75% of med-tech companies go overseas 1st because of FDA lead times and unpredictability

     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 o...