In just a few weeks the Eighth Annual Medical Device Quality Congress will be held in Bethesda, MD, on June 7-9, 2011. What can US based Medical Device Start Ups and existing multinational device companies expect from this get together? From my perspective, not much. Why? There are no industry representatives asked to participate in the program. There will be 10 speakers from CDRH (Center for Devices and Radiological Health) and 5 former FDA representatives. That is an interesting cast of characters!
My guess is that the current crop of early stage companies, as well as, most multinational companies, have low expectations. What are the overriding concerns? The time that it now takes to process a 510k application, let alone Investigational Device Exemption Applications is staggering. Many in the Industry have come to the conclusion that better quality medical care may be practiced in the European Union vs. the United States. Why is that? The answer is simple. The Food & Drug Administration is so bogged down in their Quality expectations, Engineering Principles, and Supplier Regulations, that they cannot see the trees through the forest. If a device company gains CE mark, they at least have a chance to generate a revenue stream to support their US objectives. Excessive time to market complicated by a dramatic increase in further clinical evaluation and testing, has knocked many promising products out of the running.
Let us be honest with ourselves. The FDA is trying to justify these more stringent regulations and may have to be commended for making sure that products are clinically sound, reduce morbidity and mortality. But, when the day is over, there are fewer novel devices being approved in this country. The additional monies that have to be spent just to file an application, perform additional clinical evaluations and increased testing is overwhelming,
Consequently, this pattern is taking its toll on the new product development stream and the ultimate approval of life saving, novel devices on a timely basis. These market opportunities are welcomed by the European Medical Device community with open arms.