For an innovation challenge, the FDA is looking for devices that provide more benefits than opioids, with fewer risks.
The Food and Drug Administration wants better options available for treating pain—and it is turning to developers for help.
The FDA announced this week that it is running a new innovation challenge for medical devices that provide solutions to detecting, treating and preventing addiction, addressing drug diversion and treating pain.
Applications will be accepted through September, and the developers of devices that are chosen will be able to work closely with the FDA to bring their product to market.
“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D.
Gottlieb hopes that by encouraging the development of medical devices, fewer patients will need to rely on opioid pain relief, which has a high risk of addiction.
“For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids,” he said.
Finding replacements for opioids is an important piece of confronting the opioid epidemic, he added.
“This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction,” he said. “We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”
Developers can submit devices that are in any stage of development, including the concept phase. The FDA will be looking for devices that provide more benefits than opioids, with fewer risks.
In 2012, the FDA ran a similar innovation challenge that helped develop and bring to market new ways of treating renal disease, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. He hopes this challenge will have similar results.
“The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” he said. “We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”