Innovating a Critical Path

Posted by mddiadmin on May 1, 2004

Originally Published MX May/June 2004


For medical device companies seeking to bring innovative products to market, maintaining the confidence of investors is an ongoing struggle. To do so, medtech executives must repeatedly demonstrate their preparedness to overcome whatever obstacles may stand in their way.

Such obstacles to innovation are the subject of a recent FDA white paper, Innovation, Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, issued in March. The report evaluates the slowing pace at which innovative medical therapies are reaching patients, and asserts that "If the costs and difficulties of medical product development continue to grow, innovation will continue to stagnate or decline, and the biomedical revolution may not deliver on its promise of better health."

In FDA's view, such obstacles can have a chilling effect on industry. "For very innovative and unproven technologies," says the report, "the probability of an individual product's success is highly uncertain, and risks are perceived as extremely high. Whole fields may stagnate as a result of the failure of early products."

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