Globalization Countries outside the United States can offer new markets for all medical technology companies seeking growth. Often, a European product launch can offer insight into the U.S. market potential for the product. When it comes to assessing the global potential of a medical technology, however, international experience is not always the bellwether that companies and investors seek. For instance, European product launches of stents and catheters accurately signaled their success in the United States, while launches for spinal fusion cages and alternative wound-closure products indicated quite the opposite fortune. To Wall Street investors, expansion abroad certainly fuels desire for growth.
Large companies are most likely to be rewarded for such expansion outside the United States.
By contrast, smaller companies are likely to experience intense scrutiny, as investors look for any sign of weakness in the companies' ramp-up of European sales. However, recent reforms have transformed the process into a more understandable and quantifiable sequence of events. Investors have applauded these changes because they make it easier to calculate the potential risks and rewards that may be involved in a particular product's development and approval to market. By far the loudest applause has gone to FDA's ongoing efforts to speed up review times. Compared with the one to five years that the agency was taking to process PMAs not too long ago, the new figures are encouraging.