RPP_POGS_Portable_Oxygen_Generator.pdf

REQUEST FOR PROTOTYPE PROPOSALS (RPP)

PORTABLE OXYGEN GENERATOR SYSTEM (POGS)

Other Transaction Authority Pursuant to 10 U.S.C. § 4022 Direct OTA — Prototype Project

Issuing Agency / Organization: Capability Program Executive (CPE) Ground Soldier Medical Devices (SMD) 1240 Rocky Springs Road, Fort Detrick, MD 21702

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

Solicitation Number: W81K04-25-Q-1969

Solicitation Title: Portable Oxygen Generator System (POGS) — 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: 30 June 2026

Questions Due: Refer to Solicitation Notice

Proposals Due: Refer to Solicitation Notice

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

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

NAICS Code: 339112 — Surgical and Medical Instrument Manufacturing (SB: 1,000 employees)

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). Respondents are advised to read this RPP in its entirety prior to preparing a response.

Portable Oxygen Generator System (POGS) RPP

Table of Contents Table of Contents

1.0 Acronyms and Definitions

2.0 Solicitation Overview

2.1 Purpose

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 Technical Objectives

3.3 Key Performance Parameter (KPP)

3.4 Prototype Success Criteria

3.5 Demonstration Goals

3.6 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 Requirements

5.1 Critical Operational Device Specifications (CODS)

5.2 Critical Logistical Specifications (CLS)

5.3 Additional Performance Parameters (APPs)

5.4 Cybersecurity Requirements

5.5 Security Requirements

6.0 Deliverables and Period of Performance

6.1 Prototype Deliverables

6.2 Period of Performance

6.3 Milestones

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 and Weights

8.2 Rating Definitions

8.3 FDA Status Evaluation

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 Security and Classification

10.2 AT/OPSEC

10.3 Export Control

10.4 Organizational Conflict of Interest

10.5 Proprietary Information

10.6 Communications Restrictions

11.0 Points of Contact

12.0 Attachments and Appendices

1.0 Acronyms and Definitions

Acronym Definition

ACC U.S. Army Contracting Command

APP Additional Performance Parameter

ATO Authority to Operate

CLS Critical Logistical Specification

CODS Critical Operational Device Specification

CPE Capability Program Executive

CUI Controlled Unclassified Information

DHP Defense Health Program

DLA Defense Logistics Agency

ECAT Electronic Catalog

FDA Food and Drug Administration

KPP Key Performance Parameter

MDERA Medical Device and Equipment Risk Assessment

MTEAC Medical Test and Evaluation Activity

NDC Nontraditional Defense Contractor

OTA Other Transaction Authority

POGS Portable Oxygen Generator System

PSA Pressure Swing Adsorption

RDT&E Research, Development, Test, and Evaluation

RMF Risk Management Framework

Acronym Definition

ROC Role of Care

RPP Request for Prototype Proposals

SMD Soldier Medical Devices

TAA Trade Agreements Act

USP United States Pharmacopeia

2.0 Solicitation Overview

2.1 Purpose

Capability Program Executive (CPE) Ground, Soldier Medical Devices (SMD), 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 Portable Oxygen Generator System (POGS). The purpose of this RPP is to identify, select, and award two (2) separate Other Transaction (OT) Agreements — one (1) to each of two (2) eligible respondents — for the design, development, delivery, and demonstration of prototype POGS units that address the capability gap described herein. Each awardee shall deliver two

(2) prototype units for operational and environmental testing.

2.2 OTA Authority Citation

This RPP is issued pursuant to 10 U.S.C. § 4022, which authorizes the Secretary of Defense 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. 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 Portable Oxygen Generator System (POGS) is a critical medical device used in deployed field hospitals at Role of Care (ROC) 3. The system provides medical-grade oxygen (93% ± 3% USP) and at 50 Pounds per Square Inch in Gas (PSIG) to support patient care, anesthesia equipment, ventilators, and high-pressure cylinder refilling in austere and remote operational environments where traditional oxygen cylinder logistics are complex or infeasible.

