應人類社群逐步邁向高齡化、科技化的潮流，醫療器材產業蔚為當今各國大力發展的重點產業，不僅舊有產品的生產技術日就月將，同時也借重進步科技、催生諸多新穎器材，有效提升人類生活福祉。
於此同時，觀察我國施政軌跡，雖執政者對於生技或醫材產業政策的倡議不遺餘力，國內大多數廠商卻始終在追趕產業先行者，在國際市場之成績難以比肩先進國家大廠。
首先，本研究以「鑽石理論模型」分析台灣醫療器材產業各面向，而後藉由觀察過程中的發現，選取可能對醫療器材產業發展有所影響的指標，運用「灰色系統理論」以進行關聯度分析，將最具關聯度的該些指標加以整理，回頭進行產業環境與發展前景檢視並提出觀察結果。
透過前述分析方法，可以得出「醫療器材產業從業人口數」、「國內醫療器材市場」與「產業發起的臨床試驗件數」為與醫療器材產業發展高度最具關連性的首要三項指標。本研究試以國內醫療器材業界生態作為基礎，臚列在該三項指標範疇內，我國得以發揮己身優勢、開創出具競爭力前景的可行方案。

The human community is gradually moving towards the trend of aging and technologicalization. The medical device industry is one of the key industries that are intensively developed by countries today. It not only relates to the production technology of already existed products, but also the advanced technologies and new products, which effectively promote the well-being of lives.
At the same time, observing the trajectory of governance of Taiwan, although the ruling party has spared no effort to advocate the policy about biotechnology or medical device industry, most domestic manufacturers still try to catch up with the pioneers in the industry. Not to mention that the domestic manufacturers’ achievements are difficult to compare with the leading manufacturers’ in the international market.
In the first stage, this study apply "Diamond Theory Model" to analyze the current situation of Taiwan's medical device industry. Then, through the findings in the observation process, this study selected indicators that may affect the development of the medical device industry. And applied "Grey System Theory" in order to sort out the most relevant indicators. Finally, this study reviewed the industrial environment and development prospects and propose policy recommendations.

中文部分

書籍
1. 李明軒、邱如美 (譯) (1996a)。國家競爭優勢(上) (原作者：Porter, M. E.)。台北市：天下文化。(原著出版年：1989)
2. 李明軒、邱如美 (譯) (1996b)。國家競爭優勢(下) (原作者：Porter, M. E.)。台北市：天下文化。(原著出版年：1989)
3. 施振榮，(1992)。再造宏碁：開創、成長與挑戰。台北市：天下文化。
4. 鄧聚龍，(1999)。灰色系統理論與應用。新北市：高立圖書有限公司.

期刊
5. 工研院IEK醫療器材與健康照護研究部 (2013)。全球醫療器材產業之動態與未來發展。證交資料，617，44-56。
6. 汪嘉林 (2011)。我國生技製藥產業－創新演化的回顧與前瞻。科學發展，457，146-150。
7. 吳宜靜 (2017)。各國官方醫療器材諮詢輔導制度簡介與比較。當代醫藥法規月刊，76，11-22。
8. 黃齡慧 (2014)。兩岸醫藥品後市場不良品或不良反應事件處理機制及流程之比較。當代醫藥法規，47，13-23。

