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Responsiveness and Planning Ensure Success in Quality Management

Medical Device & Diagnostic Industry
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An MD&DI February 1997 Column


Peter Chevalier has taken his work to heart, literally. Chevalier is not only a vice president and the chief quality and regulatory officer of Medtronic (Minneapolis), but he is also one of its customers. Nearly half of the pacemakers in the world are manufactured by Medtronic--his included.

Chevalier joined Medtronic in 1981 as director of clinical evaluation for the company's pacing business. He was director of research and development for Medtronic's heart-valve business from 1985 until his promotion to vice president of corporate regulatory affairs. In 1993, he was named chief quality and regulatory officer.

In his years at Medtronic, Chevalier has been responsible for several quality innovations. For example, he advocated the formation of an internal quality council, a monthly meeting of senior quality professionals representing all of Medtronic's business and geographic units. The quality council sets the overall company vision, which the individual quality managers must then implement in their areas of responsibility.

Chevalier credits some of the success of the council to a focus on supporting company managers, who have to actually implement the quality policies. "We try not to be too prescriptive," Chevalier explains. "We'd much rather have them understand what we're trying to accomplish and have them develop their own ways of doing it. That way they have greater ownership."

The council also helps to ensure a shared focus within an increasingly global company, although international differences in quality and regulatory standards are rarely a concern because Medtronic has continually revised its standards upward in anticipation of ISO 9000 and FDA's quality system regulation. "We've put in place a quality management system that meets all requirements around the world," Chevalier says.

In the past, many of the company's quality improvement decisions were based on data gathered on an annual basis. "As time has gone by, we've realized that, with the marketplace moving as rapidly as it is, a once-a-year approach is not going to be as effective," Chevalier says.

Now Chevalier places a greater emphasis on continuous feedback from the company's 30 so-called listening posts. These posts include everything from one-on-one meetings with physicians and buyer groups, to surveys distributed via the Internet, a recently introduced method welcomed by many physicians.

Chevalier came to the device industry with varied career experiences in both the public and private sectors. Before his arrival at Medtronic, Chevalier, who holds a doctorate in physiology, pursued a traditional career in academic medicine, first at the University of Delaware (Newark) and later at the Mayo Clinic (Rochester, MN), where he was professor of physiology and medicine.

He then went on to spend two years as associate director of lung diseases for the National Heart, Blood, and Lung Institute (Washington, DC), an experience that exposed him to the inner workings of life within the beltway.

"Having come here with that perspective, it's made it a lot easier for me to deal with legislative committees and to really understand how the federal government operates," he says. That perspective has also helped make Chevalier a strong and effective proponent of FDA reform. Chevalier recasts the traditionally pro-business stance of calling for limits to agency regulation in terms of his concern for patients. "FDA needs to become a patient advocate--not a business advocate, and not a consumer advocate," Chevalier says. "Patients need and want access to the latest technology, devices, and therapies."

According to Chevalier, patients often do not get fast enough access to new products in the United States, where approvals for Class III products lag three to four years behind the rest of the world. Chevalier is hopeful, though, that the new Congress will pass pending legislation aimed at shifting product liability burdens away from manufacturers of biomaterials, and at forcing FDA to meet its statutory requirement of approving Class III devices within 180 days.

He hopes that FDA will evolve to face the realities of the global market. The ability to be responsive to a changing world

is, according to Chevalier, the key to succeeding in life as well as in business. Says Chevalier, "The health-care environment around the world continues to evolve, so we need to continually look at where we're headed."

Copyright © 1997 Medical Device & Diagnostic Industry

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