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    Features

    Realizing the Promise of Pre-Validated Packaging

    Balancing product quality, patient safety, and faster time to market is possible—it takes careful consideration in packaging design and validation.

    Realizing the Promise of Pre-Validated Packaging
    Class 10,000/ISO 7 cleanroom medical device assembly and packaging operations. Image courtesy of Millstone Medical.
    Ben White, Engineering Manager, Business Development, Millstone Medical Outsourcing02.13.19
    Time to market is critical to success for OEMs when it comes to launching new product lines and devices. Yet, despite the pressure and desire to speed time to market, an OEM can never lose sight of the top priorities of product quality and patient safety. The risk is otherwise continual, and unanticipated delays can impact product launches; or, in worst-case scenarios, new technologies never reach the market at all. With the rise of robust pre-validated packaging and universal packaging solutions, preserving quality while cutting time to market by up to 50 percent is possible. This article examines the rise of pre-validated and universal packaging solutions, the promise of compressed product launch timelines, and the risk mitigation these options offer.

    Increased Scrutiny for a Growing Market
    The medical implants market is growing rapidly, projected to garner $116 billion by 2022.1 Orthopedic implants represent the largest growth sector of this market, as an increasing number of patients ages 55+ worldwide opt for surgeries that improve and extend quality of life. An increase in the aging population of the United

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