Report: More than 75% of med-tech companies go overseas first (MassDevice)
More than three-quarters of medical device makers go overseas first when launching new products, according to researchers at Northwestern University.
High costs, long review times and increasing unpredictability led more than three-quarters of medical device makers to seek overseas regulatory approval before launching a bid for FDA clearance, according to the largest-ever survey on the 510(k) review process.
Of 350 medical device company employees reviewed, 22 percent said high costs of FDA review sent them overseas and 14 percent blamed a lengthy and complicated U.S. review process, according to a report by researchers at Northwestern University.
Nearly all of the remaining 63 percent of respondents cited unpredictability as the main reason for going abroad before applying for FDA clearance, the researchers reported.
The study, which was paid for by the Institute for Health Technology Studies, drew responses from employees of small, medium and large med-tech companies recently involved in 510(k) submissions. The institute is a non-profit funded by the medical device industry.
The findings and ana...
