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The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that speaker after speaker at the annual Medical Device Innovation Consortium (MDIC) forum lauded the benefits of the government partnering with industry to bring medical devices to market faster. That’s not surprising considering MDIC bills itself as “the first public-private partnership created with the sole objective of advancing medical device regulatory science in an effort to improve product safety and performance while reducing cost and time to market.”
Robert Califf, MD, a cardiologist and longtime researcher at Duke University recently nominated by President Obama as the next commissioner of the U.S. Food and Drug Administration (FDA), gave the keynote address at last week’s event in Washington, D.C. Closer collaboration between government and industry is the wave of the future, he says.
“The value of public-private partnerships has to be kept nonpartisan and nonbiased, and I think the public is aware of that,” Califf, who is currently the second-highest ranking official at the FDA, told a packed audience.
Calling this “a new day,” Califf said patients and consumers now are players on the healthcare team. As such, device manufacturers should keep patients front and center. They should bring them to the forefront to talk about how the devices will impact their care.
“There’s an ecosystem, and I think it’s working,” Califf says. “Patients are driving quality measures. Patients are driving the need for good data. We need to hear from people about their problems.”
Speaking from the industry perspective, William A. Hawkins, retired Medtronic chairman and CEO, said the medical device industry is predicated on innovation.
“Most everything we did was in collaboration with the clinical community,” he says. “It takes a village.”
Manufacturers continue to face significant challenges in bringing products to market, Hawkins says, including the rising costs of healthcare, the increase of chronic disease, and a strict regulatory environment.
“The cost of clinical trials is increasing,” Hawkins says. “There is a burden on industry to bring technology in a timely way. There are more requirements for evidence. How do we strike the right balance?”
The answer is public-private partnerships, Hawkins adds.
Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the FDA, says while the United States has the one of the highest regulatory standards in the world, it sometimes creates disincentives for innovators who are trying to bring devices to market. The big question then becomes how do you reduce the time and cost of developing a device and bringing it to market without compromising quality and safety.
“The best and most feasible solutions are public-private partnerships,” Shuren says, adding that those partnerships are a “force multiplier.”
The CDRH already is using information from these partnerships to inform its decisions, Shuren adds.