HEALTH CARE : European Union Sets the Standards for O.C. Biomedical Companies’ Profits

To local biomedical companies, the grass sure looks greener in Europe these days.

Earlier this month, two Irvine companies, I-Flow Corp. and Advanced Sterilization Products, said separately that they had met European standards for their medical devices--and expect their international markets to boom.

Donald Earhart, president and chief executive of I-Flow, predicts the company’s annual sales of medical infusion pumps and related items to European markets will double next year to about $3.5 million. He expects that introductions of new products, including a low-cost pump model, will provide much of the growth.

“Europe will see my new [products] before the U.S. because it takes so long to get something approved here,” he said.

It takes only months to get multiple clearances to sell medical devices in 15 European countries, Orange County executives say. But here, it can take years for federal regulators to approve devices for use in the U.S. market.

The trick to cracking Europe is to meet international standards set by the European Union. Companies must pass inspections on their products’ safety, design, development and effectiveness. And they must have systems to assure quality production and customer service.

Advanced Sterilization Products went through the arduous U.S. process to win approval in 1993 for a machine that sterilizes surgical knives, forceps and endoscopes. But it took little time for the subsidiary of Johnson & Johnson in New Brunswick, N.J., to get the OK to sell it in Europe.

European certifications should help win over more customers, says Tralance Addy, Advanced Sterilization’s general manager. He estimates that the company’s European sales could double this year, though he declined to disclose sales figures.