Non-invasive, Non-pharmaceutical Peripheral Nerve Block Technology

Request for Information (RFI) Responses are due no later than 11:59 P.M. Eastern Time on Saturday, 05 December 2020 This is NOT a Request for Proposal (RFP). This RFI is not to be construed as a formal solicitation or an obligation on the part of the Government to acquire any products or services. The information requested by this RFI will be used by the Government to facilitate decision making and will not be disclosed outside of the Government. Any information provided to the Government is strictly voluntary and will be provided at no cost to the Government. This RFI is for fact finding and planning purposes only. The information will be used in conducting market research to identify qualified, experienced, and interested potential business sources in support of the Government's requirements in accordance with the critical components listed within this RFI. These critical components are subject to change prior to a formal solicitation release. The Government reserves the right to decide whether or not a small business set-aside is appropriate based on responses to this notice. Contractors are encouraged to inform the Government of any barriers that would prohibit them from competing. Contact with Government personnel, other than those specified in the RFI, by potential offerors or their employees regarding this requirement is not permitted. Combat Casualty Care Research Program (CCCRP) is tasked with researching and developing quality medical capabilities to optimize survival, recovery, and return to duty of US Service Members injured in combat. CCCRP's team of military, civilian, and contractor personnel manage the Army and Defense Health Program acquisition process to ensure the expedited conveyance of critical medical knowledge, products, and devices required by our nation's Warfighters. The primary objective of the Non-pharmaceutical Peripheral Nerve Block Program is to develop a portable non-pharmaceutical device that provides regional analgesia at the point of injury and/or during medical evacuation.. Current analgesic capabilities do not allow for point of injury application of peripheral ring nerve blocks (PRNB), or other nerve blocks, due to the training required for this analgesia method. Furthermore, PRNBs require the use of injectable analgesics that can pose a risk of diversion and require extensive training. CCCRP is looking for a solution to create a noninvasive PRNB capability that can be applied with minimal training. Ideally, training would enable proficiency by a high school graduate in no more than three training hours. PRNBs provide analgesia by preventing the action potentials of peripheral pain nerves from reaching the central nervous system. A potential way to modify neuronal action potentials is by using magnetic fields or other electric signals such as pulsed electric stimulus, to manipulate a nerve's current and by extension action potential propagation. The ability to change nerve current with electric devices has been demonstrated both in mathematical modeling and in ex vivo nerve fibers. An analgesic effect has also been achieved in rats using rotating magnets demonstrating a proof of concept. A potential solution would be a non-invasive, battery operated device capable of providing analgesia equivalent to pharmacological PRNBs by manipulating nervous system activity. The device should be designed so that it can be used without the electric current interfering other medical equipment such as those found in a hospital, ambulance, helicopter, airplane, and fresh water and salt water boat. The device should have autonomous capabilities so that it can provide PRNB for up to 72 hours without being connected to an external power socket and automatically adjust to changes in pain signaling without user input. The device should be adjustable so that it can fit all four extremities for 99% of the population and have a configuration so that it can be used on trapped limbs. Since the device will be used at the point of injury, it must be able to operate in a wide variety of temperature extremes and resistant to water (fresh and salt) and body fluids. The ideal solution would have the following key attributes: Food and Drug Administration (FDA) cleared/approved for use in trauma patients over age 18 Non-invasive or minimally invasive Capable of being used effectively for all extremities Battery life of 24 to 72 hours, or hot swappable batteries Significantly reduce pain in the extremities following severe traumatic injury CCCRP may provide regulatory expertise (programmatic expertise that includes regulatory advice, funding, etc.) to assist with obtaining FDA approval for designated indication(s). THIS IS NOT A SOLICITATION ANNOUNCEMENT OR AN RFP AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT.