B08-HT9427-26-R-E001-RPP-Amend-0001-Attachment-1-Questions-Answers.pdf

Section/Reference Question Answer

1 Not Provided One of the attachments in the RPP package for the subject solicitations is blank – Attachment F – ROM Production Unit Cost Estimates – Can you please re-send Attachment F? Will attachment F contain production quantities estimates and a production PoP?

The Government was able to successfully download Attachment F. Please attempt download using another browser or download the document to your local drive and ensuring you are opening with Adobe, not the web browser (e.g., Edge, Chrome, etc.). If you still encounter issues, recommend working with your local Information Management Office/helpdesk for assistance opening the documents. Attachment F does not include production quantities estimates and a production PoP.

Attachment F is a Contract Data Requirements List (CDRL). A CDRL is a document, typically DD Form 1423, used to identify, format, and track all technical data deliverables required under a contract. It ensures the government or client receives necessary information—such as reports, designs, and manuals—in a standardized format, with clear, binding, and actionable requirements for submission, review, and approval.

2 Not Provided Do the joint services currently use a product to “somewhat meet the need” of the requirements? At first blush, I am thinking about the Caire SAROS or equivalent. PCI is doing it’s own market research, but I am trying to understand how the joint services are currently meeting the needs of the requirement.

For the purposes of this solicitation, consider the Services have access to oxygen tanks to provide medical oxygen solutions in austere environments to treat service members with compromised lung function or injuries requiring oxygen therapy.

3 Not Provided Does the requested device need to be an oxygen generator (i.e., stores O2 in a chemical form for later release, such as the emergency units on planes) or an O2 concentrator (i.e., takes in air and produces medical grade oxygen, such as the commercial concentrators used in respiratory care)?

It can be either a concentrator or a generator, but for Focus Area #1, devices need to provide an adjustable flow rate of 3 - 7 liters per minute (LPM) and for Focus Area #2, devices need to provide an adjustable flow rate of 3 - 15 LPM. Devices for both focus areas needs to deliver 93±3% oxygen purity.

4 SOO General Attributes (page 7) How important/firm is the COGM (or COGM-A) volume requirement? Does the form factor need to be fixed as a cylinder?

Please refer to SOO Section 8.0 Constraints for specific details. No, the form factor does not need to be fixed as a cylinder. The device will be placed in the existing racks used to strap in oxygen tanks.

5 Not Provided Is the battery included in the required cylinder dimensions? Is it permissible to house the battery outside of the COGM or COGM-A volume (thus, outside of the 4.3” dia x 19” length or 5” dia x 20” length)?

Please refer to SOO Section 8.0 Constraints for specific details. Yes, the battery is included in the dimensions. The device will be placed in the existing racks used to strap in oxygen tanks.

6 Not Provided Does the output flow need to be continuous or pulsed?

Please refer to SOO Section 8.0 General Attributes for specific details. Yes, minimum requirement assume continuous flow but alternative flow modes may be proposed to meet objectives.

7 Not Provided Will the unit be operated in a closed space (i.e., with limited O2 replenishment rate)?

For Focus Area #1, the COGM device will be used primarily at Role 1 and may travel with the patient as they are transported through different Roles of Care. These are not typically closed spaces. For Focus Area #2, the COGM-A will primarily be used on aeromedical evacuation platforms. These are typically fixed wing aircrafts.

8 SOO General Attributes (page 7) How important is O2 purity? How beneficial would achieving 99% be?

Refer to SOO Section 8.0 General Attributes for specific details. For both Focus Areas, a device that can produce 93% ± 3% oxygen purity is acceptable.

9 Not Provided For a sieve-based approach, is it acceptable to use disposable columns with short lifespan? What is the minimum acceptable life (during use, not storage) of a sorbent column?

Refer to SOO Section 8.0 Maintainability Attributes for specific details. Yes, it is acceptable to design a prototype with disposable columns. It may be acceptable to use disposable columns with a short timeline. As a general guideline, yearly maintenance will not increase the logistical burden of devices. Refer to RPP Section 3.3 Maintenance and Sustainment Plan and Manufacturing and Commercialization Plan for specific details.

10 Not Provided What is the required lifetime of consumables within the O2 system?

Refer to SOO Section 8.0 Maintainability Attributes for specific details. There is no required lifetime of individual consumables within the system but all consumables must be available for purchase for the determined lifecycle of the vendor's determined lifecycle of the device for Focus Area #1, COGM. For Focus Area #2, the COGM-A device requires consumables available for purchase for at least 7 years after the last sale of the system. Refer to RPP Section 3.3 Maintenance and Sustainment Plan and Manufacturing and Commercialization Plan for specific details.

11 Not Provided Is there a maximum consumable or operating cost for the unit?

The maximum consumable or operating cost is not defined in the RPP or SOO. Refer to RPP Section 3.3 Manufacturing and Commercialization Plan for specific details.

12 Not Provided What is the estimated quantity of units to be procured and over what time?

The Government cannot commit to exact quantities at this time, but the Government wants to know what your capacity range could be. The estimated quantity for Focus Area #1 COGM is in the 5,000 - 10,000 range per year; for Focus Area #2 COGM-A it is closer to 1,000s range per year. Procurement would occur over a few years. Refer to RPP Executive Summary for specific details. The target timeline for procurement of Focus Area #1 COGM is 2031 and of Focus Area #2 COGM-A is 2032.

Procurement will occur.

RPP Attachment B, Draft OTA for Prototype, Article 1.C “ Scope”

(pages 8-9) Is the “expenditure based adjustable milestone payment structure” similar to a cost type contract?

The Draft OTA document is meant to be a example of how the agreement can be structured. Offerors may propose cost type agreements or fixed price agreements.

RPP Attachment B, Draft OTA for Prototype, Article 1.C “ Scope”

(pages 8-9) Is the OT intended to have a fixed total price, with milestone amounts adjustable only within that fixed total price?

The Draft OTA document is meant to be a example of how the agreement can be structured. Offerors may propose cost type agreements or fixed price agreements.

15 Not Provided Is there a different use duration time of use for COGM and COGM-A?

The Government does not anticipate a different duration time for COGM and COGM-A. For Focus Area #1, the COGM device will be used primarily at Role 1 and may travel with the patient as they are transported through different Roles of Care. For Focus Area #2, the COGM-A will primarily be used on aeromedical evacuation platforms and used as patients are transported.

HT9427-26-R-E001 Amendment 0001, Attachment 1: Questions & Answers from Potential Performers

Please refer to SOO Section 5.0 Period of Performance for specific details. The Government acknowledges that follow-on work may be needed to reach overall device goals. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly what follow-on work would be needed to reach overall device goals.

Yes, The Government understands the weight and size constraints are challenging. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly the dependency on flow rate to size and weight constraints and what the minimum size and weight would be to meet the flow rates or vice versa.

General Answer:

General Answer:

16 Not Provided Under Functional Attribute, does MTBSA also account for depletion of an oxygen reservoir within the specified MTBSA period while all other system hardware and software are still functional?

Please refer to SOO Section 8.0 Functional Attributes for specific details. MTBSA describes the reliability of the device and how the likelihood of the device to be functional vs. non-functional. A system abort is a severe failure of the device and the device can no longer perform its primary function to generate oxygen. Run-Time hours are the hours the device is performing its intended functions, within a 72-hour mission window. This does not include standby time when the system is not performing any functions or waiting to be used. The total active time estimated for the device during a 72-hour mission window is 48.75 run-time hours without a system abort.

17 Not Provided Under Functional Attributes, it mentions re-capturing O2 for use, and under General Attributes, SWaP and pressure metrics are listed. Are the SWaP and pressure attributes of the recapture subsystem included in the overall system metrics?

Yes, all subsystems should be included in the overall system metrics.

Programmatic & Acquisition

Questions Will the Government issue a consolidated response or revised RPP/SOO addressing Industry questions submitted prior to the proposal due date?

Yes, Amendment 0001 addresses industry questions will be issued prior to the proposal due date.

Programmatic & Acquisition

Questions If a substantial number of Industry questions are received, would the Government consider adjusting the proposal due date to allow Offerors adequate time to incorporate responses?

As part of Amendment 0001, the Government is adjusting the proposal due date, which is reflected in the amendment document.

Programmatic & Acquisition

Questions Does the Government anticipate making multiple awards under each Focus Area (COGM and COGM-A), or potentially a single award per Focus Area?

Please refer to the RPP Section 1.1, “The RPP may result in multiple awards (i.e., Other Transaction Agreements [OTA]) under each focus area."

Programmatic & Acquisition

Questions Can the Government provide an estimated funding range or notional budget for each Focus Area to assist Offerors in proposing an appropriately scoped effort?

Funding is dependent on availability. For Focus Area #1 COGM the funding estimate per award is approximately $3.2M and for Focus Area #2 COGM-A the funding estimate per award is approximately $4.4M. The Government anticipates funding multiple awards for each Focus Area.

Programmatic & Acquisition

Questions What is the anticipated timeframe between proposal submission and award notification, and how will Offerors be notified?

The anticipated time frame is dependent on the amount of submissions received. It is the Governments intent to award by end of fiscal year.

23 SOO Optional Objective 7 (page 3-6) Following successful prototype development and testing, does the Government anticipate a follow-on production OT, an IDIQ, or another competitive procurement mechanism?

Please refer to RPP Section 1.1 and SOO Section 5.0 Period of Performance for specific details. Yes, if successful at the end of the pOTA, the effort could lead to a production OT. Yes, the DHA may elect to execute an optional Objective 7 to evaluate successful completion of initial proposed work and decide to continue development through additional tasks.

24 Evaluation & Review Process Can the Government describe how proposals will be evaluated across the Technical Evaluation Panel (e.g., centralized versus distributed review by evaluation factor)?

