RPP_Scanner Ultrasonic Ocular_22Oct26.pdf

REQUEST FOR PROTOTYPE PROPOSALS

(RPP)

Scanner Ultrasonic Ocular Other Transaction Authority (OTA) Pursuant to 10 U.S.C. § 4022

Direct OTA — Prototype Project

Release Date: 22 October 2026

Portfolio Acquisition Executive (PAE) Maneuver Ground Project Manager (PM) Maneuver Medical Systems (M2S)

Scanner Ultrasonic Ocular RPP

Table of Contents Table of Contents

1.0 Acronyms and Definitions

2.0 Solicitation Overview

2.1 Purpose…………………………………………………………………………………………………………………………………….…..6

2.2 OTA Authority Citation

2.3 Background

2.4 Mission Need / Problem Statement

2.5 Prototype Scope Overview

3.0 Prototype Objectives

3.1 Operational Objectives

3.2 System Maintainability & Organic Supportability…………………….…………………………………………………….8

3.3 Prototype Success Criteria

3.4 Demonstration Goals

3.5 Transition to Follow-On Production

4.0 Eligible Responders

4.1 OTA Award Structure — Direct OTA

4.2 Nontraditional Defense Contractor (NDC) Requirements

4.3 Small Business Participation

4.4 Trade Agreements Act (TAA) Compliance

4.5 Cost Share

5.0 Technical Specifications

5.1 Critical Operational Device Specifications (CODS)

5.2 Additional Performance Attributes (APAs)

5.3 Cybersecurity Requirements………………………………………………………………………………………………………..12

5.4 Security Requirements

5.5 Warranty Requirements

5.5.1 Intellectual Property & Data Rights Warranty…………………………………………………………………..12

5.6 Intellectual Property & Data Rights Expectations (See Attachment C - Technical Data Articles Annex)……………………………………………………………………………………………………………………………………………………13

5.7 Anti-Terrorism (AT/Operational Security (OPSEC)…………………………………………………………………………….13

6.0 Deliverables and Period of Performance

6.1 Prototype Deliverables / Agreement Data Requirements List (ADRLs)

6.2 Period of Performance

7.0 Proposal Instructions

7.1 Proposal Volume Structure

7.2 Volume I — Executive Summary

7.3 Volume II — Technical Approach

7.4 Volume III — Management, Past Performance & Schedule

7.5 Volume IV — Cost / Business Proposal

7.6 Page Limitations and Format

7.7 Submission Instructions

7.8 Questions and Answers Process

8.0 Evaluation Approach

8.1 Evaluation Factors …

8.2 Rating Definitions

9.0 Award Information

9.1 Number of Awards

9.2 Estimated Funding

9.3 Follow-On Production Authority (10 U.S.C. § 4022(f))

9.4 Government Rights and Reservations

10.0 Administrative Information

10.1 Export Control

10.2 Organizational Conflict of Interest

10.3 Proprietary Information

10.4 Communication Restrictions

11.0 Points of Contact

12.0 Attachments and Appendices

Appendix E - Data Rights Assertions Table

1.0 Acronyms and Definitions

Acronym Definition

AAC Acquisition Advice Code

ACC U.S. Army Contracting Command

ADRL Agreement Data Requirements List

APA Additional Performance Attribute

ATO Authority to Operate

BMET Biomedical Equipment Technician

CLS Critical Logistical Specification

CODS Critical Operational Device Specification

CUI Controlled Unclassified Information

DHP Defense Health Program

DLA Defense Logistics Agency

DoW Department of War

ECAT Electronic Catalog

FDA Food and Drug Administration

ICP Intracranial Pressure

IOL Intraocular Lens

M2S Maneuver Medical Systems

MDERA Medical Device and Equipment Risk Assessment

MTEAC Medical Test and Evaluation Activity

NDC Nontraditional Defense Contractor

Acronym Definition

OTA Other Transaction Authority

PAE Portfolio Acquisition Executive

PM Project Manager

RDT&E Research, Development, Test, and Evaluation

RMF Risk Management Framework

ROC Role of Care

RPP Request for Prototype Proposals

TAA Trade Agreements Act

TBI Traumatic Brain Injury

2.0 Solicitation Overview

Parameter Details

Issuing Agency / Organization Portfolio Acquisition Executive (PAE) Maneuver Ground, Project Manager (PM) Maneuver Medical Systems (M2S) 1240 Rocky Springs Road, Fort Detrick, MD 21702

Agreement Activity U.S. Army Contracting Command (ACC) DoDAAC: W91CRB

Solicitation Number W91CRB-26-AWSP_Scanner_Ultrasonic_Ocular _RPP

Solicitation Title Scanner Ultrasonic Ocular - Prototype

OTA Authority 10 U.S.C. § 4022 — Other Transactions for Prototype Projects

Award Type Direct Other Transaction (OT) Agreement — NOT a FAR-based Contract

Classification / Handling Controlled Unclassified Information (CUI)

Release Date 22 October 2026

Parameter Details

Questions Due 29 October 2026

Proposals Due 3 November 2026

Anticipated Award FY27 Q1 — FY26 Defense Health Program (DHP) RDT&E 2-Year Funds

Product Service Code 6515 — Medical and Surgical Instruments, Equipment, and Supplies

NAICS Code 334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing

This document constitutes a Request for Prototype Proposals (RPP) issued under Other Transaction Authority (OTA) pursuant to 10 U.S.C. § 4022. This is NOT a solicitation for an agreement under the Federal Acquisition Regulations (FAR). Vendors are advised to read this RPP in its entirety prior to preparing a response.

