Perfusion Insider Fall 2015

State-of-the-Art Technology Helps Maintain Quality Focus at Medtronic Custom Pack Assembly

At the Medtronic custom pack assembly plant in Tijuana, Mexico, MES touch screens ensure all parts match the component assembly before moving on to the next station.

Employees at Medtronic's assembly plant in Tijuana, Mexico, design and manufacture approximately 4,000 custom pack configurations for hospitals in the United States, Canada, Latin American, Japan, and Australia. "Many of these configurations are very complex, with as many as 10 to 15 packs in one hospital," said Aldo Martinez, Medtronic Custom Perfusion Systems General Supervisor, Design and Manufacturing. "We also make, on average, 15 revisions daily to custom packs as perfusionists make changes based on actual usage."

The Tijuana facility handles a broad range of custom pack requests that begin at the hospital-sales representative level. After a preliminary design is completed, a non-sterile sample is sent to the hospital for physical review and set up in the operating room. Upon approval, manufacturing lead time is four to six weeks for the first build. If the custom pack qualifies for Medtronic's Gold Program, offered to new customers and for custom packs with new Medtronic products, clinical product is in place in 14 working days.

Customers can opt for an Inventory Management Agreement (IMA), in which Medtronic maintains the custom pack inventory at one of their distribution centers. With this agreement, inventory level is determined by the hospital and can be as little as one pack or as many as 1,000 – there is no limit. This allows hospitals to carry a small inventory for emergencies and then schedule routine shipments, which frees up valuable hospital inventory space.

Custom pack design and manufacture is a complex, fast-moving process. In Tijuana, this state-of-the-art process begins with an auto-CAD drawing that feeds into the manufacturing processes. Medtronic's unique Manufacturing Enterprise System (MES) maintains quality standards. "With MES, we take a picture of every custom pack assembly," said Martinez. "At every assembly station, a touch screen is used to ensure that all parts match the corresponding assembly. It identifies if anything is missing, added or is the wrong assembly component. The screen flashes a green light if the assembly is correct and then moves on to the next station." There are four production lines with 15 stations on each line, and each one assembles a single piece of a custom pack. Besides communicating whether the assembly is accurate, the MES scans the assembly with video cameras interfaced to touchscreen panels. When the assembly piece progresses from one station to the next, a 100% progression inspection is performed to check the previous operator's work.

When the custom pack is completed and put into the tray, another quality control process weighs the tray and compares it to historical data. If it doesn't meet the given weight, it's flagged and pulled from the line to determine if a component is missing or an additional component has been added. "The entire process speaks of our commitment to quality control," added Martinez.

Tijuana employees maintain close contact with perfusion customers, including field visits, to learn how custom packs are used so design techniques and manufacturing processes can be continuously improved.

"In addition to our quality focus, we are always trying to reduce costs," concluded Martinez. "One way we do this is by optimizing a customer's pack. They see only the clinical part of the pack and aren't necessarily aware of the manufacturing implications. Often, the best way to reduce cost is with a field visit to review the customer's cases to better understand their specific needs."

Martinez observed, "All Tijuana employees are well versed in perfusion and committed to constant improvement. As a result, we can deliver the highest level of quality to our customers and their patients."