Request for Prototype Proposal (RPP) HT9425-23-R-0065-0002 USFP (REVISED) (showing changes).pdf

REVISED – Amendment 0002

Request for Prototype Proposal (RPP)

Solicitation Number: HT9425-23-R-0065-0002

“Ultrasound Field Portable Assessment and Development Efforts”

Issued by:

The United States Army Research Acquisition Activity

808 Schreider Street Fort Detrick, MD 21702

For:

The United States Army Medical Materiel Development Activity

Fort Detrick, MD 21702

Request Issue Date: 26 July 2023

Proposal Due Date: 14 18 August 2023

RPP HT9425-23-R-0065

Table of Contents 1 Executive Summary

1.1 Purpose

1.2 Background

2 Administrative Overview

2.1 Acquisition Approach

2.2 Award Type

2.3 Period of Performance and Type of Funding Instrument Issued

2.4 Expected Award Date

2.5 Proprietary Information

3 Proposal Preparation Instructions

3.1 General Instructions

3.2 Organization of Proposal

3.3 Volume I – Technical Volume

3.4 Volume II – Administrative and Cost Volume

4 Proposal Evaluation Criteria

4.1 General

4.2 Proposal Revisions

4.3 Evaluation Factors for Award

4.3.1 Factor 1 - Technical Approach & Management Approach

4.3.2 Factor 2 - SOW

4.3.4 Factor 3 - Cost /Price

4.3.5 Administrative

4.3.6 Down Select for Continued Development

5. Proposal Submission

6. Attachments

Attachment A – Statement of Objectives (SOO) REVISED Attachment B – Warranties and Representations Attachment C – Biomedical Technology Readiness Levels (TRL) Attachment D – Medical Device Evaluation and Risk Assessment (MDERA) Attachment E – Statement of Work (SOW) template REVISED Attachment F – Agreement (Terms and Conditions) REVISED Attachment G – Cost/Price Template REVISED Attachment H – Down Selection Evaluation Criteria REVISED Attachment I – MIL-STD-810H Attachment J – Acronyms

1 Executive Summary

1.1 Purpose

This solicitation, issued by U.S. Army Medical Research Acquisition Activity (USAMRAA), located in Fort Detrick, MD, represents a Request for Project Proposal (RPP) for U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Expeditionary Medicine and Treatment (WEMT) Project Management Office (PMO). Proposals selected for award, as a result of this RPP, will be awarded under the authority of prototype Other Transaction Authority (pOTA) 10 U.S.C. 4022 (formerly 2371b).

This RPP seeks to procure a non-networked Ultrasound Field Portable System (UFPS) (including transducer(s) and viewing platform) that is handheld, reliable, easily transportable, and that has minimal power requirements that does not touch any networks, capable of withstanding Army field environmental conditions and have the ability to provide imaging quality sufficient for diagnosis in the Focused Assessment with Sonography in Trauma (FAST), Extended FAST (eFAST) and Musculoskeletal (MSK) exams. Development efforts (if needed) shall ONLY BE FOR development of a TRL 6 device that has network connectivity to get it to a TRL 7 (final prototype) device that does not have the ability to connect to networks. NO OTHER DEVELOMENT EFFORTS WILL BE PREMITTED. The system will be Government tested which consists of an operational assessment and environmental testing and then down-selected to one (1) system for the USAMMDA USFP program. The selected prototype system will then undergo a Government led Risk Management Framework (RMF) assessment, which shall require Performer support for system and software modifications to achieve an RMF-compliant system. and a limited initial procurement to fulfill Initial Operational Capability (IOC) of an estimated quantity of 1,137. The Government requires the USFP system to pass an RMF assessment to ensure any cybersecurity risks are identified and mitigated.

A follow on, sole-sourced separate award for procurement is intended to follow for an estimated quantity of approximately 3,500 systems.

1.2 Background

Inappropriate identification, care, and triage are responsible for the more than 10% of unintended outcomes following combat injury. According to the Theater Combat Casualty Care Initial Capabilities Document (ICD) there are several issues where gaps exist, including the ability to detect/diagnose injury in an austere and/or pre-hospital environment. The DoD expects a future operational environment that will require prolonged field care, delayed or denied evacuation, and increased capabilities further forward than in recent conflicts. Currently, no portable ultrasound imaging capability is fielded to the Roles 1 and 2 through a medical equipment set.

