MTEC-24-01-MPAI RPP Amendment 2.pdf

Request for Project Proposals MTEC-24-01-MPAI Number W81XWH-15-9-0001

Request for Project Proposals

Solicitation Number: MTEC-24-01-MPAI

“Fiscal Year 2024 Military Prototype Advancement Initiative (MPAI)”

Issued by:

Advanced Technology International (ATI), MTEC Consortium Manager (CM) 315 Sigma Drive

Summerville, SC 29486 for the

Medical Technology Enterprise Consortium (MTEC)

Request Issue Date: October 5, 2023 Amendment No. 01 Issue Date: December 11, 2023

Amendment No. 02 Issue Date: January 3, 2024

Enhanced White Paper Due Date: January 22, 2024 Noon Eastern Time Zone

Amendment No. 01 does the following:

Revises Section 4.2 to add Current and Pending Support as a required submission document for all Focus Areas.

Replaces Addendum 4 – Current and Pending Support template in its entirety.

Amendment No. 02 does the following:

Extends the proposal due date from January 15, 2024 to January 22, 2024.

All other terms and conditions remain unchanged.

Table of Contents

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

1.2. Purpose

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

2.2. Funding Availability and Period of Performance (PoP)

2.3. Acquisition Approach

2.4. Proposers Conference

2.5. Proprietary Information

2.6. MTEC Member Teaming

2.7. Offeror Eligibility

2.9. Cost Sharing Definition

2.10. Cost Share Requirements

2.11. MTEC Assessment Fee

2.12. Intellectual Property and Data Rights

2.13. Expected Award Date

2.14. Anticipated Enhanced White Paper Selection Notification

3 Technical Requirements

3.1. Background

3.2. Minimum Requirements for Submission of an Enhanced White Paper

3.3. Focus Areas of Interest

3.4. Additional Points of Consideration

3.5. Examples of Proposed Tasks

3.6. Potential Follow-on Tasks

3.7. Restrictions on Animal and Human Subjects, Human Anatomical Substances, or Human Cadavers

3.8. Inclusion of Women and Minorities in Study

3.9. Guidance for research studies targeting DoD personnel for survey research

3.10. Guidance for research studies targeting military families and children

3.11. Guidance for research studies involving US Army Special Operations Command

(USASOC)

3.12. Compensation to DoD-affiliated personnel for participation

4 Enhanced White Paper Preparation

4.1 General Instructions

4.2 Instructions for the Preparation & Submission of the Stage 1 Enhanced White Paper . 34

4.3 Stage 2: Cost Proposal (for Only Those Offerors Recommended for Funding)

4.4 Enhanced White Paper and Cost Proposal Preparation Costs

4.5 Freedom of Information Act (FOIA)

5 Selection

5.2 Enhanced White Paper Evaluation

6 Points-of-Contact 7 Acronyms/Abbreviations

8 Enhanced White Paper Template Addendum 1 – Technology/Knowledge Readiness Level Checklist Addendum 2 – Extramural Research Involving Human Subjects Addendum 3 – Biographical Sketch Addendum 4 – Current and Pending Support Addendum 5 – Stage 2 Evaluation Criteria

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

The Medical Technology Enterprise Consortium (MTEC) is an enterprise partnership in collaboration with industry and academia to facilitate research and development activities, in cooperation with the Department of Defense (DoD) U.S. Army Medical Research and Development Command (USAMRDC) and other Government agencies in the biomedical sciences (including but not limited to drugs, biologics, vaccines, medical software and medical devices) to protect, treat, and optimize the health and performance of U.S. military personnel. MTEC is a nonprofit corporation with the following principal objectives:

(a) engage in biomedical research and prototyping;

(b) exploration of private sector technology opportunities;

(c) technology transfer; and

(d) deployment of intellectual property (IP) and follow-on production.

MTEC is openly recruiting members to join a broad and diverse biomedical consortium that includes representatives from large businesses, small businesses, contract research organizations, “nontraditional” defense contractors, academic research institutions and not-for-profit organizations; for more information on the MTEC mission, see the MTEC website at https://mtec-sc.org/.

MTEC operates under an Other Transaction Agreement (OTA) for prototypes with USAMRDC. As defined in the OTA Guide dated July 2023, a prototype project addresses a proof of concept, model, reverse engineering to address obsolescence, pilot, novel application of commercial technologies for defense purposes, agile development activity, creation, design, development, demonstration of technical or operational utility, or combinations of the foregoing. A process, including a business process, may be the subject of a prototype project. Although assistance terms are generally not appropriate in OT agreements, ancillary work efforts that are necessary for completion of the prototype project, such as test site training or limited logistics support, may be included in prototype projects. A prototype may be physical, virtual, or conceptual in nature.

