Scaling medical technologies: Institutional barriers and strategic responses

Medical technologies (MedTech) drive healthcare innovation, yet MedTech companies often struggle to scale up due to institutional barriers. This study identifies these barriers in the Netherlands, examines strategies MedTech scale-ups use to overcome them, and provides recommendations for regulators to lower these barriers. Analyzing 15 companies, we found that entrepreneurs primarily rely on institutional maintenance strategies, such as complying with strict regulations, contextualizing innovations to minimize disruption, and hiring personnel familiar with healthcare norms. They also engage in early forms of institutional creation, including organizing stakeholder alignment meetings and persuading insurers to adjust reimbursement systems. Entrepreneurs also build support by leveraging pioneers, mobilizing social capital, and using evidence-based demonstrations to foster trust and drive normative changes. We observed no strategies aimed at institutional disruption, reflecting the highly regulated nature of healthcare and the critical role of regulations in safeguarding public health. However, we found that building legitimacy through institutional maintenance can create opportunities to influence institutional frameworks over time. Our findings highlight the importance of regulatory flexibility to encourage innovation and collaboration between MedTech entrepreneurs, insurers, and regulators. These insights offer actionable steps to address systemic barriers and foster a supportive environment for scaling MedTech innovations.