FDA Innovation Challenge hopes to combat opioid epidemic

The FDA has launched an Innovation Challenge in an attempt to combat the opioid epidemic currently facing the US.

In a direct challenge to the medtech industry, the FDA is encouraging companies to develop medical devices, diagnostic tests and digital health technologies as solutions to the opioid crisis.  

The opioid epidemic is one of the US’ most serious health concerns. It’s estimated that opioid use disorder affects over 2 million people and is particularly impactful upon minority populations. In 2016, opioids killed over 42,000 people, 40% of which involved a prescription drug.

The FDA Innovation Challenge is running from 1 June – 30 September, with applications being accepted from the organisation’s Centre for Devices and Radiological Health (CDRH). The FDA is specifically looking for devices that can lead to the prevention and treatment of opioid use. More so, developers of devices that can help better manage pain compared to opioids can also apply. Other devices identified by the FDA include diagnostics that identify patients at risk of addiction, treatments for opioid use disorder or symptoms of withdrawal, and devices or technologies that can prevent the diversion of prescription opioids. Those selected for the Challenge will work directly with the FDA to accelerate the development of their product.

Those accepted onto the challenge will receive enhanced interactions with the FDA during the development and evaluation of their product.

Speaking about the challenge, FDA commissioner Scott Gottlieb, said: “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.”

“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.” Gottlieb said.

Responding to the news, US medical device association AdvaMed, commented: “We are very supportive of FDA's innovation challenge to encourage development of medical technologies to combat the opioid crisis. Medical devices have a crucial role to play in this effort by providing solutions that have the potential to reduce our country’s dependence on opioids, as well as apps and diagnostic tests that facilitate effective pain management and help curb the misuse, abuse, and overdose of opioids. There are devices and apps that help people manage their daily medications by monitoring the dosage and schedule to encourage responsible stewardship. Additionally, medication delivery, dispensing, and disposal technology can help to prevent and detect drug diversion in health care facilities, while also promoting patient safety. AdvaMed applauds FDA commissioner Gottlieb and CDRH director Shuren for their leadership on this issue and their recognition of the importance of medical technology in this national struggle."