A prototype project may be fully funded by the DoD, jointly funded by multiple federal agencies, cost-shared, funded in whole or part by third parties, or involve a mutual commitment of resources other than an exchange of funds. Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data.

1.2. Purpose

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) to solicit current MTEC members for a broad range of medical prototype technological and knowledge solutions related to the Focus Areas of Interest (also called “Focus Area(s)”) listed below. Proposed solutions may https://mtec-sc.org/ include medical techniques, knowledge products, and materiel1 (medical devices, drugs, and biologics). Military relevance is a key feature of this RPP, especially is it relates to the USAMRDC’s Combat Casualty Care Research Program (CCCRP), Military Infectious Diseases Research Program (MIDRP), and Military Operational Medicine Research Program (MOMRP), as well as the U.S. Air Force School of Aerospace Medicine.

2 Administrative Overview

2.1. Request for Project Proposals (RPP)

MTEC, in partnership with the Government, is once again utilizing a streamlined solicitation approach for the Military Prototype Advancement Initiative (MPAI), a broad, multiple focus area RPP aimed at soliciting for and funding a wide range of projects of varying scope and maturity levels. This approach has been shown to be a better means to highlight Offeror methodologies and skills required to address the technical requirements described herein. This solicitation mechanism also includes several unique features, noted below:

• Increase information exchange between the MTEC membership and the military – This solicitation mechanism provides the MTEC membership with an official way of sending information related to their military-relevant solutions through MTEC to the military, and potentially make the military aware of new solutions that can address unmet needs.

• Provide feedback to the MTEC membership –MTEC membership will receive feedback from the Government, which can help Offerors realign to better meet the Government/military need downstream, or even find out whether the Government/military would be interested at all (a “not interested” is valuable feedback as well). Having said that, due to the anticipated high number of submissions and the need for a compressed timeline for the review cycles, feedback provided may be VERY BRIEF. Although this may be disappointing, the Government has weighed the benefits vs.

costs of this more open-ended type RPP, and in order to provide a mechanism that allows members to submit Enhanced White Papers any time during the lengthy submission period, the reviewers must be allowed the opportunity to provide more succinct feedback. To supplement these succinct reviews, MTEC has implemented an educational webinar series and through this, hopes to offer opportunities throughout the year for MTEC members to hear from and interact with the military Sponsors. While this will not allow for direct and specific feedback on Offerors’ proposals, it will allow for an open discussion regarding priorities and capability gaps within the Government’s portfolios.

• Establish an open window for the military to make awards – The solicitation mechanism is intended to provide MTEC members with an opportunity to propose solutions throughout the year. Offerors are advised that updates may be added via amendment at any time to reflect changes in Government requirements or other revisions, as

1 Materiel is defined as equipment and supplies of a military force.

appropriate. With an extended open submission period, awards may be made on a first-in, first-out basis. Additionally, the MTEC selection process for this solicitation includes a “basket” provision that permits holding proposed projects that have technical merit, but unfunded, for up to two years, which allows for efficient contracting as funding becomes available.

• Solicit for key areas to support achievement of the USAMRDC strategic objectives – The

Focus Areas of Interest will allow MTEC members to propose innovative and relevant solutions to USAMRDC’s current medical needs.

• Diversity in potential Sponsors – While USAMRDC is listed throughout this RPP, sponsoring offices from outside commands (such as the U.S. Air Force) may also participate in the source selection process and select projects for award depending on interest, programmatic alignment, and funding availability.

The Enhanced White Paper process used for this effort requires quick turnaround times by Offerors. The following sections describe the formats and requirements of the Enhanced White Paper.

Offerors who submit Enhanced White Papers in response to this RPP should submit by the date on the cover page of this RPP (see Section 4.1 for details on the submission period). Enhanced White Papers may not be considered under this RPP unless received on or before the due date specified on the cover page.

Each Enhanced White Paper submitted must be in accordance with the mandatory format provided in Section 8 of the RPP. Enhanced White Papers that fail to follow the mandatory format may be eliminated from the competition during the CM’s preliminary screening stage (see Section 5 for more details on the Selection process). The Government reserves the right to award Enhanced White Papers received from this RPP on a follow-on prototype OTA or other stand-alone OTAs as necessary to meet mission requirements.

*Note that the terms “Enhanced White Paper” and “Proposal” are used interchangeably throughout this RPP.

2.2. Funding Availability and Period of Performance (PoP)

The funding amount and PoP for this RPP is unspecified, and the number of awards is indeterminate and contingent upon funding availability. Selection of prototype projects is a highly competitive process and is based on the evaluation of the proposal’s technical merit, programmatic considerations (to include program portfolio composition), and the availability of funds. The quantity of meaningful submissions received normally exceeds the number of awards that the available funding can support. Any funding that is received by the USAMRDC and is appropriate for a Focus Area of Interest described within this RPP may be utilized to fund

Enhanced White Papers. Awards resulting from this RPP are expected to be made in FY 2024 and 2025 under the authority of 10 U.S.C. § 4022.

