國內醫療器材產學合作之治理結構與學界觀點-以科技部產學計畫為例

Abstract

近二十年來，政府因應國際趨勢更新各項生技產業政策，欲將生技產業打造為兆元產業。，「醫療器材」相較於「醫藥」子產業研發週期較短和資金需求普遍較低，並有國內的醫學、電子資訊和工業製造等領域為基礎，相當具有發展潛力。對於醫療器材之研發需求，除需現有企業投入之外，運用「產學合作」的研發方式能整合國內學術資源，帶動產業技術升級並培育業界人才。 本研究的目的是希望盤點現今政府醫療器材相關產學計畫之執行學術單位、醫材類型、資金規模等資料，同時分析學術界潛在之醫療器材研發能量，並透過深入訪談國內產學計畫經驗豐富之公私立大專院校教授，來剖析現行計畫模式之優劣處，最後提出具體建議來促進產學界互動並提升合作成效。 本研究利用交易成本理論與治理結構的架構設計研究方法和變數，並使用科技部工程司產學計畫的醫療器材案件分析資料設計訪談問卷，運用治理結構的架構彙整國內教授對科技部醫療器材產學計畫之觀點。目前科技部產學計畫屬於 「三邊治理」的架構，由政府擔任的第三方監督和輔導的角色，而學界和產業的互動則適用「關係治理」的機制，重視彼此的合作關係，案件執行上相當具有彈性，計畫本身對於中小企業較具吸引力。 對於現行的計畫和契約制度，科技部應重新檢視計畫審核標準、提供計畫成果技術轉移的公版契約範例，來解決目前大專院校與業界間的大量技轉紛爭。並參考以色列等國家，將專利所有權由學校單位釋出至企業或教授個人。以及給予新創公司和中小企業更多支持。 若未來的醫材研發資金能提高數倍，配合適當產學計畫制度，充分將學術界潛在的醫材研發能量導入適合的發展領域，例如目前已具發展基礎的隱形眼鏡和體外檢測裝置，以及高毛利率的骨科和高階手術醫材等，可望達到讓整體產值也提高數倍的效果。

In past two decade, our government try to build biotechnology into a Trillion Industry. Compared with 'Medicine', the 'Medical Device' has a shorter development cycle and lower capital demand. With the foundation of domestic electronics, information, manufacturing industry, medical device industry has a great development potential. Regarding the high research and development demand of medical device, the “industry-university cooperation” is able to integrate domestic resources into the industry, promoting industrial technology upgrading training people for the industry. The purpose of this study is to take stock of the academic units, types of medical device and scale of funds of the medical-device-related project supports by government and to analyze the potential of research and development of medical device in the academic units. Through the deeply interview with professors in the domestic university, this study evaluates the advantages and disadvantages of the current project model and finally brings forward recommendations to promote interaction between industry and university and improve cooperation effectiveness. This study uses the Transaction Cost Theory and the Governance Structure to design research methods and variables. The interview questionnaire bases on the data analysis of industry-university projects of the Ministry of Science and Technology. The current industry-university project belongs to the framework of Trilateral Governance, the role of government is a third-party supervisor and consultant. The interaction between university and industry applies the mechanism of Relation Governance, which emphases the cooperative relationship, the execution of the project is quite flexible and the current project model is more attractive to SMEs. For the current project, the Ministry of Science and Technology should re-examine the review standards, provide examples of contracts for assisting the distribution of research findings, release the patents ownership to professors or companies and give more support to startups and SMEs. If the government funds for medical devices increase several times in the future, with the appropriate system of industry-university project, the research and development energy of the academic communities will be fully imported into appropriate fields, such as contact lenses and in vitro diagnostic devices (IVD) that have been developed, or high-margin items, like orthopedics and advanced surgical materials. The total output value of medical devices has potential to increase several times.