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Trend spotting: Medical device packaging poised for automation

Long thought of as one corner of the packaging field where volume dictates manual packaging, medical device firms are starting to seek out help to automate production, assembly, and packaging. But a crucial piece of the puzzle, training automation technicians to work in a "validated environment," was missing until recently.

Pressure on device manufacturers started in the mid-1990s when the federal government (Medicare and Medicaid) instituted the DRG (Diagnostic Related Group) coding system. Uncle Sam decided what the hospital would be paid for room, drugs, surgery, prosthetics, therapy, etc.

This put huge downward price pressure on the manufacturers. Hospital buying groups, seeking volume discounts, picked two or three suppliers to bid for all the business, in exchange for even steeper discounts.

And the private insurance industry, taking the lead from the federal government, adopted DRGs as well, spawning a whole new industry in medical coding. Yet, automating the labor-intensive medical device packaging process still did not make economic sense.

Enter a second trend—the graying of the population. With seniors living longer, the demand for procedures like prosthetic hip replacements and interocular lens implants has skyrocketed.

Stuck in the "all by human hand" mode, device manufacturers have to keep hiring unskilled workers and train each one to operate in a validation environment.

With severe price competition and growing demand, coupled with rising labor and training costs, automating any part of the process—from manufacturing through product handling, assembly, and packaging—looks like an idea worth exploring.

Enter Dr. Ken Ryan, director of manufacturing automation research and education at the Center for Automation and Motion Control, Alexandria Technical College, Alexandria, MN. According to Dr. Ryan, Minnesota is the second-largest cluster hub of medical device manufacturing next to Boston, MA.

"I've got medical device manufacturers telling me they will take all the technicians I can train," says Dr. Ryan. A new facility recently opened in Maple Grove needing between 30 and 40 automation technicians.

Dr. Ryan quickly identified a key missing piece of the puzzle. "The manufacturers were impressed with our technicians' knowledge of automation," says Dr. Ryan. "But they requested we cover the basics of working in a validated environment."

Ryan and Alexandria Technical College responded by introducing a course that includes the basics of chemistry, biology, medical terminology, etc. Technicians are learning automation, but with an eye for Food and Drug Administration regulations, documentation, risk assessment, etc.

Growth can be expected for machine manufacturers—those making robots in particular—as well as suppliers of vision systems.

Ryan is convinced the complex validation issue alone would have eventually justified packaging automation even without all the other drivers.

"You must train the human each and every time," says Ryan. "You design the machine and it remembers forever."

--By Jim Chrzan, Publisher
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