A proposed budget and PoP should be commensurate with the nature, scope and complexity of the proposed research. Offerors should submit budgets that include the entire PoP of the research project. Yearly budgets should include all direct and indirect costs, based on supportable, verifiable estimates. Offerors are encouraged to scope out their budgets in alignment with major deliverables of their proposed work so that large budgets are easier to evaluate, and Sponsors can more easily allocate available funding.

For informational purposes, the average size of MTEC awards for the initial PoP is approximately $2.0 – 3.5M over a 2-3-year PoP unless otherwise specified in Section 3.

Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s).

Award funding may be structured incrementally and based upon completion of Milestones and Deliverables.

Dependent on the results and deliverables under any resultant award(s), the U.S. Government (USG) may, non-competitively, award additional dollars and/or allow for additional time for scope increases and/or follow-on efforts with appropriate modification of the award. See Section

3.6. for additional details.

2.3. Acquisition Approach

This RPP will be conducted using the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in this RPP (see Section 8 of this RPP). The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria in Section 5 of this RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2 (and may be required to submit additional documentation or supplemental information such as those examples listed under Section 4.2). Notification letters will contain specific Stage 2 proposal submission requirements.

Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 U.S.C. § 4022 section f.

The Government-selected prototype project(s) awarded as a result of this solicitation will be funded under the Other Transaction Agreement for prototype projects (OTA) Number W81XWH- 15-9-0001 with MTEC administered by the CM, ATI. The CM will negotiate and execute a Base Agreement with MTEC members (if not yet executed). The same provisions will govern this Base

Agreement as the OTA for prototype projects between the Government and MTEC.

Subsequently, any proposal that is selected for award will be funded through a Research Project Award (RPA) issued under the member’s Base Agreement. The MTEC Base Agreement can be found on the MTEC website and Members-Only website at www.mtec-sc.org.

At the time of the submission, if Offerors have not yet executed a Base Agreement, then Offerors must certify on the cover page of their Enhanced White Paper that, if selected for award, they will abide by the terms and conditions of the latest version of the MTEC Base Agreement. If the Offeror already has executed an MTEC Base Agreement with the MTEC CM, then the Offeror must state on the cover page of its Enhanced White Paper that, if selected for award, it anticipates the proposed effort will be funded under its executed MTEC Base Agreement.

2.4. Proposers Conference

MTEC intends to host a Proposers Conference that will be conducted via webinar within several weeks of the release of the RPP and may include multiple sessions as deemed appropriate.

Further instructions will be forthcoming via email. The intent of the MPAI Proposers Conference series is to provide an administrative overview of this RPP process to award and to present further insight into the Focus Areas of Interest outlined in Section 3. Offerors are advised to check the MTEC website periodically during the proposal preparation period for any clarifications found in Frequently Asked Questions (FAQ) responses.

2.5. Proprietary Information

The MTEC CM will oversee submission of Enhanced White Papers submitted in response to this RPP. The MTEC CM shall take the necessary steps to protect all proprietary information and shall not use such proprietary information for purposes other than the evaluation of an Offeror’s Enhanced White Paper and the subsequent agreement administration if the Proposal is selected for award. In accordance with the MTEC Proposal Preparation Guide (PPG), please mark all Confidential or Proprietary Information as such. An Offeror’s submission of a Proposal under this RPP indicates concurrence with the aforementioned CM responsibilities.

Also, as part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently contacts private entities (e.g., foundations, investor groups, organizations, individuals) that award grants or otherwise co-fund research, and/or operates in research areas that are aligned with those of MTEC. These private entities may be interested in reviewing certain Proposals within their program areas, allowing opportunities to attract supplemental funding sources. On your Proposal Cover Page, please indicate your willingness to allow MTEC Officers and Directors access to your Proposal for the purposes of engaging in outreach activities with these private organizations.

MTEC Officers and Directors who are granted Proposal access have signed Non-disclosure Agreements (NDAs) and Organizational Conflict of Interest (OCI) statements. Additionally, these MTEC Officers and Staff represent organizations that currently are not MTEC members, and therefore their parent organizations are not eligible to submit Proposals or receive any research http://www.mtec-sc.org/ project funding through MTEC. Additionally, all Technical Evaluation Panel participants will agree to, and sign a nonproprietary information and conflict of interest document.

2.6. MTEC Member Teaming

While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper 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. The following resources may help prime contractors provide a more complete team for this requested scope of work.