The currently fielded system, the On Site Gas Systems, Inc. POGS-33C-HV (NSN: 6550-01-687-5441, first fielded 2005), while still procurable through the Defense Logistics Agency (DLA) Electronic Catalog (ECAT) at approximately $73,413 per unit, presents significant operational and logistics challenges. At seven hundred ninety (790) pounds with a 120/208 VAC, 3-phase power requirement, the legacy system is maintenance-intensive, requires specialized power infrastructure, and its aging technology limits operational effectiveness.

Market research conducted by MilTech / Delaware Valley Industrial Resource Center (DVIRC) in December 2025 identified at least two (2) capable small business vendors able to meet the modernized requirement. A Request For Information (RFI) (Solicitation Notice ID: W81K04-25-Q-1969) was released on 28 February 2025 with responses received from at least two (2) capable small business concerns capable of supporting the prototype effort and operational objectives described herein.

2.4 Mission Need / Problem Statement

The U.S. Army requires a modernized, portable, self-contained oxygen generation system capable of supporting life-saving medical operations in austere environments at Role of Care 3. The capability gap is defined by the following deficiencies in the legacy POGS-33C:

• Excessive weight and non-portable power requirements limiting tactical mobility;

• High maintenance burden reducing operational availability due to high humidity, moisture, and potential mold contamination that have been a contributing factor to the degradation of the oxygen equipment; and

• Aging technology with increasing sustainment risk.

Failure to field a modernized replacement capability may negatively impact operational medical support effectiveness for ventilators and anesthesia systems that compromises the Army's ability to provide life-saving oxygen for ventilators, anesthesia systems, and patient transport, operations in austere environments.

2.5 Prototype Scope Overview

This RPP seeks prototype solutions that demonstrate a self-contained, portable oxygen generation system using Pressure Swing Adsorption (PSA) or equivalent technology. The prototype must produce medical-grade oxygen meeting United States Pharmacopeia (USP) standards, operate on single or double-voltage power with automatic voltage detection, and weigh no more than three hundred fifty

(350) pounds. The Government will procure two (2) prototype units per vendor (four total) for operational testing by the Medical Test and Evaluation Activity (MTEAC), to include 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 (or submit a regulatory milestone schedule establishing a defined path to clearance within 12–24 months of award) for human use. 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

• Enable deployed field hospital medical personnel to generate medical-grade oxygen on-site in austere, resource-limited environments without dependence on oxygen cylinder resupply chains.

• Provide continuous, reliable oxygen supply supporting simultaneous operation of anesthesia equipment, ventilators, and high-pressure cylinder refilling in a Role of Care 3 environment.

• Reduce logistics footprint and sustainment burden compared to the legacy POGS-33C by fielding a lighter, more maintainable, and tactically mobile system.

• Capable of operating continuously on standard commercial and tactical generator power without degradation of oxygen output in 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 Technical Objectives

• Demonstrate oxygen generation at ≥30 Liters Per Minute (LPM) at ≥93% ±3% USP purity under operational and environmental test conditions.

• Demonstrate delivery of ≥30 LPM medical-grade oxygen at 50 PSI to support anesthesia and ventilator equipment simultaneously.

• Demonstrate system operation within the weight threshold of ≤350 lbs., achieving the desired objective of ≤200 lbs.

• Demonstrate single or dual-voltage with automatic voltage detection from 110–120 VAC/60 Hz or

220–240 VAC/50 Hz without manual intervention.

• Demonstrate alarm systems or automated safeguards that detect conditions affecting oxygen purity, system performance, and patient safety (to include but not limited to power failure and purity) with noise-discipline silencing capability.

• Survive and operate after MIL-STD-810H environmental testing (High Temp 501.7, Low Temp 502.7, Rain 506.6, Vibration 514.8, Shock 516.8).

• Assess technical objectives through iterative prototype demonstration, operational user feedback, environmental evaluation, and data collection activities supporting future capability refinement and transition planning.

