Tips for European Medical Device Startups
August 29, 2013
Europe is an attractive home for many medical device startups. While the United States medical device market is very large, medtech companies face a significant number of regulatory hurdles when bringing new products to the U.S. market. Because of this, many medical device manufacturers commercialize their product in Europe before coming to the United States. In a MedCity article, several industry leaders offered valuable advice for young entrepreneurs hoping to take on the European market."Don't invest in all markets at once," says Kevin Sidow, CEO of MoxiMed. As a startup, many companies are strapped for cash. Instead of battling with FDA regulators, Sidow recommends pursuing CE Mark approval first. Armed with post-European-commercialization clinical data, companies are in a better position to get their medical device cleared or approved by FDA regulators.MoxiMed pursued European milestones first due to several unique nuances of the German market. Since Germany has a long-standing history of tibial osteotomies, the country was the perfect starting point for some of MoxiMed's devices. While Moximed is based in California, the company also maintains offices in Switzerland. "Set up relationships between key surgeons first before you begin to hire people or go to third party suppliers or agents," notes Sidow. It's also important to understand organizational differences. "Different pricing, different healthcare systems, different languages-as a smaller company that can be quite a headache," states Barry Russell, CEO of NeoSurgical. Europe isn't a single country with uniform laws. While many countries in Europe are bound together by the European Union, it's essential for startups to have the human resources and information needed to navigate these different systems.Finally, medical device startups shouldn't blindly try to win favor with European regulators before taking on the United States. While the CE Mark system may be more reasonable, it's essential to look at the fine details of a medical device and a company. CE Mark approval isn't always easier. In some cases, an FDA 510(K) clearance is easier than a CE Mark path due to classification differences.
About the Author
You May Also Like