2.6.1. MTEC Member Connect

MTEC intends to host a series of virtual “connect” session via webinar to help the membership collaborate and partner in relation to 24-01-MPAI RPP. Each organization will be allotted 1 minute to pitch accompanied by a slide. Your pitch can be focused on whatever you think would be most beneficial to you in relation to your work, for example, seeking a partner or offering a capability. There will be contact info on each slide so that you can follow-up directly with whomever you would like.

2.6.2. MTEC M-Corps

The MTEC M-Corps is a network of subject matter experts and service providers to help MTEC members address the business, technical, and regulatory challenges associated with medical product development. M-Corps offers members a wide variety of support services, including but not limited to: business expertise [i.e., business development, business and investment planning, cybersecurity, finance, intellectual asset management, legal, logistics/procurement, pitch deck coaching, transaction advice], and technical expertise [i.e., chemistry, manufacturing and controls, clinical trials, concepts and requirements development, design development and verification, manufacturing, process validation, manufacturing transfer quality management, regulatory affairs]. Please visit https://www.mtec-sc.org/m-corps/ for details on current partners of the M-Corps.

2.6.3. MTEC Database Collaboration Tool

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 (https://private.mtec-sc.org/).

2.6.4. Chat Forum

A dedicated chat forum has been established to facilitate direct interaction amongst MTEC members in relation to this active funding opportunity. The chat forum can be accessed via the “Discuss Portal” on the MTEC members-only website - https://private.mtec-sc.org/.

2.7. Offeror Eligibility

Offerors must be MTEC Members in good standing to be eligible to submit an Enhanced White Paper. Offerors submitting Enhanced White Papers as the prime performer must be MTEC members of good standing at least 3 days prior to submission of the Enhanced White Papers.

Subcontractors (including all lower tier subawardees) do not need to be MTEC members. To join MTEC, please visit http://mtec-sc.org/how-to-join/.

2.8. Statutory Requirements for the Appropriate Use of Other Transaction Authority Enhanced White Papers that do not include one of the following will not be eligible for award (See Section 3 of the PPG):

(A) At least one nontraditional defense contractor or nonprofit research institution participating to a significant extent in the prototype project; or

(B) All significant participants in the transaction other than the Federal Government are small businesses (including small businesses participating in a program described under section 9 of the Small Business Act (15 U.S.C. 638)) or nontraditional defense contractors; or

(C) At least one third of the total cost of the prototype project is to be paid out of funds provided by sources other than the Federal Government.

2.9. Cost Sharing Definition

Cost sharing is defined as the resources expended by the award recipients on the proposed statement of work (SOW). Cost sharing above the statutory minimum is not required in order to be eligible to receive an award under this RPP. If cost sharing is proposed, then the Offeror shall state the amount that is being proposed and whether the cost sharing is a cash contribution or an in-kind contribution (see Section 7.4 of the PGG for definitions); provide a description of each cost share item proposed; the proposed dollar amount for each cost share item proposed; and the valuation technique used (e.g., vendor quote, historical cost, labor hours and labor rates, number of trips, etc.).

2.10. Cost Share Requirements

In order to be compliant with 10 U.S.C. §4022, Research Projects selected for funding under this RPP are required to meet at least one of the conditions specified in Section 3 of the PPG. Beyond that, cost sharing is encouraged, if possible, as it leads to stronger leveraging of Government-contractor collaboration. For more information regarding cost share, please see Section 7.4 of the PPG.

Proposals that fail to meet the mandatory statutory conditions with regard to the appropriate use of Other Transaction authority, as detailed in Section 3 of the PPG, will not be evaluated and will be determined ineligible for award.

http://mtec-sc.org/how-to-join/

2.11. MTEC Assessment Fee

Per Section 3.4 of the Consortium Member Agreement, each recipient of an RPA under the MTEC OTA shall pay MTEC an amount equal to 2.0% of the total funded value of each research project awarded. Such deposits shall be due no later than 90 days after the RPA is executed. Awardees are not allowed to use MTEC funding to pay for their assessment fees. Therefore, Offerors shall not include this Assessment Fee as part of their proposed direct costs. Members who have not paid the assessment fee within 90 days of the due date are not “Members in good standing”.

2.12. Intellectual Property and Data Rights

Baseline IP and Data Rights for the MTEC RPA are defined in the terms of an awardee’s Base Agreement and, if applicable, specifically-negotiated terms are finalized in any resultant RPA.

MTEC reserves the right to assist in the negotiation of IP, royalties, licensing, future development, etc., between the Government and the individual performers prior to final award decision and during the entire award period.

