Harmonizing Quality Systems for the Global Market

Medical Device & Diagnostic Industry Magazine
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An MD&DI April 1998 Column

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Like everyone else in the medical device industry in the early to mid-1970s, Ed Kimmelman watched with concern and interest as FDA struggled with the task of developing and implementing medical device regulations. Now program director of regulatory affairs and regulatory compliance at Boehringer Mannheim Corp. (BMC) in Indianapolis, Kimmelman remembers participating in working groups and technical committees to develop guidance and other effective inputs to the agency during this period. He has continued that effort through the years.

"At first, FDA used a light touch in regulating medical devices," says Kimmelman, "which was appropriate in light of their good safety and performance records. Unfortunately, in the 1980s there were a number of embarrassing public health issues and situations, which led to an internal study to revamp and strengthen the medical device regulations. However, the revised approach resulted in unreasonable backlogs in device approvals and clearances."

To its credit, says Kimmelman, "in recent years FDA has tried to overcome these difficulties and has enlisted the support of and used the input from the device industry in revising the regulations.

"I'd like to see FDA continue its efforts to move regulation closer to the European model," Kimmelman says, "which relies heavily on the use of full quality assurance programs, including design control systems that are described in international standards like ISO 9001 and ISO 13485 and the European regional standard, EN 46001. Such an approach would be effective and less costly to all involved, especially for less-risky medical devices and most in vitro diagnostic devices."

Kimmelman has worked not only to develop appropriate regulations but also to help define and implement strong, effective quality systems. As the convenor (chairholder) of the ISO TC 210 working group #1, he currently leads a team of international quality systems professionals who are developing standards and guidelines for the medical device industry. "Part of our work is to tailor for the industry standardization work that has been done for more general application," Kimmelman explains. "We're also working to internationalize the input provided by regulatory focus groups like the Global Harmonization Task Force and regional standards like the European CEN." The working group has developed two standards, ISO 13485 and ISO 13488, that include specific medical device quality system requirements. The working group has also developed a guidance document for the implementation of ISO 13485 and ISO 13488, which is currently working its way through the ISO consensus process.

Kimmelman joined DuPont's (Wilmington, DE) photo products department in 1962 after graduating with a degree in mechanical engineering from Cornell University (Ithaca, NY). During his first four years with DuPont, Kimmelman earned a law degree in the evening from Seton Hall University School of Law (Newark, NJ). Kimmelman's stay at DuPont was sandwiched around a three-year hiatus in which he jointly owned and operated a small engineering and manufacturing firm in Charlotte, NC. When he returned to DuPont in 1973, he began working with medical device regulatory affairs and compliance. Starting as a regulatory affairs specialist, Kimmelman eventually headed up that activity at DuPont and then migrated into the quality systems field.

In 1992, Kimmelman took advantage of an attractive retirement package from DuPont. He left the company on June 30, and was in his new office at BMC on July 1, enjoying a 14-hour retirement. The short retirement suited Kimmelman's personality—he says he likes to keep active. Today at BMC, "I'm moving more toward working on projects rather than being manager of regulatory affairs professionals," he says.

Kimmelman believes that through hard and smart work, persistence, and patience, it will be possible to achieve a high level of harmonization in the medical device field. "The nationalistic efforts of some countries to prevent true harmonization are short-term influences that will ultimately be overcome by reason and the economic realities that are facing the industry and government," he says.

"Harmonization efforts must focus on ensuring processes that provide safe, effective, and innovative medical devices and diagnostic products at a reasonable cost," Kimmelman adds, "with only those regulatory hurdles that are absolutely necessary." He plans to work toward that objective for the rest of his professional career with the hope that he will benefit from that effort when he really retires.

Annie Gorton is a freelance contributor to MD&DI. She is based in Redondo Beach, CA.