課程大綱

開課系所 Department/Institute: 醫工所Biomedical Engineering
開課教師 Instructor: 許曉芬 Hsu, Hsiao-Fen;林建宏 Lin, Chien-hong;陳家進 Chen, Jia-Jin;陳芃婷 Chen, Peng-Ting
開課學年 Academic Year: 0111
開課學期 Semester: 1
開課序號 Serial Number: 064
課程屬性碼Course No (Attribute Code): BME 7005
課程系統碼Course System Number: P853510
分班碼 Class Code:
學分數 No. of Credits: 3
課程語言 Medium of Instruction: 英文 English

課程網址 Course Website:

https://mdic.ncku.edu.tw/writing_detail.php?id=135

先修課程或先備能力
Prerequisite Course(s):

Student Responsibilities

Attendance: Attendance will be taken at 9:10 pm each day. Please do not arrive late out of respect for the faculty and speakers. Only one unexcused absence per quarter will be permitted without affecting your grade. Please email TA if you must miss a class session.

Preparation: The weekly reading and video assignments are essential building blocks for each week’s in-class activities and deliverables. Faculty and guest speakers will expand on these materials during the academic sessions, and project assignments will draw heavily from this content. Accordingly, the assignments must be completed by the deadlines outlined in the course schedule. Student preparation will be measured via the completion of regular quizzes (see below), as well as through the caliber of in-class participation.

教師聯絡資訊 Contact with Teacher

Course Instructors:

醫工系陳芃婷教授 / Peng-Ting Chen; chen@ncku.edu.tw; Standford BioDesign Global Faculty

法律系許曉芬老師 / Hsiao-Fen Hsu; hfhsu@mail.ncku.edu.tw

機械系林建宏老師 / Chien-hong Lin; clin@gs.ncku.edu.tw

Co-ordinator: 醫工系陳芃婷教授 / Peng-Ting Chen, Professor

國立成功大學/National Cheng Kung University

生物醫學工程學系/Department of Biomedical Engineering (BME) & 醫療器材國際創新碩士班/International Institute of Medical Device Innovation (MDI)

Stanford Biodesign Global Faculty

生醫科技商品化研究室 ( BioMedical-Tech Commercialization Lab )

Office: +886-6-2757575 ext 63438; +886-6-2081744

E-mail: chen@ncku.edu.tw

助教資訊 Contact with Tutor

Research Assistant: Joan Chen; joanchen.biome@bme.ncku.edu.tw

Teaching Assistant: Johnson Huang; johnsonhuang.biome@bme.ncku.edu.tw

學習規範 Course Policy

All students accepted into the course have agreed to complete the two-semester sequence:

BIODESIGN (I) (first semester) – Select and characterize an unmet clinical need, research and validate it, and brainstorm early technology-based solutions.

BIODESIGN (II) (second semester) – Evaluate multiple technology-based solutions to the need, then select a lead solution and move it toward patient care through prototyping, technical de-risking, strategies to address healthcare-specific requirements (regulation, reimbursement), and business planning (IP, funding, commercialization).

評量方式 Grading

方法	百分比%
平時測驗 Quizzes	10
作業 Assignments	20
小組報告 Group Projects	50
出席 Participation	20

教學方法 Teaching Strategies

方法	百分比%
實作 Workshop	30
講授 Lecture	40
討論 Discussion	30

※請遵守智慧財產權觀念不得不法影印
Please follow the Intellectual Property instruction and No illegal copy

課程教材 Course Material (校外連線設定)

1.Biodesign: The Process of Innovating Medical Technologies, 2015, Second Edition, Cambridge University Press

Course Materials

Textbook: Biodesign: The Process of Innovating Medical Technologies, Second Edition, Cambridge University Press (2015).

Student Guide to Biodesign: https://biodesignguide.stanford.edu/

ebiodesign.org: This online companion to the textbook offers two types of resources:

Getting started sections - Step-by-step instructions and links to supplemental references to help you complete important project activities.

Videos – More than 350 video clips intended to enliven content in the textbook and underscore important learning points. Students will be required to watch select videos as part of their weekly pre-class assignments.

Course Site: All course materials, including reading and video assignments, quizzes, supplementary documents, and the grade book can be found on Canvas via NCKU Moodel. For easiest viewing, access weekly assignments, deliverables, and other information using the “Modules” navigation option.

參考書目 References (校外連線設定)

備註 Remarks

Coaching

The teaching team works hard to make many different types of experts available to the teams. Some of these coaching sessions take place in class, but you periodically may be asked to meet outside of class time to accommodate the availability of the mentors.

Longitudinal Project Coaching/Participants: Each team will be connected with a project coach who will meet with you regularly throughout the two-quarter course sequence. They will help guide you through your project, providing relevant experience in health tech innovation as well as helpful resources and contacts.

Clinical Coaching/Participants: Each team also will be assigned to one or more physicians and/or nurses who will play the role of a clinical mentor during the early weeks of the course. These individuals can help answer questions about the need area, serve as a sounding board during need screening/ validation, and make introductions to other clinical contacts. Teams are encouraged to re-engage with these coaches in the spring as they begin focusing on their top solutions.

