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FDA selects 8 medical device developers into opioid crisis challenge

The U.S. Food and Drug Administration took an innovative approach to combating the national opioid crisis earlier this year. The FDA issued a challenge to medical device developers to leverage technology in the fight against opioid addiction and abuse.

In response to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the federal agency received more than 250 applications from medical device developers. Last month, the FDA selected eight applicants to advance to the next phase.

Those selected will build out their ideas, which range in capabilities from predicting risk of opioid use disorder and detecting opioid overdose, to providing pain treatment alternatives and dispensing medication, according to a news release from the FDA.

The eight applicants selected are:

  • Algomet Rx, Inc.: Rapid Drug Screen for monitoring
  • Avanos: Product name and purpose have been withheld per company request
  • Brainsway, LTD: Brainsway Deep Transcranial Magnetic Stimulation Device for opioid use disorder therapy
  • CognifiSense, Inc.: Virtual Reality Neuropsychological Therapy for pain therapy
  • iPill Dispenser: iPill Dispenser for medication dispensing
  • Masimo Corporation: Product name withheld; purpose is overdose therapy
  • Milliman: Opioid Prediction Service for diagnosis
  • ThermoTek, Inc.: NanoThermTM and VascuThermTM Systems for pain therapy

iPill’s opioid dispenser

Sherie Hsieh, co-founder of iPill Dispenser, said being chosen to participate in the challenge validated her and co-founder John Hsu’s vision to revolutionize the way prescriptions are dispensed.

“We want to empower the patient experience and to empower physician engagement and also to empower our public health agencies with the data we’re able to collect,” she said.

iPill Dispenser is an opioid dispenser controlled by a mobile app. Hsu said the dispenser is a “hack-proof square box that is difficult to open.” The dispenser only allocates the prescribed amount of medication at a pre-programmed time. Unauthorized attempts to open the device trigger the release of a gel, making the opioids unusable.

“Opioids currently are prescribed in a way in which people can self-medicate,” Hsu said. “You get a bottle with a child-resistant cap and you can take one pill or the bottle… [iPill Dispenser] is opened by the iPill app. And you have to use your fingerprint and a personal, special code within the iPill app that confirms that the particular app that resides on a particular cell phone is recognized by the dispenser.”

The iPill mobile app also collects real-time data as users access the dispenser, which can be anonymously shared with public health agencies to remain HIPAA-compliant.

Added incentive

In a former interview, FDA spokesman Michael Felberbaum said that the goal of the innovation challenge was 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.”

Indeed, iPill’s Hsu said he hopes to work collaboratively with the FDA to receive financial support to complete product development, as well as regulatory support to move the iPill Dispenser into the market as quickly as possible.

“The innovation challenge is important because there are many reasons for people to have pain and there are many solutions,” Hsu said. “For the FDA to help us through this period allows us to move forward with a solution that can really help the population.”

The next steps start with a collaborative phase that focuses on creating a product profile for the selected medical devices. Product profiles will take into account risks and benefits, as well as patient needs, according to a press release. Potential regulations the device will have to adhere to will also be discussed.

In most cases, challenge participants will submit formal applications to the FDA, such as the Premarket Approval application. While the application review times will be expedited, the devices will need to adhere to the regulatory standard of demonstrating a reasonable assurance of effectiveness and safety, the release said.

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