"What they wanted to see, what they always want to see, is safety and performance, and a favorable risk-benefit ratio," she says. "We were able to position the product so that it was relatively easier to demonstrate this."

That said, Emergo's Schorre doesn't feel that companies choose Europe because it's faster or any easier to get approval than in the U.S. "European requirements are every bit as robust as the FDA's," he warns.


Instead, he feels companies choose European mainly because of economic factors.

"It's market-driven reasons," he says. "It might be the case, for instance, that there could be a better market there, less competition. Or the reimbursement scheme might be more favorable and profitable in Europe than the U.S."

The big draw for a market like Europe is that some countries are underserved, he says. For instance, a company might discover that the Polish and German markets don't have many stents being sold. "[They]might want to come in and establish dominance before some other companies do," he says. "The U.S. market can be extremely saturated."

In fact, Schorre argues, Europe can be tougher for some kinds of products to get approved. "U.S. has three classes. But Europe has two versions of Class 1, and two versions of Class 2: 2a and 2b, as well as Class 3. A product considered a Class 2 product in the U.S. could be considered Class 2b in Europe." And a Class 2b product - a higher-risk category than the U.S.'s Class 2 - would probably need some kind of clinical trial to be done, he says. "In the U.S., that might not be the case."

Sorrel agrees. "It all depends on the product regulatory pathway," she says, noting that if your product qualifies for 510(k) approval you could avoid handing in "required clinical data" that a European auditor could demand.

As an example, she mentions Novacept, which got bought by Cytyc, a woman's health care company, which in turn got gobbled up by Hologic. "They were really clever," she says. "Early clinical development work was done in Europe, but they didn't come to Europe straight on after getting the CE mark. It was easy to get a 510(k). Soon they were in every single gynecological office, then they were bought and worth tons of money."

Another driver that can't be overlooked is the exchange rate. Right now, the euros' strength relative to the dollar -as this article went to press, one euro gets you about one and a half dollars - makes U.S. medical products a bargain in Europe. "It's now difficult for a European company to compete [in Europe] with an equal U.S. company," says Schorre.

Yet, much of what countries fear in Europe is reimbursement rates - the conventional wisdom is that even though a product could fly through regulations, it won't get reimbursed by the more cost-conservative national health plans that control the Continent's health care purse-strings. But the conventional wisdom could be wrong: Sorrel says she managed to get reimbursement for a major, novel product produced by a huge U.S. manufacturer shortly after its debut. She insists there's no alternative to taking each product on a case-by-case basis. "Everything has to be looked at individually," Sorrel says. "No market opportunity should be overlooked. People have to do their homework."

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