The current handheld ultrasound market technology consists of a transducer (or transducers) that connects to an imaging platform, paired with the software application. The commercial product is developed with the civilian provider in mind, and the products have connectivity features, both for the software application and for the viewing platform, that pose a cybersecurity threat in a far-forward military operational environment. The commercial systems on the market are Technology Readiness Level (TRL) 7 and require additional assessment and modification to ensure they are operable under expected conditions.

In 2022, USAMMDA conducted an operational assessment and an environmental test to assess the commercial market’s potential to fulfill the Army’s need while the requirement was refined. The results of the testing confirmed that market technologies are available to fulfill this USFP requirement with modifications for RMF and configuration for the military (i.e. some development work may be required to remain unconnected to a network, even when performing system or software updates). Since this testing, the requirement has matured along with the market, and additional commercial systems have received FDA approval that were previously still in development.

The testing to be conducted under this requirement will be tailored for the USFP system.

2 Administrative Overview

2.1 Acquisition Approach

This RPP will be conducted in a two-step approach. The first step (go/no-go) includes preliminary screening of submitted proposals to ensure compliance with the RPP requirements (i.e. OTA qualification and TRL 6 or 7 confirmation). As part of the preliminary screening process, proposals that do not meet the requirements may be eliminated from competition or additional information may be requested. Additionally, the Government reserves the right to request additional information or eliminate proposals that do not meet these requirements from further consideration. The primary reasons for non-compliance or elimination during the initial screening is the failure to meet at least one of the three requirements listed at 10 USC 4022 (d) (1) (A) – (C); the Offeror’s proposed device does not meet the threshold specifications; and the Offeror’s proposed device does not meet the threshold TRL 6 and related parameters. For those Offeror’s who advance to the second step, full proposals will be evaluated.

USAMRAA intends to make multiple awards, from this RPP to qualified performers for completion of Objectives 1, 2 and 3. After completion of Objective 3, only one (1) awardee will be selected for completion of Objectives 4 and 5 (optional objectives to be exercised for the one Performer who advances). That is, following the completion of Objective 3 (field and operation testing), the Government will down select to a single performer for completion of Objective 4 for the continued development of the USFP system for RMF assessments and evaluations. and for Objective 5 for the manufacture and delivery of up to 1,137 USFP systems.

The down select evaluation criteria can be found at Attachment H - Down Select Evaluation Criteria

2.2 Award Type

The award type will be as follows:

Objective 1: Firm Fixed Price (FFP) Objective 2: Firm Fixed Price (FFP) Objective 3: Firm Fixed Price (FFP) Objective 4: Cost plus fixed fee (CPFF) Objective 5: Firm Fixed Price (FFP)

2.3 Period of Performance and Type of Funding Instrument Issued

The anticipated period of performance is no longer than 33 24 months (48 36 months if development is required).

Objective 1 15 months of performance if development is required (if development is not required, Performer starts at Objective 2)

1825 September 2023 – 1724 December

Objective 2 1 month of performance 1825 December 2024 – 1724 January 2025 Objective 3 8 months of performance 1825 January 2025 – 1724 September

Objective 4 12 months of performance 1825 September 2025 – 1724 September

Objective 5 12 months of performance

2.4 Expected Award Date

Offeror should plan on the period of performance beginning 1825 September 2023 (subject to change). The Government reserves the right to change the proposed period of performance start date through negotiations and prior to issuing an award.

2.5 Proprietary Information

USAMRAA will take the necessary steps to protect all proprietary information and will not use such proprietary information for purposes other than the evaluation of Offerors’ proposals and the subsequent agreement administration, if proposals are selected for award.

Additionally, all Technical Evaluation Panel participants will agree to and sign a U.S. Government non-disclosure and conflict of interest documents.

2.6 SAM.gov registration

Awardees must be fully registered in SAM.gov, have a Unique Entity Identifier (UEI), and maintain SAM.gov registration throughout performance. If NAICS code 541512 “Computer Systems Design Services” is not currently listed in the Performer’s SAM.gov account, it should be added prior to award.

3. Proposal Submission Instructions

3.1 General Instructions

This section provides general guidance for preparation of the proposal as well as specific instructions on the format and content of the proposal. The Offeror’s proposal must include all requested documents and information and shall be submitted in accordance with the instructions in this RPP. The prototype proposal submissions must contain Volume I – Technical and Volume II - Administrative and Cost/Price Proposal as described in this section and must be in accordance with the mandatory format described in this RPP. The proposal shall be in compliance with requirements as stated in the Statement of Objectives (SOO).

