Due to the urgent need, the managing consortium has suspended some—but not all—of its members-only restrictions.
Experts say the only way to defeat the current coronavirus pandemic is with comprehensive testing and tracing to identify infected persons and ensure they don’t come into contact with others. To achieve this, the Army wants to fast-track development of wearable detection technologies that can predict infection and alert the wearer and others around them.
On Monday, the Army issued a request for project proposals through the Medical Technology Enterprise Consortium “to develop a wearable diagnostic capability for the pre‐/very early‐symptomatic detection of COVID‐19 infection.”
Using its other transaction authority—an iterative, fast-paced funding mechanism outside the Federal Acquisition Regulation—the Defense Department set aside $25 million for this effort, with plans to make up to 10 awards.
“Physiologic surveillance for COVID‐19 positive individuals that do not yet show clear medical symptoms is an ultimate goal,” the solicitation states, citing the need for advanced algorithms to predict infection. “Physiological signatures therefore must produce predictive algorithms that can be tied into validated and relevant antibody/molecular measurements.”
The perfect solution will be designed so the device’s output—a determination on whether the person poses an infection risk—can be easily decipherable by non-medical or -technical personnel and to be “minimally-invasive” for the wearer.
“Device(s) should be designed to be worn for continuous physiological monitoring in a non-obtrusive manner and should not affect the daily activity of the wearer,” the solicitation states.
Physiological indicators should include, “but are not limited to, physiological markers of early COVID symptomology—elevated temperature/fever, respiratory difficulty/cough, etc.—antibodies against COVID-19, and molecular biomarkers indicative of COVID-19 exposure.”
The data generate and transmitted by the device must also be secured at the highest level, per regulations under the Health Insurance Portability and Accountability Act, or HIPAA.
Army contracting officials said the military would prefer a single device that meets all needs but will accept pitches for a combination of technologies and sensors.
The winning bidders should also be prepared to work through any necessary FDA approvals required, including obtaining an Emergency Use Authorization within the first 45 days of the contract.
The Army is not looking for the latest, undeveloped tech. Instead, the requirement calls for all submissions to be at least at Technology Readiness Level 3 or 4—working proof-of-concept or tested in a laboratory environment—or above. More specifically, proposed technologies should “currently be in development or commercially available,” according to the solicitation.
MTEC said the contract will be awarded on an accelerated timeline through its “Enhanced White Paper” method, with awards expected within four weeks from the white paper deadline: 12 p.m. May 13.
Due to the urgent need to deploy this technology mid-crisis, MTEC is also suspending its members-only submission requirement. As with other OTA consortia, MTEC usually restricts access to the requirements and submissions to its membership.
“Due to the critical and urgent nature of the technical topic area, MTEC membership is NOT required for the submission of an Enhanced White Paper in response to this MTEC RPP,” the solicitation states. However, vendors will be required to join the consortium if their white paper is chosen to move forward to award.
The contract is set to run for nine months.