3.3 Key Performance Parameter (KPP)

The Key Performance Parameter (KPP) for the POGS is FDA clearance or demonstration of a credible and supportable regulatory pathway. Respondents that do not currently possess FDA 510(k) clearance for a Class II medical device (or FDA registration for a Class I device) shall demonstrate a credible and supportable regulatory strategy, including projected regulatory milestones, supporting documentation, and anticipated timeline for achieving regulatory approval within 12–24 months. Failure to demonstrate reasonable progress toward FDA clearance within the proposed regulatory timeline may impact continued prototype evaluation, follow-on activities, or transition planning under the OT Agreement.

3.4 Prototype Success Criteria

ID Success Criterion Threshold / Objective Verification Method

SC-01 FDA 510(k) Clearance (Class II) or FDA Registration (Class I)

Achieved within 12–24 months post-award (Submit regulatory milestone schedule)

FDA clearance documentation

SC-02 Oxygen Generation ≥30 LPM at ≥93% ±3% USP purity

Threshold: ≥30 LPM / ≥93% ±3%

Calibrated flow meter and oxygen analyzer test

SC-03 Medical Oxygen Delivery ≥30 LPM at 50 PSI

Threshold: ≥30 LPM at 50 PSI Pressure gauge and flow measurement

SC-04 System Weight ≤350 lbs. Objective: ≤200 lbs. Certified scale measurement

SC-05 Voltage Operation 110–120 VAC (60 Hz) and/or 220–240 VAC (50 Hz) automatic voltage detection

No manual intervention required

Functional demonstration both voltages

SC-06 MIL-STD-810H Survivability Pass all applicable test methods

Government T&E Activity test report

SC-07 Alarm Systems Functional (Power, Purity)

All alarms functional with silence capability

Functional test

3.5 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; and Environmental Testing conducted in accordance with MIL-STD-810H at a Government-designated test facility. The Government will provide test coordination support. Respondents shall provide technical representatives to support testing events. Operational use feedback and test data collected during evaluation events may be used to support iterative prototype refinement and future capability development planning.

3.6 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 three hundred and four (304) POGS units during FY28 through FY32 without further competition, pursuant to 10 U.S.C. § 4022(f). The Government's intent is that each awarded vendor 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. The estimated lifecycle value of follow-on production is approximately $8.1M (Option A, without cylinder refill) to $34.1M (Option B, with cylinder refill capability).

4.0 Eligible Responders

4.1 OTA Award Structure — Direct OTA

This RPP is issued directly by CPE Ground, SMD, 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) separate OT Agreements, one (1) to each of two (2) qualified respondents, for two (2) prototype units each (four total). Each award is independent; respondents compete for one (1) of the two (2) available awards. The 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. Respondents 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 December 2025 identified at least two (2) capable small businesses as capable of supporting the operational and technical objective of this prototype effort. The applicable NAICS code is 339112 (Surgical and Medical Instrument Manufacturing) with a Small Business size standard of one thousand (1,000) employees. Respondents 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 Trade Agreements Act (TAA). Respondents are required to complete and submit DFARS Provision 252.225-7020, 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. Respondents must clearly identify the country of origin for all major components.

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, respondents 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 Requirements

The following requirements define the minimum acceptable performance and logistical standards for the POGS prototype. The requirements are categorized as Critical Operational Device Specifications (CODS — mandatory threshold), Critical Logistical Specifications (CLS — mandatory), and Additional Performance Parameters (APPs — desired but not required for acceptability). Respondents must meet all CODS and CLS minimum requirements to be considered acceptable.

5.1 Critical Operational Device Specifications (CODS)

# CODS Minimum Requirement Desired Characteristic

1 FDA Regulatory Clearance System must obtain FDA 510(k) clearance (Class II) or FDA registration (Class I) for human use within 12–24 months of agreement award. Offerors must submit a regulatory milestone schedule.

Minimum Required

Quality Management System (QMSR, ISO 13485)

The device to be manufactured under a compliant QMS (QMSR/ISO 13485, effective Feb 2026)

Minimum Required

2 Power Supply 110–120 VAC, 60 Hz AND/OR 220–240 VAC, 50 Hz with automatic voltage detection. If battery charging is required, both voltage ranges must support charging.