The Offeror shall comply with the terms and conditions contained in their Base Agreement regarding IP and Data Rights, as modified by the specifically-negotiated IP and Data rights terms herein. It is anticipated that anything created, developed, or delivered under this proposed effort will be delivered to the Government with Government Purpose Rights or unlimited data rights unless otherwise asserted in the proposal and agreed to by the Government.

Rights in technical data in each RPA shall be determined in accordance with the provisions of MTEC Base Agreement.

Note that as part of Stage 1 of the RPP process (submission of an Enhanced White Paper), Offerors shall complete and submit Attachment 6 of the PPG (Intellectual Property and Data Rights) with the Signature of the responsible party for the proposing Prime Offeror.

2.13. Expected Award Date

Offeror should plan on the PoP beginning no sooner than 4 months after the submission deadline (subject to change). The Government reserves the right to change the proposed PoP start date through negotiations via the CM and prior to issuing an RPA.

2.14. Anticipated Enhanced White Paper Selection Notification As the basis of selections is completed, the Government will forward their selections to the MTEC CM to notify Offerors. All Proposers will be notified by email from the MTEC CM of the results of the evaluation. Those successful will move forward to the next stage of the process.

Offerors are hereby notified that once an Enhanced White Paper has been submitted, neither the Government nor the MTEC CM will discuss evaluation/status until after the Offeror receives the formal notification with the results of this evaluation.

3 Technical Requirements

3.1. Background

Current wartime operations assume that the United States and our allies will maintain air, land, maritime, space and cyber superiority. Future conflicts against peer and near-peer adversaries are expected to be layered stand-offs and fought across multiple domains. Mission success will be determined by our ability to compete to expand the competitive space, penetrate both strategically and operationally, disintegrate enemy’s defenses, exploit enemy weaknesses, and re-compete to consolidate gains. Medical capabilities play a critical role in each aspect of the future battlespace and must modernize rapidly to maintain Force readiness and increase soldier lethality.

3.2. Minimum Requirements for Submission of an Enhanced White Paper Enhanced White Papers submitted in response to this RPP shall meet the following minimum requirements:

1. Demonstrate Military Relevance: Proposed projects shall focus on providing medical solutions to support readiness and care in future battlefield scenarios.

2. Fit the Prototype Definition: Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. The definition of a “prototype” is as follows: (A) a prototype project addresses a proof of concept, model, (B) reverse engineering to address obsolescence, (C) a pilot, novel application of commercial technologies for defense purposes, (D) agile development activity, (E) the creation, design, development, demonstration of technical or operational utility, or (F) combinations of the foregoing. A process, including a business process, may be the subject of a prototype project.

3. Meet the Minimum Knowledge/Technology Readiness Level (KRL/TRL): The minimum acceptable KRL/TRL at the time of submission of the Enhanced White Paper is at least KRL/TRL 3 for most of the focus areas listed herein. Offerors have achieved KRL/TRL 3 if:

• Knowledge Products: Offeror has validated hypotheses that suggest applications (e.g., prediction for prognosis, screening for diagnosis, or treatment for prevention)

• Pharmaceutical (Drugs): Offeror has demonstrated initial proof-of-concept for candidate drug constructs in a limited number of in vitro and in vivo research models

• Pharmaceutical (Biologics, Vaccines): Offeror has demonstrated initial proof-of-concept for biologic/vaccine constructs in a limited number of in vitro and in vivo research models.

• Medical Devices: Offeror has demonstrated initial proof-of-concept for device candidates in a limited number of laboratory models (may include animal studies).

• Medical Information Management (IM)/Information Technology (IT) & Medical Informatics: Medical Informatics data and knowledge representation schema are modeled.

Offerors should note that all topics within Focus Areas 1 (Combat Casualty Care), as well as Focus Areas 3.10 and 3.13 require a minimum TRL/KRL of 4.

*NOTE: Full definitions of TRLs can be found here. More information regarding KRLs can be found here.

4. Represent New Submission to MTEC: The focus of this effort is on proposed solutions that have not been submitted to MTEC under previous RPPs within the past 2 years, including the 22-02-MPAI and 23-06-USAMRDC-MultiTopic. The Government is already aware of concepts submitted in response to previous MTEC solicitations; therefore, such projects are not allowed to be resubmitted here. This RPP is intended only for submission of new projects to MTEC or substantially revised or modified proposals in accordance with previous Government feedback, not identical resubmissions.

5. Align to a Specified Focus Area of Interest: Enhanced White Papers shall align to a single

Focus Area of Interest specified in Section 3.3 below. Failure to align to a single Focus Area of Interest may result in an “Unacceptable” rating and render the proposal ineligible for award.

**NOTE: Failure to meet any or all of these minimum requirements may result in an overall “Unacceptable” rating of the Enhanced White Paper with minimum or no additional feedback provided.

