Ever reach into your pocket and find a little piece of paper that reads, “Personally Inspected by No. 13?” Ever wonder who No. 13 is?

I watched, with amazement, the manufacture of something more critical than clothing and heard stories of people actually tracking down the maker of the item. In this case, the item is a heart replacement valve. And while the recipient of the valve does not get a little piece of paper with a number on it, occasionally they seek the person who made the heart valve keeping them alive. How they do it is another, longer story. This story is about packaging and transporting of these vital parts. It’s an engaging story.

The Tour of Advance Manufacturing, produced and directed by Development Counsellors Inc., has taken me to some fascinating places. Few, however, have offered the absorption of Edwards Lifesciences in Irvine, California, a thriving business climate, even during these troubled times.

Edwards has been manufacturing life-saving and life-extending products for more than 30 years. Jim Zeferjahn, its global supply chain vice president, says until recently the company had a rather conventional distribution system with 38 centers around the world. He has now consolidated those centers into a dozen regional hubs, making it possible to get a heart valve delivered to a surgeon anywhere in the world within four hours.

Valves are not built on a just-in-time basis. Zeferjahn calls it an order/replenishment process — building to a push-forecast. “Actually, the demand for heart valves is relatively constant,” says Zeferjahn. “Demand is so predictable, the push-forecast methodology is more on target than a rarely accurate sales-driven guesstimate.”

And how does this affect the packaging function? Because of consistency in forecasting, with performance-based packaging, Zeferjahn has been able to use less-expensive forms of shipping. “We ship 80 to 90 percent of our products overseas via ocean container,” he says. And designing a package for the environment it will pass through is much easier than designing for the unknown.

Heart valves do, however, create some interesting packaging challenges. Because packages will be traveling in sea containers, special temperature monitors are installed on the packages. Humidity inside the sea containers and distribution centers is also monitored. The porcine heart replacement valve, Edwards’ biggest seller, has a shelf life of about two years. Once it’s inside you, you’re good to go for many more.

Todd Abraham, vice president, manufacturing, says the nature of the product is such that the company ships a lot of air. Each valve is sealed in a bottle, placed in a specially designed box, then with multiple boxes, into another container with the thermometer mounted on the outside.

Edwards has recently reconfigured its packaging functions into three teams. One team works directly with new product development engineers. They are in at the beginning to lend their expertise to the manufacturing process.

A second team works specifically on existing packaging problems. They are tasked with finding ways to do better what they’re already excellent at doing. Quite a challenge.

A third team has been formed to handle labeling issues. Edwards produces labels in 11 languages for its products. There are mandates from the Food and Drug Administration as well as compliance requirements from customers making demands. In addition, Abraham says the company is currently involved in two RFID tag initiatives — for inventory tracking and tracing — not to go on the valves. One involves smart shelves at the customers’ locations to automatically trigger replenishment.

So, in these uncertain times, when many companies are cutting packaging staffs and giving the work to mercenaries, it warms the cockles of my heart to find a company recognizing the importance of the role of company packaging engineers.

Clyde E. Witt, executive editor

cwitt@penton.com