Mar 31, 2020
The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into or beyond non-clinical trials, have established large-scale cGMP manufacturing capability, or utilize an approved platform. This includes information regarding diagnostics, therapeutics, vaccines, and other products or technologies relevant to addressing the coronavirus outbreak.
Emergo by UL recently heard from two medical device manufacturers who were seeking our advice on ways to make their products more readily available to help address the coronavirus crisis. The first company, Through the Cords, produces an articulating endotracheal tube introducer designed to provide a low exposure risk alternative to standard intubation rescue techniques with high exposure risk profiles. The top priority when intubating COVID-19 patients is to protect the providers during this high exposure risk procedure. The company began scaling two weeks ago. The second, Shreis Scalene Sciences, has a technology that is designed, as a preventive measure, to deactivate the coronavirus and therefore decrease environmental viral load as sort of a room “disinfector.” Both products seem to nicely “fit the bill” for what BARDA is asking for.
Portal will funnel COVID-19 research ideas and engage with stakeholders
Through BARDA, the US government is providing a portal for the 2019 novel coronavirus (SARS-CoV-2) medical countermeasures task force as a single point of entry for the submission of market research packages and meeting requests from interested stakeholders (e.g., similar to those described above). Through the portal, stakeholders are asked to register an account and subsequently log in and provide a brief description of their product or technology, accompanied by a slide deck, manuscript, publications, or other non-confidential information of their choosing. Both companies described above were directed to the portal.
According to the portal’s website, ideal technologies and products would (but are not required to) be:
- Relevant to the US government COVID-19 medical countermeasure research and development efforts and/or Emerging Infectious Disease rapid response capabilities
- Utilizing an already-approved platform, have non-clinical data suggesting efficacy, and/or have significant manufacturing capability
- Fully owned or licensed by the stakeholder organization (with full IP rights and/or freedom to operate)
Prior BARDA program provided template for crisis portal
The coronavirus portal was repurposed by BARDA from its existing TechWatch program, which focuses on outreach to stakeholders across the medical countermeasure enterprise and engagement with them through meetings to discuss their product candidates and technologies and their possible alignment with BARDA’s mission. Until further notice, the TechWatch program will suspend all activities that are not related to addressing the COVID-19 crisis.
Hopefully there will be many more medical technology ideas like those described above that can help us move past this unprecedented crisis as quickly as possible with minimal loss of life and physical harm. Stay well, everyone!
Related US FDA medical device and IVD regulatory resources:
- FDA submission consulting for medical devices and IVDs
- FDA medical device classification primer
- Whitepaper: Understanding the US FDA medical device classification system
- Whitepaper: Early communication with the US FDA
- Video: US FDA Quality System Regulations (21 CFR Part 820) compliance
Author
- James Keller