Minimum Required

3 Oxygen Concentration ≥93% ±3% USP oxygen purity Minimum Required

4 Weight ≤350 lbs. total system weight Desired: ≤200 lbs.

5 Oxygen Flow for Anesthesia/Ventilator Compatibility

Generates medical-grade oxygen at ≥30 LPM at 50 PSI to support simultaneous operation of anesthesia equipment and ventilators

Minimum Required

6 Oxygen Generation Capacity

Generates ≥30 LPM total oxygen at ≥93% ±3% USP purity

Minimum Required

# CODS Minimum Requirement Desired Characteristic

7 Monitors and Alarms The system shall include alarms or automated safeguards that detect conditions affecting oxygen purity, system performance, and patient safety.

Minimum Required

5.2 Critical Logistical Specifications (CLS)

# CLS Minimum Requirement

1 TAA Compliance System, accessories, and repair parts comply with TAA. Vendor shall complete and submit DFARS 252.225-7020 TAA Certificate (Attachment A).

2 Repair Parts Support Full listing of repair parts identifying high-failure items (by OEM and Government SME input), country of origin, availability, proprietary vs. commercial status, and procurement availability through commercial or OEM distribution channels.

3 Technical Manuals 1 physical and 1 digital User/Operator Manual; 1 physical and 1 digital Maintenance/Service Manual.

4 RMF / Authority to Operate

(ATO)

Vendor completes Government-provided Risk Management Framework (RMF) documentation, Medical Device and Equipment Risk Assessment (MDERA) supporting cybersecurity compliance and Authority to Operate (ATO) activities.

5 Copyright Release Vendor provides operational and maintenance copyright/distribution release supporting Army Technical Manual development and distribution throughout the force.

6 Special Tools Vendor identifies specialized tools required for repair/maintenance and makes them available for purchase.

7 Network Capability Standalone device — does NOT require Wi-Fi, internet connectivity, or network connection for functionality.

8 Training Two (2) on-site CONUS operator training sessions at agreed-upon date/location for approximately 5–10 people per session. Desired:

one operational video training or access to training site per device.

9 Warranty Minimum 1-year warranty covering all parts, in-house labor, and technical support. Desired: 3-year warranty.

# CLS Minimum Requirement

10 Delivery Delivery of prototype units 120–180 days after agreement award.

5.3 Additional Performance Parameters (APPs)

# APP Description

1 DLA ECAT Onboarding Vendor works with DLA Troop Support to add product to ECAT agreement vehicle, 3rd party, or Prime Vendor agreement for future procurement and service agreements.

2 Maintenance Kits Vendor demonstrates capability to develop and provide fieldable maintenance kits supporting operational sustainment.

3 Manufacturing Capacity Vendor provides manufacturing capability and production scalability information supporting assessment of production capacity, supportable order quantities and delivery schedules (relevant to 304-unit follow-on production).

4 TMDE Vendor identifies any Test, Measurement, Diagnostic, and Evaluation Equipment (TMDE) required to operate, calibrate, maintain, or troubleshoot the device.

5 Maintenance Manual Task Identification

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

6 Reusable Hardened Transport Case

POGS configured in one or multiple reusable hardened transport cases (e.g., Pelican/Hardigg) with protective foam, ruggedized wheels, adjustable handle. Case designed to meet MIL-STD-810H:

501.7 High Temp, 502.7 Low Temp, 506.6 Rain, 514.8 Vibration,

516.8 Shock.

7 Packaging with IUID POGS packed with all components in hardcases with approved marked data plates including Item Unique Identification (IUID) in accordance with DFARS 252.211-7003; list of case contents with picture; closed-cell foam inserts protecting during transport and environmental conditions.

8 Cylinder Filling Capability System capable of refilling a size “D” oxygen cylinder at a rate within twelve (12) minutes per cylinder to two thousand two hundred (2,200) PSI.

5.4 Cybersecurity Requirements

All prototype units shall comply with applicable DoD cybersecurity policies. The POGS is required to be a standalone device that does not connect to DoD networks during normal operation. Respondents shall complete the MDERA questionnaire provided by PM SMD as Attachment B. The MDERA addresses system identification, hardware/firmware, operating systems, applications, data processing capabilities, and cybersecurity posture. Respondents shall support RMF/ATO documentation activities in coordination with PM SMD cybersecurity personnel. CUI handling requirements apply; respondents shall comply with DFARS 252.204-7012 and National Institute of Standards and Technology NIST SP 800-171.