The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of stated claims. The proposal shall not simply rephrase or restate the Government’s requirements, but rather shall provide convincing rationale to address how the Offeror intends to meet these requirements. The Offeror shall assume that the Government has no prior knowledge of the Offeror’s capabilities and will base its evaluation solely on the information presented in the Offeror’s proposal unless otherwise specified. The Offeror shall provide as specifically as possible, the actual methodology it proposes to use to accomplish and satisfy all requirements. By submitting a proposal, the Offeror represents that it will be responsible for meeting the requirements specified in the

RPP.

Elaborate brochures or documentation, binding, detailed artwork, or other embellishments are unnecessary and not desired.

If the Offeror believes that the requirements in these instructions contain an error, omission, or are otherwise unsound, the Offeror shall immediately notify the Agreements Specialist listed, herein, in writing with supporting rationale.

Submission Format Each volume shall be submitted electronically in searchable Portable Document Format (PDF) format. The files shall be virus and malware free. Files shall not be password protected. Files shall not include hyperlinks. The electronic submission shall be compatible with Microsoft Office 2013 and Adobe Acrobat 2017.

Volume Content Each volume shall be written on a standalone basis and contain a cover page. Information required for each evaluation factor that is not found in its designated volume may not be considered in the evaluation. The information in each volume shall be specific and complete as well as legible, clear, and concise.

Cost/Price Information All cost/price information shall be addressed ONLY in Volume II - Administrative and Cost/Price. Do not address cost/price in the Volume 1 - Technical Volume. Estimated levels of effort, material, quantities, labor hours, labor categories, consultant services, travel requirements, materials, and equipment needed, and if applicable, sub-performers can be contained in the Technical Volume in sufficient detail only so the Government may adequately evaluate the Offeror’s understanding of the requirements. In addition, Cost/Price shall be submitted on the government provided Attachment G - Cost / Price Sheet Template only and shall include all formulas and links, including applicable sub-performer costs/price. The Offeror’s cost/price written narrative shall be submitted with

Volume II - Administrative and Cost/Price.

3.2 Organization of Proposal

The Offeror shall prepare the proposal as set forth in the Proposal Organization Table below. The titles and contents of the volumes shall be as defined in the table below. There shall be two (2) separate and distinct volumes: Volume I

- Technical Volume & Volume II - Administrative and Cost/Price Volume.

Proposal Organization

Volume I Section Title Page Limit

Volume I: Technical

Cover Page/Letter 2 pages Table of Contents 1 page Attachment B - Warranties and Representations N/A Attachment C – Biomedical Technology Readiness Level Threshold Checklist (TRL)

N/A

Attachment D - Medical Device Evaluation and Risk Assessment (MDERA)

N/A

Attachment E - Statement of Work (SOW) Template No page limit Technical Approach (w/ Prototype & Assay Development Strategy, Assay & Device Integration & Refinement, Testing Strategy)

10 pages

Management Approach (w/ Project Schedule, Regulatory Strategy & Manufacturing Approach)

10 pages

Teaming Agreement No page limit Integrated Master Schedule (IMS) No page limit

Volume II Section Title Page Limit

Volume II: Administrative and Cost/Price

Cover Page 1 page

Table of Contents 1 page

Attachment F - Agreement (Terms and Conditions) w/ Attachment 2 & 3 (if applicable)

N/A

Attachment G - Cost / Pricing Sheet Template N/A Cost/Price written narrative No page limit Acceptable Accounting System No page limit

3.3 Volume I - Technical Volume

Cover Page/Letter The Offeror shall provide a cover page/letter to include a concise narrative summary of the entire proposal, including significant risks, and a highlight of any key or unique features, excluding cost/price. The salient features should tie in with Section 4.3 Evaluation Factors for Award. Any summary information presented here shall not be considered as meeting the requirements for any portions of other volumes of the proposal.

Table of Contents The Offeror shall include a table of contents for Volume I.

Warranties and Representations Offeror shall fill out and submit Attachment B - Warranties and Certifications.

Medical Device Evaluation and Risk Assessment (MDERA) (Deliverable 14 of the SOO) Offer shall fill out and submit Attachment D - Medical Device Evaluation and Risk Assessment (MDERA)

Statement of Work (SOW) Template Offeror shall fill out and submit Attachment E - Statement of Work (SOW) template. The Offer shall fill in the specific tasks to be completed for each objective (see last page). The SOW tasks shall link to the prototype and assay development strategy, testing and modification approach, and project schedule as described in the Technical Approach. The Offeror’s SOW is the primary document detailing the tasks proposed.

