25-06-ExMedModernize_RPP_Final.pdf

Request for Project Proposals

Solicitation Number: MTEC-25-06-ExMedModernize

Modernization of Expeditionary Medicine (EXMED) Warfighter Prototypes

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: May 20, 2025

Enhanced White Paper Due Date: June 13, 2025 Noon Eastern Time

Request for Project Proposals MTEC-25-06-ExMedModernize Number W81XWH-15-9-0001

Table of Contents

1 Executive Summary

1.1. The Medical Technology Enterprise Consortium

1.2. Purpose

1 Administrative Overview

2.1. Request for Project Proposals (RPP)

2.2. Funding Availability and Period of Performance

2.3. Acquisition Approach

2.4. Offeror Eligibility

2.5. Proprietary Information

2.6. Proposers Conference

2.7. MTEC Member Teaming

2.8. Cost Sharing

2.9. MTEC Assessment Fee

2.10. Intellectual Property and Data Rights

2.11. Expected Award Date

2.12. Anticipated Enhanced White Paper Selection Notification

3. Technical Requirements

3.1. Background

3.2. Objective

3.3. Solution Requirement

3.4. Potential Follow-on Tasks

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

4. Enhanced White Paper Preparation

4.1. General Instructions

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

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 6 Points-of-Contact 7 Acronyms/Abbreviations 8 Enhanced White Paper Template Addendum 1 – 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.

For more information on the MTEC mission, see the MTEC website at http://mtec-sc.org/.

MTEC operates under an Other Transaction Agreement (OTA) for prototypes with USAMRDC awarded under the authority of 10 U.S.C. § 4022. The term “prototype project” includes a project that addresses (A) a proof of concept, model, or process, including a business process, (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, or demonstration of operational utility, or (F) any combinations of the foregoing. Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. For more information on the prototype definition, please see the Proposal Preparation Guide (PPG) located on the MTEC Site: https://mtec-sc.org/proposal-submit.

1.2. Purpose

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC in support of the Defense Health Agency and Program Executive Office, Unmanned and Small Combatants (PEO USC) Expeditionary Missions (EXM) (PMS 408). Military relevance is a critical component of the Enhanced White Paper submission. Strategic oversight for the award(s) supported by this RPP will be provided by PMS 408.

This RPP is focused on creating a systems integration approach to developing an array of medical solutions related to evaluating and optimizing Warfighter prototypes for forward stabilization, resuscitative care, primary care, dental services and force health protection in support of the modernization of expeditionary medicine (EXMED), in particular for implementation on the newly envisioned navy Expeditionary Fast Transport (EPF) ships. These new EPF ships for medical are able to receive and treat casualties in littoral areas to meet mission requirements of a distributed maritime operation and expeditionary advanced base operations, which is anticipated in future conflicts with peer competitors. Role 2 (R2) care and advanced surgical support afloat in littoral conditions is currently not a Naval capability.

http://mtec-sc.org/ https://mtec-sc.org/proposal-submit

Current medical technologies are inadequate for surgical care aboard an EPF Flight II platform, not interoperable, and do not meet the requirements of the EXMED family of systems (FoS) Capabilities Development Document (CDD). Therefore, this prototype project is an innovative business arrangement for a system integrator to identify and rapidly test these expeditionary medical solutions. This RPP aims to establish an agreement with an organization able to provide the integration of technology, resources and expertise required to translate technologies related to Warfighter expeditionary medicine through the required development activities to transition to the Warfighter and the commercial marketplace. This RPP also intends to fund several prototypes to be advanced with this initial RPP, and includes the innovative business component of identifying, rapidly prototyping and testing additional medical solutions related to expeditionary medicine.

In order to modernize the DoD to be a ready and resilient Force, PMS 408 is seeking to build a capability through MTEC that is poised to rapidly advance prototypes related to Warfighter expeditionary medicine and transition these to both the Warfighter and the commercial marketplace as appropriate. This effort requires multiple prototype solutions (hereafter referred to as EXMED technologies) that address forward stabilization, resuscitative care, primary care, dental services and force health protection.

