CS_RFI_MPNB 29 October revision.docx

UNCLASSIFIED

REQUEST FOR INFORMATION

REQUEST FOR INFORMATION (RFI) NO: DSM-20-293

1.0 RFI TITLE: Non-invasive, Non-pharmaceutical Peripheral Nerve Block Technology

2.0 AGENCY: United States Army Medical Research and Development Command (USAMRDC)

3.0 OFFICE: Combat Casualty Care Research Program (CCCRP)

4.0 LOCATION: Fort Detrick, MD

5.0 SUBJECT: The Combat Casualty Care Research Program (CCCRP) of the United States Army Medical Research and Development Command (USAMRDC) is conducting market research to determine what potential solutions are currently available, or can be further developed, to meet requirements for a technology, or suite of technologies, for a portable non-pharmaceutical device that provides regional analgesia at the point of injury and/or during medical evacuation. This market research is to collect information on capabilities that are in development, or currently available, and may assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: In accordance with Federal Acquisition Regulation (FAR) 15.201 "Exchange with industry before receipt of proposals," this RFI is for information and planning purposes only at this time, and shall not be construed as a solicitation or as an obligation on the part of the USAMRDC, or collaborative Department of Defense (DoD) activities. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

7.0 DESCRIPTION: 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.

8.0 OBJECTIVE: 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).

9.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a Capabilities Statement. The subject header of the email for submission of questions and/or the RFI response shall be: Non-pharmaceutical Peripheral Nerve Block Technology. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately.

9.1 REQUIRED INFORMATION: Fill in the below table when responding to this RFI.

RFI Number

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

CAGE Code

DUNS Number

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program

Company is / is not a prime or sub to any Government contract or agreement vehicles such as a consortium or IDIQ. If company is prime or sub, please list contract/agreement number

9.2 Current Technical Expertise, Knowledge and Management Capability, and Cost

a. Executive Summary

b. Capability Statement

i. Describe the existing technology

1. Ability to provide analgesia with a Non-Pharmaceutical Peripheral Nerve Block

a) Food and Drug Administration (FDA) cleared/approved for use in trauma patients over age 18

b) Non-invasive or minimally invasive

c) Capable of being used effectively for all extremities

d) Battery life of 24 to 72 hours (type of battery and if hot-swappable)

e) Significantly reduce pain in the extremities following severe traumatic injury

f) Size/weight/cube

2. Technology Readiness Level (TRL) (http://acqnotes.com/acqnote/tasks/technology-readiness-level)

3. Manufacturing Readiness Level (MRL) (http://acqnotes.com/acqnote/careerfields/manufacturing-readiness-levelmanufact)

ii. Describe the existing technology’s method and corresponding Non-Pharmaceutical Peripheral Nerve Blocks.

iii. Describe the current status (completion of, start of, or plan for):

1. Current development efforts for delivering a prototype or FDA-cleared device for Non-Pharmaceutical Peripheral Nerve Block

2. Regulatory status and anticipated FDA pathway for an approved/cleared device for an indication for Non-Pharmaceutical Peripheral Nerve Block

3. An estimate of the projected costs of the developmental and regulatory work described above

4. Training and usage of technology by user on patients

5. Intellectual property ownership of the technology under development

6. Target customer base (commercialization strategy)

7. Manufacturing strategy

iv. Describe how the existing technology is logistically supportable (maintenance, software updates, battery life (if applicable), and reliability)

v. Describe your approach to meet current cybersecurity and Risk Management Framework requirements (NIST Special Publication 800-37, Guide for Applying the Risk Management Framework)

vi. Describe any current use of the technology; including how long it has been used and a listing of current customers with contact information (if applicable)

vii. What is the estimated or actual cost per device as it stands today and at the point of commercialization; include any parts, supply, and consumable items, as well as training, software maintenance, and manuals

10.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to Mrs. Deanna Moose at deanna.s.moose.civ@mail.mil no later than the close of business December 5, 2020. Questions about this RFI should be submitted no later than 4:00 PM EDT on November 25, 2020. Telephonic communication will not be considered as submission nor receive response.

Responses shall be limited to five pages, answer the questions posed in Section 9 and submitted via e-mail only. The font shall be Times New Roman, size 12, single space. Electronic files shall not exceed 3 MB. All submissions become Government property and will not be returned.

UNCLASSIFIED