Please refer to RPP Section 3 Proposal Preparation Instructions and Section 4 Proposal Evaluation for Award for specific details. Every proposal will get a comprehensive review and evaluation, but each volume should be separate and distinct.

25 Evaluation & Review Process What is the anticipated duration of the initial compliance screening prior to full technical evaluation? Initial compliance screening prior to technical evaluation will occur upon receipt of the proposal.

Technical Requirements & Performance Clarifications

Do the minimum requirements assume continuous flow only, or may pulse-dose or alternative flow modes be proposed to meet performance objectives?

Please refer to SOO Section 8.0 General Attributes for specific details. Yes, minimum requirement assume continuous flow but alternative flow modes may be proposed to meet objectives.

Technical Requirements & Performance Clarifications

For COGM-A, can the Government clarify required or preferred parameters for ventilator interfacing, including connection type, outlet pressure tolerances, flow mode, and any data or control signals exchanged between systems?

Please refer to SOO Section 8.0 General and Interoperability Attributes. There are no required data parameters for ventilator interfacing at this time. For Focus Area #2 COGM-A, should use standard fittings and be developed to with the ability to exchange data with ventilators using closed-loop-control systems. The COGM-A device must have a 55 ±5 psi outlet pressure.

Technical Requirements & Performance Clarifications

Is the device required to mechanically mount to specific aircraft, ground vehicles, or other medical equipment, or should Offerors propose mounting solutions appropriate to intended platforms?

No, Offerors should not propose development of mounting solutions appropriate to intended platforms at this time. The device will be placed in the existing racks used to strap in oxygen tanks. Refer to SOO Section 8.0 General Attributes for specific details, Focus Area #1 COGM devices must fit securely in a space 4.3 inches in diameter and 19 inches long. Focus Area #2 COGM-A devices must have fit in spaces 5 inches in diameter and 20 inches long.

29 Sustainment Considerations Based on lessons learned from the OGFP program, does the Government anticipate additional sustainment, dormant storage, or long-term reliability requirements to be addressed during this effort?

Please refer to RPP Section 1 Executive Summary and SOO Section 8.0 Maintainability and Storage Attributes for specific details. Yes, the effort focuses on developing easy-to-maintain oxygen generation devices. Refer to the RPP Section 3.3 Maintenance and Sustainment Plan for additional details.

30 Sustainment Considerations Can periodic preventive maintenance be performed during the 12- or 18-month shelf-life period, and if so, are there any constraints on such activities?

Please refer to RPP Section 1 Executive Summary and SOO Section 8.0 Maintainability and Storage Attributes for specific details. Refer to the RPP Section 3.3 Maintenance and Sustainment Plan for additional details. Yes, periodic preventative maintenance can be performed. As a general guideline, yearly maintenance will not increase the logistical burden of devices.

31 Not Provided I am interest in submission proposal on Compact Oxygen Generation Medical Devices: Compact Oxygen Generation, Medical (COGM) and Compact Oxygen Generation, Medical – At Altitude (COGM-A). I didn't see this Solicitation in DOD Submission site. Please share link where I can submit this proposal by online.

Please refer to RPP Section 6 Proposal Submission for specific details. Proposals must be submitted by email to all listed in this section.

32 Not Provided The scope of effort in Attachment A requires that a visual indication of pressure be present on the user interface. Is this referencing output pressure or internal system pressure?

In SOO Section 8.0 General Attributes, the interface must be button-based and use a physical interface to display relevant for device function. Assume pressure refers to outlet pressure described under general attributes for COGM-A devices. Offerors may propose to display internal pressure if important to user.

33 Not Provided Please provide further instructions for Attachment F and/or provide clarification as to what data/expenses it’s referencing.

Please refer to SOO Section 4.0 Objectives for specific details. Attachment F is shared as reference only at this time. In Objective #3 for Manufacturing the Manufacturing and Commercialization Plan will include a rough order of magnitude estimate of production unit costs. The technical data of production unit costs will be captured in Contract Data Requirements List (CDRL A002).

34 Not Provided Is the revision released in 2012 the most current revision of the Joint En Route Care Equipment Test Standard?

Please refer to SOO Section 1.0 Purpose. Final devices will meet Joint Enroute Care Equipment Test Standard (JECETS) and a copy of the standard will be shared following the award.

35 Not Provided What is the average turnaround time for military testing/JECETS completion per Deliverable 7?

Deliverable 7 is for delivery of the prototypes to the Government only. Prototype maturity will determine what testing the Government will submit prototypes to. The timeline for testing and turnarounds will be determined during the Period of Performance.

36 Not Provided What can be provided to better understand the level of detail required/expected for the proposal technical volume plans vs what is developed/defined following contract award?

Please refer to RPP Section 4.3 for specific details. The technical volume should demonstrate an understanding of the objectives outlined in the SOO. The technical volume should also demonstrate that the plans and strategies are feasible and realistic to obtain Offeror defined objectives. Please refer to RPP Attachment B to include sub-attachment 1 Statement of Work for specific details. The Offeror's Statement of Work will define what objectives will be achieved following the contract award and the tasks needed to achieve those objectives.

