Abstract
<sec> <title>UNSTRUCTURED</title> <p>Background: High-risk medical devices have transformed modern healthcare through continuous technological innovation. However, recurring safety controversies, regulatory failures, product recalls, and corporate misconduct have demonstrated that technological superiority alone cannot guarantee sustainable market success. Existing literature primarily addresses isolated aspects of these crises, such as regulatory compliance, device safety, or post-market surveillance, without providing an integrated lifecycle framework describing how organizations recover institutional trust following major crises. Objectives: To propose a conceptual Crisis-to-Trust Lifecycle Framework that integrates regulatory science, corporate governance, social sustainability, value-based healthcare, and Trust Capital into a unified model explaining long-term competitiveness in high-risk medical devices. Methods: A narrative conceptual review was conducted by synthesizing evidence from regulatory science, healthcare management, social sustainability, lifecycle regulation, organizational trust, and medical device governance. Previous conceptual models addressing crisis management, post-market surveillance, evidence generation, and stakeholder trust were integrated into a unified lifecycle framework. Results: The proposed framework describes ten sequential stages in the evolution of high-risk medical devices: Innovation, Commercialization, Rapid Market Expansion, Safety Signals, Regulatory Investigation, Corporate Crisis, Brand Repositioning, Evidence Generation, Trust Recovery, and Trust Capital. Rather than representing isolated events, these stages form a continuous cycle in which scientific evidence, transparency, and governance progressively restore institutional trust following crises. Conclusions: Sustainable competitiveness depends not only upon technological innovation but also upon an organization's ability to transform crises into opportunities for evidence generation and trust recovery. The Crisis-to-Trust Lifecycle Framework provides a conceptual model that may guide manufacturers, regulators, clinicians, and policymakers toward more resilient medical device ecosystems.</p> </sec>