Medical device execs are warning that the industry's competitive edge in the U.S. and overseas is being jeopardized by increased regulatory scrutiny, the Salt Lake Tribune reports. In fact, many believe the FDA has gone too far in using its regulatory authority; however, some executives have been reluctant to comment publicly about this issue.
The paper provides the example of Biosensors International, which shut down its operation in Southern California. Execs said the reason was that it would take too long to get its new cardiac stent approved by the FDA. "It's available all over the world, including Mexico and Canada, but not in the United States," said CEO Jeffrey Jump, an American who runs the company from Switzerland. "We decided, let's spend our money in China, Brazil, India, Europe."
Jump last year said he is positive about prospects for his sector in Switzerland. In 2009, Biosensors achieved a 45 percent annual sales increase with most of the $107 million taken through the Swiss office. "We expect to continue the growth pattern we began last year," Jump told Swisster at the time. Recently, the company reported results for Q3 2011. Total product sales were $37.9 million, a 17 percent increase over the previous quarter, and a 27 percent increase over the $29.8 million reported in the Q3 of fiscal year 2010.
Merit Medical Systems also has had problems with the agency's review time. "We have one product that has been under a 510(k) review by the FDA for almost a year," Merit CEO Fred Lampropoulous, said, explaining the device is a catheter that can be used to remove blood clots from vessels that feed the heart. "We're selling it in Europe and everyone who uses it says its great, but I can't get it through the FDA."
And the numbers are showing the FDA is getting tougher. Last year, it granted 19 premarket approvals--down from 48 in 2000. And many execs say U.S. patients are being deprived of the latest technology because companies routinely seek approval for new devices in Europe first.