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Global Medtech Industry Holds Steady Amidst Recession
Date:10/13/2009

marketing clearance, which requires that a product be substantially equivalent to a device cleared by the FDA or marketed before 1976. Changes to the approval process could increase the time and expense of bringing new products to market.

Medtech business model under strain: Financial and regulatory developments are placing increased strain on the traditional medtech emerging company business model, which is based on a streamlined regulatory pathway that allows for rapid innovation cycles and relatively quick exits for investors. In addition to potentially longer product approval timelines and increased reimbursement uncertainty, reduced levels of capital across the global financial markets will result in less capital invested in medtech and likely a drop off in M&A exits in the sector. This will create new challenges for companies to fund their innovation and provide adequate returns for their investors.

"While the industry faces financing and other challenges, it has successfully used its ingenuity to overcome similar issues in the past," remarked Heinrich Christen, Ernst & Young's Medtech Leader for Europe, Middle East, India and Africa. "Within this challenging environment, companies will need to be nimble and creative in tackling a host of challenges simultaneously, including: using capital more efficiently, adapting business strategies for a changing regulatory environment, finding new methods to demonstrate product value, and embracing innovation in their business models as much as they do with their products."

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