American expat and newly named (July 2010) CEO of Swiss-based (Morges) Biosensors International, Jeffrey Jump, oversees a company with advanced drug-eluting stents used throughout the developed world, with one notable exception: the United States.

Biosensors’ BioMatrix stent system includes a biodegradable polymer that degrades into the body’s lactic acid so that the polymer dissolves with the drug—Biolimus A9— a highly lipophilic derivative of sirolimus and an automated stent coating technology that directly deposits the coating on the outside stent surface (the tissue side) and not on the inside, where the drug can enter the bloodstream.

So why isn’t this technology in the United States? “We have an OUS – outside the U.S. – strategy,” Jump recently told a group of international journalists at the Federal Institute of Technology (EPFL) in Lausanne during a weeklong Swiss medtech tour sponsored by the Swiss Consulate General. The Indiana University grad’s career started in 1979 with Irvine, CA- based, heart-valve implant maker Shiley Inc (now a Pfizer subsidiary) before he came to Switzerland in 1988 for a management buyout of Haemonetics (blood processing systems). Jump also held senior management positions with several startups before joining Biosensors in 2003 as Managing Director –BESA (Biosensors Europe SA); he was named CEO of BioSensors this past July.

So why the OUS strategy? Simply put, gaining U.S. approvals take too long and cost too much, said Jump. “In Europe, the process takes 6 months to 2 years; in Japan, the process takes 3 to 5 years and costs about $3 million; and in China, it takes 3 to 5 years and costs less than Japan.”

What about the U.S.? “We’re looking at 2 to 7 years and costs of $50 to $150 million.”

Before readers go blaming the FDA, Jump says large U.S. device makers are the ones driving up the cost of approvals. “The FDA doesn’t decide what companies must do to prove products are safe and effective, the companies decide that,” Jump opined. “So the companies with lots of money decide to do large, expensive studies to prove their technologies work. In this way it becomes a protectionist tool.”

Jump’s candor is perhaps second only to his business acumen. Last month, Biosensors completed the purchase of Sunnyvale, CA-based CardioMind. The company’s Sparrow stent system is the world’s smallest, with a 70% smaller diameter than approved stents, allowing it to be placed in peripheral space in the feet and legs as well as in the brain. Jump expects to buy another company in the weeks ahead.

“Both of these companies had U.S. strategies, but ran out of money before they could get to the U.S. market. One spent $80 million, and the other spent $140 million.”

Lest you think Jump is one smug expat without concern for us Yanks, Jump offers this: “As an American, I’m saddened by the time and cost required to make these life-enhancing technologies available in my country. People there (U.S.) still think America is the best medical arena in the world. The truth is, it’s not. What America has are highly trained individuals without access to the latest technology; that has me really concerned.”

What about you? Please share your comments and please answer this month’s Reader Poll question: Does the time and money spent to gain U.S. approvals hurt or help America in terms of having the latest medical technology available vs. the rest of the developed world?

Note: More coverage of Swiss Medtech will appear in future issues of Medical Edge as well as Medical Design.