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.
“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.
Participation in the Innovation Pathway, which will map out a regulatory course for the device, is expected to bring better outcomes for all the parties involved, Roy said. It's the first time he will go through the FDA's regulatory process, and he expects that participation will provide “comfort and assurance” to the potential investors.
“Most of us have academic roots,” Roy said. “As scientists, we'll be better informed. The lessons learned will help us do this better the next time around.”
The device industry is somewhat skeptical about the program. In a 2011 letter to the FDA, the Advanced Medical Technology Association recommended expanding the number of devices that would be included in the program. AdvaMed noted in the letter that, according to the language the FDA published in the Federal Register, “all products, not just those selected for the Innovation Pathway, should be reviewed in a manner to ‘help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safety and based on sound science.'”
The organization continues to advocate for broader inclusion in the program.
“We commend FDA for expanding its Innovation Pathway initiative to more devices and encourage them to move as rapidly as possible to include other innovative device categories, especially those that treat patient conditions for which there are few, if any, options,” AdvaMed said last week in an e-mailed statement.
While the device industry claims the FDA is slow, unpredictable and inconsistent in its product reviews, the FDA has argued that many of the submissions it receives are of poor quality and require additional attention from the staff.
The Innovation Pathway is one initiative expected to address the complaints of both sides.
It's not the only reflection of the friction between the device industry and the FDA these days. The five-year user-fee agreement that both parties agreed to in February requires the FDA to undergo a third-party review of its own review pathways while industry will pay the FDA $595 million, more than double what it paid during the last five years.
“Many executives are wondering what impact the FDA's pathway will have on them,” said Dr. Ron Ginor, CEO of Becker & Associates Consulting, a scientific consulting firm in Washington.
For the three companies that were selected to participate, the impact will be significant, Ginor said, but it is not likely to carry over to other small device companies in the U.S.
So far, established device companies have had little involvement in the program. Of the 32 applicants to the ESRD program, the majority came from “small start-up businesses or academic institutions,” according to the FDA.
The first device of the four selected to participate in the Innovation Pathway was developed by the Defense Advanced Research Projects Agency, a Defense Department agency that created a brain-controlled robotic arm that is currently in clinical trials.
Another device category is expected to be introduced by the FDA this year.
“I hope the program gets more broadly embraced,” Ginor said. “Innovation is good for saving lives and money.”