3.3. Focus Areas of Interest

To meet the intent of this RPP, each Enhanced White Paper SHALL specifically address ONLY ONE Focus Area of Interest described below. Offerors are not limited to a single Enhanced White Paper submission. Projects that fail to align with only one of these Focus Areas of Interest may not be considered for funding.

FOCUS AREA 1 – COMBAT CASUALTY CARE: Because battlefield conditions impose severe constraints on available manpower, equipment, and medical supplies available for casualty care, there is a need for medical interventions that can be used within the battle area or as close to it as possible, before or during medical evacuation. This area prioritizes technologies that are easily transportable (i.e., small, lightweight, and durable in extreme environments and handling), easy to use and require low maintenance. The following are Focus Areas of Interest (not listed in order of importance):

FA 1.1 - Blood Product Development: Next generation resuscitation technologies and strategies to extend the shelf-life and/or minimize the cold chain for whole blood and other https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf https://www.mtec-sc.org/wp-content/uploads/2020/12/Knowledge-Readiness-Levels-KRLs-Information.pdf blood products. This may include optimization of storage techniques or development of novel technologies that function similarly to blood products in terms of volume expansion, hemostasis, and oxygen carrying capabilities. Potential technologies may include infusible hemostatics (i.e., nanoparticle solutions), oxygen carriers, and combination blood products.

Technologies should effectively manage hemorrhage with attributes that include ease of delivery/use, extended shelf-life, and storage in extreme conditions. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to clearance or approval by the U.S. Food and Drug Administration (FDA) in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs.

FA 1.2 - Anti-shock Pharmacology: Evaluation of drugs to mitigate the pathophysiology associated with hemorrhagic shock. Therapeutics should address metabolic acidosis, mitochondrial dysfunction, and/or trauma-induced coagulopathy. Priority will be given to evaluation of existing pharmaceutical technologies that can be repurposed for this indication.

Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs.

FA 1.3 - Battlefield Pain Control: This focus area of interest is seeking novel solutions (i.e., analgesics and anesthetics) to manage acute battlefield pain that are devoid of performance-limiting side effects. Therapeutics should address the management of pain following traumatic injury (i.e., hemorrhage) and impacts to cardiovascular and respiratory responses.

Solutions may include systemic therapeutics, as well as next generation regional analgesia techniques. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs.

FA 1.4 - Organ Support Devices and Therapeutics: Novel technologies and optimization of current technologies are required to provide renal support in the austere setting and treat ischemia reperfusion injury in severely injured casualties. Solutions may include pharmaceuticals or medical devices. All solutions should prioritize ease of delivery and the need for reduced size, weight and power (SWAP). Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs.

FA 1.5 - Surgical Support Technologies: This focus area of interest is seeking novel solutions to extend surgical capability and enable surgical procedures to be safely performed at Roles of Care 2-3.2 Current surgical capabilities are relatively cumbersome and more mobile surgical capabilities typically have significantly reduced patient capacity. Novel solutions should increase surgical capacity and decrease SWAP requirements, contributing to improved mobility. This focus area includes both surgical technologies as well as technologies that enable forward surgical capability such as advanced imaging, surgical sterilization, and intelligent anesthesia capabilities. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs.

FA 1.6 - Complex Wound Management: Advanced wound management therapies and solutions for operationally relevant trauma injuries such as complex soft tissue, open fracture, penetrating torso, and blast injuries. Additionally, development of solutions for delays in care of penetrating abdominal injuries and prevention/management of deep space infections are of particular interest. Proposed solutions should be optimized for far forward use with low SWAP requirements. Priority will be given to technologies that can be applied early in the treatment course following injury or initial debridement in order to impact the trajectory of wound recovery. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs.

FA 1.7 - Burn Wound Recovery: This focus area of interest is seeking safe, effective, field deployable, topical and/or systemic treatment capabilities (i.e., best practices/Clinical Practice Guidelines) to promote rapid recovery of skin functions following deep partial thickness and/or full thickness burn injury, agnostic of mechanism. This may include novel and/or repurposed therapeutics capable of initiating/accelerating burn wound healing and closure (including temporary or permanent coverage). Prioritized candidate solutions will reduce follow-on medical care required for full functional recovery, improve burn-injured Warfighter function far forward in austere or prolonged care scenarios, avoid post-burn complications, as well as improve long-term clinical and functional outcomes. This topic prioritizes capability development other than antimicrobial treatments. Studies focused primarily on developing a delivery platform are of significantly less interest compared to studies of the efficacy of the novel or repurposed therapeutics themselves. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL 4, where proposed clinical trials and translational studies are of high interest. Enhanced white papers must also describe the pathway to FDA clearance or approval in sufficient detail (where applicable).

