I read an interesting article this week in the Winston-Salem Journal from a Cook Medical Executive about a new tax coming in 2013 and a FDA that has been acused of stalling new and innovative products coming to market. This effects everyone, including the small start-up that is struggling for funding, the big company trying to justify their R&D, but mostly it effects the millions of people around the world that would otherwise benefit from these new products. I came away from this article thinking that this could really hurt American medical device companies.
Recently, this has effected drugs getting to market by adding 20% of review time. For medical devices is has been worse, some estimating 510K clearances were slowed by as much as 43% and novel technologies over 70% versus speed to market and approval in years prior. I’m a fan of the FDA protecting the public, I just hope they are not only searching for reasons why to slow a company but also looking for reasons to bring innovation to the people.