U.S. medical device makers have been flocking to Europe in recent years.
The general industry perception is that the European regulatory process is quicker, more efficient and more predictable than the U.S. Food and Drug Administration’s process for clearing medical devices. A study earlier this year sponsored by the top device industry trade group in the U.S. found that the European process is just as safe as — and quicker than — its American counterpart.
Start-ups, then, which must constantly focus on capital efficiency, may find that Europe holds lots of appeal for early commercialization.
That was the idea behind a presentation on the Cleveland Clinic campus from two German healthcare consultants — Natan Paz, CEO of Mex, and Robert Haustein, a research associated with IGES. Following are a few key points from their presentation titled “Generating Initial Revenues in Europe.”
- A CE Mark doesn’t guarantee market acceptance: The CE Mark, which is basically the European regulatory equivalent of 510(k) clearance in the U.S., essentially just means your product “doesn’t blow up,” Haustein said. It doesn’t mean a device is efficacious and it doesn’t mean anyone in Europe will use it.
- Court the doctors: To gain market acceptance, establish relationships with physicians who are key opinion leaders (KOLs) in your specialty. Focus on a mix of working physicians to serve as KOLs, and in particular, department heads. “The closer your company is to the physician, the higher your chances of success,” Paz said.
- Rely on the locals: Use a local specialist on the ground in each key country to manage product launch and reimbursement. You’ll need someone who knows the local language and culture.
- European distributors won’t help start-ups much: Distributors are much more helpful for established products. They aren’t set up to manage new product innovations, won’t help with market development and could prevent the companies they represent from obtaining key user feedback.
- Do clinical studies in key markets: Even though the European Union has 27 member countries, each country’s health system essentially operates independently. So don’t think that a clinical trial conducted in Poland will carry much weight in Germany. To get on the pathway to reimbursement in a certain country, collect your clinical data in that country.
Photo from flickr user centralasian