2.1 Purpose

Portfolio Acquisition Executive (PAE) Maneuver Ground Project Manager (PM) Maneuver Medical Devices (M2S) is issuing this Request for Prototype Proposals (RPP) under Other Transaction Authority (OTA) pursuant to 10 U.S.C. § 4022 to solicit prototype project proposals for a Scanner Ultrasonic Ocular device.

The purpose of this RPP is to identify, select, and award two (2) prototype Other Transaction (OT) Agreement —for the delivery and demonstration of prototype scanner ultrasonic ocular devices that address the capability gap described herein. The awardee(s) shall deliver four (4) prototype devices for operational and environmental testing. The goal is to procure an FDA-approved commercial solution that requires minimal to no modifications to meet the technical specifications identified herein.

2.2 OTA Authority Citation

This RPP is issued pursuant to 10 U.S.C. § 4022, which authorizes the Secretary of War and the Secretaries of the Military Departments to carry out prototype projects directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of War (DoW). Awards made under this RPP are Other Transaction (OT) Agreements—NOT contracts, grants, or cooperative agreements— and are not subject to the Revolutionary Federal Acquisition Overhaul (RFO) or Defense Federal Acquisition Regulation Supplement (DFARS) unless specifically incorporated. This effort is not conducted under FAR Part 15 source selection procedures.

2.3 Background

The Scanner Ultrasonic Ocular is a critical medical imaging device used in deployed Field Hospitals at Role of Care (ROC) 3. It provides rapid diagnostic visualization of eyeball structures and performs essential intraocular lens (IOL) calculations. The system enables military clinicians to noninvasively examine the eye anteriorly and posteriorly, enhancing ophthalmic trauma diagnostics in austere remote environments. The currently fielded device, the Sonomed E-Z Scan AB5500+ (NSN: 6510-01-486-3181, manufactured in 2004), is no longer procurable or supportable through the Defense Logistics Agency (DLA) Electronic Catalog (ECAT). The End-of-Life notification significantly impacts the sustainability and viability of the system, particularly for military medical professionals who depend on this device to provide critical diagnostic and procedural capabilities in austere, deployed environments.

2.4 Mission Need / Problem Statement

The U.S. Army requires a Commercial-Off-The-Shelf (COTS) or Non-Developmental Item (NDI) ultrasonic ocular scanner device capable of supporting ophthalmic diagnostic operations in austere ROC 3 environments with little to no modification. Ultrasonic ocular scanner capabilities are required for the following reasons:

• Trauma Assessment & Internal Eye Imaging: when swelling, cataracts, or heavy bleeding blocks a physical view of the eye, clinicians must be able to visualize the interior of the eye and orbit to aid in diagnosing retinal detachments and locate intraocular combat debris.

• Emergency Surgical Planning: Clinicians must be able to measure axial length and lens thickness to quickly calculate accurate replacement intraocular lens (IOL) power for patients requiring urgent ocular reconstructive surgery.

• Rapid Traumatic Brain Injury (TBI) Screening Support: Clinicians must be able to non-invasively scan the optic nerve sheath diameter to monitor for signs of elevated intracranial pressure (ICP) in patients suffering from traumatic brain injuries.

Failure to field a modernized ultrasonic ocular scanner system will negatively impact the Army’s ability to provide ophthalmic diagnostic imaging capabilities in deployed austere environments, compromising operational and medical readiness and survivability of Warfighters.

2.5 Prototype Scope Overview

This RPP seeks commercial off the Shelf (COTS) or Non-Developmental Item (NDI) prototype solutions for a modernized ultrasonic ocular scanner system requiring little to no modification to the baseline commercial system. The prototype must support A-Scan biometry (including axial length and IOL power calculations) and B-Scan diagnostic imaging (providing high-resolution posterior and anterior segment visualization). The system must operate on dual-voltage power with automatic voltage detection and include a backup battery to maintain system capabilities when a The prototype solution shall support the operational objectives and technical specifications identified within this RPP.

The Government intends to procure four (4) prototype units to be utilized for operational testing by the Medical Test and Evaluation Activity (MTEAC) and environmental testing conducted in accordance with

MIL-STD-810H. This is a commercial-derivative technology prototype effort. Proposed solutions shall be Food and Drug Administration (FDA) cleared for human use as well as Trade Agreements Act (TAA) Compliant.

This effort is structured as a prototype experimentation and operational evaluation activity intended to support iterative assessment, user feedback incorporation, operational data collection, prototype refinement, and transition planning for future operational capability development.