5.5 Security Requirements

This effort is classified UNCLASSIFIED // (CUI). No facility or personnel security clearances are required for proposal submission. Anti-Terrorism / Operational Security (AT/OPSEC) review has been completed in accordance with DHA Form 337 (dated 13 January 2026, reviewed by ATO Kenner R. Samuels, DJ4).

6.0 Deliverables and Period of Performance

6.1 Prototype Deliverables

CDRL Deliverable Due Date Format / Notes

D-001 Prototype POGS Units (2 per vendor)

120–180 days after award

Per CODS/CLS specifications

D-002 User/Operator Manual — Physical

(1) and Digital (1)

With unit delivery Delivered in English language format

D-003 Maintenance/Service Manual — Physical (1) and Digital (1)

With unit delivery Delivered in English language format

D-004 Repair Parts List 15 days after award Electronic spreadsheet identifying high-failure and mission-critical components, parts numbers, sourcing information, and commercial/OEM availability.

D-005 MDERA Questionnaire (completed) 30 days after award Per PM SMD template (Attachment B)

D-006 TAA Compliance Certificate (DFARS 252.225-7020)

With proposal / at award

Attachment A

CDRL Deliverable Due Date Format / Notes

D-007 Training — 2 On-Site CONUS Operator Sessions

TBD — coordinated with Government

~5–10 personnel per session

D-008 Operational Training Video or Training Site Access

TBD — per device Digital delivery

D-009 FDA Clearance Documentation (510(k) or Class I Registration)

Within 12–24 months of award

FDA official clearance letter

D-010 Special Tools List 15 days after award Identify tools required and procurement sources

D-011 Copyright/Distribution Release for Army TMs

60 days after award Written release letter

D-012 Test Support — Technical Representative

During Government T&E events

Vendor-funded

D-013 Bi-Weekly Meetings Commencing 15 days after award

Virtual / Teleconference

6.2 Period of Performance

The estimated period of performance is 12 months, commencing on the date of award. The Government estimates award on or about during FY26 Q4. Prototype unit delivery is required 120–180 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.

6.3 Milestones

# Milestone Event Target Date / Timeframe

M-01 Award / Kickoff Meeting NLT 14 days after award

M-02 MDERA Submission NLT 30 days after award

M-03 Prototype Unit Delivery (2 units per vendor) 120–180 days after award

M-04 Training (Session 1) TBD — coordinated with Government

M-05 Training (Session 2) TBD — coordinated with Government

# Milestone Event Target Date / Timeframe

M-06 Government Operational Testing (MTEAC) Government scheduled following prototype delivery and test readiness determination

M-07 Government Environmental Testing (MIL-STD-810H) Government scheduled following prototype delivery and test readiness determination

M-08 FDA Clearance / Registration FDA clearance or registration milestone schedule

M-09 Period of Performance End Twelve (12) months after award

7.0 Proposal Instructions

7.1 Proposal Volume Structure

Volume Title Page Limit

Volume I Executive Summary 5 pages max

Volume II Technical Approach 25 pages max

Volume III Management, Approach, Relevant Experience & Schedule 15 pages max

Volume IV Cost / Business Proposal No page limit

7.2 Volume I — Executive Summary

Overview of proposed prototype solution and how it addresses the POGS 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 proposed system. Summary of FDA status: current clearance held or planned regulatory pathway toward FDA clearance within 12–24 months after award. Total proposed cost and proposed period of performance.

7.3 Volume II — Technical Approach

Detailed description of the proposed POGS system, including model name/number and technology approach (e.g., Pressure Swing Adsorption (PSA) technology, compressor design). Compliance matrix addressing each CODS requirement (minimum and desired) and each CLS requirement — clearly indicate

Meets / Does Not Meet / Exceeds Desired Objective for each item. FDA regulatory status: current 510(k) clearance number, or detailed plan and milestone timeline for obtaining FDA clearance within 12–24 months of award. Technical data supporting performance claims: oxygen flow rate, purity, pressure output, weight, dimensions, power specifications. Description of dual-voltage auto-switching capability.

