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FDA's Marlowe addresses medical device makers

The Food and Drug Administration continues to be challenged by limited financial resources.

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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 of 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.

Packaging must be integrated from the start

“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.

HealthPACK concludes March 9 and will include a morning Standards and Technology Track followed by an International Packaging Track.

A change to new conference management starting with next year's show was also announced. Click here for more information.

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