Innovation and Risk Management in High-Risk Medical Device Development: Lessons from Japanese Venture Companies

Abstract

This article investigates the unique challenges and strategic responses associated with developing high-risk medical devices, emphasizing insights from the Japanese medical technology sector. Utilizing a comprehensive case study of Sun Medical Technology Institute, the research highlights critical strategies, including technological diversity management, simplification of device structures, adoption of low-tech solutions, and leveraging strategic external collaborations to mitigate developmental risks and resource constraints. Additionally, the study explores regulatory complexities, underscoring the importance of proactive compliance strategies in navigating stringent regulatory frameworks effectively. By integrating quantitative patent data analyses, including Lorenz curves and Gini coefficients, the findings reveal the significant impact of technological diversification on innovation performance and risk reduction. The article further discusses managerial implications such as decision-making styles, market orientation, and the strategic application of digital technologies. Ultimately, this study provides practical guidance and theoretical insights for venture companies aiming to successfully navigate the complex landscape of high-risk medical device innovation.