Technical Approach The Offeror shall submit a written technical approach which effectively demonstrates the Offeror’s clear understanding and approach to achieving of all the objectives outlined in the SOO. The technical approach shall include Prototype Development Strategy, Device Integration & Refinement, and Testing Strategy.

The technical approach shall also address how the Offeror intends to achieve the following:

REQUIRED Attributes o U.S. FDA Clearance o Taking current TRL 6 (if not already TRL 7) (defined as a prototype that has network connection capabilities) USFP system to a TRL 7 (defined as a final prototype that does not connect to any network, store or share patient information) USFP system o Only receive software updates every 18 months and remain functional (see below for plan to address this) o U.S. FDA clearance for use in the abdomen and Ccapable of performing FAST exams o U.S. FDA clearance for use in the abdomen and cardiac use andCcapable of performing e-FAST exams o U.S. FDA clearance for musculoskeletal use and Ccapable of performing MSK/MSKI exams o Have a 95% probability of completing 24 total run time hours within a 3-day timespan without a

System Abort (SA), which equates to 468 hours Mean Time Between System Abort (MTBSA) DESIRED Attributes o A rechargeable power source o Power source should last for two hours at the highest setting o The complete USFP system should not weigh more than three (3) pounds o The complete USFP system should be a cube of no more than 280 cubic inches o The fully functional USFP system should be operational at all settings at 49°C o The fully functional USFP system should be operational at all settings at -1°C o Have transducers to perform FAST, eFAST and MSK exams o Have at least 8 GB of storage space

Provide system maintenance data (Deliverable 10 of the SOO) on the following metrics and how it was obtained (measured, estimated, etc.), if available:

o Mean Time Between System Abort (MTBSA) (Deliverable 10 of SOO) o Mean Time Between Maintenance (MTBM) (Deliverable 10 of SOO) o Mean Maintenance Time (MMT) (Deliverable 10 of SOO) o Mean Logistics Delay Time (MLDT) (Deliverable 10 of SOO)

Provide information for the viewing platform and transducer(s) battery information for the following:

o Fully charged battery life when not in use o Service life of the battery, how long will the battery hold >/= 80% charge o Recharge time for a fully used battery o Anticipated service time of the battery component of the transducer

Provide viewing platform specifications Provide a Software update plan (Deliverable 11 of the SOO) that identifies how the system will receive software updates without connecting to a wireless network while extending the software update cycle out to at least 18 months (Deliverable 24 of the SOO).

o How will the application and any necessary software be updated?

o How often is the software required to update?

o How frequently must the application be connected to the internet to maintain full operation?

o Are automatic updates able to be disabled?

o Can the device be updated manually?

Can the device be updated without internet capabilities?

If it can be updated without internet capabilities, please explain the process.

Management Approach The Offeror shall submit a written management approach which effectively demonstrates the Offeror’s approach for accomplishing the requirements of the SOO, including project schedule, project risks, regulatory schedule, and manufacturing approach.

Integrated Master Schedule (IMS) (Deliverable 4 of the SOO) If development work is needed, the Offeror shall provide a detailed Integrated Master Schedule (IMS) specifying developmental plans to the proposed device/system. This solicitation seeks a handheld, portable ultrasound system that does not have any network access/capability. The Offeror shall propose an IMS that shows what the anticipated steps, and overall timeline are, in order for all components of the Offeror’s proposed device/system to meet the non-network accessibility requirement. The Offeror shall submit the proposed IMS electronically, in either Microsoft Excel or Microsoft Project.

Teaming Agreement The Offeror shall include evidence (e.g., statement of intent to enter into a teaming agreement) of sub-performer/offeror relationships, if sub-performers/offerors are proposed.

NOTE: Offerors who propose consultants, subawards, consortiums or contractual arrangements with foreign organizations or foreign collaborators shall provide additional justification explaining why the foreign organization or foreign individual can carry out the scope of work more effectively than a U.S. organization or U.S. individual.

3.4 Volume II - Administrative and Cost Volume

Cover Page The Offeror shall include a Cover Page for Volume II.

Table of Contents The Offeror shall include a table of contents for Volume II.