37 Not Provided Is there an expectation on whether continuous or pulse flow is used?

Please refer to SOO Section 8.0 General Attributes for specific details. Yes, minimum requirement assume continuous flow but alternative flow modes may be proposed to meet objectives.

38 Not Provided Is there a noise level requirement?

Please refer to RPP Section 1 Executive Summary for specific details. No, there is not a noise level requirement described in the solicitation but prototypes will adhere to relevant regulatory agencies and industry best practices.

39 Not Provided Could the Government please provide the anticipated funding availability or target budget for this program so that we may appropriately scope our proposal and align with the Government’s expectations?

Funding is dependent on availability. For Focus Area #1 COGM the funding estimate per award is approximately $3.2M and for Focus Area #2 COGM-A the funding estimate per award is approximately $4.4M. The Government anticipate funding multiple awards for each Focus Area.

40 Not Provided What is the anticipated award date It is the Governments intent to award before the end of the fiscal year.

41 Not Provided

On Page 8, one of the eligibility requirements mentioned is “(A) Demonstrated that there is at least one (1) nontraditional defense or one (1) non-profit research institute participating to a significant extent in the prototype project”. However, the subsequent section states “NOTE: One statutory condition for the use of a Prototype OT is if the performing team does not include either an NDC or a small business concern participating to a “significant extent” in the prototype project; when this occurs, it is then required to have at least 1/3 of the total cost of the prototype project to be paid by the parties, other than the Federal Government.” Given the stipulations of 10 U.S.C. § 4022, which indicate that a non-profit research institution can satisfy the "significant participation" condition in lieu of having an NDC on the team or providing a one-third cost share, could the Government please confirm that the statement in the note should also include non-profit institutions in addition to NDCs and small businesses?

Additionally, will Attachment C: Warranties and Representations be updated to reflect the inclusion of non-profits as well?

As part of Amendment 0001, the Government has modified the RPP, section 2.6 Preliminary Screening & Eligibility first table to remove the NOTE. In addition, Amendment 0001 will also revise Attachment C: Warranties and Representations to ensure the eligibility requirements match 10 U.S.C. § 4022, specifically sections (d)(A), (d)(B), and (d)(C).

42 Not Provided What is the Government’s anticipated project start date? What is the total funding available for this effort, what is the anticipated total funding range (low–high) per award for COGM and COGM-A (and does it vary by Focus Area), and does the Government intend to make a single award or multiple awards?

Funding is dependent on availability. For Focus Area #1 COGM the funding estimate per award is approximately $3.2M and for Focus Area #2 COGM-A the funding estimate per award is approximately $4.4M. The Government anticipates funding multiple awards for each Focus Area.

43 Not Provided Is it acceptable to structure the effort as a phased approach within a single pOTA (e.g., Phase 1: prototype refinement; Phase 2:

verification/validation; Phase 3: regulatory preparation), or does the Government prefer the effort be proposed as one continuous program?

Please refer to RPP Section 3.2 Organization of Proposal and SOO Section 5.0 Period of Performance. Yes, either structure is acceptable. Consider that target timelines for Focus Area #1 for COGM is regulatory approvals by 2029, procurement by 2031 and for Focus Area for COGM-A is regulatory approvals by 2030 and procurement by 2032.

44 SOO page 1 If an offeror proposes two closely related device variants—one optimized for COGM and one for COGM-A—would this approach be considered acceptable for evaluation under the solicitation, or does the Government strongly prefer a single device applicable to both Focus Areas?

Please refer to RPP Section 1 Executive Summary for specific details. Yes, it is acceptable. While a single device that meets all attributes for both Focus Area #1 COGM and Focus Area #2 COGM-A is preferred, the Government anticipates needing 2 separate devices to meet the portability needs of Focus Area #1 COGM and high oxygen flow of Focus Area #2 COGM-A.

45 Not Provided Does the Government prefer that key performance testing be conducted at Government facilities (e.g., Army/DoD laboratories), or are accredited third-party laboratories acceptable for primary verification testing?

Please refer to RPP Section 3.3 Volume 1: Technical for specific details. Yes, it is acceptable to propose using third-party laboratories to demonstrate achieving minimum performance attributes.

46 Not Provided Does the Government prefer a firm-fixed-price, milestone-based payment structure, or an expenditure-based financial approach for this effort?

Please see RPP Section 2.1 Award Type for specific details. Any award type can be proposed and should support the needs of the Offeror and proposal.

47 Not Provided If the award will be incrementally funded, what is the Government’s anticipated initial obligation amount at award, and should offerors plan for potential funding gaps between increments?

Yes, the award will be incrementally funded and an estimated incremental funded schedule is typically provided at the time of award. The initial obligation amount at award will be determined by the Offeror's spend plan. Funding is always dependent on availability but the Government plans funding to cover the Period of Performance at execution of the award.

