It isn't the first time FDA has turned to medtech for solutions to opioid misuse and abuse, but now the agency is officially challenging the medical device and diagnostics industry to step up in the ongoing war on opioids.
FDA recently launched an innovation challenge to spur the development of devices, digital health technologies, and diagnostic tests that could provide novel solutions in response to the opioid epidemic.
That's not to say the industry hasn't already put forth some effort in this area. Manufacturers of naloxone products – a drug designed to potentially save a person's life in the event of an opioid overdose – have initiated donation programs to make the products more accessible to schools and community organizations. And late last year FDA granted a new indication to Innovative Health Solutions allowing its NSS-2 Bridge nerve stimulator to be used for opioid withdrawal.
Other emerging devices that could curb opioid use and provide alternative pain management solutions include spinal cord and nerve stimulation systems, and even a blood-based test from Pathway Genomics designed to steer patients with a possible genetic predisposition to opioid dependence away from potential abuse.
Recently, a Sarasota, FL-based company met with government officials, including FDA, to tout its smart dispenser. Robrady said its PILL device is designed to address potential misuse or overdose by allowing access to medication only at appropriate times as prescribed by a physician. A digital timer on the dispenser keeps patients informed of the time between doses.
"Medical devices, including digital health devices like medical mobile apps, have the potential to play a unique and important role in tackling the opioid crisis," said FDA Commissioner Scott Gottlieb, MD.
He used the example of medical devices that can effectively address local pain syndromes, which in turn could reduce the use of systemic opioids.
FDA said the new challenge will provide selected companies with the opportunity to work closely with the agency to accelerate the development and review of the products. The goal is to provide additional incentives for developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies, FDA 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 new and effective ways to help reduce the scope of this crisis," Gottlieb said.
The new challenge is open to products in any stage of development, from concept to testing, the agency noted. It is also 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.
FDA is accepting submissions now through Sept. 30, and selected applicants are expected to be announced in November. Submissions will be evaluated based on the product's feasibility, potential public health impact, and novelty of the concept, the agency noted.
Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health, pointed out that this is not the first time FDA has initiated a challenge of this type. In 2012 the agency launched a challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease, he said. The agency has also been making a noticeable effort to collaborate more with industry.
