Medical Device Makers Tackle FDA Rules With PLM

Jeanne Iasella is governed by regulations. Iasella is the CIO at Medrad Inc., a $411-million company that makes devices for imaging and diagnostic procedures. And when Medrad makes a design change -- say, a plastic component is ditched in favor of a titanium one -- that change must be authorized by numerous people within the company and documented.

Focus On: Medical Devices
Top business challenge: To comply with the FDA's ever-changing regulations while managing growth.
Solution: To decrease time to market of new products by streamlining administrative and manufacturing processes.
How IT can help: By deploying product lifecycle and business process management systems to reduce the reliance on paper.

"Just to get the signatures of six people could take months," Iasella says.

As with all companies that make medical devices, Medrad must pay heed to the Food and Drug Administration (FDA), whose mandates cover everything from device design and manufacturing to marketing and processing complaints.

Industry insiders say that the pile of change request documents can be an inch thick. And the FDA requires such documentation for every change related to design, manufacturing, packaging, labeling, distribution and marketing.

While many midmarket firms remain mired in paper, what increasingly defines the $78 billion medical device industry -- besides the looming presence of the FDA -- is growth. The average rate of growth for medical device manufacturers is 6%, according to the Advanced Medical Technology Association (AdvaMed). In the past five years, the Indianola, Pa.-based Medrad has increased its revenue by 15%.

To say Iasella was being choked by the amount of paper is an understatement. To tackle the challenge, Iasella deployed product lifecycle management (PLM) software, which manages the entire lifecycle of a product from its conception stage through its design and manufacturing stages and, finally, through service and disposal.

This was first published in March 2007

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