20-08-NCH RPP Announcement.docx

Announcement for Request for Project Proposals - NCH Number W81XWH-15-9-0001

Solicitation Number: MTEC 20-08-NCH “Noncompressible Hemorrhage (NCH) Control Technology”

The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on the development of a prototype that can stop life threatening bleeding in the abdominal 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, 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 clearance/approval by the U.S. Food and Drug Administration (FDA) for use in trauma patients

· 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 a 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 one hour

· Be at a technology readiness level (TRL) of 5 or above [For definitions of TRLs: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]

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 Follow-on Work:

There is the potential for award of one or more follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work):

· Clinical Studies

· Establish robust quality system

· Improve efficiency and reproducibility of manufacturing process for scale up

· Work towards FDA clearance/ approval

· Military environmental and operational assessments

· Device ruggedization for operation in military environments

· Initial Procurement

POTENTIAL FUNDING:

The U.S. Department of Defense (DoD) currently has available up to $1.45 Million Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) Fiscal Year (FY) 19 and FY20 funds. Any potential follow-on funding would be negotiated based on outcomes, cost sharing, partner matching and estimates for additional study completion.

It is expected that MTEC will make a one award to a qualified team to accomplish the statement of work. If a single proposal is unable to sufficiently address the entire scope of a specific focus area, several Offerors may be asked to work together in a collaborative manner. However, if an optimal team is not identified, then MTEC may make multiple, individual awards to Offeror(s) to accomplish subset(s) of the key tasks.

The Period of Performance (POP) is not to exceed two years; however, faster timelines are highly encouraged.

ACQUISITION APPROACH:

Full proposals are due no later than May 19, 2020 at 12:00pm Eastern Time. 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. MTEC membership is required for the submission of a full proposal in response to this MTEC RPP. Offerors submitting Full Proposals as the prime contractor must be MTEC members of good standing by May 13, 2020. To join MTEC, please visit http://mtec-sc.org/how-to-join/

A Proposers Conference via webinar will be held for interested parties to have their questions answered by the USG after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled.

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:

Please direct your inquiries and correspondence to the following contacts:

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

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

· MTEC Member Collaboration Database Tool – Ms. Melissa Sanchez, MTEC Executive Assistant, melissa.sanchez@ati.org

Sincerely, MTEC Project Team image1.png image2.png