Description of alarm systems and noise-discipline silencing. MIL-STD-810H testing history and/or proposed environmental test approach. Description of cylinder refill capability (if proposed as an Additional Performance Parameter (APP)). Description of hardened transport case configuration (if proposed as an APP). Data rights position and intellectual property strategy. Transition plan: approach to DLA ECAT/Prime Vendor onboarding for follow-on production. Risk identification and mitigation approach.

7.4 Volume III — Management, Past Performance & Schedule

Company background, organizational structure, and relevant experience in medical oxygen generation systems. Key personnel and qualifications. Past performance: at minimum two (2) relevant agreements or sales of portable oxygen generation systems, including customer name, agreement/order number if applicable, system delivered, quantity, and period. Manufacturing capability: current production capacity and ability to support three hundred and four (304)-unit follow-on production in FY28–FY32.

Proposed milestone schedule from award through end of performance period. Approach to providing two (2) on-site CONUS training sessions. Small business subcontracting approach (if applicable).

7.5 Volume IV — Cost / Business Proposal

CLIN Description Qty Pricing

CLIN 0001 Prototype POGS Units 2 EA Unit Price: $_____ Total:

CLIN 0002 Training — On-Site CONUS Operator Sessions 2 EA Unit Price: $_____ Total:

CLIN 0003 Warranty (1 year minimum — parts, labor, tech support)

2 EA Unit Price: $_____ Total:

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

CLIN 0005 Optional: Cylinder Refill Upgrade (APP-8, if separate priced)

2 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 follow-up production. If proposing cylinder refill capability (APP-8), provide separate pricing for that option. Provide proposed payment schedule (e.g., milestone-based payments).

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 than 1600 Eastern time on the date identified in the solicitation notice. Submission Method: DoD SAFE file transfer or email submission. Submit to: Kristin Anderson, Agreements Officer | Copy: Roxanne A. Dalrymple, Agreements Specialist

All volumes must be submitted as separate PDF files using the naming convention:

[CompanyName]_POGS_RPP_[SolicitationNumber]_Vol[X]_[Title].pdf. The Government intends to acknowledge receipt within 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 to kristin.l.anderson24.civ@army.mil with copy to roxanne.a.dalrymple.civ@army.mil no later than 8 July 2026 at 3:00 P.M. 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 evaluate proposals using comparative methodology focused on prototype relevance, operational suitability, technical feasibility, schedule realism, transition feasibility, and cost reasonableness. 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.

Evaluation will focus on the extent to which proposed solutions meet mandatory prototype requirements, demonstrate operational effectiveness, reduce sustainment burden, support deployed medical operations, and provide a viable pathway to operational fielding and follow-up production.

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8.1 Evaluation Factors and Weights

# Factor Weight Type Description

1 Technical Approach 30% Rated How well the proposed system addresses CODS/CLS requirements, innovation of approach, and completeness of technical data provided

2 Performance Compliance

(CODS/CLS)

Pass/Fail Mandatory Failure to meet mandatory CODS and CLS requirements may result in the proposal being removed from further consideration

3 Reliability, Maintainability & Supportability

15% Rated Warranty offered, repair parts availability, ease of maintenance, and long-term sustainment plan

4 Schedule Realism 10% Rated Feasibility of 120–180 days delivery, milestone realism, ability to support Government test events

5 Past Performance 10% Rated Relevant experience delivering portable oxygen generation systems; delivery performance; customer satisfaction

6 Cost / Price 35% Reasonablen ess

Total proposed cost evaluated for fairness and reasonableness; cost realism analysis conducted; lower cost more favorable when technical merit is comparable

Note: Technical factors combined (Performance Compliance + Technical Approach + Reliability + Schedule + Past Performance = 65%) are significantly more important than Cost/Price (35%). However, among proposals meeting mandatory prototype requirements, cost/price differences will be carefully considered. A proposal receiving an Unacceptable rating under the mandatory Performance Compliance factor may be removed from further evaluation consideration.