2 For more information on Roles of Care: ROC_Ref_Card_V12__June_2019.pdf (mtec-sc.org) https://mtec-sc.org/wp-content/uploads/2022/07/ROC_Ref_Card_V12__June_2019.pdf

FA 1.8 - En Route Care: This focus area of interest seeks advanced methods and/or materiel solutions to enable high volume or prolonged patient movement. Technologies should be supported by preliminary, published data with a focus on mitigating the potential negative effects of patient movement in an operational environment while also optimizing care to multiple patients simultaneously. Additional considerations include functionality and effectiveness under conditions of vibration, acceleration, altitude and extreme environments. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL/KRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs and KRLs.

FA 1.9 - Autonomous Care and Evacuation: This focus area of interest seeks advanced data-driven solutions for the optimization of provider(s) treatment based on dynamic monitoring of available resources and casualty status. Solutions should present an analysis of critical factors (e.g., casualty status, casualty location, number of providers, medical supplies, environmental constraints, etc.) and an artificial intelligence/machine learning (AI/ML) algorithm which optimizes casualty priority and provider alignment/assignment to increase clinical capacity at the point of injury. Solutions should focus on the clinical aspects of optimizing triage, patient management, and medical regulating, rather than logistics or re-supply. It is encouraged that the algorithmic solution be compatible/capable of being deployed with existing field medic platforms (such as BATDOK, MEDCOP, etc.). Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL/KRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section

3.2 of this RPP for more information related to TRLs and KRLs.

FA 1.10 - Semi-autonomous Procedural Support: This focus area of interest seeks technologies that enable semi-autonomous assistance for resuscitative procedures using AI and robotic technologies. These technologies should optimize the technical completion of the necessary task through speed, efficiency, and accuracy in order to improve the safe completion of the procedure while mitigating training decay and differences in provider expertise. Example technologies include facilitating venous and arterial access, as well as regional analgesia. Offerors submitting proposals to this focus area of interest must provide preliminary/published data in the Enhanced White Paper that supports a minimum TRL/KRL 4 and describe the pathway to FDA clearance or approval in sufficient detail (where applicable). See section 3.2 of this RPP for more information related to TRLs and KRLs.

FA 1.11 – Military-Civilian Partnerships for Trauma: This focus area aims to develop and implement a pilot program that expands an already existing military-civilian partnership focused on training and sustainment of military personnel for the care and treatment of traumatic injuries and the conduct of military-relevant research and development. The Enhanced White Paper shall briefly outline the proposed methodology to demonstrate a course of action that: i) evaluates return on investment for military-civilian trauma partnership models, including clinical productivity, financial metrics, skill acquisition metrics and academic/research productivity; ii) evaluates, optimizes, and validates training and sustainment methods for military personnel within these partnerships; and iii) optimizes partnership models for successful conduct of military relevant research and development in the care of traumatic injuries. The Enhanced White Paper shall briefly outline the proposed methodology to the extent possible that demonstrates the Offeror’s capability and its understanding of the resources (to include subject matter experts, subcontractors, and potential prototypes under development) required to address this technical requirement.

This focus area of interest will prioritize already existing military-civilian partnerships with the aim to optimize them for trauma training and military relevant trauma research, rather than establishing new partnership sites. It is encouraged that proposed projects include the following:

Access to study populations and existing data already collected from human subjects that support the goals of this program and the ability to maintain and interpret these data;

Ongoing relationships with both non-Government and DoD organizations that comprise the military-civilian partnership;

Experience with care and treatment of traumatic injuries in civilian populations that translate to military-relevant use cases;

Access to prototypes in development for the care and treatment of traumatic injuries;

Access to human patients with traumatic injuries [to compare with military patients to build the capability of predictive models and strategies for clinical interventions];

and, The focus to be metric-driven with requirements for prototype development toward clinical interventions, endpoints, policy and processes for the care and treatment of traumatic injuries.

It is expected that outcomes will be transitioned to inform prototype development for military-relevant use cases, clinical practice guidelines, training, and clinical trial endpoints.

FA 1.12 – Studies in Ukraine: The current conflict in Ukraine provides an unprecedented opportunity to understand medical care and challenges associated with modern large scale combat operations. Section 736 of the Fiscal Year 2023 National Defense Authorization Act has directed the U.S. DoD to seek partnerships with Ukraine in the area of trauma education and research. This funding opportunity prioritizes both capability development and study of medical care challenges within the current conflict. NOTE: Enhanced White Papers submitted to this focus area of interest must provide a clear benefit to the Ukraine system of care, as well as providing lessons learned for the U.S. military medical system in anticipation of potential future large-scale conflicts. At the time of proposal submission, Offerors must provide documentation of: 1) Ability to conduct work within Ukraine without U.S. personnel entering the country; 2) Evidence of a capable Ukrainian partner and any necessary support from the Ukraine Ministry of Health or Ministry of Defense; and 3) Where appropriate, a clear plan for necessary regulatory, ethics, and human protections approvals within the U.S.

and Ukraine.

