醫療科技創新概論
Introduction to Medical Technology Innovation
| 節 | 週四 |
|---|---|
3 10:10–11:00 | 醫療科技創新概論 BI311 2 節連堂 |
4 11:10–12:00 |
* 根據陽明交大上課時間表所列
醫療保健產品的對象是人,生命攸關,需要特別監管,即使相同疾病會因人因地因國而異。醫療科技的創新要能成功,也就完全不同於其他應用或領域。本課程將先說明醫療行為的本質以了解為何需要特別的法規與要求,逐㇐介紹醫療器材相關法規、要求、臨床與挑戰,舉例介紹資訊科技在醫療的應用,並介紹醫療科技創新從需求、發明、到實現的基礎流程。 Medical products are designed for humans and are crucial to life, requiring special regulation. Even the same disease can vary depending on the person, place, and country. The innovation of medical technology, to be successful, is entirely different from other applications or fields. This course will first explain the nature of medical behavior to understand why special regulations and requirements are necessary. It will introduce regulations, requirements, clinical aspects, and challenges related to medical devices step by step, provide examples of the application of information technology in healthcare, and outline the basic process of medical technology innovation from needs, invention, to implementation. 課程的目標: ● 了解醫療行為本質,醫療器材的特殊要求,以及醫療技術成功實現的關鍵。 ● 了解醫療科技創新的流程,作為找到未被滿足的健康需求、發明有意義的解決技術、並在目標市場具體實現的策略。 ● Understand the nature of medical behavior, the special requirements for medical devices, and the key factors for the successful implementation of medical technology. ● Comprehend the process of medical technology innovation to identify unmet health needs, invent meaningful solutions, and concretely implement strategies in the target market.
無
* 主要以講授為主,部分課程邀請就實際案例及方法進行報告或演練(智慧醫療實例,設計思考) * 重要參考:設計思考方法,梅約醫院的醫療創新,史丹佛大學的BioDesign • Primarily lecture-based, with some sessions inviting reports or exercises on real cases and methods (examples of smart healthcare, design thinking). • Key references: Design Thinking methodology, medical innovation at Mayo Clinic, Stanford University's BioDesign.
每位學生選定㇐個主題,從未滿足需求,發明構想,到實施策略的創新流程,依課程進度製作報告,並在學期末製作投影片上台報告(依時間及人數來自願或抽籤決定上台報告組別,二到三人㇐組) 期末就主要學習概念作一測驗 Each student will choose a topic and follow the innovation process from unmet needs, invention ideas, to implementation strategies. They will create reports according to the course schedule and prepare a presentation to be given at the end of the semester (the presenting groups will be determined by voluntary sign-up or drawing lots, with two to three students per group). There will be a final exam covering the main concepts learned in the course.
- 醫療科技應用範例 Examples of Medical Technology Applications
- 醫療科技創新的流程 The Process of Medical Technology Innovation
- 醫療創新簡介 Introduction to Medical Innovation
- 期末專題報告 Final Project Report
- 醫療器材的要求 Requirements for Medical Devices
| 週次 | 主題 |
|---|---|
| 第 1 週 | 醫療創新簡介 (Introduction of Medical Innovation) |
| 第 2 週 | 醫療的本質 (The Nature of Medical Behaviors) |
| 第 3 週 | 醫療品質系統 (Quality Management System) |
| 第 4 週 | 臨床關聯性 及 臨床試驗 (Clinical Association and Clinical Trials) |
| 第 5 週 | 查驗登記,個資保護 (Product Registration and Privacy Issues) |
| 第 6 週 | 雙十節休假 (Double Tenth Day Vacation) |
| 第 7 週 | 設計思考 (Design Thinking) |
| 第 8 週 | 需求探索 (Needs Exploration) |
| 第 9 週 | 需求篩選 (Needs Screening) |
| 第 10 週 | 智慧醫療應用實例 (Examples of Smart Medical Devices) |
| 第 11 週 | 概念創新 (Concept Innovation) |
| 第 12 週 | 概念篩選 (Concept Screening) |
| 第 13 週 | 策略發展 (Strategy Development) |
| 第 14 週 | 生意規劃 (Business Planning) |
| 第 15 週 | 醫療科技創新的需求、機會、與挑戰 ((The Requirements, Opportunities, and Challenges of the Innovation of Medical Technology) |
| 第 16 週 | 學期作業報告 (Term Project Reporting) |
教科書(請註明書名、作者、出版社、出版年等資訊): Biodesign: The Process of Innovating Medical Technologies, 2nd Edition, Paul G. Yock 等人,Cambridge University Press,2015