Short abstract:

This research adopts the national biotechnology sectoral innovation system as the main framework to explore how institutional factors shape the development of smart medical device innovation ecosystem. It provides insights for the mutual shaping between the innovation ecosystem and institutions.

Long abstract:

Applying ICT, artificial intelligence, and machine learning technologies to medical device products has created significant challenges to transforming the medical device sector from traditional medical devices to intelligent medical devices. How do institutional factors facilitate the transformation of the medical device innovation system? This research adopts the national biotechnology sectoral innovation system as the main framework. The study adopts a mixed-method approach, combining the analytical hierarchical process, in-depth interview, scitometric mapping, and documentary analysis to explore the key factors that will transform and develop Taiwan's smart medical device industry. The results show that the most critical criteria affecting the transformation of Taiwan's intelligent medical device innovation system are the stock of knowledge, which includes technological accumulation in related sectors, national funding of basic research, and national scientific education. From scientometric mapping on the data gathering from Mesh-term, we found the medical device sector recently focusing on equipment development and reagent kits diagnostic development. The Taiwanese government has started incentives, investing resources and funds to support the development of the medical device sector. However, the pre-market safety evaluation regulations are not well-developed, which challenges the commercialization process of technology research and development. This paper will be one of the very few papers combining the framework of the national biotechnology innovation system with the analytical hierarchical process. Overall, this paper will be of interest to offer insights into Taiwan's strategies and initiatives to enhance the policy framework and the competitiveness of global intelligent medical device development.