這門課的目的是讓學生將所學應用於醫療產業時能具備基礎之知識與視野。同學將學習生醫信號量測與分析方法, 以及開發醫療電子器材時, 其軟硬體認證之相關法規。修課同學在基礎法規與醫學課程後,可結合生醫信號量測工具提出創新的醫療電子器材與資訊應用構想,除了在課堂上報告其創意、理論基礎、市場調查及所需經過的醫療認證程序外,也鼓勵將此構想與醫事人員討論以符合實際需要與商業模式。課程結束後可學習到醫療電子與資訊軟硬體的基礎知識, 並培養評估臨床應用可行性的能力。
學習目標:
1. 了解醫療電子器材軟硬體認證之相關法規
2. 具有基礎生醫信號量測與特徵分析的能力
3. 了解醫療電子器材軟硬體的臨床需求
4. 學習從醫事人員, 病人, 與企業的角度看醫療器材研發
教科書:

課程大綱 分配時數 核心能力 備註
單元主題 內容綱要 講授 示範 隨堂作業 其他
課程簡介與醫學倫理
醫學倫理、各國醫療法規介紹、台灣醫療法規介紹、台灣醫電產業前景與方向、人體臨床試驗法規介紹
6 12345678
人體可量測之生醫信號及其臨床價值
生理學
3 12345678
生醫信號之量測原理,軟硬體設計, 與資料分析
各子系統介紹, 心電圖, 腦電圖, 肌電圖, 心音, 血壓, 血氧量測實驗與信號分析
24 12345678
醫療儀器認證法規及使用安全規範
醫電器材查驗登記法規與過程(US FDA, Taiwan FDA)
9 12345678
醫療電子器材軟硬體:創新構想與個案討論
以法規、製造品質、查驗登記等考量,討論個案構想的設計因素
3 12345678
醫電器材上市經驗談
醫電器材上市經驗談、包括:創意發想、智財保護、臨床試驗、優良製造系統、查驗登記申請、後市場使用監控
3 12345678
醫療器材臨床試驗
醫療器材軟硬體的試驗方法與實務
3 12345678
個案討論與成果報告
以技術、法規、製造品質、查驗登記、臨床試驗等考量,討論其構想之設計因素
3 12345678

教育目標
1.具獨立從事學術研究或產品創新研發之人才
2.具團隊合作精神及科技整合能力,並在團隊中扮演領導、規劃、管理之角色
3.具自我挑戰與終身學習能力之人才
4.具有學術倫理、工程倫理、國際觀之人才

核心能力
1.具有資訊工程與科學領域之專業知識(Competence in computer science and computer engineering.)
2.具有創新思考、問題解決、獨立研究之能力(Be creative and be able to solve problems and to perform independent research.)
3.具有撰寫中英文專業論文及簡報之能力(Demonstrate good written, oral, and communication skills, in both Chinese and English.)
4.具策劃及執行專題研究之能力(Be able to plan and execute projects.)
5.具有溝通、協調、整合及進行跨領域團隊合作之能力(Have communication, coordination, integration skills and teamwork in multi-disciplinary settings.)
6.具有終身學習與因應資訊科技快速變遷之能力(Recognize the need for, and have the ability to engage in independent and life-long learning.)
7.認識並遵循學術與工程倫理(Understand and commit to academic and professional ethics.)
8.具國際觀及科技前瞻視野(Have international view and vision of future technology.)

請尊重智慧財產權,不得非法影印教師指定之教科書籍

教學要點概述:
1. 教材編選(可複選):自編簡報(ppt)教科書作者提供
2. 教學方法(可複選):講述板書講述
3. 評量工具(可複選):上課點名 0%, 隨堂測驗0%, 隨堂作業30.00%, 程式實作30.00%, 實習報告0.00%,
                       專案報告20.00%, 期中考0%, 期末考30.00%, 期末報告0%, 其他10.00%,
4. 教學資源:課程網站 教材電子檔供下載 實習網站
5. 教學相關配合事項:

課程目標與教育核心能力相關性        
請勾選:12345678
1 具有資訊工程與科學領域之專業知識(Competence in computer science and computer engineering.)
為何有關:
Students will learn signal processing from both hardware and software aspects. They will also learn the basic physiology, clinical experiments design, and regulations.
達成指標:
Students will learn signal processing from both hardware and software aspects, the basic physiology, clinical experiments design, and regulations.
評量工具(可複選):
Expected final grade: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
2 具有創新思考、問題解決、獨立研究之能力(Be creative and be able to solve problems and to perform independent research.)
為何有關:
They will come up with new ideas about medical devices, and try to make their designs to fulfill all requirements.
達成指標:
Come up with a well-defined and implementable idea about medical devices
評量工具(可複選):
Expected grade from the project, term paper, and class participation: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
3 具有撰寫中英文專業論文及簡報之能力(Demonstrate good written, oral, and communication skills, in both Chinese and English.)
為何有關:
A certain level of report writing and public speaking is required.
達成指標:
Students will submit the reports for each homework. and also present their ideas.
評量工具(可複選):
Expected grade from the term paper and final presentation: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
4 具策劃及執行專題研究之能力(Be able to plan and execute projects.)
為何有關:
They will be requested to do literature surveys for their ideas, and also find solutions regarding the engineering side of the application.
達成指標:
To see if their ideas and solutions are mature
評量工具(可複選):
Expected grade from the term paper and final presentation: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
5 具有溝通、協調、整合及進行跨領域團隊合作之能力(Have communication, coordination, integration skills and teamwork in multi-disciplinary settings.)
為何有關:
Students will be asked to form groups and come up with one idea for each group after discussion with other members.
達成指標:
A complete and successful term paper and presentation.
評量工具(可複選):
Expected grade from the research journal, term paper, and evaluations to other group members: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
6 具有終身學習與因應資訊科技快速變遷之能力(Recognize the need for, and have the ability to engage in independent and life-long learning.)
為何有關:
The course arrangements make students to learn things different from their original training. In addition they need to apply what they have learned in computer engineering to medical field.
達成指標:
A complete and successful term paper and presentation.
評量工具(可複選):
Expected grade from class participation and term paper: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
7 認識並遵循學術與工程倫理(Understand and commit to academic and professional ethics.)
為何有關:
Regulations and ethics about clinical studies will be discussed in this course.
達成指標:
In the term paper, the proposed idea about the new medical devices can follow the right procedures to pass all hypothetical regulations.
評量工具(可複選):
Expected grade from parcipation of engineering/medical ethics class, certificate/regulation class, and term paper: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60
8 具國際觀及科技前瞻視野(Have international view and vision of future technology.)
為何有關:
The course includes medical devices regulations established by not only the Taiwan FDA but also organizations from the USA or Europe. Students will also gain insights from visiting hospitals and communicating with clinicians.
達成指標:
Students are equipped with knowledge about the development and regulations of medical devices and are aware of the current technologies used in the medical field.
評量工具(可複選):
Expected grade from class participations and term paper: Level 5:90 and above; Level 4:80-89; Level 3:70-79; Level 2:60-69; Level 1:less than 60