網際網路
9. Leadership (2017)。醫療器材單一稽核計畫Medical Device Single Audit Program, MDSAP。取自 https://www.isoleader.com.tw/home/iso-coaching-detail/MDSAP
10. 灰色關聯分析 (GRA)的理論及應用 (matlab和python) (2018)。CSDN。
取自https://blog.csdn.net/starter_____/article/details/82085040
11. 一O四人力銀行 (2019a)。2019年薪資情報，2019年薪資情報>醫療／保健服務人員>醫療設備控制人員。取自https://www.104.com.tw/jb/wage/list?type=1&jobcat=2015002000&cat=jobother
12. 一O四人力銀行 (2019b)。2019年薪資情報，2019年薪資情報>生技／醫療研發類人員>醫療器材研發工程師。取自 https://www.104.com.tw/jb/wage/list?type=1&jobcat=2008003000&cat=jobmake
13. 行政院 (2017)。行政院會通過「醫療器材管理法」草案。焦點新聞。取自 https://www.mohw.gov.tw/cp-16-38880-1.html
14. 行政院新聞傳播處 (2016)。推動臺灣生醫產業發展—打造臺灣成為亞太生醫研發產業重鎮。行政院全球資訊網。取自 https://www.ey.gov.tw/hot_topic.aspx?n=1790530619D64B88&sms=3D3EC61B5354AFE2.
15. 科技會報辦公室 (2012)。臺灣生技產業起飛行動方案。取自https://ws.ndc.gov.tw/Download.ashx?u=LzAwMS9hZG1pbmlzdHJhdG9yLzEwL3JlbGZpbGUvNjA5NS8xMTcxMS8wMDEyNDQ1XzEyLnBkZg%3D%3D&n=55Sf5oqA6ZG955%2Bz6LW36aOb6KGM5YuV5pa55qGIICDooYzli5XoqIjnlasucGRm&icon=..pdf
16. 科技會報辦公室 (2016)。全力推動生醫產業創新方案 打造台灣成為研發產業重鎮 發展生技產業成為兆元產業。取自 https://www.ey.gov.tw/Page/448DE008087A1971/b1f16e16-f3eb-488d-ada7-a9c289d444cc
17. 財政部關務署 (2018)。97-106年 進出口貨物價值排行統計 - 總值 按貨品別。取自 https://portal.sw.nat.gov.tw/APGA/GA01
18. 財團法人醫藥工業技術發展中心 (2016)。醫療器材臨床試驗豁免(IDE)利益風險決議考量因素。取自https://www.mdic.org.tw/Law_detail/5904
19. 國家發展委員會 (2017)。協調推動產業創新計畫。取自 https://www.ndc.gov.tw/Content_list.aspx?n=9D024A4424DC36B9&upn=6E972F5C30BF198F.
20. 國家實驗研究院 (2014)。國研醫材創價聯盟啟動 引領台灣直衝兆元產值。取自 https://www.narlabs.org.tw/xmdoc/cont?xsmsid=0I148622737263495777&sid=0I163377989760838255
21. 產經觀測站 (2018)。醫療新南向 要組國家隊。取自 http://www.srido.org.tw/newsouthboundpolicy/201
22. 經濟部工業局 (2017)。2017生技產業白皮書。取自https://www.moeaidb.gov.tw/ctlr?PRO=publication.rwdPublicationView&id=3382
23. 經濟部統計處 (2019)。工業產銷存動態調查-業別統計。取自 https://dmz26.moea.gov.tw/GMWeb/investigate/InvestigateDB.aspx
24. 葉席吟 (2015)。醫療器材產業之產學鏈結探討。科技政策觀點。取自 https://portal.stpi.narl.org.tw/index/article/10097
25. 葉席吟 (2016)。精準醫療之各國推動政策觀察。科技政策觀點。取自https://portal.stpi.narl.org.tw/index/article/10278;jsessionid=A99B47720ACB77FD1D21611B6DEC6612
26. 人體試驗管理辦法 (2016)。衛生福利部。取自https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0020162
27. 醫療法 (2018)。衛生福利部。取自https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0020021
28. 衛生福利部 (2019)。醫療保健支出占GDP之比率。取自 https://www.gender.ey.gov.tw/gecdb/Stat_Statistics_DetailData.aspx?sn=jtg6KRQTviFsfOzy4n38lQ%3D%3D&d=194q2o4%2BotzoYO%2B8OAMYew%3D%3D
29. 衛生福利部食品藥物管理署 (2016)。醫療器材分類分級查詢資料庫。取自 http://mdlicense.itri.org.tw/MDDB/Classification/Classification.aspx
30. 衛生福利部統計處 (2018)。106年死因統計結果分析。取自https://dep.mohw.gov.tw/DOS/cp-3960-41756-113.html
31. 衛生福利部食藥署 (2013)。衛生福利部食品藥物管理署申請案件處理期限表。取自https://www.fda.gov.tw/TC/siteContent.aspx?sid=2953
32. 顏嘉妤 (2016)。國內醫療器材臨床試驗申請法規介紹。取自 http://www.cde.org.tw/ReadFile/?p=News&n=f398d826-2da7-44c9-8887-10afb4dc276b.pdf

英文部分

書籍
1. Porter, M. E. (1990). The Competitive Advantage of Nations. In (pp. 247-252): New York: Free Press.