1 Administrative Overview

2.1. Request for Project Proposals (RPP)

MTEC is utilizing an accelerated approach to award for this RPP. This streamlined approach is anticipated to be a better means to highlight Offeror methodologies and skills required to address the technical requirements described herein. The Enhanced White Paper process 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. 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).

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

2.2. Funding Availability and Period of Performance

The U.S. Government (USG) currently has available a total of approximately $800,000 for this effort, for direct and indirect costs. Dependent on the results and deliverables under any resultant award(s), the (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. The funding estimated for this RPP is approximate and subject to realignment. Award and funding from the Government is contingent upon the availability of federal funds for this program.

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).

MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work.

However, 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, or the Government may award to multiple Offerors if an optimal team is not identified, and multiple awards are deemed to be in the Government’s best interest. See the “MTEC Member Teaming” section below for more details.

The period of performance (PoP) is not to exceed 18 months.

2.3. Acquisition Approach

This RPP will be conducted using the Enhanced White Paper approach.

• Stage 1 – Enhanced White Paper: 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. The Offeror(s) whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to Stage 2. The notification letter(s) will contain specific Stage 2 proposal submission requirements.

• Stage 2 – Cost Proposal: Submission of a full cost proposal. Additionally, based upon the results of the technical evaluation, the Offeror(s) may be required to submit additional documentation or supplemental information such as those examples listed under Section 4.3).

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 (OTA) for prototype projects 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 http://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. 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 https://mtec-sc.org/join. A UEI and CAGE code are also required for submission of an enhanced white paper. For more information, please visit: https://mtec-sc.org/proposal-submit.

2.5. Proprietary Information

The MTEC CM will oversee submission of proposals and analyze cost proposals submitted in response to this RPP. The MTEC CM shall take the necessary steps to protect all proprietary proposal information and shall not use such proprietary information for purposes other than the evaluation of an Offeror’s proposal and the subsequent agreement administration if the proposal is selected for award. In accordance with the 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.

MTEC Officers and Directors who are granted proposal access have signed Nondisclosure 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 project funding through MTEC.

Also, as part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with 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.

Therefore, on your Proposal Cover Page, please indicate your willingness to allow MTEC Officers http://mtec-sc.org/ https://mtec-sc.org/join and Directors access to your Proposal for the purposes of engaging in outreach activities with these private entities.

2.6. Proposers Conference

MTEC intends to host a Proposers Conference that will be conducted via virtual webinar on May 30, 2025, at 12:00pm (Noon) EST. The intent of the Proposers Conference is to provide an administrative overview of this RPP process to award and present further insight into the Technical Requirements outlined in Section 3 of this RPP. To register for this conference, please use this link: https://ati.zoomgov.com/webinar/register/WN_oXhaILIJRUmkJn3OsSshWQ.

2.7. 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.

MTEC’s new website features a new functionality to assist members in team building. MTEC’s New Member Profiles can help you identify potential teaming partners among other MTEC members, including innovators, service providers, and MTEC M-Corps [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]. It can be accessed via the https://mtec-sc.org/members

If you are in need of additional teaming assistance, then you are encouraged to reach out to the points of contact listed herein.

2.8. Cost Sharing

Cost sharing is defined as the non-Federal 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. 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. 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.

Additionally, Section 7.4 of the PPG contains information on cost share definitions and directions for inclusion.

2.9. MTEC Assessment Fee

Per the Consortium Member Agreement (CMA), each recipient of an RPA under the MTEC OTA shall pay MTEC an amount equal to 2% 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. The MTEC Assessment Fee is not allowable as a direct charge to any resulting award or any other contract.

Therefore, Offerors shall not include this Assessment Fee as part of their proposed direct costs.

https://ati.zoomgov.com/webinar/register/WN_oXhaILIJRUmkJn3OsSshWQ https://mtec-sc.org/members

Members who have not paid the assessment fee within 90 days of the due date are not “Members in good standing”.

2.10. Intellectual Property and Data Rights

Baseline IP and Data Rights for MTEC RPAs 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.

See Attachment 6 of the PPG for more detail. 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) as an appendix to the Enhanced White Paper with the Signature of the responsible party for the proposing Prime Offeror.

For more information, the CM has published a resource for Offerors entitled, “Understanding Intellectual Property and Data Rights” on the MTEC members-only website.