48 Not Provided

Attachment A (SOO) states: “Reliability/ Mean Time Between System Abort (MTBSA): Must have 87% probability of completing a 72-hour operation (48.75 run-time hours) without System Abort, or a MTBSA of 350 hours. A 90% probability of completing a 72-hour operation (48.75 run-time hours) without System Abort, or a MTBSA of 462 hours is desired.”

Please define what constitutes “run-time hours” within the 72-hour operation (e.g., active measurement/processing only vs.

powered-on standby), and confirm the assumed duty cycle or operational profile used to derive 48.75 run-time hours.

Please refer to SOO Section 8.0 Functional Attributes for specific details. MTBSA describes the reliability of the device and how the likelihood of the device to be functional vs. non-functional. A system abort is a severe failure of the device and the device can no longer perform its primary function to generate oxygen. Run-Time hours are the hours the device is performing its intended functions, within a 72-hour mission window. This does not include standby time when the system is not performing any functions or waiting to be used. The total active time estimated for the device during a 72-hour mission window is 48.75 run-time hours without a system abort.

49 Not Provided

The solicitation specifies a minimum shelf life of 12 months (desired 18 months). Does this requirement apply only to the primary device, or does it also apply to all stored items provided with the system (including consumables, ancillary supplies, and replaceable parts/spares) under the specified storage conditions? Additionally, is shelf-life measured from the date of manufacture or the date of delivery/acceptance?

Please refer to SOO Section 8.0 Storage Attributes for specific details. This applies to all items provided with the system, or all items sold as a unit. Shelf-life is measured from the date of manufacture and expiration date determined by the manufacturer.

50 SOO General Attributes (page 7) Would different form factors than a cylinder be acceptable?

a. Why is the cylinder shaped preferred

Yes, different form factors other than a cylinder are acceptable. The form factor does not need to be fixed as a cylinder. The device will be placed in the existing racks used to strap in oxygen tanks. Refer to SOO Section 8.0 for specific details, Focus Area #1 COGM devices must fit securely in a space 4.3 inches in diameter and 19 inches long. Focus Area #2 COGM-A devices must have fit in spaces 5 inches in diameter and 20 inches long.

51 Not Provided Does the weight and volume envelop include batteries?

Yes, the weight and volume include the batteries. The battery is included in the dimensions. The device will be placed in the existing racks used to strap in oxygen tanks. in the existing racks used to strap in oxygen tanks. Refer to SOO Section 8.0 for specific details, Focus Area #1 COGM devices must fit securely in a space 4.3 inches in diameter and 19 inches long. Focus Area #2 COGM-A devices must have fit in spaces 5 inches in diameter and 20 inches long.

52 Not Provided What would be the maximum budget to develop each device?

There is no maximum budget for a proposal. However, funding is dependent on availability. For Focus Area #1 COGM the funding estimate per award is approximately $3.2M and for Focus Area #2 COGM-A the funding estimate per award is approximately $4.4M. The Government anticipates funding multiple awards for each Focus Area.

53 Not Provided For Focus Area #1 – COGM device the capabilities are mentioned as 3-7 lpm minimum. Is it 3 lpm or 7 lpm that is the minimum oxygen flow required from this device at USP grade 93 ± 3% purity?

a. Should it also be able to provide up to 7 lpm flow on the maximum end, with desired up to 15 lpm?

Please see SOO Section 8.0 Constraints for specific details. For Focus Area #1 the device must be able to provide a flow rate at least between 3 LPM and 7 LPM. A flow rate of between 3 LPM and 15 LPM is desired. The flow rate should be adjustable within that range so Providers can choose a flow rate within the minimum and maximum range.

54 Not Provided For Focus Area #2 – COGM-A device the capabilities are mentioned “same as COGM” but provide up to 15 lpm oxygen flow at USP grade 93 ± 3% purity with delivery at 55 ± 5 psi pressure with only small change in form factor while the weight requirements are same. This requirement is challenging (delivering at high pressure and larger flows)

Please see SOO Section 5.0 Period of Performance and 8.0 Constraints for specific details. Yes, the Government understands the weight and size constraints are challenging. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly what follow-on work would be needed to reach overall device goals.

55 Not Provided COGM-A mentions altitude, while COGM does not. Up to what altitude does the two systems need to be rated for operation?

Please see SOO Section 8.0 Constraints for specific details. Both COGM and COGM-A must be designed with considerations they will be in use while remaining with the patient as they travel on both helicopters (rotary wing) and airplanes (fixed wing).

56 Not Provided

In the functional attributes section of device requirements, “Oxygen Recapture” it is mentioned that “For products prone to oxygen supply depletion through natural off-gassing; the device must have the option or ability to capture and reuse oxygen released through off-gassing to reduce waste. The ability to completely eliminate waste is desired.”

a. Could you explain the “oxygen depletion through natural off-gassing” mentioned here?

One example of a product prone to oxygen supply depletion through natural off-gassing is liquid oxygen systems that provide medical oxygen.

