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 replaced his company's outdated enterprise resource planning system with Oracle's eBusiness Suite, he had to find a robust barcode scanning and labeling solution that would integrate with the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.
LifeCell enabled that traceability through its Gemini system. The ClearOrbit SCE system provides peel-off stickers to attach to a patient's chart as well as to a hospital's material management log. Each of the approximately 1,000 units LifeCell produces each day must receive an individual SKU number, which is generated by the Oracle system and stored in an Oracle database. ClearOrbit's Gemini software is directly connected to that database and retrieves the SKU numbers along with other information that is to be printed on the peel-off labels. When a shipment is prepared, each SKU is tracked via a barcode scanner that runs on the Gemini software and manages the dissemination of information to and from the ERP system. The highly traceable process also provides precise billing records.
Regulation Recognition
LifeCell Corp. was formed in 1986 to market a unique tissue preservation technology developed by Dr. Stephen Livesey and his colleagues at the University of Texas. Over the next several years, LifeCell's scientists worked to broaden the applications of this technology to a variety of tissues, including dermis, blood vessels, and nerves.
The ultimate result was an acellular tissue "matrix" that resists infection and rejection, can be stored for long periods, and is as strong as synthetics while being far more pliable. In addition to AlloDerm's inherent benefits for reconstructive surgical procedures, it serves as an alternative for a certain percentage of the population that simply doesn't tolerate the synthetic material commonly used in such procedures, according to Hansard.
Human tissues intended for transplantation have been regulated by the FDA since 1993. That oversight got tougher last fall in response to two cases of serious violations of safety requirements pertaining to the recovery of tissues. Current good tissue practices (CGTP) require manufacturers to recover, process, store, label, package, and distribute human cells or tissues in a way that prevents the introduction, transmission, or spread of communicable diseases and prevents contamination during manufacturing. An additional safeguard is the requirement that, if a manufacturer enters into an arrangement with another organization to perform any step in the process (such as recovery), the manufacturer must ensure that those activities comply with applicable CGTPs.
For LifeCell, that means balancing all those considerations with the need for speed. The intrinsic perishability of the company's offerings calls for rapid progress throughout the receiving, processing, and shipping operations, all while maintaining absolute traceability. The result is necessarily efficient, with the Gemini software enabling rapid movement and error prevention.
"Manufacturers today don't want to be in the warehousing business," Sumner says. Many manufacturers used to maintain large warehouses, but with the current widespread emphasis on lean methods to streamline shipping operations, inventories are minimally maintained, he adds.
Sumner says ClearOrbit's other medical and pharmaceutical manufacturing customers face similar FDA requirements, which also call for complex labeling capabilities. Most of these customers run ClearOrbit's rules-based label compliance manager product, with which business managers can make changes to the software's configuration without having to involve their IT departments, as it negates hard coding between applications.
LifeCell has worked with ClearOrbit over the course of the companies' relationship to add functionality to the SCE software. "We strove for enhancements the whole [medical/pharmaceutical] industry needed regarding FDA's robust requirements," Hansard says. "The needs of regulated healthcare manufacturers often come as afterthoughts because it's a relatively small vertical."