2.11. Expected Award Date

Offerors should plan on the period of performance beginning September 30, 2025 (subject to change). The Government reserves the right to change the proposed Period of Performance start date through negotiations via the CM and prior to issuing an RPA.

2.12. Anticipated Enhanced White Paper Selection Notification As the basis of selections is completed, the Government will forward its selection(s) 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

EXMED solutions are intended to be mobile, resilient, modular, scalable, and extensible capabilities that ensure uninterrupted and secure HCD within medical units and throughout the continuum of care as well as enable MEDC2/MEDLOG and PM (e.g., medical regulating) functionality. 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.

Naval forces must be able to coordinate and execute highly distributed operations over oceanic distances. Distributed naval forces and increased adversary lethality require distributed and tailorable medical capabilities. These capabilities must be modular, scalable, and adaptable to various platforms and facilities to ensure forces have access to flexible and agile medical capabilities that enable timely response. The Program Executive Office, Unmanned and Small Combatants (PEO USC) Expeditionary Missions (EXM) (PMS 408) seeks to overcome the medical and logistical challenges present in these environments by providing forward stabilization, resuscitative care, primary care, dental services, and force health protection capabilities to Naval Operating Forces during contingency and/or large-scale combat operations (LSCO).

Within PMS408, the government has developed initial concept prototypes related to En Route Care Systems (ERCS), Expeditionary Resuscitative Surgical Systems (ERSS), Expeditionary Medical Units (EMU), Ashore Theater Hospitalization Systems (ATHS), Certified Diagnostic Mobile Laboratories (CDML) and other Forward-Deployable Preventive Medicine Units [FDPMU; and Certified Diagnostic Mobile Laboratory (CDML)], as well as the information technology system/s required for patient movement. Each of these provide an aspect of the overall capability set for the EXMED family of systems (FOS). For example, ERCS provides patient movement in the theater of operations. ATHS offers an agile R3 capability. Given the tyranny of distance in LSCO, R2 and R3 capabilities must be readily accessible (i.e., within range of ERCS) to ensure quick life-saving treatment and movement of patients to the next level of care (e.g. R1 to R2 care). Pre-positioned and accessible R2 and R3 assets can also support timely resupply of ERCS. Together, these capabilities, as well as materiel solutions, enable and enhance first responder care and delayed evacuation care.

3.2. Objective

In order to modernize the DoD to be a ready and resilient Force, PMS 408 is seeking to build a capability through MTEC that is poised to rapidly advance prototypes related to Warfighter expeditionary medicine and transition these to both the Warfighter and the commercial marketplace as appropriate. This effort requires multiple prototype solutions (hereafter referred to as EXMED technologies) that address forward stabilization, resuscitative care, primary care, dental services and force health protection.

3.3. Solution Requirement

The U.S. Government is seeking the solutions capable of satisfying the following capabilities:

Task 1 – Prime Integrator capabilities to translate prototypes. The project shall be led by an “integrator” proficient at leveraging capabilities available to advance these prototypes in coordination with PMS 408. Due to the Integrator’s specialized expertise, this approach will de-risk technology development by providing capability/expertise to successfully optimize and implement these technologies in an expeditionary medicine setting. The integrator will work closely with PMS 408 to incorporate service member feedback into the testing/evaluating process, while continually synchronizing and integrating efforts to optimize prototype development. In coordination with the PMS 408 PMO and stakeholders, the Integrator will conduct evaluation and testing of the PMS 408 project portfolio to determine potential candidate expeditionary medicine technology prototypes for Fleet modernization efforts within the EXMED capabilities. Task 1 includes the following:

a. Develop detailed test plans for required EXMED Capabilities that meet Requirements in CDD.

b. Conduct survey of Fleet Exercises and outline plans and activities by fiscal year for targeted opportunities to conduct evaluations and testing of prototypes that meet CDD Requirements.

c. Develop working groups or regular meetings with EXM Capability Stakeholders within Naval Medicine Enterprise to ensure collaboration among partner commands exists (e.g. Navy Medicine manning requirements at tests).

d. Outline areas of acceptance and concern within EXM Capabilities that need addressed through government resourcing for modernization or replacement of technology/technologies encompassing EXMED Capabilities based on results of independent evaluation and testing.

e. Develop detailed test reports for EXMED Capabilities upon completion of evaluation and testing for PMS 408 review.

