結合專利分析與臨床研究探討醫療器材之市場發展契機：以植牙領域為案例

Abstract

因醫療科技與生活水準的提升，大大增長了人類的平均壽命。在此趨勢下更促使醫療器材研發及 其市場的蓬勃發展。根據相關統計，2012 年全球醫療市場的年產值將約已達3,000 億美金，2017 年則 預估將會達到4,344 億美元(Global Information, Inc., 2012)，一再顯示醫療器材市場可觀的發展潛力。 又根據世界智財組織的統計，1995 年至2008 年間，電腦科技、電子機械、通訊科技、藥學以及醫療 科技領域的專利申請數量具高度的成長(World Intellectual Property Organization, 2011)，科技的日新月 異使得專利及技術文獻的大量產出，讓有效而快速的知識分析瞭解，成為科技研發管理與科技行銷決 策的一大挑戰。因此本研究提出結合專利分析與臨床文獻分析，建立醫療器材研發與市場發展的分析 方法論，並以植牙連接 (Dental Implant Connection) 技術作為深入分析探討的案例。專利文件具有豐 富的技術資訊與創新價值，但專利文件常包含艱深的詞彙並且數量龐大，使得專利分析常需大量的人 力與資源。又醫療器材研發內容，除了牽涉產品的創新設計外，尚須透過嚴謹的臨床實驗驗證其可行 性與安全性，才能了解該產品或技術是否有效且具市場性。因此本研究提出結合知識探勘、本體論與 綜合分析的方法，用以分析專利文件與臨床實驗文獻，期望能提高研發時分析技術內涵之效率，期能 精準掌握未來醫療科技研發與市場之正確方向。

The progress of medical technology and living standards has increased the average human lifespan. The medical equipment market is rapidly increasing with a rise in income and an aging world population. The value of the medical equipment market is expected to reach US$ 300 billion in 2012, and the forecast for the medical equipment industry is valued about US$ 430 billion in 2017 (Global Information, Inc., 2012) indicating that the medical equipment market has great potential for development. During the period from 1985 to 2008, the volume of patent applications worldwide increased rapidly. Computer technology, electrical machinery, pharmaceuticals, digital communication, and medical technology accounted for the largest share of total growth (World Intellectual Property Organization, 2011). In order to validate and success of new medical equipment and drugs, clinical trials on patients are performed. The large volume of patent documents are very difficult for researchers and market strategists to thoroughly and effectively analyze and synthesize the value of patents. However, clinical trials demonstrate successful usage whereas patents may indicate untested, untried or even failed innovations. This study proposed a methodology of combining patent analysis with clinical trials to analyze emerging medical developments and marketing directions. Knowledge discovery, ontology, text and data mining, and metadata analysis are approaches used in this study to analyze the patent documents and clinical trials literature. The text and data mining techniques are used to extract the key terms of patent documents and clinical trials. The domain ontology is built to express key concepts of domain knowledge. Metadata analysis is used to identify the effect sizes among the clinical studies as a means to rank patented innovations. The research will use the dental implant technical domain as a case study to help researchers and market analysts understand the medical technology market trends and determine the future directions. In addition, the ability to link successful clinical trials and their effectiveness to patent designs and innovations provides a new means to assess patent value and to delineate between failed innovations and successful implementation of medical technology.