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The reason the European market place is so critical to your new medical device is because regulatory approval usually is gained one to two years before FDA approval in the U.S.
The ultimate global success hinges on a ‘make or break’ moment in time when the device is launched on the U.S. market.
Thus, a fortuitous opportunity exists to use Europe, Middle East & Africa (EMEA) to rapidly advance your development efforts in a commercial setting.
Ideally, by the time the new device hits the U.S. market it is on its second or third generation, any training issues are resolved, and one knows how physicians will use the device.
The learning and the credibility in EMEA adds exponential value to a young start-up’s larger goals of succeeding in the U.S. or capitalizing on an acquisition exit strategy at the right moment of strength with a major industry player.
Momentum is value.
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