Task 2 – Development, Optimization, Implementation of EXMED technology prototypes.

Implement optimization activities to modernize candidate prototype projects according to the EXMED CDD specifications:

• Utilize performer resources or methodologies to advance candidate technology prototypes for implementation in the modernized expeditionary medicine environment (i.e., PMS 408 FoS). Modernization efforts may include, but are not limited to:

o Clinical Testing o Biocompatibility studies o Prototype refinement/maturation progressing toward a clinical product o Stability and shelf-life studies o Prototype delivery for military-relevant testing o Development of DoD 5000 documentation and activities to support acquisition maturation

3.4. Potential Follow-on Tasks

Under awards resulting from this RPP, there is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the initial PoP. Follow-on work may include increasing the number of prototypes evaluated, optimized and modernized by the Integrator, and advancing technical testing in relevant or simulated operational environments.

3.5. Restrictions on Animal and Human Subjects, Human Anatomical Substances, or Human

Cadavers

3.5.1. Research Involving Humans: All DoD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight’s (OHARO) Office of Human Research Oversight (OHRO) and Dept of Navy Human Research Protections Program (HRPP) prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee review. Allow a minimum of 2 to 3 months for OHRO and HRPP regulatory review and approval processes.

3.5.2. Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies.

Proposals must comply with the above-mentioned restrictions and reporting requirements for the use of animal and human subjects, to include research involving the secondary use of human biospecimens and/or human data. The Awardee shall ensure local IACUC and IRB approvals, continuing review (in the intervals specified by the local IRB, but at a minimum, annually), and approval by the USAMRDC OHARO. Offerors shall include IRB and OHARO review and approval in the SOW/Milestones Table submitted in Stage 2 of the RPP process (if invited), as applicable.

The USAMRDC OHARO will issue written approval to begin research under separate notification.

Written approval to proceed from the OHARO is also required for any Research Project Awardee (or lower tier subawards) that will use funds from this award to conduct research involving human subjects. Offerors must allow at least 30 days in their schedule for the USAMRDC OHARO review and authorization process.

4. Enhanced White Paper Preparation

4.1. General Instructions

Enhanced White Papers should be submitted by the date and time specified on the cover page using BIDS: https://submissions2.ati.org/ATI2/Portal.nsf/Start?ReadForm. See Attachment 7 of the PPG for further information regarding BIDS registration and submission. The Offeror shall include MTEC Solicitation Number (MTEC-25-06-ExMedModernize) in the Enhanced White Paper.

The Enhanced White Paper format provided in this MTEC RPP (Section 8) is mandatory. Note that Cost Proposals are only required for Stage 2 and are not part of the initial Enhanced White Paper submission. Offerors are encouraged to contact the Points-of-Contact (POCs) identified herein up until the Enhanced White Paper due date/time to clarify requirements (both administrative and technical in nature).

All eligible Offerors may submit Enhanced White Papers for evaluation according to the criteria set forth herein. Offerors are advised that only ATI as the MTEC’s CM, with the approval of the DoD Agreements Officer, is legally authorized to contractually bind MTEC into any resultant awards.

4.2. Instructions for the Preparation & Submission of the Enhanced White Paper Offerors submitting an Enhanced White Paper in response to this RPP shall prepare all documents in accordance with the following instructions:

Offerors should submit files in Microsoft Office formats or Adobe Acrobat (PDF – portable document format) as indicated below. ZIP files and other application formats are not acceptable.

All files must be print-capable, searchable, and without a password required. Filenames must contain the appropriate filename extension (.docx, .doc, .pptx, .ppt .xlsx, .xls or .pdf). Filenames should not contain special characters. Apple users must ensure the entire filename and path are free of spaces and special characters.

An automated BIDS receipt confirmation will be provided by email. Offerors may submit in advance of the deadline. Neither MTEC nor ATI will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror receives errors and fails to upload the full submission prior to the submission deadline, the submission may not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission.

