Actions have consequences – often unintended ones. And the same is true for inaction.
Remember the medical device “gap” of the 1990s? That’s when Europe was outpacing the United States in bringing new medical technologies to market. Well – the gap is back, it’s growing – and it has consequences.
The #1 consequence is that Americans don’t have access to new technologies that make a difference. It also means that American companies (and their investors) wonder whether continued investment in research and development is worth it.
And what’s on the other side of the equation? One would think, well, safety. After all, nobody wants the FDA to approve unsafe medical technologies. Sure enough. But there’s no evidence that these newer options available in Europe are anything except safe and effective. Hence, there is a gap in care but none is device safety. What’s wrong with this picture?
All this while we debate reform to (among other things) the 510(k) process. Reform? Good. Better? Sure. But we must also address the issues of better with faster. We must learn from Europe. We must harmonize with Europe. And we mustn’t ignore the reality that the medical technology gap is widening and that this fact has consequences for the public health in the United States today as well as for the competitiveness of the American medical technology industry in the future.
A new survey of medical technology companies and investors (by Josh Makower, MD Consulting Professor of Medicine, Stanford University; Aabed Meer MD-MBA, and Lyn Denend Research Associate, Stanford University – with support from the Medical Device Manufacturers Association, the National Venture Capital Association, and multiple state medical industry organizations) is important reading -- and not just for industry and investors, but for thought leaders and policy makers – and especially those at CDRH.
The full report can be found here.