3.0 Prototype Objectives

3.1 Operational Objectives

Proposed prototype solutions must demonstrate the capability to meet the following operational objectives to support medical operations in ROC 3 environments:

• Enable deployed clinical staff to safely visualize ophthalmic structures and perform biometric computations without reliance on external network connections.

• Provide high-resolution ultrasound imagery to identify intraocular foreign bodies, retinal tears, and vitreous anomalies when direct ophthalmoscopic view is restricted.

• Minimize weight and packaging size to enable single-operator transportability within standard medical assemblage configurations.

• Capable of operating continuously on standard commercial and tactical generator power in the

Continental United States (CONUS) (110 – 120 VAC/60 Hz) and/or Outside Continental United States (OCONUS) (220 – 240 VAC/50 Hz) power infrastructure.

3.2 System Maintainability & Organic Supportability

Organic Maintenance Preferred: The Government highly desires a system that is designed to be maintainable by military Biomedical Equipment Technicians (BMETs) at the Field (User) and Depot levels.

Sustainment Strategy Preference: The Government strongly prefers proposals that minimize or eliminate the need for commercial service contracts or proprietary service agreements. Solutions that allow self-sufficiency in the field for routine calibration, preventive maintenance, troubleshooting, and repairs will be evaluated as highly favorable.

Open Supportability: It is highly desirable that preventative and corrective maintenance can be performed using standard, non-proprietary tools and diagnostic equipment. Any requirement for proprietary diagnostic software, specialized vendor-only calibration tools, or proprietary training certifications to perform basic repairs should be explicitly disclosed and technically justified in the proposal.

Highly Desired OEM Certification Pathway: In cases where the proposed system has technical or legal barriers that mandate proprietary or Vendor-trained technicians to perform specialized maintenance, software updates, or calibrations, vendors are strongly encouraged to offer comprehensive, OEM-equivalent training and certification program for designated military BMET personnel. Providing a defined training pathway that certifies and authorizes military technicians to conduct repairs, preventative maintenance, and calibrations—granting them identical permissions, software keys, and tool access as commercial field representatives—will be evaluated highly favorably under Factor 4 (RMS) as a viable method to achieve organic self-sufficiency.

Manuals and Documentation: The vendor is encouraged to deliver complete technical manuals, schematics, parts lists, and troubleshooting guides to support self-sufficiency in the field, including licensing rights to reproduce these materials (see Section 6.1, A-016).

3.3 Prototype Success Criteria

The prototype project will be deemed successful upon completion of this effort, where the Awardee delivers the user manuals, test reports, test prototypes, and all documentation required prior to procurement in accordance with Section 6.1 Deliverables.

3.4 Demonstration Goals

Prototype units will undergo two (2) phases of testing following delivery:

• Operational Testing: Conducted by the MTEAC in a controlled operational environment simulating field hospital conditions.

• Environmental Testing: Conducted in accordance with MIL-STD-810H at a Government-designated test facility.

The Government will provide test coordination support. The vendor shall provide technical representatives to support testing events. Operational user feedback and test data collected during evaluation events may be used to support iterative prototype refinement and future capability development planning.

3.5 Transition to Follow-On Production

Upon successful completion of prototype testing and validation, the Government intends to pursue follow-on production of up to approximately ten (10) units to meet total program requirements, without further competition, pursuant to 10 U.S.C. § 4022(f). The Government's intent is that after the initial system warranty period concludes, the selected Vendor(s) will work with the Defense Logistics Agency (DLA) Troop Support to add their device to the DLA Electronic Catalog (ECAT) or a Prime Vendor contract vehicle to facilitate rapid procurement and delivery to the Warfighter.

4.0 Eligible Vendors

4.1 OTA Award Structure — Direct OTA

This RPP is issued in support of PAE Maneuver Ground, PM M2S, under its standalone OTA authority pursuant to 10 U.S.C. § 4022. This is a DIRECT OTA — consortium membership is NOT required. The Government intends to award two (2) OT Agreements, for four (4) prototype devices. Government reserves the right to make a single award, additional awards, or no award depending on the quality of proposals received and funding availability.

4.2 Nontraditional Defense Contractor (NDC) Requirements

10 U.S.C. § 4022 requires that, to the maximum extent practicable, at least one party to a prototype OTA is either: (1) a nontraditional defense contractor (NDC); or (2) a nonprofit research institution. A NDC is an entity that has not, for a period of at least one (1) year prior to the date of the OT Agreement, entered into or performed on any contract or subcontract subject to full coverage under the Cost Accounting Standards (CAS) prescribed pursuant to 41 U.S.C. § 1502. Vendors must identify whether they qualify as an NDC and provide supporting justification in their proposal. If no party qualifies as an NDC or nonprofit, the Government may still proceed if at least one-third of the total cost is provided by non-Federal Government sources.

4.3 Small Business Participation

Market research conducted in September 2026 identified at least three (3) small businesses as capable of supporting the operational and technical objective of this prototype effort. The applicable NAICS code is 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) with a Small Business size standard of one thousand (1,000) employees. Vendors shall be registered in SAM.gov at the time of proposal submission. The Government encourages participation from capable small business concerns and nontraditional defense contractors capable of supporting the operational and technical objectives of this prototype effort.

