From Bench Top to Bedside
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There are many reasons for the current growth spurt in medical device innovation. For one thing, aging baby boomers are more than happy to spend their money on devices that will help them live longer or better.
"You see a bigger growth [in innovation] in areas associated with an aging population," says Jay Goldberg, the director of the health-care technologies management program at Milwaukee's Marquette University, who points to examples in orthopedics and the cardiovascular arena.
The spread of diabetes is creating a growing market of consumer medical products such as blood-glucose meters. And on the regulatory front, the Food and Drug Administration, the agency responsible for approving new devices, endorsed new design standards in 2001 that have forced every device manufacturer to focus on human factors in design.
"There's a new focus on innovation and ideas that change health care for the patient," said Mary Beth Privetera, a faculty member in the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati.
Privetera said the best product design goes from "bench top to bedside," meaning that it reflects the latest advancements in medical science and product engineering, as well as the functional, ergonomic, and other needs of both doctors and patients.
Political and social changes can create new needs, which open up opportunities for innovation. Rising obesity rates, for instance, and the "graying" of the U.S. have spurred development of insulin-management solutions and a new hip-replacement technique. War, Privetera points out, drives improvements in prosthetics.
BUILDING ON SUCCESS.
Other innovations reflect more incremental breakthroughs in diagnostic or imaging technologies. New CT scanners, for example, are smaller or more powerful than previous models, though the basic technology has not changed. These advances can have significant impact, either by bringing the cost down, by allowing hospitals to bring the machine to the patient rather than the other way around, or by enabling doctors to catch diseases far earlier.
Such incremental innovations also offer manufacturers a regulatory advantage. By building on old technologies rather than starting from scratch, manufacturers can move new products to market quickly, without being stalled by FDA-mandated clinical trials. "Companies are always jockeying to be the next one with the one generational advance," said Steve Halasey, an editor at Medical Device & Diagnostic Industry magazine, adding that progress in the medical device industry is more incremental than in other subsectors such as drugs or biotechnology.
After reviewing products introduced over the past few years and talking to industry experts, BusinessWeek.com selected 10 innovative products to highlight. The Birmingham Hip, for instance, uses a new material to revolutionize hip-replacement surgery, while the OmniPod Insulin Management System makes diabetes treatments needle-free.
We focused on products that improve on an existing solution or address a previously unsolved problem—from high-tech CT scanners to an ear curette that incorporates the old technology of LEDs. Some, like the LifePort kidney carrier, can be life-saving. Others, such as a solar-powered battery recharger, will bring hearing aids within reach of millions in the developing world. Every one of these products relies on a winning combination of technology and design to fill a medical need.
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