生醫創新對醫學領域的影響相當大，許多臨床需求可以隨著生物醫學創新的推進而得到解決。自COVID-19發生以來，生醫產業背負著維持人類生命健康的重任。然而生醫創新是一個複雜而專業的領域，總是面臨著眾多的挑戰。因此生醫創新是否能即時進入市場甚為重要。生醫產業為台灣重點發展產業之一。然而在生醫創新商品化方面，對於市場定位不明確等皆為導致國內生醫創新失敗原因之一。從失敗中學習被認為是邁向成功的重要一步，但是目前很少有研究討論生醫創新過程中所遭遇的障礙。本研究以生醫商品化中心的審查委員、專案經理、創新團隊做為訪談與問卷普查的母體，透過內容分析法將文獻回顧與訪談結果進行障礙的整理。並將生醫創新過程所遭遇的障礙分為四個階段：Identification Failure、Conception Failure、Development Failure及Implement Failure。根據問卷調查的結果，採用Difficulty – Importance analysis（DIA）、決策實驗室分析法（DEMATEL）和網絡關係圖（NRM），建構DIA – NRM模型了解生醫創新過程所遭遇的障礙之間的關聯性並提出解決生醫創新障礙的戰略路徑。綜合審查委員、專案經理及創新團隊對於各障礙的看法不同，對各階段提出解決之最佳策略路徑。解決Identification Failure的最佳策略路徑自解決臨床需求評估不足開始；解決Conception Failure的最最佳策略路徑自解決法規可行性評估不足開始；解決Development Failure的最佳策略路徑自解決試量產計劃不足開始；解決Implement Failure的最佳策略路徑自解決營運規劃不周開始。本研究的目的為補足當前生醫創新過程中遇到的困難相關的研究缺口。此外，也為生醫創新業者提供最佳策略解決路徑，以減少障礙發生率和從失敗中學習的機會。

Biomedical innovation has a tremendous impact on the medical field, clinical need can be resolved with the advancement of biomedical innovation. Since the outbreak of COVID-19, the biomedical industry has taken on the responsibility of maintaining human life and health. Nevertheless, biomedical innovation is a complex and specialized field that faces numerous challenges, therefore it will be essential for biomedical innovations to enter the market in a timely manner. Biomedical industry is one of the key development industries in Taiwan. However, when it comes to commercialization, such as unclear positioning on the market, which leads to the failure of domestic biomedical innovation. Learning from failure is considered an essential step towards future success, however there are few studies discuss the barrier encountered during biomedical innovation. Therefore, this study take the reviewer committees, project managers and innovation teams of BioMed Commercialization Center (BMCC) as the population of census, the barriers organize from literature review and interview results through content analysis. The barriers that encounter during biomedical innovation process are classified into Identification Failure, Conception Failure, Development Failure and Implementation Failure. Based on the results of the questionnaire, using Difficulty – Importance analysis (DIA), decision laboratory analysis method (DEMATEL) analysis and Network Relation Map (NRM), constructing DIA - NRM model to clarify the relationship between the barriers and strategic pathway to overcome the failure. Based on the result of reviewer committees, project managers and innovation teams have different perceptions of each barrier, the strategic pathway to solve each stage is proposed. The optimal strategy pathway of solving Identification Failure begin with clinical need evaluation shortage; the optimal strategy pathway of solving Conception Failure begin with regulatability evaluation shortage; the optimal strategy pathway of solving Development Failure begin with Pilot production planning insufficiency; the optimal strategy pathway of solving Implement Failure begin with Ill-conceived operation planning. The purpose of this study is to fill the research gap relating to barriers encountered during biomedical innovation process. In addition, it provides biomedical innovators the best strategic pathways to reduce the incidence of barriers and opportunities to learn from failures.

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