The medical device industry has recently evolved into a strategic and competitive sector in international trade, driven by technological complexities, regulatory requirements, and geopolitical transformations. Under such conditions, the development of exports in this industry—particularly in the Persian Gulf markets—requires the adoption of innovative trade diplomacy approaches and effective coordination between governmental and firm-level actors. Accordingly, the present study aims to design a trade diplomacy model for the medical device industry, focusing on export-oriented firms operating in these markets.This research adopts a qualitative approach based on grounded theory (Strauss and Corbin paradigm model). Data were collected through semi-structured interviews with 15 experts, including industry managers, academic scholars, and policymakers, and analyzed using open, axial, and selective coding, leading to the identification of approximately 300 initial codes and the development of a paradigmatic model.The findings indicate that causal conditions include competitive, geographical, political, and cultural factors, while the central phenomenon is grounded in adaptability, regional convergence, and optimal resource allocation. Moreover, international relations, policymaking, and competitive potential were identified as contextual conditions, and political and financial risks as intervening conditions. Key strategies include technological acceleration, multilateral collaboration, and market intelligence development, with outcomes reflected in export dynamism, knowledge-based economic development, and the strengthening of health diplomacy.Overall, institutionalizing trade diplomacy at the macro-policy level can serve as a strategic instrument for promoting knowledge-based exports, reducing external vulnerabilities, and enhancing sustainable competitive advantage in the medical device industry