4.4 Trade Agreements Act (TAA) Compliance

All proposed systems, accessories, and repair parts shall be compliant with the TAA. Vendors are required to complete and submit a Trade Agreements Certificate (Attachment A of this RPP). The end product and all components must be manufactured in the United States or a TAA-designated country.

Vendors must clearly identify the country of origin for all major components. This certificate is required prior to award.

4.5 Cost Share

Cost share is not required for this prototype effort. The Government has determined that cost share is not a condition of award under this RPP. However, vendors who propose voluntary cost share will have that contribution noted positively during evaluation as an indicator of commitment to the prototype effort and transition to production.

5.0 Technical Specifications

The following specifications define the performance standards for the Scanner Ultrasonic Ocular prototype. The specifications are categorized as Critical Operational Device Specifications (CODS — threshold) and Additional Performance Attributes (APAs — desired but not required for acceptability).

Vendors must meet all CODS minimum specifications, or present a justification to meet the specifications, to be considered acceptable. Vendors shall outline where each COD/APA is located within the proposal.

5.1 Critical Operational Device Specifications (CODS)

# CODS Minimum Specification Desired Characteristic

1 Food and Drug Administration (FDA) Regulatory Oversight

The system shall be cleared by the FDA with a 510(k) approval for human use if it is a Class II medical device. If the system is Class I medical device, it shall be registered with the FDA for human use.

Minimum Required

2 Anatomical Visualization

Provide clear images of anatomical structures in both the anterior and posterior segments of the eye.

Minimum Required

3 Measurements Provide internal eye structure measurements and perform intraocular lens (IOL) calculations.

Minimum Required

4 Diagnostic Capabilities Provide diagnostic images that detect ocular trauma, retinal detachments, vitreous inflammation or debris, hemorrhage, lens dislocation, retinal tears, intraocular foreign bodies, and masses in the back of the eye.

Minimum Required

5 Ultrasound Probe Types Provide A-Scan (Amplitude Scan) probes and B-Scan (Brightness Scan) probes.

Provide UBM (Ultrasound Biomicroscopy) probes. Probes can operate with a sterile sleeve.

6 Power Operate on 110 – 120 VAC (60 Hz). The system operates on 110 – 120 VAC (60 Hz) and 220 – 240 VAC (50 Hz). Runs on battery power for 30 – 60 minutes.

5.2 Additional Performance Attributes (APAs)

# APA Description

1 Maintenance Kits Vendor demonstrates capability to develop and provide fieldable maintenance kits supporting operational sustainment, if needed.

2 Maintenance Manual Task Identification

Vendor identifies operator-level and maintenance-level tasks within technical manuals that may be performed by Army personnel without vendor support.

3 Reusable Hardened Transport Case

Vendor shall provide a ruggedized case (or cases) for safe transport and shipment of the system. If not met, the vendor shall confirm willingness to collaborate with 3rd-party provider (Government- or vendor-identified) to create or modify the case. Case designed to meet MIL-STD-810H: 501.7 High Temp, 502.7 Low Temp, 506.6 Rain,

514.8 Vibration, 516.8 Shock.

4 Open-Architecture Consumable Interchangeability

Designed to utilize standard, non-proprietary consumables to ensure complete operational supportability in environments with restricted supply chains.

5.3 Cybersecurity Requirements

All prototype units shall comply with applicable Department of War (DoW) cybersecurity policies. The Scanner Ultrasonic Ocular is required to be a standalone system that does not connect to DoW networks during normal operation. Vendors shall address if an Authority To Operate (ATO) has been established for the system or the status. Vendors shall support Risk Management Framework (RMF)/ATO documentation activities in coordination with PM M2S cybersecurity personnel. Controlled Unclassified Information (CUI) handling requirements apply; vendors shall comply with National Institute of Standards and Technology NIST SP 800-171.

5.4 Security Requirements

This effort is classified UNCLASSIFIED // (CUI). No facility or personnel security clearances are required for proposal submission.

5.5 Warranty Requirements

The vendor shall provide a minimum 1-year warranty covering all parts, in-house labor, and technical support, commencing upon device delivery. For the subsequent production phase, the desired baseline warranty period is three (3) years, commencing when the devices are formally accepted by the receiving military unit.

5.5.1 Intellectual Property & Data Rights Warranty

The Vendor further warrants that the Government’s reproduction, distribution, and internal use of delivered technical manuals, schematics, and training materials, strictly for the purposes of military training, operational use, and organic maintenance, will not violate any copyrights, proprietary markings, or end-user licensing restrictions. The Vendor may need to add distribution statements and CUI markings to the technical manuals, schematics, and training materials deliverables.

