By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH), and Jonathan Jarow, M.D., Chief Medical Officer, Office of Device Evaluation, CDRH
Opioid abuse, misuse and addiction has become one of the most profound public health crises facing the U.S. today. It is also a very personal issue for many people, impacting individual lives and families. Many of us may know someone struggling with opioid addiction. The crisis of opioid overdose deaths requires innovative approaches, and the FDA is taking steps to make significant inroads against this tragedy. This includes efforts to help those currently addicted to opioids and taking steps to help prevent new cases of addiction while ensuring patients with true clinical need are getting thoughtful, careful and tailored approaches to manage their pain. More than 72,000 Americans died from drug overdoses in 2017, including illicit drugs and prescription opioids.
A visionary approach to prevent and treat opioid use disorder
As part of the FDA’s ongoing commitment to address the opioid crisis, the FDA’s Center for Devices and Radiological Health (CDRH) launched an Innovation Challenge in May 2018. The challenge was intended to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain.
The goal was to provide additional incentives for medical device developers to invest in products that can address the addiction crisis and advance the development of innovative, safe and effective technologies. We received more than 250 applications from medical device developers.
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. 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.
Based on these criteria, eight submissions were selected. The following selected proposals include therapeutic and diagnostic medical devices intended to treat opioid use disorder, detect and treat overdose, dispense medication and treat pain:
- Brainsway, Ltd (Brainsway Deep Transcrainal Magnetic Stimulation (DTMS) Device)
- Avanos (Pain therapy Device)
- iPill Dispenser (iPill Dispenser)
- Masimo Corporation (Overdose Detection Device)
- ThermoTek, Inc. (NanoThermTM and VascuTherm TM Systems)
- Milliman (Opioid Prediction Service)
- Algomet Rx, Inc. (Rapid Drug Screen)
- CognifiSense, Inc. (Virtual Reality Neuropsychological Therapy)
While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review. Breakthrough Device designation will be granted to those devices selected in the Challenge that meet the statutory criteria for designation upon request by the sponsor. 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. The review of these applications will be expedited to minimize review times, however, patient safety is our number one priority and all product applicants will still be held to the FDA’s gold standard and required to meet the applicable standard of safety and effectiveness.
For those applicants we did not select for the challenge as well as the makers of other devices to address the opioid crisis, we still encourage you to engage with us through the pre-submission process and other available avenues as you develop and test your technologies in support of a future premarket submission.
Medical devices — a viable option for preventing and treating opioid use disorder
We believe the greatest opportunities for medical devices to help prevent opioid use disorder are devices that could help identify people likely to become addicted, devices that manage pain as an alternative to opioids or reduce the need for opioid medications. For example, the development of a diagnostic device, whether it be an in vitro diagnostic test, software or a mobile medical app, could be highly impactful in identifying those patients for whom extra caution should be exercised when prescribing opioids for acute or chronic pain.
In the past few years CDRH has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies. Those novel devices may reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain.
The Innovation Challenge is another example of how we continue to look for ways to bring advanced treatments, including medical devices, to the individuals who need them. Working collaboratively with the selected developers will hopefully drive innovation and successfully bring these products to market.
We are encouraged, inspired, and motivated by the robust interest that resulted from the Innovation Challenge. The engagement and participation from so many developers is indicative of the dire need we face for new ways to treat this disease, and that medical devices, including digital health technologies, like mobile medical apps, will play a critical role in the FDA’s all hands on deck approach to confronting the opioid epidemic.