Remember computer companies' promises about creating a paperless society? If you don't recall, it's because those promises were swamped by the reams of paper spewing from printers. But soon, thanks to new federal regulations, paper could finally be history, at least in the world of medical design.
Medical device manufacturers now can submit the documentation for their new products for approval either by paper or in electronic form. But new rules promulgated by the U.S. Food and Drug Administration will force manufacturers to choose either paper or electronic format by 2005. The betting is that no one will choose paper. That means CAD, FEA, and PDM (product data management) software will become even more important in the medical industry.
Among federal requirements that will boost usage of PDM is one condition that will force manufacturers to ensure that only those people with specific authorization will be able to access design data. All PDM systems—from PTC's Windchill (www.ptc.com) to EDS's TeamCenter (www.eds.com) and Dassault's SmarTeam (www.3DS.com)—make provisions for that kind of security.
"We use the public key infrastructure, so when an engineer opens an application, he provides an electronic signature using some device, like a card, retinal scanner, thumbprint, or whatever they choose," says Greg Cathcart, director of life-science applications at PTC.
Of course, medical-device design engineers already are among the biggest users of 3D solid modeling, and for good reason. "It works," says Maurice Lavimodiere, engineering manager at Southmedic Inc. (www.southmedic.com, Barrie, Ont.). "With wire frame, too often you'd draw something, then flip and find it was not right, so you would have to redraw it."
Using SolidWorks 3D solidmodeling software from SolidWorks Inc. (www.solidworks.com), Lavimodiere recently designed an oxygen delivery system that operates much like a telephone headset, so it is not as irritating as many other breathing assistance devices. "A tremendous increase in design speed" was possible, since the solid modeling was right the first time, he says. That freed him from the touch-up that often forced him to trim lines on wire frame models.
It isn't just in the design period alone that CAD tools impact time to market. If those tools provide good documentation, they can shorten the approval cycle. Shaving a couple of months off the FDA approval time and bringing a product out earlier can mean as much as 50 percent more sales during those two introductory months, PTC's Cathcart says.
Additionally, design engineers are turning to CAD tools for visual representation when they need to make presentations.