The following two focus areas of interest are listed in order of priority:

FA 1.12.1 - Clinical Trial Capabilities: This focus area aims to develop and implement a pilot program focused on 1) developing observational and/or interventional human subject testing capabilities, and 2) using these capabilities to conduct clinical studies related to care of the war wounded in Ukraine. Example areas in need of these clinical capabilities and subsequent evaluation include, but are not limited to: wound infection/management, tourniquet use, hemorrhage and resuscitation, evacuation, traumatic brain injury, rehabilitation and traumatic stress. Of particular interest is the impact of time delays between wounding and initial care as well as throughout the care continuum. Trauma registry development and data analysis is an additional priority.

FA 1.12.2 – Evaluation of Casualty Care Technologies in Ukraine: This focus area of interest aims to evaluate, optimize, and/or validate casualty care technologies for use in the forward operational environment. Examples of proposed studies could focus on the evaluation of utility, ease of use, compatibility with the forward operating environment, and clinical outcomes. The project deliverable could also include recommendations for technology improvements to optimize use in the forward operating environment. Priority will be given to proposed casualty care technologies that are (not listed in order of importance):

currently in development by the U.S. DoD;

have obtained regulatory clearance/approval from a European body and interested in pursuing approval via the U.S. FDA; or have obtained regulatory clearance/approval by the U.S. FDA but need funding for validation studies in a forward operational environment.

FOCUS AREA 2 – MILITARY INFECTIOUS DISEASES: This technology area focuses on vaccines, drugs, vector detection assays, and novel therapeutics to treat multidrug-resistant organisms in combat wound infections, as well as vector control measures for insect vectors that transmit naturally occurring endemic diseases with demonstrated or potential capability to decrease military operational effectiveness. This area specifically focuses on solutions for prolonged care scenarios, where wound infection poses a significant threat to operational readiness and effectiveness, as well as solutions enhancing medical readiness in response to infectious diseases encountered by Service members during deployment that can significantly impact performance.

The following are focus areas of interest (not listed in order of importance):

FA 2.1 - Prophylactic to Prevent Infection in Battlefield Wounds from Complex Traumatic

Penetrating Injuries in a Far-Forward, Austere Environment: This focus area of interest seeks the development of materiel solutions that have the following required solution characteristics:

Must be able to conform to 3-dimensional wound shape (i.e., not a bandage) Must be self-absorbing or removable through wound irrigation

Must be effective against at least one, but preferably multiple, high priority pathogens: Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, Staphylococcus aureus

NOTE: Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

In addition, it is strongly preferred that proposed solutions provide the following desired solution characteristics:

Integration of novel antibiotic drug classes against Gram-negative pathogens Single solution with ability to provide antibiotics, pain analgesics, and/or hemostasis compounds

At the time of proposal submission, it is strongly preferred that Offerors also include the following in their enhanced white papers:

Toxicity data (if required by FDA) Regulatory strategy with documented FDA engagement (including minutes from pre-submission meetings)

FA 2.2 - Pathogen Agnostic Countermeasures for the Treatment of Sepsis Caused by Wound

Infection: Development of drug / biological treatments for sepsis, including host-based therapeutics.

Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

Toxicity data (if required by FDA) are preferred

FA 2.3 - Antivirals for the Prevention and/or Treatment of Endemic and Emerging Infectious

Diseases (Non-biothreat Pathogens): Development of broadly acting antivirals (small molecules, innovative antibody approaches, repurposed antivirals) that can be administered via oral (PO), intramuscular (IM), transdermal (TD) or subcutaneous (SC) routes (Intravenous (IV) not preferred) that are effective against pathogens relevant to the military:

Two or more pathogens from the Bunyavirales order (e.g., Lassa virus, Crimean Congo

Hemorrhagic Fever virus, Severe Fever with Thrombocytopenia Syndrome virus) The Flaviviridae family with Dengue virus as the primary target (against all four serotypes) and all other flaviviruses as secondary targets

NOTES:

Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

Inclusion of toxicity data (if required by FDA) are preferred.

Regulatory strategy with documented FDA engagement (including minutes from pre-submission meetings) is strongly preferred

FA 2.4 - Prevention of Endemic Diarrheal Diseases: Development of immunoprophylactics for endemic viral diarrheal diseases, with a focus on norovirus.

NOTES:

Offerors must include preclinical efficacy data in the enhanced white paper at the time of submission.

Inclusion of toxicity data (if required by FDA) are preferred.

FA 2.5 - Knowledge Product…