Abstract
<sec> <title>UNSTRUCTURED</title> <p>Background: Pricing of high-risk implantable medical devices extends beyond manufacturing costs and reflects multiple dimensions, including technological innovation, regulatory credibility, long-term clinical evidence, surgeon confidence, and patient trust. Premium pricing strategies are commonly adopted by manufacturers seeking market differentiation. However, the appropriateness of premium pricing following major regulatory controversies remains poorly understood. Objectives: This article examines the determinants of pricing in the breast implant industry and discusses whether commercial premium pricing should be supported by proportional clinical value and institutional trust. Using the Korean breast implant market as an illustrative case, we propose a value-based framework for evaluating pricing strategies after regulatory crises. Methods: A narrative review was conducted integrating literature on medical device economics, value-based healthcare, regulatory science, post-market surveillance, corporate reputation, and breast implant safety. Publicly available information regarding the Korean breast implant market was reviewed to illustrate conceptual relationships between pricing, evidence generation, and stakeholder confidence. Results: Pricing of implantable medical devices reflects a multidimensional value proposition rather than production costs alone. Long-term clinical evidence, regulatory compliance, international utilization, independent scientific publications, post-market surveillance, and surgeon confidence collectively contribute to perceived value. Following regulatory crises, premium pricing strategies that are not accompanied by proportional evidence generation may create a gap between commercial positioning and perceived clinical value. Conclusions: Premium pricing should represent accumulated clinical value rather than marketing strategy alone. Sustainable competitiveness in the breast implant industry requires continuous investment in scientific evidence, regulatory transparency, and stakeholder trust.</p> </sec>