Innovation fast-track?
FDA program aims to speed device approval
The Food and Drug Administration is shepherding some promising medical devices to market, but it’s unclear whether the initiative will satisfy the industry’s complaints that the agency’s reviews are slow and unpredictable.
The FDA’S Innovation Pathway program, launched in 2011, matches the makers of “breakthrough” devices with an FDA case manager in an effort to reduce the time and cost it takes for a company to bring a device to market.
The FDA has two goals: shorten the time from concept to market, and transform the relationship between the FDA and industry, said Megan Moynahan, acting associate director for technology and innovation in FDA’S Center for Devices and Radiological Health.
“It will stretch the bounds of our understanding of the science and the regulation,” Moynahan said.
Four devices have been selected to partici- pate in the program, including the three products used to treat end-stage renal disease that were announced last week as the latest Innovation Pathway participants.
The devices include a dialysis-access graft device that allows clinicians to selectively control blood flow, which was developed by Greenville, S.C. devicemaker Creativasc Medical; a wearable artificial kidney developed by Blood Purification Technologies in Beverly Hills, Calif.; and an implantable artificial kidney developed by a researcher at the University of California at San Francisco.
Shuvo Roy, a bioengineer and professor at the UCSF School of Pharmacy, and Dr. William Fissell, a nephrologist at the Cleveland Clinic, invented the implantable artificial kidney.
The device is unique in that it is implanted, provides continuous therapy and requires surgery. Roy said that while investors have shown interest in the device, many have concerns about the effort needed to get the device through the FDA’S stringent premarket approval process for novel products.
“How will you address the regulatory issues that will come up? How will the FDA handle this?” are the questions Roy said he hears most from potential investors.
The device has received about $4.5 million from government grants and private philanthropists so far, and it needs an estimated $20 million to get the product through the first clinical trial, which has an expected start date in 2017.