Recent calls for U.S. companies to consider Europe as a model for success in funding innovation, while having a modicum of truth (clearly, companies should be considering all possible markets as models for success), strike me nonetheless as rather narrow-minded and short-sighted. The ostensible reasons for this are that, first, the recent revisitation of the the FDA's 510(K) process has subjected manufacturers/innovators to unreasonable uncertainty and, second, the Obama healthcare reform legislation has produced "radical changes" that subject potential U.S. market participants to uncertainty and presumably unmanageable change in the developmental process.
The advent of new paradigms driving investment, such as healthcare market reform and regulatory reform, has a distinct tendency among those seeking to be visionaries in the market to point to new directions. This is understandable, for any company seeking to capitalize on opportunities and/or hedges against market challenges would be foolish to not consider the significance of new market dynamics. However, the opportunity to consider Europe is no less, or more, an opportunity to be considered now than it has ever been since the English language has established its dominance in international commerce or since the 300 million people in the United States concluded that healthcare was an inalienable right.
The U.S. remains the single-largest healthcare market in the world. Whether one considers medical devices, pharmaceuticals, biotech or any other healthcare product market, the U.S. remains the top market opportunity. The growth in China, while yet another challenge/opportunity to consider does not diminish the market demand in the U.S. Less challenging financing or regulatory options in Europe (or elsewhere) do not diminish the existing infrastructure for medtech innovation in the U.S. Analysts who contrast universal healthcare as the greater justification for market opportunity than the 50 million uninsured U.S. patients fail to understand that demand exists, and drives, medtech innovation, despite adequate cost mechanisms. This is not a statement of endorsement for the reform-deficient U.S. healthcare system; it is simply a reiteration that market demand (not cost) drives medtech.
So, yes, let's consider Europe (and China, Australia, India, or anywhere else) as potential model(s) for funding medtech, but let's not also lose sight of the big elephant in the room, that insatiable demand for medtech innovation in the U.S. Those who believe that the CE Mark and terms like the "European Union" suggest a consolidated, pan-European market represent an opportunity more attractive than the even dysfunctional U.S. medtech market will be surprised to find the U.S., in an objective comparison, represents a substantially greater attraction, even with all its shortcomings.