20-08-NCH_PreAnnouncement.pdf

Pre-Announcement, March 2020

PRE-ANNOUNCEMENT

“Noncompressible Hemorrhage (NCH) Control Technology”

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on a solution that can stop life threatening bleeding in the intracavitary region of patients who are delayed in receiving definitive surgical care.

PROGRAM BACKGROUND:

Hemorrhage is the leading cause of trauma-related death in both civilian and military populations. A study of 4,596 battlefield fatalities from Operation Iraqi Freedom and Operation Enduring Freedom determined that hemorrhage accounted for 91% of potentially survivable fatalities occurring prior to arrival at a Medical Treatment Facility (Eastridge et al., 2012). Additionally, of those 888 deaths attributable to hemorrhage, 67% were from truncal hemorrhage (Eastridge et al., 2012). This supports the vital need for intervention in far forward military environments.

SOLUTION REQUIREMENTS:

A noncompressible hemorrhage control solution should:

• Be capable of minimizing and/or stopping life threatening noncompressible bleeding in the abdominal intracavitary region of the body without causing further damage

• Be more efficacious, operational and environmentally suitable and affordable than the current standard of care

• Be easily usable by combat medics, physician’s assistants, and/or physicians at Point of Injury, Role 1 and during patient transport without additional equipment. For more information on Role 1 capabilities for the Services, please refer to the Emergency War Surgery (https://www.cs.amedd.army.mil/borden/FileDownloadpublic.aspx?docid=6f9e0685-1290- 4e92-8277-c1e7b0f2fef0)

• Be bioabsorbable or easily removable without causing further damage (if applicable to the technology)

• Achieve FDA clearance/approval for use in trauma patients https://www.cs.amedd.army.mil/borden/FileDownloadpublic.aspx?docid=6f9e0685-1290-4e92-8277-c1e7b0f2fef0 https://www.cs.amedd.army.mil/borden/FileDownloadpublic.aspx?docid=6f9e0685-1290-4e92-8277-c1e7b0f2fef0

• Be a small form factor, which does not add any significant weight or cube to the medical personnel’s sets, kits or outfits (SKO’s).

• Have low logistical footprint (e.g. storage conditions, shelf life, rugged)

• Require no specialized maintenance personnel, maintenance requirements, or tools to employ or maintain the system

• Be used as intended in austere military operational environments (e.g. low visibility, extreme temperature variations, blackout conditions, ruggedness)

• Be capable of passing military testing requirements including but not limited to airworthiness, safe-to-fly testing and environmental testing as stated in the appropriate documents (for example, the current MIL STD 810 and Joint Enroute Care Equipment Test Standard (JECETS))

• Be capable of functioning in a prolonged field care setting in future Multi-Domain Operations (MDO) where evacuation is not guaranteed within 1 hour

• Be at a TRL of 5 or above at the time of submission

Offerors will be asked to provide solutions that meet or will meet as many of the above needs as possible.

They are encouraged to bring partnerships to their proposals to allow for the best possible solution. Initial work will include prototype development through proof of concept in a clinical study or system prototype demonstration in a relevant or operational environment; costs would be allowable for subject matter expertise, consultation to develop a regulatory strategy, testing and evaluation, and clinical trial support.

If the solution has already achieved FDA clearance/approval, Offerors will be asked to provide relevant information in their proposal.

POTENTIAL FUNDING:

The U.S. Government (USG) Department of Defense (DoD) anticipates the total project funding for the initial two (2) year effort to be up to $1.45 Million in Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) funds. Award funding is expected to be structured incrementally and based upon completion of Milestones and Deliverables. The USG may apply additional dollars and time for follow-on efforts via post award modification to any resultant awards after the evaluation and acceptance of work and cost plan

MTEC expects to make one or more awards to a qualified team to accomplish the statement of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner. See the “MTEC Member Teaming” section below for more details.

The initial Period of Performance (POP) is not to exceed two years.

ACQUISITION APPROACH:

Full proposals will be required in response to this upcoming RPP thus reflecting a single stage acquisition approach. The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on www.beta.SAM.gov to notify interested parties. The RPP is expected to be released by the end of March 2020 and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of a full proposal in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

MTEC MEMBER TEAMING:

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government.

MTEC members are encouraged to use the MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed.

The Collaboration Database Tool can be accessed via the “MTEC Profiles Site” tab on the MTEC members-only website.

MTEC:

The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters’ health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No.

W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations.

POINTS OF CONTACT:

For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts:

http://www.beta.sam.gov/ http://mtec-sc.org/how-to-join/ http://mtec-sc.org/how-to-join/

• Technical and membership questions – Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org

• Programmatic questions – Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.org

• MTEC Member Collaboration Database Tool – Ms. Melissa Sanchez, MTEC Program Administrator, melissa.sanchez@ati.org

Sincerely, MTEC Project Team mailto:lauren.palestrini@officer.mtec-sc.org mailto:kathy.zolman@ati.org mailto:melissa.sanchez@ati.org