Required Submission Documents (5): Submitted via BIDS (5MB or lower per document)

1. Enhanced White Paper: one Word or PDF document. The Enhanced White Paper is limited to ten (10) pages including cover page. (Section 8 of the RPP)

2. Warranties and Representations: one signed Word or PDF document (Attachment 3 of the PPG)

3. Statement of Work (SOW)/Milestone Payment Schedule (MPS): one Word or PDF document (Attachment 4 of the PPG) https://submissions2.ati.org/ATI2/Portal.nsf/Start?ReadForm

4. Current and Pending Support: one Word or PDF document (Attachment 5 of the PPG) summarizing other sponsored research for each person who will contribute significantly to the proposed prototype project. The information for previous support should include the past five (5) years, unless otherwise specified in the request.

5. Intellectual Property and Data Rights Assertions: one signed Word or PDF document (Attachment 6 of the PPG)

Optional Submission Documents (1): Submitted via BIDS (5MB or lower per document)

1. Letter(s) of Support, One word or PDF document as applicable, if the prototype project will require access to active-duty military patient populations and/or DoD resource(s) or database(s).

Page Limitation: The Enhanced White Paper is limited to ten (10) pages (including cover page).

References may be included in the Enhanced White Paper and are excluded from the page limitation. The following Appendices are excluded from the page limitation: (1) Warranties and Representations, (2) Statement of Work / Milestone Payment Schedule, (3) Current and Pending Support, and (4) Intellectual Property and Data Rights Assertions.

The Enhanced White Paper and its Appendices must be in 12-point font (or larger), single-spaced, single-sided, 8.5 inches x 11 inches. Smaller type may be used in figures and tables but must be clearly legible. Margins on all sides (top, bottom, left, and right) should be at least 0.5 inch.

Enhanced White Papers and Appendices exceeding the page limitations and/or the file size specified above may not be accepted. Each document shall be uploaded to BIDS separately (see Attachment 7 of the PPG for BIDS instructions).

FOR INFORMATION ONLY: Please note a full Cost Proposal will be requested if the Enhanced White Paper is recommended for funding (see Section 4.3 for additional details). Furthermore, additional attachments/appendices (henceforth referred to as supplemental information) to this proposal submission may be requested after completion of the technical evaluation to include the following:

• Letter(s) of Support, as applicable, if the prototype project will require access to active-duty military patient populations and/or DoD resource(s) or database(s).

The exact requirements of any such supplemental information are subject to change and will be provided at the time (or immediately following) the technical evaluation summary is provided (as part of the Selection Notification described in 2.12).

4.3. Stage 2: Cost Proposal (for Only Those Offerors Recommended for Funding) Offerors that are recommended for funding will receive notification letters which will serve as the formal request for a full Cost Proposal (and may contain a request for Enhanced White Paper revisions and/or supplemental information, such as those examples listed in the section above, based on the results of the technical evaluation). These letters will contain specific submission requirements if there are any changes to those contained in this RPP. However, it is anticipated that the following will be required:

Required Submission Documents (2): Submit to mtec-contracts@ati.org

• Section I: Cost Proposal Narrative: one Word or PDF document

• Section II: Cost Proposal Formats: one Excel document

See below for additional instructions. Also refer to Addendum 1 of this RPP for details on how the full Cost Proposals will be evaluated:

The Cost Proposal shall be submitted in two separate sections. One Word (.docx or .doc) or PDF file for Section I: Cost Proposal Narrative and one Excel (.xlsx or .xls) file for Section II: Cost Proposal Formats is required.

Offerors are encouraged to use their own cost formats such that the necessary detail is provided. MTEC will make cost proposal formats available on the Members-Only MTEC website.

The Cost Proposal formats provided on the MTEC website and within the PPG are NOT mandatory.

Each Stage 2: Cost Proposal submitted must be in accordance with the requirements of the PPG found on the MTEC website, https://mtec-sc.org/proposal-submit. Those Offerors invited to submit a Cost Proposal are encouraged to contact the MTEC CM with any questions.