5.6 Intellectual Property & Data Rights Expectations (See Attachment C – Technical Data Articles Annex) To support rapid fielding and operational self-sufficiency in austere, remote, or contested environments, the Government requires specific data rights and intellectual property parameters. This prototype project is a commercial-derivative technology effort; the Government does not seek ownership of baseline commercial hardware designs, manufacturing blueprints, or software source code. However, the Government expects the following rights to protect operational readiness:

• The Government’s expectations regarding intellectual property and data rights are set forth in Attachment C – Technical Data Articles Annex. Vendors shall comply with Article III (Rights in Technical Data and Computer Software – Commercial-Derivative Prototype) of that Annex. In particular, the Government requires Unlimited Rights in technical data first produced or specifically modified under this Agreement, and a perpetual, royalty-free license for all operation and maintenance manuals, schematics, parts lists, and troubleshooting guides to support organic BMET maintenance at Field and Depot levels. Organic maintenance performed in accordance with the manuals provided shall not void the warranty. Use of third-party ruggedized cases shall also not void the warranty.

• Operating Software & Firmware: See Attachment C, Article III for the full license rights, including software keys, calibration tools, and organic maintenance provisions.

• Warranty Protection for Self-Repair: See Attachment C, Article III. Organic maintenance by Government BMETs and use of third-party ruggedized cases shall not void the warranty.

5.7 Anti-Terrorism (AT)/Operational Security (OPSEC)

An AT/OPSEC review has been completed per DHA Form 337 (dated 13 January 2026). The designated AT/OPSEC reviewer has reviewed this requirements package and confirmed compliance with DHA-AI 078 (Antiterrorism Program) and DHA-AI 5200.03 (Operations Security). CUI provisions apply. Vendor employees requiring access to Government facilities must complete AT Level I Awareness training within thirty (30) days of agreement start date and comply with all installation access requirements.

6.0 Deliverables and Period of Performance

Unless a specific due date is outlined in the table below, Vendors may propose reasonable due dates for each deliverable in their technical proposal. All proposed due dates are subject to Government review, negotiation, and bilateral agreement prior to award.

6.1 Prototype Deliverables / Agreement Data Requirements List (ADRL)

ADRL Deliverable Due Date

A-001 Award / Kickoff Meeting No Later Than (NLT) 14 days after award

A-002 Monthly Progress Reports Monthly based upon award date

A-003 Four (4) Scanner Ultrasonic Ocular Prototype Units 45-60 days after award

A-004 User/Operator Manual — Physical (1) and Digital (1) Maintenance/Service Manual — Physical (1) and Digital (1)

Vendor Proposed

A-005 Copyright Release — Copyright release allowing the Government to reproduce and distribute training materials, manuals, and technical data for internal military use.

Vendor Proposed

A-006 Provisioning & NSN Generation — Comprehensive logistics data (e.g., Bill of Materials, CAGE codes, part numbers) required to generate National Stock Numbers (NSNs) for the complete system, major components, and repair parts.

Vendor Proposed

A-007 TAA Compliance Certificate (Trade Agreements Act) With proposal / at award

A-008 Training — Up to two (2) On-Site CONUS Operator Sessions Vendor Proposed

A-009 Operational Training Video or Training Site Access Vendor Proposed

A-010 Special Tools List — Vendor identifies specialized tools required for repair/maintenance and makes them available for Government purchase, as applicable.

Vendor Proposed

A-011 Cybersecurity / ATO Documentation — Vendor completes Government-provided RMF documentation, Medical Device and Equipment Risk

Vendor Proposed

ADRL Deliverable Due Date

Assessment (MDERA) supporting cybersecurity compliance and ATO documentation.

A-012 Test Support — Technical Representative During Government T&E events

A-013 Recurring Meetings Vendor Proposed

A-014 Supplemental Documentation — all additional reports, manuals, or technical data items

Vendor Proposed

A-015 Final Report — Performance summary, lessons learned, final budget justification.

Vendor Proposed

A-016 Organic Maintenance Support Plan & License (Highly Desired) — Plan outlining how the Government may perform organic repairs utilizing military BMET personnel, to include requested technical manual reproduction rights, schematics access, or voluntary diagnostic software permissions.

Vendor Proposed

A-017 Item Unique Identification (IUID) – Vendor shall mark all tangible prototype hardware deliverables with a MIL-STD-130N compliant 2D Data Matrix and human-readable text using Construct 2 (CAGE, Original Part Number, Serial Number) and provide an electronic IUID/pedigree data report to the Agreements Officer Technical Representative (AOTR) upon milestone delivery.

Vendor Proposed

A-018 Data Rights Assertions (Appendix E) — Identification and Assertion of Use, Release, or Disclosure Restrictions per 10 U.S.C. 3772

Pre-Award / With Proposal

6.2 Period of Performance

The estimated period of performance is twelve (12) months, commencing on the date of award. The Government estimates award during FY27 Q1. Prototype unit delivery is expected 45-60 days after award. The period of performance includes prototype unit delivery, training support, Government operational testing, and environment testing conducted in accordance with MIL-STD-810H.

7.0 Proposal Instructions

7.1 Proposal Volume Structure

Volume Title Page Limit

Volume I Executive Summary 1 page max

Volume II Technical Approach 7 pages max

Volume III Management, Past Performance & Schedule 5 pages max

Volume IV Cost / Business Proposal 3 pages max

7.2 Volume I — Executive Summary

• Overview of proposed prototype solution and how it addresses the Scanner Ultrasonic Ocular capability gap.

