Your Turnkey International Division for Medical Devices

A healthcare-focused investor held several medtech assets across Europe and Asia, each operating in silos. The firms lacked a unified strategy to enter the US or other stringent regulated markets. As due diligence teams began focusing more heavily on global scale potential and regulatory robustness, the investor needed a partner to turn fragmented expansion attempts into a coherent, value-creating plan. Without coordination, portfolio companies were duplicating regulatory eff

A VC-backed US company with a breakthrough Class II device had saturated its initial US niche and needed international growth to support its next funding round. Leadership was enthusiastic about “going global,” but had no in-house expertise in EU MDR, MHRA guidance, or reimbursement approaches in emerging markets. Attempts to explore multiple countries simultaneously led to scattered conversations, inconsistent distributor quality, and growing concern from the board about reg

A mid-sized European device manufacturer with strong CE Mark credentials had repeatedly failed to crack the US market. They had trialed two US distributors, both selected through existing relationships. Launches stalled, regulatory expectations were misunderstood, and leadership viewed the US as “too hard and too expensive.” Meanwhile, investors were pressuring management to access the US reimbursement upside and justify prior R&D and clinical investments. Each delay increase