突破性技術創新對於一個國家的企業、產業乃至於經濟發展，都會有非常深遠的影響。突破性技術往往代表著新應用、新市場、新產業、甚至新經濟，但是要實現這些前景，必須先突破原本產業內的舊制度限制，建立一套新技術的制度規範，才能讓突破性技術可以實現在產業中應用。然而過去對於突破性技術創新的研究缺乏一個整體觀，以致於在判斷重要議題上容易出現盲點。本研究嘗試整合系統及行動兩種觀點，提出一個整合性的概念框架，探索突破性技術創新從學術端到市場端的制度化過程中，行動者與制度環境之間的交互作用，以及其所衍生出的重大挑戰及課題。本文將制度化過程分成三個階段，鑲嵌化、正當化、組織化，分別對應不同的行動者、行動策略及制度環境。實證上，本研究透過長期觀察單一個案的歷史演變，探討2000年到2021年間，台灣再生醫療技術在生技製藥產業中發展的動態過程，在鑲嵌化、正當化、組織化階段，如何一步一步突圍，讓不同領域的行動者開始產生共識，進行各種策略行動，甚至影響到政府立新法，讓突破性技術可以跨過原有制度的新之不力因素，進入產業的整個制度化過程。透過本文突破性技術創新的制度化框架將有助於增進我們對於突破性技術創新在科技政策、創業管理、科技管理、策略管理等領域的認識；也有助於釐清現有研究的缺口，並對未來可能的研究方向提出建議。

Radical technological innovations have far-reaching impacts on the development of firms, industries, and economies in a country. However, because of lack of an integrative framework, past researches on radical technological innovations make identify key issues difficult. This paper aims to integrate both system and agency perspectives to propose an integrative conceptual framework for exploring the institutionalization process of radical technological innovations from the academic end to the market end, particularly the interactions between actors and their institutional environments, and associated major challenges and key issues. The institutionalization process has been divided by three stages, embedding, legitimizing and organizing, corresponding to three different types of actors, strategic action and their embedded institutional environments. This study empirically observes the dynamic process of Taiwan regenerative medical technological innovation development in biotechnology and pharmaceutical industry during 2000-2021 and explores how different actors take various strategic actions to affect government’s enactment of new laws and how breakthrough technologies could overcome the new ineffective factors of original system to enter the institutionalization process of the industry. This framework will contribute enhancing our understanding of radical technological innovations in technology policy, entrepreneurship management, technology management and strategic management to overcome the blind spots of past researches, and also help elucidate current research gaps, and suggest future research directions.

一、中文部分
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