Attachment F – Agreement (Terms and Conditions) The Offeror shall submit a red line version (i.e. track changes) of the Agreement (Terms and Conditions) incorporating any proposed changes and revisions. If no proposed changes/language are required, please indicate this by submitting a signed copy of the Agreement (Terms and Conditions). Attachment 2 & 3 (within the Agreement (Terms and Conditions)) shall be filled out and submitted, if applicable.

Cost/Price These instructions are to assist the Offeror in submitting cost/price information/basis for estimate that is required to determine realism, reasonableness, and completeness fair, reasonableness and realism of its proposed cost/price.

Compliance with these instructions is mandatory and failure to comply may result in rejection of the Offeror’s proposal. Unrealistically low or unreasonably high proposed costs or prices, initially or subsequently, may be grounds for considering the proposal unacceptable, either on the basis that the Offeror does not understand the requirement or has otherwise made an unrealistic or unreasonable proposal.

The Offeror shall submit a cost/price proposal using Attachment G - Cost / Price Sheet Template. The pricing sheet shall include all formulas, calculations, and links for review. The pricing sheet shall show proposed dollar values for the entire effort, including all direct and indirect costs and fees, where applicable.

Cost/Price shall be as follows:

Objective 1: Firm Fixed Price (FFP) Objective 2: Firm Fixed Price (FFP) Objective 3: Firm Fixed Price (FFP) Objective 4: Cost plus fixed fee (CPFF) Objective 5: Firm Fixed Price (FFP)

In addition to Attachment G - Cost / Price Sheet Template, the Offeror shall submit a written cost/price narrative.

This narrative shall provide a detailed and comprehensive description of proposed labor, hours, direct, indirect, and other direct costs, estimating techniques used and allocation methods that correlate in sufficient depth with the tasks in the SOW. For objective 4, the Offeror shall provide cost build up data for loaded labor rates beginning with the unloaded labor rate through application of indirect and profit and/or fee. The Offeror shall not propose labor rates that are derived from blending two or more separate Performers or sub-Performers. Proposed indirect shall be based on Offeror’s current Forward Pricing Rate Agreement and/or three-year historical trend. The narrative shall indicate how the proposed cost/price is realistic, reasonable, and complete. fair, reasonable, and realistic. Rate and pricing information is required for the Government to properly perform a cost/price analysis of the proposal.

Accounting System Although the requirements of FAR 16.301-3(a)(3) do not apply, an expenditure-based OT agreement that provides for payment based on amounts generated from the awardee’s financial or cost records require the awardee to have an accounting system capable of identifying the amounts/costs to individual agreements/contracts. The Offeror shall describe how the capability of its accounting system meets this requirement. If the Offeror is currently under administration or audit cognizance of the Defense Contract Management Agency (DCMA), the Defense Contract Audit Agency (DCAA), or other Government agency, the name, email address, and telephone number of the Government Agency’s Point of Contact shall be furnished.

4 Proposal Evaluation Criteria

4.1 General

Potential award will be based on the Government’s proposal evaluation and subsequent exchanges with the Offeror (if needed). The Government reserves the right to reject the Offeror’s proposal, and to award no agreement contract at all, depending on the quality of the proposal submitted and the availability of funds. The proposal shall be complete, shall arrive by the date and time indicated in this RPP and shall be compliant with all solicitation preparation instructions. The proposal will be evaluated on an “best value” “acceptable / unacceptable” basis.

Best Value - The Government will conduct the source selection based on the evaluation criteria and ratings contained within this RPP. The overall award decision will be based upon a Best Value determination and the final award selection(s) will be made to the most advantageous offer(s). Based on the results of the Stage 2, the Government reserves the right to negotiate and request changes to any or all parts of the proposal to include the

SOW.

4.2 Proposal Revisions

The Agreements Officer may request or allow proposal revisions to clarify and document understandings reached during negotiations. The Agreements Officer may establish a cut-off date only for receipt of final proposal revisions.

The request for final proposal revision shall advise the Offeror that the final proposal revision shall be in writing and that the Government intends to make award without further revisions.

