醫療器材產業政策比較分析

Abstract

本研究主要探討醫療器材產業之創新政策，研究方法結合國家創新系統與產業創新系統之觀念，以創新密集服務業之產業創新系統與政策分析醫療器材產業，以專家問卷方式求得醫療器材產業創新所需之要素，進一步找出現有醫療器材產業政策工具與產業創新要素之關聯性，期望能提供臺灣推動醫療器材產業創新政策擬定之參考。

本研究主要專注於產業層級與國家層級。在產業層級部分，首先針對醫療器材產業現況與美國、歐盟、大陸、臺灣之現行政策進行資料蒐集，並以產業創新系統之模式，透過專家問卷，得出醫療器材產業創新需求要素。在國家層級方面，將各國現有之醫療器材政策歸納至國家創新系統之十二項政策工具，並分析整理各項政策所涵蓋之產業創新需求要素，透過統計方法分析各國與總體之醫療器材產業政策。

產業層級之實證結果顯示，醫療器材產業定位將走向專業服務與流程創新，其所需之產業創新系統需求為產業環境構面之「需求條件」、「相關與支援性產業」與「企業策略、結構與競爭程度」，技術系統構面之「知識的本質與擴散機制」、「產業網路連結性」。

國家層級之實證結果顯示，目前醫療器材產業現有政策以「法規及管制」之政策工具比率最高，達28.0%，而「科學與技術發展」次之，為14.7%，第三為「公營事業」政策，為12.0%，而臺灣目前政策偏向為「法規及管制」，為25.0%，次之為「公營事業」，為20.0%，第三為「科學與技術發展」，為15.0%。

The study investigates the innovation policies of medical device industry. From the point of view of the Innovative Intensive Services, the methodology constructs an integrated model of Industrial Innovation Systems and National Innovation Systems. The expert survey identifies the industrial innovative factors of the medical device industry. Furthermore, the study will examine the correlation between the policy instruments and the industrial innovation requirements. The results of the study can serve as reference for Taiwan government in planning innovation policies of the medical device industry in the future.

The study focused on the industrial level and the national level. In terms of the industrial level, the study collected the information of the current situation of the medical device industry and the related policies in US, EU, China, and Taiwan. The analysis used the industrial innovative system model to find the innovative required factors of the medical device. In terms of the national level, the study categorized the current related policies into the 12 policy instruments of the National Innovation Systems, and analyzed the relation between the current related policies and industrial innovative required factors.

Results of the study in the medical device at the industrial level reveal that the Industry is moving toward the direction of Unique Service and Process Innovation. The critical factors of Industrial Innovation System in Industrial Environment include Demand Conditions, Related and supporting industries and Firm Strategy, Structure, and Rivalry, whereas the critical factors of Technological Systems include Nature of Knowledge and Spillover Mechanisms and Connectivity.

Results of the study in the medical device industry at the national level reveal that the highest rated policy instrument is Laws and Regulations (28.0%), the second rated instrument are Scientific and Technical (14.7%) and the third rated instrument is Public Enterprises (12.0%). The highest rated policy instruments in Taiwan are Laws and Regulations (25.0%), the second rated instrument are Public Enterprises (20.0%) and the third rated instrument is Scientific and Technical (15.0%).