- FDA has selected eight medtech companies from a pool of more than 250 applicants as winners of its Innovation Challenge, launched by CDRH in May to incentivize the development of medtech solutions to address opioid abuse.
- The companies that stood out to FDA will gain access to increased collaboration with agency experts and guidance for clinical trial development plans. While FDA approval is not guaranteed for the winners, most of the companies will likely submit a 510(k), PMA, Investigational Device Exemption or De Novo application, which will then have expedited review by the agency. The winning products will also be given consideration for Breakthrough Device designation, a provision created by the 21st Century Cures Act.
- The various products are in different stages of development and range from categories like diagnostics, to pain therapy, to medication dispensing and patient monitoring.
The push to use medtech to help stem the tide is a relatively new development in the crisis that economists estimate has cost America more than $1 trillion since 2001. HHS declared the crisis a public health emergency in 2017.
With an estimated 130 or more Americans dying every day from opioid-related drug overdoses, public officials are desperate to curb drug diversion and addiction with new strategies.
"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," CDRH officials said in a statement Friday.
Officials evaluated proposals based on product feasibility, potential public health impact and novelty of concept.
Several of the winning companies are creating pain management alternatives. Hackensack, New Jersey-based Brainsway is adapting its transcranial magnetic stimulation therapy helmet, which has FDA approval for models treating depression and OCD, to target parts of the brain associated with opioid use disorder. A spokesperson for the company said that Brainsway had initially hoped the opioid-related configuration would launch in 2020, but that the FDA challenge win may change the timing.
Silicon Valley-based CognifiSense has also taken a non-invasive pain management approach through development of its Virtual Reality Neuropsychological Therapy (VRNT), a proprietary software that runs on commercially available VR equipment. It's aimed at reducing chronic pain by addressing maladaptive changes in the brain which help drive and sustain pain, according to co-founder and CEO Tassilo Baeuerle.
"We hope that VRNT will offer physicians and patients an adjunct or potentially even an alternative to opioids," Baeuerle said in an email to MedTech Dive. "The regulatory requirements and regulatory path for such therapies are still evolving, so the opportunity to work so early and closely with the FDA will greatly benefit us as we pursue regulatory approval."
Anesthesiologist John Hsu, founder and CEO of iPill Dispenser, told MedTech Dive that health systems too often serve addicts rather than individuals at risk of becoming addicted.
His product, a clinician-controlled app connected to a highly-secure, at-home opioid dispenser, aims to help doctors monitor their patients' pain treatment and wellbeing while also preventing opioid misuse by individuals without prescriptions.
Hsu said he's talked with Optum and Express Scripts about testing his product, for which he submitted a patent on Jan. 1, 2017, and hopes to attain 510(k) approval within the next year.
"We've been treating the symptom, I'm actually treating the cause. People overconsume drugs, I'm trying to make it controlled and managed," he said.
A MarketsandMarkets estimate values the global pain management device market to reach $4.64 billion by 2021. Medical device developers are capitalizing.
"We're making very heavy investment in opioid-free breakthrough pain relief technology," said Lee Burnes, SVP of Global R&D in the Clinical and Medical Affairs division at Avanos.
Avanos has focused on continuous peripheral nerve blocks and opioid analgesics. Burnes declined to offer details of the company's winning product, but said it leverages machine learning.
He said the goal of using these types of technology is to "help allow physicians to not to have to prescribe opioids to patients to deal with their pain coming out of surgery," which would "eliminate one of the gateways for how people get exposed to and then ultimately potentially addicted to opioids."
Other FDA selections included a rapid drug screen product by Algomet Rx, pain therapy systems from ThermoTek, an opioid prediction service by Milliman and an overdose therapy by Masimo Corporation.
Outside of the challenge, recent opioid abuse-fighting technologies to hit the market include a drug diversion watchdog software jointly developed by BD and Microsoft, saliva-based drug screens from Premier Biotech and a dose-controlling app for a Medtronic pain pump.