• Company name, CAGE code, SAM.gov UEI, business size representation, and socioeconomic status, if applicable.

• NDC qualification statement or cost-share position if NDC status cannot be established.

• TAA compliance statement and country of origin for the proposed system.

• Total proposed cost and proposed period of performance.

7.3 Volume II — Technical Approach

• Detailed description of the proposed ultrasonic ocular scanner system, including model name/number and technology approach/design configuration (integrated device vs. modular system).

• Compliance matrix addressing each CODS specification (minimum and desired) clearly indicating Meets / Does Not Meet / Exceeds Desired Objective for each item.

• FDA regulatory status: current 510(k) clearance number or Class I registration status.

• Technical data supporting performance specifications as outlined therein.

• Description of hardened transport case configuration (if proposed as an APA) or willingness to collaborate with a 3rd-party provider (Government- or Vendor-identified) to create or modify a ruggedized case.

• Data rights position, intellectual property strategy, and details of any voluntary Organic Maintenance Support Plans, reproduction licenses, or diagnostics access permissions (A-016) proposed by the Vendor.

• Approach to addressing the deliverables in Section 6.1.

• Risk identification and mitigation approach.

The Vendors must also include the completed Appendix E - Data Rights Assertions Table in this volume.

7.4 Volume III — Management, Past Performance & Schedule

• Company background, organizational structure, and relevant experience in ultrasonic ocular scanner systems.

• Key personnel and qualifications.

• Past performance: at minimum two (2) relevant contracts or commercial sales of ultrasonic ocular scanner systems, including customer name, agreement/order number if applicable, system delivered, quantity, and period.

• Manufacturing capability: current production capacity and ability to support a ten (10)-unit follow-on production run.

• Proposed milestone schedule from award through end of performance period.

• Approach to providing up to two (2) on-site CONUS training sessions. If specialized proprietary technician training is required to perform maintenance or calibrations, the Vendor is highly encouraged to submit their proposed training plan to certify military BMET personnel to OEM-equivalent standards.

• Small business subcontracting approach (if applicable).

7.5 Volume IV — Cost / Business Proposal

CLIN Description Qty Pricing

CLIN 0001 Baseline Prototype Ultrasonic Ocular Scanner Units (full system)

2 EA Unit Price: $_____ Total:

CLIN 0002 Training — On-Site CONUS Operator Sessions BMET Service/Maintenance Training (if proposed/applicable)

2 EA Unit Price: $_____ Total:

CLIN 0003 Warranty (Baseline 1-Year) 2 EA Unit Price: $_____ Total:

CLIN 0004 Packaging and Shipping 2 EA Unit Price: $_____ Total:

CLIN 0005 Documentation/Deliverables (A-001 through A-018) 1 EA Unit Price: $_____ Total:

CLIN 0006 Ruggedized Transport Case (Vendor supplied or 3rd party)

2 EA Unit Price: $_____ Total:

CLIN Description Qty Pricing

CLIN 0007 Modification (if any minimal modifications are required)

1 EA Unit Price: $_____ Total:

CLIN 0008 Software License/Diagnostics (if applicable) 1 EA Unit Price: $_____ Total:

TOTAL PROPOSED COST $_____

Provide basis of estimate for each proposed cost element, including labor, material, overhead, and profit/fee, as applicable CLIN. Identify any proposed volume pricing, production scalability considerations, or pricing assumptions relevant to anticipated ten (10) unit follow-up production. The vendor shall provide proposed payment schedule (e.g., milestone-based payments).

The vendor’s price proposal must be all-inclusive and holistic, representing the total price to deliver the complete, functioning system (including all software, hardware, warranties, and deliverables). However, if any modification (minimal or otherwise) is required to meet a performance specification in this RPP, the Vendor must explicitly discuss the technical nature of the modification, price it separately under CLIN 0007, and submit a detailed delivery schedule demonstrating that modified prototype units will be delivered to support scheduled Government testing windows. Failure to separate baseline COTS/NDI costs from modification costs, or failure to provide an aligned delivery timeline, may result in the proposal being deemed non-compliant.

7.6 Page Limitations and Format

Page limits are strict. Pages exceeding stated limits will not be evaluated. A page is defined as one side of a sheet of 8.5“ x 11” paper with minimum 11-point Arial font, 1-inch margins, and standard single spacing. Graphics, figures, and tables count toward page limits. Covers, tabs, compliance matrices, and the table of contents do not count toward page limits.

7.7 Submission Instructions

Proposals must be submitted no later 3 November 2026 at Eastern Time on the date identified in the solicitation notice.

• Submission Method: DoD SAFE file transfer or secure email submission.

• Submit to: Michael James, Agreements Officer - michael.c.james78.civ@army.mil

• Copy to: Matt McNeely, Agreements Specialist - matthew.j.mcneely2.civ@army.mil

All volumes must be submitted as separate PDF files using the naming convention: [Company Name]_Scanner Ultrasonic Ocular _RPP_W91CRB-26-AWSP_Vol[X]_[Title].pdf. The Government intends to acknowledge receipt within two (2) business days. Late proposals will not be accepted unless a formal

RPP Amendment extends the deadline. Verbal communications are not binding. Proprietary information must be clearly marked on each page containing such information.

