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.
"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.
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