What are the Issues Commercializing Europe?

The lack of a consistent health care policy across EMEA countries complicates launching and achieving the sales success that holds so much value for a new device. The strong government pressures to reduce the overall healthcare costs and the subsequent hospital cost containment measures present a challenging task for start-ups to reach their potential in EMEA.

A new device can get access to EMEA from a regulatory point of view (CE Mark), but the mechanism in EMEA that regulates the commercial impact of a product is, amongst others, the national healthcare reimbursement system.

Certain countries in EMEA have experienced erosion in reimbursement levels (France, Germany) that put a downward pressure on sales prices. The overall margins are not going to be as large as the U.S. market, but the volumes are particularly significant for a new device’s first commercial experience.

Cost and reimbursement issues are challenging, and understanding the issue country by country is important. For example, Germany appears to be the largest market for many device segments because of its volume, but Greece can be much more profitable because of its higher pricing and easier access.

Start-ups must recognize the issues are complex and each country is different. The sales strategy must include sales representatives who speak the native language of the physicians and understand the specific issues and cultural differences.

Is it simple/easy to go to EMEA? No, but with Q’s European specialist team understanding the markets, the few U.S. start-ups we pursue for representation will want a European ‘first’ commercialization strategy for long proven product development reasons, and will have the confidence Q will deliver results.