8.2 Rating Definitions

Rating Description

Outstanding Exceeds requirements with significant strengths; low risk; surpasses CODS desired characteristics and multiple APPs

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

meets some desired characteristics and APPs

Rating Description

Acceptable Meets all minimum requirements; no significant weaknesses; minimal APPs met

Unacceptable Fails to meet one or more minimum CODS or CLS requirements; proposal eliminated from award consideration

8.3 FDA Status Evaluation

FDA clearance status will be evaluated as follows: Proposals from vendors holding current FDA 510(k) clearance for a system meeting CODS will be rated more favorably on this element; Proposals demonstrating a credible and supportable FDA clearance plan with a regulatory milestone schedule (pre-submission/Q-Sub meeting, testing completion, 510(k)/De Novo submission) projecting a path to clearance within 12–24 months will be rated Acceptable; Proposals that do not address FDA clearance or that present an implausible clearance timeline will be rated Unacceptable.

9.0 Award Information

9.1 Number of Awards

The Government intends to make two (2) OT Agreement awards — one (1) for each of two (2) qualified respondents — each for two (2) prototype POGS units. Awards are independent; each respondent competes for one (1) of the two (2) available awards. The Government reserves the right to make fewer awards, additional awards, or no award based on proposal quality and funding availability. One vendor cannot receive two (2) awards if they propose two (2) different designs.

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 three hundred and four (304) POGS units during FY28–FY32 without further competitive procedures. Estimated follow-on production value:

$8.1M (Option A) to $34.1M (Option B). Respondents should factor this transition potential into their proposals, including DLA ECAT/Prime Vendor onboarding plans.

9.4 Government Rights and Reservations

• The Government reserves the right to:

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

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

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

• 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 respondents.

10.0 Administrative Information

10.1 Security and Classification

This effort is UNCLASSIFIED // CUI. No facility clearance or personnel security clearances are required.

CUI handling is required per DFARS 252.204-7012 (NIST SP 800-171 compliance). Respondents handling CUI shall maintain a current NIST SP 800-171 assessment in SPRS in accordance with DFARS 252.204- 7020.

10.2 AT/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. Performer employees requiring access to Government facilities must complete AT Level I awareness training within thirty (30) days of agreement start date and complying with all installation access requirements.

10.3 Export Control

This effort involves medical device technology. Respondents 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.

10.4 Organizational Conflict of Interest

Respondents 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 respondents to develop appropriate mitigation measures where possible.

10.5 Proprietary Information

Respondents 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.

10.6 Communications Restrictions

From the date of this RPP release through award, ALL communications regarding this RPP must be directed exclusively to the Agreements Officer (Kristin Anderson) 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)

Kristin Anderson Agreements Officer

U.S. Army Contracting Command (ACC) kristin.l.anderson24.civ@army.

mil Primary POC for all inquiries.

Agreements Specialist Roxanne A. Dalrymple Agreement Specialist

U.S. Army Contracting Command (ACC) roxanne.a.dalrymple.civ@army .mil Copy on all communications.

Technical / Requirements POC

(AOTR)

MAJ Jaime Perales Assistant Product Manager (APM)

CPE Ground, Soldier Medical Devices

(SMD)

Fort Detrick, MD jaime.a.perales3.mil@army.mil Communications through AO only.

Product Lead Dana Love Product Lead

CPE Ground, Soldier Medical Devices

(SMD)

Program oversight.

Communications through AO only.

12.0 Attachments and Appendices

Reference Title / Description Status / Instructions

Attachment A DFARS 252.225-7020 Trade Agreements Certificate Required — submit with proposal

Reference Title / Description Status / Instructions

Attachment B Medical Device and Equipment Risk Assessment (MDERA) Questionnaire

Required — submit NLT 30 days after award

Attachment C Requirements Document: CODS / CLS / APPs (Full Version)

Reference — incorporated by reference

Attachment D D&F — OTA Determination and Findings Reference — incorporated by reference

Attachment E Cost Proposal Format / Template Reference — use for Volume IV

Attachment F Additional Attachment (As Needed) TBD

END OF REQUEST FOR PROTOTYPE PROPOSALS

PORTABLE OXYGEN GENERATOR SYSTEM (POGS)

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