The FDA has created an innovation challenge to incentivize the development of medical devices that combat the opioid crisis. Successful applicants will work closely with the FDA to cut the time it takes to bring their products to market.
Medical devices are already tackling the misuse of opioids from some angles, most notably by using neurostimulation to treat pain. The FDA sees scope to improve these and other therapeutic devices, providing nonopioid pain relief to more people, and to deploy other technologies to tackle multiple other aspects of the crisis. In the FDA’s vision, devices will do everything from identifying people at risk of addiction and treating opioid-use disorder to preventing the diversion of prescription drugs.
To realize this vision, the FDA is offering to help developers of the most promising technologies. The FDA wants companies with relevant products at all stages of development from concept to testing to apply to participate in its innovation challenge. The agency created the challenge to spur investment in medical technologies and shorten their path through development and regulatory review.
“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,” FDA commissioner Scott Gottlieb, M.D., said in a statement. “We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies.”
Gottlieb fired off a wide-ranging list of devices and applications that could benefit from the scheme. Developers of devices, diagnostics, mobile apps and clinical decision support software are all eligible to participate in the initiative.
The FDA is accepting applications until the end of September. Officials will then assess the feasibility, potential impact and novelty of each proposal before picking the successful applicants in November.
Medical device trade group AdvaMed welcomed the initiative, applauding Gottlieb and FDA device director Jeff Shuren, M.D., for “their leadership on this issue and their recognition of the importance of medical technology in this national struggle.”