7.8 Questions and Answers Process

All questions must be submitted in writing via email to Michael James (michael.c.james78.civ@army.mil) with copy to Matt McNeely (matthew.j.mcneely2.civ@army.mil) no later than 29 October 2026 at 15:00 Eastern Standard Time (EST). Questions and official Government responses will be posted as an RPP Amendment. Verbal communications are not binding. No individual responses will be provided.

8.0 Evaluation Approach

The Government will conduct a comprehensive, holistic, and qualitative evaluation of each vendor's Prototype Proposal. All parts of the RPP and the vendor’s corresponding submission will be considered during the evaluation process. To align with the Army's rapid modernization goals, the Government is seeking mature, low-risk solutions. The Government intends to acquire COTS or NDI requiring little to no modification. Proposals for developmental items, or those requiring significant engineering or redesign of the baseline commercial system, do not meet the intent of this RPP and will be evaluated unfavorably or excluded from consideration. The Government will evaluate proposals using a comparative methodology to determine the "best fit" (best value) for the Army's operational requirements. Proposals will be evaluated by a Government evaluation team consisting of technical, programmatic, operational, and cost/business subject matter experts. This prototype effort is not a FAR Part 15 source selection and does not utilize Lowest Price Technically Acceptable (LPTA) procedures or rigid mathematical scoring.

The Government reserves the right to select a prototype solution that represents the overall "best fit" to meet the Army's mission, even if the proposed solution does not meet 100% of the individual technical or performance specifications outlined within this RPP. If no vendor meets all performance specifications, the Government may evaluate and select the proposal(s) that offer the most advantageous combination of capability, technical maturity, schedule realism, and cost.

8.1 Evaluation Factors

Rather than applying rigid percentages or weights, the Government will evaluate proposals holistically across the following integrated areas. When determining the "best fit," the non-cost areas (Areas 1 through 6), when combined, are more important than Cost/Price (Area 7). Past Performance will be evaluated as Acceptable/Unacceptable. Cost/Price will be evaluated for reasonableness and realism and will not be provided with an adjectival rating.

# Factor Description

1 Technical Approach The feasibility, soundness, and maturity of the proposed design configuration (integrated device vs. modular system) and the testing methodology required to deliver and validate the prototype.

# Factor Description

2 Technical Maturity and Commerciality

Assessment of the baseline system's status as a COTS or NDI solution (whether proposed as a single integrated device or a modular system).

Solutions requiring little to no modification will be evaluated highly favorably. If minimal modifications are required to meet a specification, they must be technically justified, clearly explained, and priced separately. Proposals for developmental items requiring significant redesign or developmental engineering will be graded unfavorably or excluded from consideration.

3 Performance Compliance The vendor’s demonstrated capability to meet or exceed all Performance Specifications, administrative and hardware deliverables, and operational requirements outlined within this RPP. A proposal that fails to meet threshold Performance Specifications may be excluded from further evaluation.

4 Reliability, Maintainability & Supportability

Evaluates the terms of the warranty offered, readiness and availability of repair parts, ease of maintenance in austere environments, and the long-term sustainment plan. Highly favorable evaluation will be given to systems designed to be maintained organically by military BMETs at the Field and Depot levels without proprietary tools or software.

Proposals that voluntarily minimize these sustainment barriers, provide complete organic technical documentation (A-016), or offer an OEM-equivalent BMET training/certification pathway (A-008) will be graded favorably.

5 Schedule Realism The feasibility and realism of the proposed timeline to meet all milestone deliverables, including the vendor's demonstrated ability to support scheduled Government test and evaluation events.

6 Past Performance The vendor’s relevant experience and track record in delivering diagnostic ultrasound systems, historical delivery performance, and overall customer satisfaction.

7 Cost / Price The overall reasonableness, realism, and completeness of the proposed cost structure. The cost must be holistic, encompassing all elements of the system. Any required modification costs must be broken out and priced separately from the baseline COTS/NDI system cost. While technical merit is of primary importance, Cost/Price will be a determining factor among proposals of relatively equal technical merit.

8.2 Rating Definitions

Rating Description

Outstanding Exceeds specifications with significant strengths; low risk; surpasses CODS desired characteristics and multiple APAs.

Good Meets all specifications with some strengths above minimum; low to moderate risk;

meets some desired characteristics and APAs.

Acceptable Meets all critical specifications OR meets the majority of specifications where any unmet criteria pose only a negligible risk to overall mission execution. No significant weaknesses.

Marginal Fails to meet one or more minimum specifications, but the core solution remains a viable COTS/NDI system. The unmet specifications present a moderate, yet acceptable, risk or operational trade-off. The Government may still consider this solution for award if it represents the overall "best fit" among available options.

Unacceptable Fails to meet critical specifications, resulting in an unacceptable operational risk or a total inability to perform the core mission. Alternatively, the proposal requires significant developmental engineering. Proposal is eliminated from award consideration.

