McClellan Challenges Industry to Improve Development Process

Originally Published MDDI December 2003

NEWSTRENDS

Erik Swain

If medical device manufacturers are serious about getting more products to market quickly, they need to make their development processes more efficient, the FDA commissioner said recently.

Research and development spending in the healthcare industry has skyrocketed in the last decade, but PMA submissions to FDA are down, Commissioner Mark B. McClellan, MD, PhD, told the Cleveland Clinic Medical Innovation Summit in October. 

Private R&D spending for all healthcare sectors has doubled since 1995 to more than $50 billion per year, but “it seems fewer new-product applications are reaching FDA than in a decade,” McClellan explained. “This is not acceptable. Now is the time for more effort. PMAs are way down and I don't see the trend reversing.” 

He acknowledged that the agency can do more to speed up review times and help prevent multiple review cycles, and is committed to achieving the goals outlined in the Medical Device User Fee and Modernization Act of 2002. He said, however, that the review process is a small percentage of the overall development timeline, and more progress will come from industry's improvements in development. Reducing review cycle times “is an extremely important step to companies bringing new-product applications to us, but it has a limited impact on the overall product development impact and cost,” he said. 

He said the agency would make an effort to share its knowledge of how to create efficiencies in development. “FDA has more expertise than anywhere, and we need to share these developments,” he said. “If device developers are not able to take advantage of new approaches, it's because they don't know about them or they don't know how FDA will perceive them. Then device development is longer, harder, and more uncertain than it needs to be.”

Broadly, improving development means “conducting more-targeted clinical trials, coming up with more-reliable manufacturing methods, and bringing in high-quality applications the first time around.” 

Most of his more specific recommendations pertained to pharmaceutical development. But some suggestions, such as using newer technologies in characterizing combination products and implementing six-sigma principles in manufacturing, targeted the device industry as well. 

“More scientific inquiry needs to be focused on how we can develop manufacturing techniques, and make better predictions of safety and effectiveness,” he said.

In an address later in the conference, William C. Weldon, chairman and CEO of Johnson & Johnson (New Brunswick, NJ), noted that medical product development is always going to have some element of trial and error in it, and thus will always have inefficiencies.

“The business of medical innovation is high risk, high reward,” he said. “That's not well-understood by critics. While medical devices can be developed faster than drugs and cost less to develop, the product life cycles are short, and products can be supplanted before reimbursement is arranged.” 

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