Service Member (SM) Wearable Traumatic Brain Injury (TBI) Device

The purpose of this requirement is to award a research and development (R&D) contract for an FDA approved, Soldier-wearable device that will meet the U.S. Military needs to prevent brain injuries and maintain the safety and performance by those exposed to potentially concussive events including, but not limited to, blast pressure waves generated by missiles, improvised explosive devices; occupational exposure to overpressures from relevant weapon systems (ex. breaching charges, outgoing mortars/artillery, and shoulder-launched weapons); and impact by an object. To meet the Military need, the prototype and eventually the final marketed production device will possess, at a minimum, the threshold attributes and eventually meet the objective attributes stipulated in Section 1 of the Statement Of Objectives in the attached Request For Proposal (RFP). The vendor will perform and be responsible for any and all research and development activities, manufacture, compliance with applicable FDA regulations including 21 Code of Federal Regulations (CFR) Part 312 sub-part D (as it pertains to FDA-Sponsorship of clinical trials), and will be expected to serve as the sponsor for device submission to the FDA for pre-market approval of the device for the intended use/indication for use. The vendor will produce prototype devices and test and production representative devices for limited user testing, operational assessment (OA) and initial operational test and evaluation (IOTE), and clinical evaluation to support a pre-market submission to the FDA for an intended use/indication for use that encompasses Government needs. The vendor will also produce a final FDA-approved device in the quantity required by the Government. The vendor shall develop the device in accordance with all applicable State laws, Federal laws, Department of Defense (DoD) regulations, and U.S. Army regulations. 

Aim 1 will accomplish the research and development of a device with the stipulated attributes, and production of prototype devices to be assessed in limited user testing and environmental resilience testing. 

Aim 2 will accomplish production of representative test and production articles to facilitate the conduct of operational assessment and initial operational test and evaluation, respectively.

Aim 3 will accomplish clinical evaluation of the device and FDA pre-market approval of the device for the intended use/indication for use.

The Contractor shall conduct a pivotal clinical study that supports the proposed intended use and indication for use of the device. This study shall encompass creating a clinical study protocol and documentation supporting the clinical study and conducting the clinical trials in a manner that successfully supports the Contractor’s regulatory plan.

The Contractor shall provide sufficient production representative articles for the clinical trials including a contingency plan for replacement of defective and/or production articles that may be lost or damaged during a pivotal clinical trial

The Contractor shall write, edit, and submit the FDA submission packet, and respond promptly to questions from the FDA and the Government including requests for information and data.

Aim 4 will accomplish scaling of production to fulfill the potential device quantity need of the Government.