4.3 Evaluation Factors for Award

The evaluation of the proposal in response to this RPP shall be based on a comprehensive review and evaluation of the proposal against all evaluation factors. Acceptable/Unacceptable rRatings consistent with the evaluation criteria will be derived from the Offeror’s demonstrated ability to perform the work in accordance with all aspects of requirements outlined in the RPP. The Government will evaluate each proposal against the evaluation factors detailed below and assign an adjectival rating to the non-cost/price factor(s) consistent with those defined in Table 1 (Non-Cost/Price Rating Assessments). The Government will evaluate the overall cost/price for realism, reasonableness, and completeness. The Offeror shall clearly state how their proposal meets it intends to meets the objectives and, if possible, exceeds the RPP requirements. If the proposal does not reflect an acceptable technical/management approach or indicates a failure to comprehend the complexity and risks of the requirement, this may constitute grounds for rejection of the proposal. The Offeror shall clearly demonstrate how it intends to accomplish the objectives stated in the RPP. Mere acknowledgement or restatement of a requirement or objectives is not acceptable. The Government will evaluate proposals using the following criteria listed in descending order of importance:

Evaluation Factors

Factor Number Evaluation Factors

Technical and Management Approach

2 Statement of Work

3 Cost / Price

Table 1: Non-Cost/Price RatingsRating Standards for Evaluation Factors 1 (Technical & Management Approach) & Evaluation Factor 2 (Statement of Work)

RATING DESCRIPTION

OUTSTANDING Proposal meets the 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.

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

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.

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

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

4.3.1 Factor 1 – Technical & Management Approach

Technical and Management Approach The Offeror’s proposal will be evaluated to the degree to which the technical and management approach demonstrates a clear understanding of all the objectives outlined in the SOO and how it will be achieved, is comprehensive and realistic, mitigates risk, and meets timelines.

Factor 2 - SOW

Statement of Work (SOW) The SOW will be evaluated to determine the proposed tasks are accurate and appropriate in meeting the objectives as well as to the degree to which it is consistent with the proposed technical and management approach in achieving the objective.

Factor 3 – Cost / Price

Cost/Price The Offeror’s cost/price proposal and rationale/basis of estimate will be evaluated to determine whether the proposed cost is realistic, reasonable, and completefair, reasonable and realistic. To make this determination, the Government may use analysis techniques including, but not limited to, verification of cost/price data, evaluation of cost/price elements, comparison of cost/price proposed by the Offeror for individual cost/price elements with actual costs previously incurred by the same Offeror, previous cost/price estimates from the Offeror for the same services, and independent government cost estimates by government personnel. The Government will independently review and evaluate specific elements of the Offeror’s proposed cost/price to determine realism, reasonableness, and completeness. determine whether the estimated proposed cost/price elements are realistic for the work to be performed; reflects a clear understanding of the requirements; and are consistent with the unique methods of performance and materials described in the Offeror’s technical and management approach and the statement of work. The evaluation will include analysis of the proposed cost/price together with the supporting cost/price information.

Realism: Cost/price is “realistic” when they are neither excessive nor insufficient for the effort to be accomplished.

Estimates must also be realistic for each objective when compared to the total proposed cost/price, reflects a clear understanding of the requirements, and are consistence with the Technical & Management Approach and SOW.

Reasonableness: Cost/price must, in its nature and amount, represent a price to the Government that a prudent person would pay in the conduct of competitive business. The Offeror shall show that sound, rational judgment was used in deriving and applying cost methodologies. Normally, price reasonableness is established through cost and price analysis.

Completeness: Cost/price must clearly and thoroughly document the rationale supporting the proposed cost/price and its compliance with the requirement of the solicitation. The proposal shall clearly and thoroughly document the cost/price information supporting the proposed cost/price in sufficient detail and depth. Rate and pricing information is required to properly perform the cost/price analysis of the proposal.

5. Proposal Submission:

RPP QUESTIONS DUE: Questions regarding this RPP shall be submitted no later than: 123:00 PM eastern, 024 August 2023

PROPOSALS DUE: 5:00 PM eastern, 14 August 2023 12:00 PM eastern, 18 August 2023

SUBMIT TO: Mr. Chris Sult, USAMRAA Agreements Specialist via email at: christopher.m.sult.civ@health.mil

6. Attachments:

Attachment A – Statement of Objectives (SOO) REVISED Attachment B – Warranties and Representatives Attachment C – Biomedical Technology Readiness Levels (TRL) (reference only)

Attachment D – Medical Device Evaluation and Risk Assessment (MDERA) Attachment E – Statement of Work (SOW) Template REVISED Attachment F – Agreement (Terms & Conditions) REVISED Attachment G – Cost / Price Template REVISED Attachment H – Down Selection Evaluation Criteria REVISED Attachment I – MIL-STD-810 Attachment J – Acronyms

(end of RPP)