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Government and medical technology leaders on Wednesday took what they say is the first step toward more quickly -- yet safely -- developing, testing and approving new devices in the United States.

The idea behind a memorandum of understanding between the Minnesota trade association LifeScience Alley and the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is to find common ground and improve collaboration in the area of regulatory science, said Dr. Jeffrey Shuren, director of the center.

If the industry, academia and the FDA can work together to develop and share expertise and technology, Shuren said, it can eventually shorten the approval process and reduce the cost for new devices. That's a critical issue in Minnesota, home to industry leader Medtronic and hundreds of smaller device companies.

"This could reduce the time from development to approval by months to years and cut costs by millions," Shuren said.

LifeScience Alley and CDRH officials have been meeting for more than a year to come up with ways to advance what Shuren calls "regulatory science." They announced the memorandum of understanding, which was also signed by Gov. Mark Dayton, at the LifeScience Alley Conference & Expo at the Minneapolis Convention Center.

Regulatory science refers to the tools, methods and approaches used to assess the safety, effectiveness, performance and quality of medical products, Shuren said.

Dale Wahlstrom, president and CEO of LifeScience Alley and the BioBusiness Alliance of Minnesota, called the agreement "a critical step in the process of realigning the day-to-day interactions between medical device companies and the FDA."

He added: "It builds the foundation for specific projects that will improve the environment in which the medical device industry is operating, which will help to ensure the availability of life-enhancing and lifesaving devices for patients."

Rather than 20 companies working on a cardiac device conducting 20 separate tests for the FDA to assess, Shuren asked, what if those 20 companies worked together to develop a single test? That would save time and expense. Or, instead of conducting battery after battery of clinical trials on living patients, companies shared computer models to eliminate some of those rounds of tests?

"We're not talking about sharing technology to share your devices," Shuren said. "We're talking about sharing the tools used to assess those devices."

But Allan Robinson, whose company, NeoCardial Technologies, faces another six years of work before reaching clinical trials on its cardiac assist device, said he is skeptical.

For one thing, he said, there already are plenty of computer models and accepted tests out there that could be used by the FDA to shorten the approval process. Yet, Robinson said, his company will spend years and up to $60 million before its device hits the market.

"Those things have been sitting around for a long time," he said. "The proof is in the pudding."

But Shuren pointed to dozens of collaborative projects already taking place among the CDRH, universities and medical technology companies, developing virtual patients and more detailed computer models of the human heart, the circulatory system and the skeletal system.

By working cooperatively to more quickly assess potential flaws and successes with devices before clinical trials begin, the entire approval process can be improved, Shuren said.

James Walsh • 612-673-7428