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 replaced his company's outdated enterprise resource planning system with Oracle's eBusiness Suite, he had to find a robust barcode scanning and labeling solution that would integrate with the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.

Because of the nature of its products, LifeCell's operations are heavily regulated by the U.S. Food and Drug Administration (FDA). The manufacturing process must be highly documented, from the initial receipt from skin donors, through processing in sophisticated clean room environments, to final delivery to a hospital operating room.

Tracing the Steps

Most of LifeCell's extensive in-house data resides in its Oracle ERP system. Each highly detailed step in the manufacturing and distribution process must be tracked and remain traceable throughout the company's entire supply chain — right into a hospital's operating room — and beyond, when it becomes part of the recipient patient's records.

To achieve that visibility, LifeCell chose ClearOrbit's Gemini supply chain execution (SCE) software. Hansard says LifeCell conducted a thorough examination of the solution landscape and found that Gemini was the only SCE solution that filled the company's requirements for robust scanning and label generation capabilities and also integrated smoothly with the Oracle ERP system — without the need for expensive custom coding.

Warren Sumner, ClearOrbit's vice president of marketing and strategy, says that many of his company's customers use the Gemini barcode label and tracking software in tandem with an ERP system to manage their shipping and receiving processes. The ClearOrbit software "puts Oracle on handheld devices and simplifies [the] user's interface to Oracle," Sumner says. Gemini also tracks the movement of materials from receipt through manufacturing operations and then through outbound shipping.

Hansard says that while it is physically possible to comply with FDA guidelines using a paper-based manual process, it simply doesn't make sense because the chance of human error is so great due to the sheer amount of data and steps involved in LifeCell's internal and external tracking processes. Automation, on the other hand, because it can guarantee compliance with the various guidelines and regulations a company like LifeCell must adhere to on a daily basis, is a must-have for his company and for the healthcare industry as a whole, he says.

"Manufacturers must produce a genealogy for everything made in healthcare," Hansard says. Keeping complete batch records — a standard part of any pharmaceutical or medical manufacturer's practice — calls for a robust system designed for applying barcoding and laser scanning capabilities, as well as tracking the lot numbers on the tissues LifeCell receives from its suppliers. In the event of a recall, that information ensures the best possible medical care for patients who have received the company's products.