Team Dynamics Coaching: Given the intensive nature of the class project experience, it is not unusual for teams to have conflicts of some type during the course. However, we believe the process of working through these issues is a valuable part of the learning experience. Team dynamics coaches will participate in class sessions periodically through the two-semester sequence. If you or your team would like to request additional assistance with team dynamics, please contact Joan Chen (joanchen.biome@bme.ncku.edu.tw).

Subject Expert Coaches: subject matter experts will come to class to advise the project teams in specific content areas (e.g. intellectual property, regulatory, payment, business models). Completing the advance preparation assignments for these meetings is essential for getting maximum benefit from the interactions.

Presentation Coaching: In second quarter, teams will meet outside of class with a presentation expert for one session. This individual will watch a “run through” of the spring final presentation and make suggestions. We strongly encourage all members of the team to attend, but recognize that this may not be possible due to scheduling challenges (please make a best effort).

基本素養 Basic Literacy

■ 理解專業醫學與工程倫理及社會責任

Understand professional medical and engineering ethics and society responsibility

■ 培養有效溝通、表達及團隊合作精神之能力

Cultivate effective communication, presentation, and cooperation

■ 培養終身學習的能力

Lifelong learning ability

■ 培養具備國際觀及外語能力

Global vision and foreign languages

核心能力 Competence

■ 特定領域之專業知識

Specific fields of expertise

■ 創新思考及獨立解決問題之能力

Innovative thinking and independent problem solving ability

□ 撰寫專業論文之能力

The professional thesis writing ability

■ 良好的國際觀

Perfect international perspective

□ 與不同領域人員協調整合之能力

Coordination and integration ability with different areas personnel

■ 策劃及執行專題研究之能力

Planning and execution of a research project capability

■ 領導、管理及規劃之能力

Leadership, management and planning ability

■ 終身自我學習成長之能

Growth of life-long self-learning ability

課程概述 Course Description

一、教學內容: 本課程的目的是培養生物醫學設備創新和設計方面的人才。本課程將指導學生通過認識臨床需求、驗證產品設計、探索市場機會、法規和專利佈局來進行創新的醫療器械設計。在本課程中，在多位醫生和工業從業人員的密集指導下，來自不同領域的學生將共同設計創新的醫療設備，進一步開展實用的商業項目並完成商業計劃。二、教學目標: 1. 確定臨床需求。 2. 設計創新的醫療設備。 3. 分析市場需求，法規和專利。 4. 制定商業計劃以實現醫療設備的商業化。 5. 著重「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。 6. 深入探討醫療行為中所遭遇到的問題，進而提出解決方案，並設計出創新之醫療器材。 7. 從醫療環境中發掘臨床問題，找出臨床需求，並養成解決問題的能力。 8. 真實體驗醫療技術發展的實際課程
To provide students with an intensive, hands-on introduction to the process of health technology innovation. Specifically, as part of a project team, you will learn how to identify a significant unmet healthcare need, design a new technology to address it, and prepare to bring that solution into patient care.

課程學習目標 Course Objectives

Learn the process of health technology innovation

Learn how to identify a significant unmet healthcare need

Design a new technology to address unmet need and bring into patient care

課程進度 Progress Description

	進度說明 Progress Description
1	Course journey overview and expectations
2	Need exploration: Clinical Immersion & Choosing a Need Area
3	Need exploration: Clinical Immersion & Need Statement
4	Disease State Fundamentals
5	Existing Solutions
6	Stakeholder Analysis
7	Market Analysis
8	Needs Selection
9	Need presentations and feedback
10	Ideation
11	Initial Concept Selection
12	Brainstorming
13	Intellectual Property Basics
14	Regulatory Basics
15	Reimbursement Basics
16	Business Models
17	Concept Exploration and Testing
18	Final

　以上每週進度教師可依上課情況做適度調整。The schedule may be subject to change.

課程是否與永續發展目標相關調查
Survey of the conntent relevant to SDGs

本課程與SDGs相關項目如下：
This course is relevant to these items of SDGs as following:

健康與福祉 (Good health and Well Being)

有關課程其他調查 Other Surveys of Courses

1.本課程是否規劃業界教師參與教學或演講? 是，約 6 次
Is there any industry specialist invited in this course? How many times? Yes, about 6 times.
2.本課程是否規劃含校外實習(並非參訪)? 否
Are there any internships involved in the course? How many hours? No
3.本課程是否可歸認為學術倫理課程? 否
Is this course recognized as an academic ethics course? In the course how many hours are regarding academic ethics topics? No
4.本課程是否屬進入社區實踐課程? 否
Is this course recognized as a Community engagement and Service learning course? Which community will be engaged? No

醫療器材創新設計（一）BIODESIGN(1) - IDENTIFY UNMET NEEDS & PRACTICE INVENTION 本資訊僅提供本校師生參考。有著作權，非本校人員若欲使用本資訊，請洽本校取得授權。 © (2008-2023) National Cheng Kung University ALL RIGHTS RESERVED.