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題名 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
作者 田燿瑄
貢獻者 陳桂恒<br>吳豐祥
田燿瑄
關鍵詞 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
日期 2020
上傳時間 2-Mar-2020 11:35:26 (UTC+8)
摘要 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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描述 碩士
國立政治大學
科技管理與智慧財產研究所
105364102
資料來源 http://thesis.lib.nccu.edu.tw/record/#G0105364102
資料類型 thesis
dc.contributor.advisor 陳桂恒<br>吳豐祥zh_TW
dc.contributor.author (Authors) 田燿瑄zh_TW
dc.creator (作者) 田燿瑄zh_TW
dc.date (日期) 2020en_US
dc.date.accessioned 2-Mar-2020 11:35:26 (UTC+8)-
dc.date.available 2-Mar-2020 11:35:26 (UTC+8)-
dc.date.issued (上傳時間) 2-Mar-2020 11:35:26 (UTC+8)-
dc.identifier (Other Identifiers) G0105364102en_US
dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/128978-
dc.description (描述) 碩士zh_TW
dc.description (描述) 國立政治大學zh_TW
dc.description (描述) 科技管理與智慧財產研究所zh_TW
dc.description (描述) 105364102zh_TW
dc.description.abstract (摘要) 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。		zh_TW
dc.description.abstract (摘要) 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.		en_US
dc.description.tableofcontents 第壹章 緒論 1
第一節 研究背景 1
第二節 研究動機 5
第三節 研究問題與目的 6
第四節 研究流程與論文架構 7
第貳章 文獻探討 8
相關名詞中英對照 8
第一節 人因工程及可用性 9
（一）、 人因工程定義 9
人因工程與影響因素分類 10
（二）、 產品的人因工程測試與評估－可用性（Usability） 11
可用性評估測試分類 13
（三）、 人因工程與可用性在醫療器材之應用與文獻 19
第二節 醫療器材及上市前法規與商業化 21
（一）、 醫療器材定義 21
（二）、 美國FDA醫療器材上市前法規申請規範流程 22
上市前法規申請流程：PMA、510(k)、De Novo 24
（三）、 新醫療器材商業化流程 29
第三節 商業面之進入障礙 33
（一）、 經營管理策略下之進入障礙 33
（二）、 醫療器材相關進入障礙 37
（三）、 台灣醫療器材管理相關文獻回顧 41
第四節 文獻小結 47
（一）、 文獻小結*重修 47
（二）、 研究缺口 49
第參章 研究方法 50
第一節 研究架構 50
第二節 研究方法理論 51
第三節 研究對象 53
第四節 資料收集方式 54
第五節 研究限制 55
第肆章 個案公司分析 57
第一節 MASIMO 非侵入式連續偵測血氧儀 57
第二節 RESAPP 呼吸疾病聲音分析診斷軟體 78
第三節 個案資料統整分析 100
第伍章 研究發現與討論 103
第陸章 結論與討論 110
第一節 研究結論 110
第二節 研究建議 114
(一)、 實務意涵 114
(二)、 後續研究建議 115
參考資料 117
【中文文獻】 117
【英文文獻】 120		zh_TW
dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0105364102en_US
dc.subject (關鍵詞) 醫療器材zh_TW
dc.subject (關鍵詞) 人因工程與可用性zh_TW
dc.subject (關鍵詞) 美國上市前法規zh_TW
dc.subject (關鍵詞) 進入障礙zh_TW
dc.subject (關鍵詞) Medical Deviceen_US
dc.subject (關鍵詞) Human Factor Engineering and Usabilityen_US
dc.subject (關鍵詞) FDA Premarket Notificationen_US
dc.subject (關鍵詞) Entry Barriersen_US
dc.title (題名) 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zh_TW
dc.title (題名) The relationship between human factor engineering (Ergonomic), FDA medical device regulatory pathway and business market entry barriers of medical device companyen_US
dc.type (資料類型) thesisen_US
dc.relation.reference (參考文獻) 中文文獻
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dc.identifier.doi (DOI) 10.6814/NCCU202000207en_US