論文摘要:

本論文以開放式創新(OI)，探討外部知識與技術導入程序，如何改善高階醫材在新產品研發(NPD)過程中帶來的效益。並以兩個個案研究，分別由量化分析及質性研究，經實驗、訪談與深入調查方式為本研究方法。個案研究一，以攜帶式生理監視器新產品開發為例，應用於急救市場端。經由實驗認知演練方法，比較兩種不同介面設計，所產生的差異與影響。並分別以30個樣本，來自三個不同專業背景的使用族群，由階層式臨床實驗獲得結果，經統計分析及ANOVA假設檢定作為結果驗證。

個案研究二，以企業導入外部創新發展新產品為例。資料取得，經由企業研發高階管理者訪談與深入調查實際運作情形，並結合10位外部專家及產、官、學、研等代表，藉開放式論壇獲得。本例研究目的，在分析企業導入開放式創新作為新產品開發過程，企業面對創新的需求與跨組織的認知差異及創新障礙等。

本論文提出知識聚落(KC)的概念，做為開放式創新關鍵的一部份。並以跨組織管理必須結合競合策略作為突破創新障礙，提出效益化高階醫材新產品研發模式，為本研究貢獻。研究證實，高階醫材屬於跨領域技術的整合，為加速新產品研發並突破企業內部資源的限制，外部開放式創新將有利於關鍵技術的取得，並提升新產品研發成功機率。

關鍵字: 新產品研發 (NPD); 開放式創新(OI); 知識聚落(KC)

ABSTRACT

This thesis proposes an effective new product development (NPD) model that aims to improve the effectiveness of innovative NPD in the advanced medical devices industry. By adopting open innovation (OI), this study examines two cases using quantitative and qualitative analysis. In case I, a portable patient monitor for emergency medical services is taken as an example of NPD. By using Cognitive Walkthrough experimental methods, we compare the differences and influences generated by two user interface designs. The data obtained from 30 samples and three user groups from different professional backgrounds through the hierarchical exercise process are validated by statistical analysis and ANOVA hypothesis testing.

In Case II, enterprises adopt OI to develop new products. Through interviews and in-depth investigation, combined with the opinions of 10 external experts from industry, government, academic, and research institutions derived via an open forum, we explore how enterprises adopt external innovation for NPD. We also investigate the demand for innovation, cognitive differences in cross-organizational management, new barriers facing enterprises, and influence of OI on NPD.

This study proposes the concept of a knowledge cluster (KC) as part of the OI process and cross-organization management with a co-opetition strategy to overcome innovation barriers. Hence, the NPD model for advanced medical devices is the main contribution of this study. This study confirms that advanced medical devices must integrate interdisciplinary technology and knowledge in order to accelerate NPD and overcome internal resource constraints. Therefore, adopting an outside-in process of OI is conducive to the acquisition of key technologies and to increasing the probability of successful NPD.

Keywords: New Product Development ; Open Innovation ; Knowledge Cluster

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