9.0 Award Information

9.1 Number of Awards

The Government intends to award two (2) awards. The Government reserves the right to make more than two (2) awards or no awards based on proposal quality and funding availability.

9.2 Estimated Funding

Funding is provided under FY26 Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) 2-year funds. Funding is subject to availability and Congressional appropriation. The Government does not guarantee obligation of all available funding.

9.3 Follow-On Production Authority (10 U.S.C. § 4022(f))

This OT Agreement is issued with a provision for follow-on production pursuant to 10 U.S.C. § 4022(f).

Upon successful prototype completion and validation, the Government may award a follow-on RFO based production agreement or OT Agreement for approximately ten (10) ultrasonic ocular scanner units without further competitive procedures. Vendors should factor this transition potential into their proposals, including DLA ECAT/Prime Vendor onboarding plans.

9.4 Government Rights and Reservations

• Award only specific components of a modular system if a vendor’s complete package is too expensive or risky.

• Cancel this RPP at any time without obligation to any vendor.

• Make more than two (2) awards, a single award, or no award.

• Adjust the number of prototype units purchased from the vendor.

• Conduct discussions or negotiations with one (1) or more vendors.

• Waive informalities or minor irregularities.

• Award based on initial proposals without discussions.

• Reject any or all proposals.

• Request additional information without creating an obligation to award.

• Request additional supporting documentation or clarification from vendor.

• Select a proposal for award that represents the overall "best fit" to meet the Army's mission, even if the proposed system does not meet 100% of the individual technical or performance specifications outlined within this RPP.

• Accept or reject any proposed system modifications (minimal or otherwise) and negotiate the removal or inclusion of specific modification costs prior to award.

• Award only specific modular components or subsets of a proposed system to meet the Government's requirements.

10.0 Administrative Information

10.1 Export Control

This effort involves medical device technology. Vendors are responsible for determining and complying with all applicable export control requirements under the Export Administration Regulations (EAR) and International Traffic in Arms Regulations (ITAR). Foreign nationals may require export authorization prior to participation.

10.2 Organizational Conflict of Interest

Vendors must disclose any actual or potential Organizational Conflicts of Interest (OCI) in their proposal.

Failure to disclose a known OCI may result in disqualification or agreement termination. The Agreements Officer will review all disclosed OCIs and work with vendors to develop appropriate mitigation measures if applicable.

10.3 Proprietary Information

Vendors may include proprietary or business-sensitive information in their proposals. Such information must be clearly marked as proprietary on each affected page. The Government will handle properly marked proprietary information in accordance with applicable law. The Government is not responsible for protection of information not clearly marked as proprietary.

10.4 Communications Restrictions

From the date of this RPP release through award, ALL communications regarding this RPP must be directed exclusively to the Agreements Officer (Michael James) through the Q&A process described in Section 7.8. Unauthorized contact with program office personnel, technical Point of Contacts (POCs), end users, or any other Government representative regarding this RPP may result in disqualification.

11.0 Points of Contact

All RPP-related communications must be directed to the Agreements Officer as specified in Section 7.8.

Role Name / Title Organization Contact Info

Agreements Officer

(AO)

Michael James Agreements Officer

U.S. Army Contracting Command (ACC) timothy.j.compton7.civ@army.m il Primary POC for all inquiries.

Agreements Specialist Matt McNeely Agreement Specialist

U.S. Army Contracting Command (ACC) roxanne.a.dalrymple.civ@army.

mil Copy on all communications.

Technical / Requirements POC

(AOTR)

MAJ Ashley Roberts

(APM)

Project Manager (PM) Maneuver Medical Systems (M2S) ashley.r.roberts30.mil@army.mil Communications through AO only.

Technical / Requirements Alternate

POC

Briana Kenerson (PO) Project Manager (PM) Maneuver Medical Systems (M2S) briana.a.kenerson.civ@army.mil Communications through AO only.

Product Manager LTC Dana Bal (PdM) Project Manager (PM) Maneuver Medical Systems (M2S)

Program oversight.

Communications through AO only.

12.0 Attachments and Appendices

Reference Title / Description Status / Instructions

Attachment A Trade Agreements Act (TAA) Certificate Required — submit with proposal

Attachment B Additional Attachment (As Needed) TBD

Reference Title / Description Status / Instructions

Appendix E Data Rights Assertions Table Required — submit with proposal

Appendix E - Data Rights Assertions Table In Appendix E, the Vendor is required to list all technical data and computer software to be delivered to the Government, including that which will be delivered with Unlimited Rights or Unrestricted Rights. The Vendor is required to list any deliverables (to the Government) from subcontractors or vendors. Also, the Vendor is required to identify any known restrictions on any data deliverables to the Government;

this includes open-source software licenses that may impact the Government’s rights. A sample Data Assertions Table is below.

Technical Data or Computer Software to be Furnished With Restrictions

Basis for Assertion Asserted Rights Category

Name of Person Asserting Restrictions

(LIST) (LIST) (LIST) (LIST)

END OF REQUEST FOR PROTOTYPE PROPOSALS

Scanner Ultrasonic Ocular

Issued pursuant to 10 U.S.C. § 4022 — Other Transactions for Prototype Projects