4.4. Enhanced White Paper and Cost Proposal Preparation Costs The cost of preparing Enhanced White Papers and Cost Proposals in response to this RPP is not allowable as a direct charge to any resulting award or any other contract. Additionally, the MTEC Assessment Fee (see Section 2.9 of this RPP) is not allowable as a direct charge to any resulting award or any other contract.

4.5. Freedom of Information Act (FOIA)

To request protection from FOIA disclosure as allowed by 10 U.S.C. §4021(i), Offerors shall mark business plans and technical information with a legend identifying the documents as being submitted on a confidential basis. For more information, please refer to Section 6.1.1 of the MTEC

PPG.

5 Selection

5.1 Preliminary Screening

The CM will conduct a preliminary screening of submitted Enhanced White Papers to ensure compliance with the RPP requirements. As part of the preliminary screening process, Enhanced White Papers that do not meet the requirements of the RPP and/or the statutory requirements for the appropriate use of Other Transaction Authority (described within Section 3 of the PPG) may be eliminated from the competition or additional information may be requested by the CM.

Additionally, the Government reserves the right to request additional information or eliminate Enhanced White Papers that do not meet these requirements from further consideration.

5.2 Enhanced White Paper (Stage 1) Evaluation

The CM will distribute all Enhanced White Papers that pass the preliminary screening (described above) to the Government for full evaluation. Evaluation of Enhanced White Papers will be based on an independent, comprehensive review and assessment of the work proposed against the stated source selection criteria and evaluation factors. The Government will evaluate each Enhanced White Paper against the evaluation factors detailed below and assign adjectival ratings to the non-cost/price factor(s) consistent with those defined in Table 2 (General Merit Rating Assessments). The Offeror shall clearly state how it intends to meet and, if possible, exceed the RPP requirements. Mere acknowledgement or restatement of a RPP requirement is not acceptable. The overall award decision will be based upon a best value determination by considering factors in addition to cost/price.

The evaluation factors and evaluation criteria are described below in descending order of importance.

Evaluation Factors

1. Programmatic and Technical Relevance

2. Personnel and Team

Evaluation Factor #1 – Programmatic and Technical Relevance:

The Offeror’s proposal will be assessed for the degree to which the Offeror demonstrates a strong solution to the defined unmet military medical need consistent with Section 3 of the RPP. The proposal will also be assessed for relevancy, thoroughness, and completeness of the proposed approach (e.g., the technical merit). The Government’s evaluation of this factor may include the degree to which the following are addressed and demonstrated:

• Clear and appropriate objectives that describe a feasible solution;

• Focused and detailed methodologies to address the requirements outlined in Section

3.3;

• Thorough and complete SOW and ROM Cost Estimate; and,

• Whether the proposal includes a realistic, achievable performance schedule with a plan to address potential risks that could delay or otherwise impact performance.

Evaluation Factor #2 – Personnel and Team:

This factor will evaluate the strength of the organization/team, including the Offeror’s resources, expertise, and experience of proposed personnel. Specifically, this factor may include assessment of the Offeror’s experience fielding identified analogous solutions and experience with military medical solutions and projects. As part of this evaluation factor, the Government may also consider the project management plan and the ability for the technical and management team to execute the proposed SOW in an efficient and effective manner. Key personnel will be assessed based on the relevant qualifications demonstrated (i.e., ability to support this effort).

5.3 Adjectival Merit Ratings

The Offeror’s resources (key facilities, equipment, etc.), project management plan, expertise, and experience of personnel may also be considered as part of this factor. Assessment of the Offeror’s resources may include the level of security achieved by resources (facilities and equipment) as well as the availability of resources (e.g., labs, networks, development environments) sufficient to meet the requirements herein (e.g., EM testing). The Government may also consider whether the proposal includes strategies to address potential risks that could delay or otherwise impact performance.

Table 1 explains the adjectival merit ratings that will be used for the Evaluation Factors.

Evaluation factors will be described using the following adjectival merit ratings: outstanding, good, acceptable, marginal, unacceptable.

Please also refer to Section 5.4 for definitions of general terms used in technical evaluations.

Upon review and evaluation of the Proposals, the Government sponsor will perform proposal source selection. This will be conducted using the evaluation factors detailed above. The

TABLE 1 - GENERAL MERIT RATING ASSESSMENTS

RATING DESCRIPTION

OUTSTANDING

Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

GOOD

Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

ACCEPTABLE

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

MARGINAL

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths.

