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| Title: | 人因工程與醫療器材之美國上市前法規申請及市場進入障礙的關係
The relationship between human factor engineering (Ergonomic), FDA medical device regulatory pathway and business market entry barriers of medical device company |
| Authors: | 田燿瑄 |
| Contributors: | 陳桂恒
吳豐祥
田燿瑄 |
| Keywords: | 醫療器材
人因工程與可用性
美國上市前法規
進入障礙
Medical Device
Human Factor Engineering and Usability
FDA Premarket Notification
Entry Barriers |
| Date: | 2020 |
| Issue Date: | 2020-03-02 11:35:26 (UTC+8) |
| Abstract: | 人因工程為考量使用者與產品間理解與互動的科學，也是透過理論、準則、數據等資料等設計出優化使用者與整體感受之科學。隨著老年化社會與醫療的發展，醫療器材也更為重視人因工程與可用性之考量，並著重使用者與醫材之操作介面流程，FDA考量重點為醫材臨床使用情境下之安全性與有效性，確認當危害發生時，能有效降低風險在可控制之範圍內。
本研究以申請美國之非侵入式醫療器材作為研究對象，從人因工程與可用性、美國上市前法規、商業面之進入障礙三個層面進行剖析，透過蒐集個案之次級資料進行比較，探討個案公司在此層面間之交互作用，歸納彼此之間影響之關係，並歸納出結論以提供未來有興趣之臺灣醫療器材廠商可操作之參考。
本研究得到之結論包括:(1)後進醫療器材公司可從領導品牌醫療器材所 揭露的資訊中找到人因工程與可用性之相關資訊;(2) 後進醫療器材公司可從 醫療器材領導品牌的上市前法規總結報告書及人因工程與可用性相關資訊，推 敲其產品臨床適應症、特徵、安全性與有效性等;(3)醫療器材後進者會因為 領導品牌所建立之市場進入障礙，而影響其人因工程與可用性之規劃和上市前 法規申請的臨床適應症佈局。
Human factor engineering is the scientific discipline which considers the relationship between user and product, and which design to optimize overall system performance through theory, principle, data and method. Also, with on coming of aging society and technology improvement, more and more medical device takes human factor as consideration to focus on user interface of medical device. Moreover, FDA take human factor engineering and usability report to make sure medical device’s safety and effectiveness, to prevent low harm from risks.
This research focuses on non-invasive medical device companies and tries to analyze the interaction within three key aspects: human factor engineering and usability, premarket notification, market entry barriers. Through case study and secondary analysis. For Taiwan medical device company to develop strategy which want to USA market.
In the end, the main conclusions that in this research include: (1) Follower medical device company can find out human factor engineering and usability from the leading company’s open information. (2) Follower medical device company can find product’s Intended use, safety and effectiveness data from leading company’s premarket notification summary report and human factor engineering usability information. (3) The leading medical device company established market entry barriers will affect Follower company product human factor engineering, usability evaluation and premarket notification intended use and pathway. |
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| Description: | 碩士
國立政治大學
科技管理與智慧財產研究所
105364102 |
| Source URI: | http://thesis.lib.nccu.edu.tw/record/#G0105364102 |
| Data Type: | thesis |
| DOI: | 10.6814/NCCU202000207 |
| Appears in Collections: | [科技管理與智慧財產研究所] 學位論文
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