EMEA Launch Strategy for IoT-Enabled Medical Device
10 weeks | Strategy project
The Challenge
A US-based MedTech company had developed an IoT-enabled monitoring device with strong clinical evidence but no commercial presence in Europe. They needed a comprehensive EMEA launch strategy that addressed regulatory, reimbursement, and go-to-market challenges simultaneously.
Our Approach
We developed an integrated launch strategy covering regulatory pathway (MDR classification and CE marking roadmap), reimbursement landscape analysis across five priority markets, and a phased go-to-market plan. We identified and evaluated potential distribution partners, designed the pricing architecture, and created a health economics value dossier for payer engagement. The strategy balanced speed to market with sustainable commercial foundation building.
Results
- Defined a 3-market priority launch sequence
- Identified reimbursement pathways in Germany, UK, and Nordics
- Selected and onboarded distribution partners in 4 countries
- Created a health economics value dossier for payer engagement