Originally Published MDDI
August 2004
Looking Ahead
Industry Pioneer
Michael J. Miller
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Not many people can say they’ve held the same leadership position for 35 years. But Michael J. Miller has been CEO of the Association for the Advancement of Medical
Instrumentation (AAMI) since 1969, two years after its founding. During that time, he has overseen the development of safety and technical standards and educational programs in the United States and around the world.
In AAMI’s early years, the organization played a crucial role in shaping the United States’ first attempts at medical device regulation. It convened a conference in 1969 that brought together industry, government, doctors, hospitals, and academia to produce a report that outlined the principles for the first medical device regulations in 1976.
“In the 1960s, doctors were creating devices on an ad hoc basis, and manufacturing companies saw more opportunities to produce devices,” Miller says. “Both groups wanted to make sure that legislation did not restrict or hinder the development of devices.”
By the time regulation came into play, HIMA (now AdvaMed) was formed to be the industry’s trade association and Washington lobby, and AAMI took up voluntary standardization as its main cause, with consensus instead of advocacy as its mode. “Our focus shifted to education, standards, communication, and providing a basis for understanding the regulations as a means of enhancing safety,” Miller says.
Once Europe adopted a common market, the landscape for international standardization was set, and Miller played an integral part in getting the U.S. device industry involved in the global process. AAMI members became the U.S. representatives to a number of committees that wrote crucial standards sanctioned by ISO and other international bodies. FDA adopted a number of them as consensus standards, making the inspection process less burdensome for firms that demonstrated that they were following them. “These efforts are important not only because they forge consensus and enhance safety, but also because they make sure that world markets stay open,” Miller says.
Miller, who has a law degree, came to AAMI because he decided working with an association would be more interesting than practicing law. He has stayed for 35 years because “it’s been an excellent way to make an impact.”
Copyright ©2004 Medical Device & Diagnostic Industry
