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FDA's Marlowe Addresses Medical Device Makers

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year's HealthPACK medical device conference in New Orleans.

"Packaging is one of the most important issues in designing medical products," Marlowe told an audience that by unofficial count was about 160.

He also said "packaging contributed to the largest number of product failures," although not recalls. The problems included mislabeling and seal failures.

Marlowe said that in looking for next-generation packaging, two key issues must be addressed: Quality by design, and a commitment to the development of performance standards for medical device products.

"Quality has to be designed in from the beginning," he said. "Companies need to include packaging engineers in the design team. Packaging machinery tends to be an afterthought in some companies. That has to be integrated into the design and production stream of the company."

He also recommended that medical device manufacturer representatives should "get into operating suites and watch from the gallery to see how their products and packaging are used, talk to physicians that use the products, and witness the way they open, dispose, and use their package. You'll find it to be very instructive."

HealthPACK is dedicated to creating a forum for ideas and solutions to help medical device professionals create efficient, innovative packaging. The event includes conferences, tabletop exhibits, and opportunities for attendees to focus on key industry issues while addressing individual needs with leading suppliers and service vendors.

New HealthPACK management

Near the end of the event's first day, Pat Farrey of Landon, Farrey & Associates, Inc. (LF&A) announced that LF&A will manage and produce HealthPACK. LF&A specializes in providing professional management services to packaging-related associations and conferences.

Farrey noted that next year's event will take place March 4 – 6, 2008, at the Sheraton Gunter Hotel in San Antonio. More information is available at www.healthpack.net. Farrey thanked Steve Bunnell, Colleen Murphy, and Guy Wray for their work in HealthPACK's continued growth, and announced that Curt Larsen and John Spitzley would continue in their roles as program co-chairmen. [HCP]

By Jim Butschli, Editor
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