An Interpretive Structural Modeling Approach for Biomedical Innovation Strategy Models with Sustainability

In recent years, the biomedical startup industry has flourished, and yet, it still faces challenges in adapting to changing market demands. Meanwhile, the widespread use of single-use medical devices generates significant waste, posing threats to environmental sustainability. Addressing this issue has become a critical challenge for humanity today. The study aimed to delve into the specific difficulties faced by Taiwanese biomedical entrepreneurs during the innovation and development of medical devices from a sustainability perspective and to explore solutions. This study collected first-hand experiences and insights from Taiwanese biomedical entrepreneurs through a literature review and expert questionnaires. It employed Interpretive Structural Modeling to analyze the development stages and interrelationships of biomedical device startups for building sustainable biomedical innovation. The Clinical Needs Assessment is revealed as the most influential factor, shaping Regulatory Feasibility Evaluation, Clinical Trial Execution, and Market Access Compliance. Our findings provide a structured problem-solving framework to assist biomedical startups in overcoming challenges while incorporating energy-saving and carbon reduction processes to achieve environment sustainability goals. The results of this study show that biomedical innovation practitioners should prioritize integrating sustainability considerations directly into the earliest stage of a Clinical Needs Assessment.