57 Not Provided Does this mean the Oxygen produced by the COGM or COGM-A could be captured and re-used to reach to high delivery flow rates requested in the small form factor?

It would be acceptable to propose this method, but it would still have to meet target timelines and regulatory approvals.

58 SOO General Attributes (page 7) Do both devices need batteries and the same 2-hour battery life? There are conflicting times for battery life, one says 2 hours and the next sentence says 3 hours.

Please refer to SOO Section 8.0 Constraints for specific details. The 2-hour battery life is the minimum. The 3-hour battery life is a desired level.

59 Not Provided

Can hot swappable keep the system so that parameters are not changed and the reboot process doesn’t occur while a battery is replaced?

a. Adding an internal rechargeable battery large enough to run pumps to produce oxygen for the 10 second transition time may add significant hardware and sizing.

b. By having a small internally rechargeable battery to keep settings on, provide diagnostics, and maintain the previous operation will allow the unit to start right back up, producing oxygen near or at the previous point if performed within a reasonable time.

c. Turning off the unit completely off is generally the issue, as parameters are reset, the unit has not shutdown properly so stored oxygen is released, and the re-boot usually has a two-minute start up period once the battery is replaced.

Please refer to SOO Section 8.0 Constraints for specific details. The battery should be able to be recharged while still producing oxygen or the device should not have to be turned off to recharge.

60 Not Provided

What vehicle power is available and desired for the device to be designed to?

a. Are secondary power converters like specific AC/DC or DC/DC for certain vehicle outputs sufficient to handle the conversion prior to the device?

b. Would this count towards the weight and size?

Please refer to SOO Section 8.0 Constraints for specific details. Assume that as long as the device meets the minimum power attributes and be designed to use standard converters. No, secondary power converters would not count towards weight and size.

61 Not Provided What would be the maximum budget to develop each device up to and including objective 7?

There is no maximum budget for a proposal. However, funding is dependent on availability. For Focus Area #1 COGM the funding estimate per award is approximately $3.2M and for Focus Area #2 COGM-A the funding estimate per award is approximately $4.4M.

62 Not Provided What is the expected budget range to support FDA approval and commercialization beyond objective 7? There is no maximum budget for follow-on work to achieve FDA clearance. However, funding is dependent on availability.

63 Not Provided Are both technologies needing to be rated for airworthiness? Please refer to SOO Section 8.0 Constraints for specific details. Yes, both technologies need to be rated for airworthiness.

64 Not Provided

Power requirements are listed as 110/220AC, 60-400Hz, and 10-28VDC.

a. Do these devices need to have all these power input options or just one of them?

a.1. I.E. Our smaller powered systems are designed to take 28vdc batteries and require 110AC when using the external power supply. It can be designed in other manners, but it adds massive hardware internally to do so.

b. If not, which power requirements are required for COGM and COGM-A separately?

Please refer to SOO Section 8.0 Constraints for specific details. Yes, the devices need to be designed for all these power options because they will be used across multiple Roles of Care.

65 SOO Functional Attributes (page 8) Is MTBSA the time between operations?

a. Is this for both technologies

Please refer to SOO Functional Attributes for specific details. MTBSA describes the reliability of the device and how the likelihood of the device to be functional vs. non-functional. A system abort is a severe failure of the device and the device can no longer perform its primary function to generate oxygen. Run-Time hours are the hours the device is performing its intended functions, within a 72-hour mission window. This does not include standby time when the system is not performing any functions or waiting to be used. The total active time estimated for the device during a 72-hour mission window is 48.75 run-time hours without a system abort.

66 Not Provided Are tactical modes required for both technologies?

a. Are there preferred features such as infrared only?

Please refer to SOO Section 8.0 Constraints for specific details. Any technology that connects to a network wirelessly needs to be designed with the option to switch off wireless capabilities. Infrared is not a minimum attribute.

67 Not Provided Are there different weight requirements for the COGM and COGM-A?

a. Is there flexibility on these constraints as a function of flow rate and purity?

Please refer to SOO Section 8.0 Constraints. No, there is no different weight requirements for the 2 Focus Areas or between COGM and COGM-A. The Government acknowledges that follow-on work may be needed to reach overall device goals.

68 SOO page 1 Who is the general end user and where is the primary application?

Please refer to RPP Section 1 Executive Summary, SOO Section 1.0 Purpose and 2.0 Background section for specific details.

Medical personnel across all specialties from Medics to Physicians will be using either COGM or COGM-A devices. For Focus Area #1, the COGM device will be used primarily at Role 1 but may stay with the patient during transport through the different Roles. For Focus Area #2, the COGM-A device will be used primarily on aeromedical evacuation platforms.

69 Not Provided Is the oxygen flow rate or dimensional constraint more important?

a. Making a unit at 20”L with 4.3” diameter may be more obtainable at 3LPM

Yes, the Government understands the weight and size constraints are challenging. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly the dependency on flow rate to size and weight constraints and what the minimum size and weight would be to meet the flow rates.

