Beyond Price: Trust as a Measurable Asset in High-Risk Medical Devices Toward a Trust Capital Framework for Sustainable Medical Device Innovation (Preprint)

<sec> <title>UNSTRUCTURED</title> <p>Background: Technological innovation and regulatory approval have traditionally been regarded as the principal drivers of competitiveness in the medical device industry. However, repeated regulatory failures and product safety controversies have demonstrated that market success depends equally upon long-term stakeholder trust. Despite its importance, trust remains poorly conceptualized and is rarely incorporated into frameworks evaluating medical device competitiveness. Objectives: To propose a conceptual framework that recognizes institutional trust as a measurable strategic asset in the lifecycle management of high-risk implantable medical devices. Methods: A narrative review integrating regulatory science, corporate governance, healthcare economics, social sustainability, value-based healthcare, and medical device lifecycle management was conducted. Existing concepts of organizational trust and healthcare governance were synthesized to develop a multidimensional Trust Capital Framework. Results: Institutional trust emerges from six interdependent domains: regulatory integrity, clinical evidence, scientific transparency, post-market surveillance, corporate governance, and stakeholder confidence. Together, these domains form Trust Capital, an intangible yet measurable organizational asset that influences market acceptance, premium pricing, regulatory resilience, and long-term competitiveness. Conclusions: Future competitiveness of high-risk medical devices should be evaluated not only by technological innovation or market performance but also by the continuous accumulation of Trust Capital throughout the product lifecycle.</p> </sec>