Every year, scientists think up brilliant, often life-changing, procedures and devices that seem to take ages to reach the market (if at all). The problem? These medical breakthroughs and technological game-changers must undergo stringent Food and Drug Administration review processes that can take years and millions of dollars to complete.
While thorough trials are obviously never a bad thing, sometimes a proposed technology is just too important to let wait.
Case in point: the artificial kidney.
Last week, the FDA announced that it would be putting University of California San Francisco artificial kidney research on the “fast-track” to the market. The team’s research has been selected for the government organization’s Innovation Pathway, a program intended to cut the time it takes for breakthrough medical technologies to reach patients.
Innovation Pathway can cut in half to 150 days the time for the most-stringent review process for higher-risk devices, the FDA said. Reviews will be shorter because the agency and device manufacturers meet early in development to plan clinical trial designs that will most likely result in approval, Megan Moynahan, acting associate director for technology and innovation at the FDA, said on a conference call with reporters.
The device would be more than welcome on the current market. In the U.S. alone, more than 570,000 people suffer from chronic kidney failure and 92,000 of these patients were left on the waiting list for transplantation last year.
The UCSF team’s mechanical device would combine with actual lab-grown cells to perform the water balancing and metabolic functions of the kidneys. The artificial organ wouldn’t require pumps or an outside power supply—the body’s own blood pressure would push along filtration.
The coffee-cup sized artificial organ would allow patients with chronic kidney failure to live without dialysis or the immune suppressant medication usually required to keep a transplanted kidney from being rejected by the body.
Researchers hope to begin clinical trials in 2017.