FDA launches innovation challenge to spur development of medical devices
The U.S. Food and Drug Administration launched on Wednesday an innovation challenge to spur the development of medical devices, including digital health technologies and diagnostic tests that could provide novel solutions to detecting, treating and preventing addiction, addressing diversion and treating pain. The initiative is part of the agency’s ongoing commitment to address the epidemic of opioid misuse and abuse.
The challenge will provide those companies that are selected by the FDA under this new program with the opportunity to work closely with the agency to accelerate the development and review of their products. The goal is to provide additional incentives for product developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies.
“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 Scott Gottlieb, FDA commissioner. “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. 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. 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.”
The agency is encouraging developers to submit proposals. These could include products such as diagnostics to identify patients at increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics (such as opioid-sparing or replacement therapies for acute or chronic pain), treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices or technologies that can prevent diversion of prescription opioids.
The challenge is open to products in any stage of development, from concept to testing. The challenge also is open to developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.
The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on the product’s feasibility, potential public health impact, and novelty of the concept.
In the past few years, the FDA has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies, such as brain and spinal cord stimulators that can relieve pain and reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain. The FDA also recently granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.
The challenge will provide those companies that are selected by the FDA under this new program with the opportunity to work closely with the agency to accelerate the development and review of their products. The goal is to provide additional incentives for product developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies.
“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 Scott Gottlieb, FDA commissioner. “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. 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. 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.”
The agency is encouraging developers to submit proposals. These could include products such as diagnostics to identify patients at increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics (such as opioid-sparing or replacement therapies for acute or chronic pain), treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices or technologies that can prevent diversion of prescription opioids.
The challenge is open to products in any stage of development, from concept to testing. The challenge also is open to developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.
The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on the product’s feasibility, potential public health impact, and novelty of the concept.
In the past few years, the FDA has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies, such as brain and spinal cord stimulators that can relieve pain and reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain. The FDA also recently granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.