期刊
2. Bloland, P., Simone, P., Burkholder, B., Slutsker, L., & De Cock, K. M. (2012). The Role of Public Health Institutions in Global Health System Strengthening Efforts: The US CDC's Perspective. PLOS Medicine, 9(4), e1001199. doi:10.1371/journal.pmed.1001199
3. Dickler, H. B., Korn, D., & Gabbe, S. G. (2006). Promoting Translational and Clinical Science: The Critical Role of Medical Schools and Teaching Hospitals. PLOS Medicine, 3(9), e378. doi:10.1371/journal.pmed.0030378
4. Fleminger, J., & Goldacre, B. (2018). Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register. PLOS ONE, 13(3), e0193088. doi:10.1371/journal.pone.0193088
5. Geremia, F. (2018). Quality aspects for medical devices, quality system and certification process. Microchemical Journal, 136, 300-306. doi:10.1016/j.microc.2017.04.018
6. Hines, J. Z., Lurie, P., Yu, E., & Wolfe, S. (2010). Left to their own devices: breakdowns in United States medical device premarket review. PLOS Medicine, 7(7), e1000280-e1000280. doi:10.1371/journal.pmed.1000280
7. Kramer, D. B., Baker, M., Ransford, B., Molina-Markham, A., Stewart, Q., Fu, K., & Reynolds, M. R. (2012). Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance. PLOS ONE, 7(7), e40200. doi:10.1371/journal.pone.0040200
8. Kramer, D. B., Xu, S., & Kesselheim, A. S. (2012). How does medical device regulation perform in the United States and the European union? A systematic review. PLOS Medicine, 9(7), e1001276-e1001276. doi:10.1371/journal.pmed.1001276
9. Li, T.-W., Tu, P.-W., Liu, L.-L., & Wu, S.-I. (2015). Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan. BioMed research international, 2015, 670420-670420. doi:10.1155/2015/670420
10. O'Connor, B., Pollner, F., & Fugh-Berman, A. (2016). Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLOS ONE, 11(8), e0158510-e0158510. doi:10.1371/journal.pone.0158510
11. Rising, J. P., & Moscovitch, B. (2015). Characteristics of Pivotal Trials and FDA Review of Innovative Devices. PLOS ONE, 10(2), e0117235. doi:10.1371/journal.pone.0117235
12. Roberto, A., Radrezza, S., & Mosconi, P. (2018). Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar. Journal of ovarian research, 11(1), 28-28. doi:10.1186/s13048-018-0404-1
13. Ross, J. S., Blount, K. L., Ritchie, J. D., Hodshon, B., & Krumholz, H. M. (2015). Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey. Medical devices (Auckland, N.Z.), 8, 241-249. doi:10.2147/MDER.S82964
14. Sorenson, C., & Drummond, M. (2014). Improving medical device regulation: the United States and Europe in perspective. The Milbank quarterly, 92(1), 114-150. doi:10.1111/1468-0009.12043
15. Stern, A. D. (2017). Innovation under Regulatory Uncertainty: Evidence from Medical Technology. Journal of public economics, 145, 181-200. doi:10.1016/j.jpubeco.2016.11.010

網際網路
16. export.gov. (2018). Taiwan - Medical Devices. Taiwan Country Commercial Guide. Retrieved from https://www.export.gov/article?id=Taiwan-Medical-Devices
17. FDA. FD&C Act Chapter V: Drugs and Devices. Federal Food, Drug, and Cosmetic Act (FD&C Act). Retrieved from https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/fdcactchaptervdrugsanddevices/default.htm
18. FDA. (2017). Digital Health Innovation Action Plan. Retrieved from https://www.fda.gov/media/106331/download.
19. FDA. (2018). What is a Medical Device Recall? Medical Device Recalls. Retrieved from https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm
20. Fortune. (2018). Fortune 500. Retrieved from http://fortune.com/fortune500/
21. OECD. (2019). Health spending. Retrieved from https://data.oecd.org/healthres/health-spending.htm
22. Tippmann, N. (2018). Medical Device Companies - Top 100 In 2018. Retrieved from https://www.greenlight.guru/blog/top-100-medical-device-companies

.