The FDA will pilot 3 kidney disease therapy devices through the federal watchdog agency’s Innovation Pathway program, aiming to reduce the cost of getting life-saving devices to market.
The watchdog agency selected an implantable renal assist device under development at the University of California in San Francisco, a wearable artificial kidney by Blood Purification Technologies Inc. and a hemoaccess valve system from CreatiVasc Medical.
Each device meets a need in a the end-stage renal market, which Medicare alone paid $29 billion for in 2009, Center for Devices & Radiological Health chief Dr. Jeffrey Shuren said during a conference call today.
The FDA will launch each project using a team-based approach and dedicated resources, including an assigned case manager to shepherd the devices from early research through clinical studies and finally to the market.
The FDA hopes that, in creating a road-map for review, they can avoid pitfalls for products that are so different from existing devices that decision-makers can’t rely on precedent in managing scientific and risk-benefit concerns, often resulting in 4 to 7 years of back-and-forth between the device maker and the agency, Shuren said.
"Because we’ve done all this work in advance and we’ve cut out a lot of inefficiencies and we know a lot of the answers in advance, our sense is that many of these applications for the high-risk products are going to be more likely to fall in the category of timeframe that we are trying to achieve, and have yet to have achieved, for our expedited review, and that’s approximately 180 days," Shuren said. "That’s where we’re kind of shooting for."
Although the program focuses on ESRD therapies, the federal watchdog agency plans to apply the lessons learned to future medical device review programs, and potentially to larger government initiatives.
"The FDA, in the course of 6 months, put together an amazing team of the best internal innovators at the centers and external entrepreneurs in residence, who teamed up in lean-innovation mode to put together this incredibly exciting new pathway and news tools that will be utilizable across all of the pre-market programs," the White House’s brand-new chief technology officer Todd Park said during the call. "Actually, we’ve been so enthused about the success that we’ve been seeking to clone this innovation mode of development across HHS and potentially more broadly across the government as well."
The agency debuted its Innovation Pathway in February 2011 with a military project to create a prosthetic arm controlled by a brain-implanted microchip, granting the device priority review. The FDA announced in January that it would launch Innovation Pathway using its Entrepreneurs in Residence Program, a collaborative initiative aimed at bringing outside experts into the fold, including the recently retired CEO of Medtronic(NYSE:MDT), Bill Hawkins.