70 SOO General Attributes (page 7) Can we use a larger diameter and length?

a. 4.375” ID x 20” L

b. What dimension constraints can flex?

Please refer to SOO Section 8.0 Constraints for specific details. The device will be placed in the existing racks used to strap in oxygen tanks. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly the dependency on flow rate to size and weight constraints and what the minimum size and weight would be to meet the flow rates.

71 Not Provided

Is a closed-circuit device optional?

a. Recirculate the expired O2 90%, reject CO2, and resupply with small oxygen rate (1.5 LPM with 30 BPM example)

b. This would make the technology smaller

c. The downside is that it will only work with tied to a breathing loop (simple mask will not work). Custom masks and tubing will need to be created to facilitate bag valve masks and ventilators

Please refer to SOO Section 8.0 Constraints for specific details. For Focus Area #1, the COGM device does not need a closed-circuit ability. For Focus Area #2, the COGM-A device must have the ability to interface with closed loop control systems. Both Focus Areas require a minimum of 3 LPM. Yes, it is assumed that closed-loop control would be when the device is interfacing with other devices like a ventilator and not a face mask only.

72 Not Provided Is the 12-month shelf life for a stored module with no use or is that with continuous use?

Please refer to SOO Section 8.0 Constraints for specific details. This applies to all items provided with the system, or all items sold as a unit. Shelf-life is measured from the date of manufacture and expiration date determined by the manufacturer. It is for a stored module with no use.

73 SOO page 1 Who is the general end user and what is the primary application of COGM-A?

Please refer to RPP Section 1 Executive Summary, SOO Section 1.0 Purpose and 2.0 Background section for specific details.

Medical personnel across all specialties from Medics to Physicians will be using either COGM or COGM-A devices. For Focus Area #1, the COGM device will be used primarily at Role 1 but may stay with the patient during transport through the different Roles. For Focus Area #2, the COGM-A device will be used primarily on aeromedical evacuation platforms.

74 Not Provided Can you define what the closed loop control integration and Net Ready requirements are?

Please refer to SOO Section 8.0 Constraints for specific details. For Focus Area #1, the COGM device does not need a closed-circuit ability. For Focus Area #2, the COGM-A device must have the ability to interface with closed loop control systems. The Services would like COGM-A devices to be interoperable with ventilators that have closed-loop control, which can automatically adjust the amount of supplemental oxygen delivered through the ventilator based on physiological feedback from the patient. Any device that connects to the network wirelessly needs to have the ability to be switched on or off. Any device that connects to the network has added cybersecurity requirements.

75 Not Provided

Why is 55 PSIG output needed on the COGM-A?

a. To our knowledge all Zoll, Thornhill Ventilators, Hamilton ventilators have low pressure oxygen support which means they do not control the oxygen flow rate, rather the oxygen concentrator will do this at a low pressure.

b. We have heard that the reason for high pressure could be due to the Fabius Trio anesthesia device because it does not have low oxygen supply ports. However, it is rumored that this device is no longer being supported by Drager in the near future.

c. The MADAM anesthesia device does not require high pressure oxygen and is the only device to our knowledge that will be competing with the Fabius Trio.

Please refer to SOO Section 8.0 Constraints for specific details. Yes, the Government understands that certain ventilators and models no longer require high pressure outlet pressure. This is a minimum attribute for Focus Area #2, COGM-A devices only that may need to connect to ventilators that require a outlet pressure.

76 SOO General Attributes (page 7) Does COGM-A need to have a battery?

Please refer to SOO Section 8.0 Constraints for specific details. Yes, the battery attribute applies to Focus Area #2, for COGM-A devices.

77 SOO General Attributes (page 7) Does COGM-A need to be 99% O2?

Please refer to SOO Section 8.0 Constraints for specific details. No, for Focus Area #2, the COGM-A device must have a minimum of 93% ± 3% purity.

78 SOO General Attributes (page 7) Does it need to be 15 LPM or is there a range?

Please see SOO Section 8.0 Constraints for specific details. For Focus Area #1, devices need to provide an adjustable flow rate of 3 - 7 LPM and for Focus Area #2, devices need to provide an adjustable flow rate of 3 - 15 LPM.

79 Not Provided Is a device that accepts several COGMs with a booster package sufficient to hit higher flows and pressure? Please refer to SOO for specific details. It would be acceptable to propose this approach to meet attributes.

80 SOO General Attributes (page 7)

First, is there any flexibility regarding the overall device footprint? If the performance requirements could be met—but would require a change in form factor—would that be acceptable? Moving away from a cylindrical structure could significantly improve serviceability, increase O₂ output and battery life, allow higher operating pressures, and make large scale manufacturing more efficient.

Please refer to SOO Section 8.0 Constraints for specific details. The form factor does not need to be fixed as a cylinder. The device will be placed in the existing racks used to strap in oxygen tanks. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly the dependency on flow rate to size and weight constraints and what the minimum size and weight would be to meet the flow rates.

