Navigating Regulatory and Institutional Constraints to Scale Internationally : A Study of Medical Technology Startups’ Strategic Engagement with Business Ecosystems

Sammanfattning

This study examines how regulatory and institutional constraints shape medtech startups’ strategic engagement with business ecosystems during international scaling. Existing ecosystem research has largely focused on lightly regulated and platform-based industries, while international business research has primarily approached scaling from a firm-centric perspective. Consequently, limited attention has been given to how ecosystem structures and governance dynamics shape international expansion in highly regulated sectors. Drawing on a hermeneutic–interpretivist perspective and an abductive research approach, the study applies a qualitative multiple-case design focused on Swedish medtech startups and supporting ecosystem actors. Empirical data were collected through semi-structured interviews with startups, incubators, healthcare organizations, and public institutions involved in regulatory approval, clinical validation, reimbursement, and market access. The analysis combines ecosystem theory, institutional theory, legitimacy theory, and resource dependence theory. The findings demonstrate that international scaling in medtech is shaped less by market demand and more by the ability to navigate institutionally embedded ecosystem structures. Regulatory and institutional conditions function as primary coordinating forces shaping legitimacy, interdependence, and strategic decision-making across the ecosystem. Rather than solely enabling growth, ecosystems may also constrain scaling by creating dependencies on regulators, healthcare providers, and certification bodies. The study contributes to ecosystem and international business research by developing the Recursive Constraint Scaling Model, a process-oriented framework explaining how regulation, coordination, legitimacy, and strategic positioning interact during international scaling under institutional constraint.