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Editorial from the April 2007 issue of Managing Automation

Every Step of the Way

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Abstract:Biomedical manufacturer LifeCell Corp. takes supply chain execution to the next level, applying just-in-time track and trace to its products under the watchful gaze of the FDA.
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Hugh Hansard faced a common challenge. After the vice president of manufacturing operations and information technology at biotech manufacturer LifeCell Corp. replaced his company's outdated enterprise resource planning system with Oracle's eBusiness Suite, he had to find a robust barcode scanning and labeling solution that would integrate with the new system and support the company's just-in-time supply chain.

It sounds like a straightforward mission, but Hansard's company is no ordinary manufacturer. LifeCell is one of only a handful of U.S. biomedical companies operating in the relatively new field of biosurgery. LifeCell makes regenerative, human-derived tissue that aids the body's healing process after reconstructive surgical procedures, which means the company must observe stringent governmental regulations for tracking and tracing its products.

LifeCell's first clinical product, AlloDerm, was brought to market in 1994. Used in a variety of applications, including plastic reconstructive, general surgical, burn, and periodontal procedures, AlloDerm is described as a "human dermal matrix." It is derived from de-cellularized skin, which acts as a scaffold for the repopulation of a patient's normal tissue. The matrix enables the human body to regenerate lost tissue in the same way that it naturally replaces damaged or inadequate tissue throughout life.

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