More than 115 people die each day from an opioid-related overdose, according to the National Institute on Drug Abuse. To help address this public health crisis, the FDA’s Center for Devices and Radiological Health (CDRH; Washington, DC) launched an Innovation Challenge in May 2018, encouraging medical device developers to find innovative, safe and effective technologies to address the addiction crisis. From more than 250 submissions, the agency recently selected eight that fully met its criteria.
“In each proposal, applicants described the novelty of the medical device or concept; the development plan for the medical device; the team who would be responsible for developing the device; the anticipated benefit of the device when used by patients; and the impact on public health as compared to other available alternatives,” wrote CDRH Director Jeff Shuren, MD, and Jonathan Jarow, MD, on the FDA website. “Medical devices at any stage of development were eligible for the challenge. Feasibility and the potential impact of the FDA’s participation in development to expedite marketing of the device were also factors considered when reviewing the submissions,” they wrote.
The eight companies and technologies selected are as follows:
- BrainsWay Ltd.’s Deep Transcranial Magnetic Stimulation Device, which has been approved by FDA for treatment of obsessive-compulsive disorder;
- Avanos’ pain therapy device;
- iPill Dispenser, a digital biometrical controlled mobile app that dispenses pills only as prescribed;
- Masimo Corp.’s overdose detection device;
- ThermoTek Inc.’s NanoTherm and VascuTherm thermal compression therapy products;
- Milliman, a global actuarial firm, and its Opioid Prediction Service;
- Algomet Rx Inc. for its rapid drug screening product; and
- CognifiSense Inc., a Silicon Valley startup that is developing virtual reality–based therapy.
CDRH notes that these products will not automatically receive marketing authorization from the FDA, but that the device developers will benefit from increased interaction with CDRH experts, guidance for clinical trial development plans and expedited review. If the company requests it and meets statutory requirements, Breakthrough Device designation can be granted. “In most cases, applicants will eventually submit one or more formal applications to the FDA, such as an Investigational Device Exemption, De Novo request, 510(k) premarket notification or Premarket Approval," said CDRH. The review of these applications will be expedited to minimize review times.