Risk of unsuccessful performance is high.

UNACCEPTABLE Proposal does not meet requirements and contains one or more deficiencies. Proposal is not awardable.

Government will conduct an evaluation of all qualified proposals. The Source Selection Authority may:

1. Select the proposal (or some portion of the proposal) for award

2. Place the proposal in the Basket if funding currently is unavailable; or

3. Reject the proposal (will not be placed in the Basket)

In rare cases, the following recommendation may be provided: “Recommendation Undetermined.” This is reserved for situations in which additional information/documentation is needed by the Government evaluators before finalizing a recommendation to one of those listed above and is intended to facilitate the release of all evaluator comments within the BIDS System.

The RPP review and award process may involve the use of contractor subject matter experts (SMEs) serving as nongovernmental advisors. All members of the technical evaluation panel, to include contractor SMEs, will agree to and sign a Federal Employee Participation Agreement or a Nondisclosure/Nonuse Agreement, as appropriate, prior to accessing any proposal submission to protect information contained in the Enhanced White Paper as outlined in Section 2.5.

5.4 Definition of General Terms Used in Evaluations

Significant Strength – An aspect of an Offeror's proposal that has appreciable merit or appreciably exceeds specified performance or capability requirements in a way that will be appreciably advantageous to the Government during award performance.

Strength – An aspect of an Offeror’s proposal that has merit or exceeds specified performance or capability requirements in a way that will be advantageous to the Government during award performance.

Weakness – A flaw in the proposal that increases the risk of unsuccessful award performance.

Significant Weakness – A flaw that appreciably increases the risk of unsuccessful award performance.

Deficiency – A material failure of a proposal to meet a Government requirement or a combination of weaknesses in a proposal that increases the risk of unsuccessful award performance to an unacceptable level.

The following terms may be used to evaluate the Rough Order of Magnitude (ROM) cost/price estimate:

Sufficient - The ROM estimate is within the available funding limits and considered appropriate to successfully complete the proposed project

Insufficient - The ROM estimate is lower than what is considered appropriate to successfully complete the proposed project

Excessive - The ROM estimate is higher than what is considered appropriate to successfully complete the proposed project

6 Points-of-Contact

For inquiries, please direct your correspondence to the following contacts:

• Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Manager, Ms. Taylor Hummell, mtec-contracts@ati.org

• Technical and membership questions should be directed to the MTEC Biomedical Research Associate, Dr. Chuck Hutti, Ph.D., chuck.hutti@ati.org

• All other questions should be directed to the MTEC Program Manager, Mr. Evan Kellinger, mtec-sc@ati.org

7 Acronyms/Abbreviations

ACURO Animal Care and Use Review Office ATI Advanced Technology International ATHS Ashore Theater Hospitalization Systems CDD Capabilities Development Document CDML Certified Diagnostic Mobile Laboratories CM Consortium Manager DCAA Defense Contract Audit Agency DCMA Defense Contract Management Agency DoD Department of Defense EMU Expeditionary Medical Units EPF Expeditionary Fast Transport EXM Expeditionary Missions EXMED Expeditionary Medicine ERCS En Route Care Systems (ERCS) ERSS Expeditionary Resuscitative Surgical Systems FDPMU Forward-Deployable Preventive Medicine Units FOIA Freedom of Information Act FoS Family of Systems Government U.S. Government, specifically the DoD HRPP Human Research Protections Program IACUC Institutional Animal Care and Use IP Intellectual Property (e.g., patents, copyrights, licensing, etc.)

