It looks like a marriage made in marketing heaven: combining drug components with already FDA-approved medical devices to yield drug-eluting stents, drug-delivery pumps, and other combination products. Navigant Consulting forecasts the market for combination products at an estimated $9.5 billion worldwide by 2009. Pharma and device companies are pushing new business frontiers to remain competitive, but new challenges are also encountered as they pursue these boundary-blurring innovations. Combination product shelf life, sterilization, FDA classification and regulatory issues, as well as cross-corporate cultural differences have emerged as potential roadblocks to a happy union. Can the merger of technologies benefit your operations and bottom line?
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