81 Not Provided Second, will expected volume projections be shared during the upcoming meeting? Having at least a directional estimate of potential unit demand is critical for securing long lead components and ensuring we can establish a stable supply chain for the coming years.

The Government cannot commit to exact quantities at this time, but the Government wants to know what your capacity range could be. The estimated quantity for Focus Area #1 COGM is in the 5,000 - 10,000 range per year; for Focus Area #2 COGM-A it is closer to 1,000s range per year. Procurement would occur over a few years. Refer to RPP Section 1 Executive Summary for specific details. The target timeline for procurement of Focus Area #1 COGM is 2031 and of Focus Area #2 COGM-A is 2032.

Procurement will occur.

82 Not Provided To Clarify: Funding: FA1: 3.2M, FA2: 4.4M Total or per award?

Funding is dependent on availability. For Focus Area #1 COGM the funding estimate per award is approximately $3.2M and for Focus Area #2 COGM-A the funding estimate per award is approximately $4.4M. The Government anticipates funding multiple awards for each Focus Area.

83 SOO page 2 Are there any limitations to where parts can be sourced from? Similar to NDAA compliance?

Please refer to the SOO Section 3.0 Scope of Effort for requirements regarding Trade Agreements Act compliance. Potential Performers share responsibility with the Government for ensuring compliance with applicable National Defense Authorization Act (NDAA) sourcing restrictions, including limitations on the procurement of covered telecommunications equipment, services and other restricted components. Potential Performers are expected to exercise due diligence in the verifying of all parts and materials incorporated into deliverables.

84 Not Provided Does the Government have platforms / locations identified for form-fit-function iterative development cycles? If so, where are they and how does the coordination take place.

No, there are no pre-determined locations for testing and iterative development cycles. Deliverable 7 is for delivery of the prototypes to the Government only. Prototype maturity will determine what testing the Government will submit prototypes to.

The timeline for testing and turnarounds will be determined during the Period of Performance.

85 Not Provided is there a preference for CONUS manufacturing/Final Assembly?

Please refer to the SOO Section 3.0 Scope of Effort for requirements regarding Trade Agreements Act compliance. Potential Performers share responsibility with the Government for ensuring compliance with applicable National Defense Authorization Act (NDAA) sourcing restrictions, including limitations on the procurement of covered telecommunications equipment, services and other restricted components. Potential Performers are expected to exercise due diligence in the verifying of all parts and materials incorporated into deliverables.

86 Not Provided How will this program interact with currently funded similar programs, i.e.. SOCOM, NIH?

The current acquisition program works with stakeholders through monthly meetings and continuously monitors the market for commercially available device that meet the needs of our end users.

87 Not Provided Are there procurement dollars in the POM after the 5 year R&D initiative? Funding is dependent on availability. The current solicitation utilizes RDT&E dollars.

88 Not Provided SOO states airworthiness requirement for aeromedical evacuation aircraft. Is there a specific standard (w/number) it must meet?

Please refer to SOO Section 1.0 Purpose. Final devices will meet Joint Enroute Care Equipment Test Standard (JECETS) and a copy of the standard will be shared following the award.

89 Not Provided

Can you please be explicit on the regulatory end goal (e.g. Regulatory approvals by 2029)?

"Objective 4 is considered achieved when all FDA submissions and feedback are received, and test reports are submitted."

So FDA approval is not required by 2029? Just filing?

Please refer to SOO Section 1.0 Purpose. These are our target timelines and the Government prefers a shorter schedule. No, FDA approval is not required by 2029. The Government acknowledges that follow-on work may be needed to reach overall device goals. Consider proposing objectives that can be achieved within the Period of Performance and describe succinctly what follow-on work would be needed to reach overall device goals.

90 Not Provided Can you Verify the plans required for inclusion in the 20 pages (Vol 1) are part of the 20-page limit (Section 3.2).

Please verify that the PMP and the QMP are included within the 12-page limit of the Management Approach (Volume 2)

Please refer to the RPP Section 3.2 Organization of Proposal for Volume and Page Limits. Volume I: Technical, Technical Approach shall include the following: Description of current state of the prototype technology and final end-state concept, Prototype Development Plan to include Design Refinement, Testing Plan, Regulatory Strategy, Maintenance and Sustainment Plan, and Manufacturing and Commercialization Plan. The page limit for the Technical Approach is 20 pages. Volume II:

Management, Management Approach shall include the following: Project Management Plan (PMP) (with Integrated Master Schedule (IMS), Identification of Key, Personnel, Risk Management Plan, Spend Plan, and Quality Management Plan). The page limit for the Management Approach is 12 pages.

91 Not Provided Can we propose to both items with two separate technologies?

Please refer to RPP for specific details. Yes, it is acceptable to propose to both Focus Areas with 2 separate technologies with 2 separate proposals if needed. The Government recommends being clear in which Focus Area the proposal is submitted for.

92 Not Provided Response times for review?

The Government's response time is dependent upon the total amount of proposals received. It is the Government's intent to award by the End of the Fiscal Year.

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