IRB Institutional Review Board LSCO Large-Scale Combat Operations mailto:mtec-contracts@ati.org mailto:chuck.hutti@ati.org mailto:mtec-sc@ati.org

MPS Milestone Payment Schedule MTEC Medical Technology Enterprise Consortium NDA Nondisclosure Agreement OCI Organizational Conflict of Interest OHARO Office of Human and Animal Research Oversight’s OHRO Office of Human Research Oversight OTA Other Transaction Agreement PDF Portable Document Format PEO USC Program Executive Office, Unmanned and Small Combatants POC Point-of-Contact PoP Period of Performance PPG Proposal Preparation Guide PTSD Post-Traumatic Stress Disorder R&D Research and Development R1, R2, R3 Role 1, Role 2, Role 3 ROM Rough Order of Magnitude RPA Research Project Award RPP Request for Project Proposals SME Subject Matter Expert SOW Statement of Work USAMRDC U.S. Army Medical Research and Development Command USG U.S. Government

8 Enhanced White Paper Template

Cover Page

[Name of Offeror] [Address of Offeror]

[Phone Number and Email Address of Offeror]

Unique Entity ID: [UEI] CAGE code: [CAGE code]

[Title of Enhanced White Paper]

[Offeror] certifies that, if selected for award, the Offeror will abide by the terms and conditions of the MTEC Base Agreement.

[Offeror] certifies that this Enhanced White Paper is valid for 3 years from the close of the applicable RPP, unless otherwise stated.

[A proprietary data disclosure statement if proprietary data is included. Sample:

This Enhanced White Paper includes data that shall not be disclosed outside the MTEC Consortium Management Firm and the Government and shall not be duplicated, used, or disclosed, in whole or in part, for any purpose other than to evaluate this Enhanced White Paper and negotiate any subsequent award. If, however, an agreement is awarded as a result of, or in connection with, the submission of this data, the MTEC Consortium Management Firm and the Government shall have the right to duplicate, use, or disclose these data to the extent provided in the resulting agreement. This restriction does not limit the MTEC Consortium Management Firm and the Government's right to use the information contained in these data if they are obtained from another source without restriction. The data subject to this restriction is (clearly identify) and contained on pages (insert page numbers).]

Willingness to allow MTEC Officers access to your Solution Brief for the purposes of engaging in outreach activities with private sector entities: Indicate YES or NO [As part of MTEC’s mission to incorporate philanthropic donations, MTEC frequently makes contact with private sector entities (e.g., foundations, investors, organizations, individuals) that award grants or otherwise co-fund research, and/or operate in research areas that are aligned with those of MTEC. Additional private entities may be interested in reviewing certain Solution Briefs within their program areas, allowing opportunities to attract supplemental funding sources. Please indicate your willingness to allow MTEC access to your Solution Brief for the purposes of engaging in outreach activities with these private sector entities. MTEC staff has signed Nondisclosure Agreements (NDAs) and Organizational Conflict of Interest statements.]

[Title of Enhanced White Paper]

Programmatic Relevance

• Provide the background and the Offeror’s understanding of the problem and/or technology gap/process deficiency.

• Describe how the proposed technology meets the needs specified in this RPP.

Scope Statement

• Define the scope of the effort and clearly state the objectives of the project.

Scientific Rationale / Preliminary Data

• Describe the scientific rationale for the project, including a brief description of previous related work data that supports the feasibility of proposed work.

Technical Approach

• Describe the design, methods, and materials required to accomplish the proposed approach. Describe the proposed methodology in sufficient detail to show a clear course of action to address the solution requirements (Section 3.2)

• Offerors are encouraged to provide a rough order magnitude price for each task required to meet the solution requirements

Anticipated Outcomes/Impact

• Provide a description of the anticipated outcomes from the proposed work. List milestones and deliverables from the proposed work.

• Describe the impact that the proposed project would have, if successful, in supporting the goal of this effort.

Potential Follow-On Work

• Specify the objective of each proposed follow-on task as it relates to Section 3.4 of the

RPP.

• Briefly outline the proposed methodology by task to the extent possible to demonstrate a course of action that addresses the technical requirements described in this RPP.

• Indicate the proposed PoP (duration) for the potential follow-on work in total.

• Specify a total cost (including direct and indirect costs) for each task.

Technical and Management Team

• Describe the qualifications and expertise of the proposed personnel and organizations that will perform the proposed work.

• Describe the overall project management plan that clearly defines roles and responsibilities. This plan should include a communication and conflict resolution plan if the proposal involves more than one company/institution/organization.

• Describe the ability of the management team to advance the technology.

Resources

• Identify any key facilities, equipment and other resources proposed for the effort.

Identified facilities, equipment…