Vendor Questions and Government Responses RPP HT9425-23-R-0065-0002 USFP.pdf

Offeror Question Government Response

We would like to formally request a 30‐day extension based on the scope of work required to respond to this

RPP/Solicitation.

The RPP close date will be revised from Monday, 5:00pm eastern 14 Aug

23 to: Friday, 12:00pm eastern 18 Aug 23.

If all these documents need to be reviewed, answered, and returned, it will be very difficult if not impossible to get this accomplished in the timeframe that you have laid out. Has there been any consideration of giving more time to accomplish this review and response? If not, I would like to formally request a time extension, so we have adequate time to review and respond to the request.

See response under #1 (General questions).

What are the requirements required by a foreign entity to be eligible to submit for this OTA? E.g., TAA or other document requirements that need to be submitted

The same requirements that apply to domestic entities apply to foreign

OT. Section 3.3 of the RPP states, "NOTE: Offerors who propose consultants, subawards, consortiums or contractual arrangements with foreign organizations or foreign collaborators shall provide additional justification explaining why the foreign organization or foreign individual can carry out the scope of work more effectively than a U.S. organization or U.S. individual."

Do we need to submit the SOW on August 14th or is it due at the time of the award at a later date?

Refer to Section 3.2 of the RPP and Attachment E ‐ SOW template (last page). SOW is due with proposal submission.

I am confused with the Excel spreadsheet for pricing. This seems to be for a “project or prototype.” Again, our device is already developed and commercially available on the government ECAT and FSS contractual ordering systems.

How do I and where do I respond on this Excel spreadsheet with pricing for our device?

Please refer to Section 3.4 of the RPP.

Will this be required to be purchased off a DLA or VA contract or is this an Open Market Bid?

This requiremnet will result in an prototype Other Transaction Authority

(pOTA). Please refer to Section 1.1 of the RPP and the Attachment A ‐

Statement of Ojectives (SOO).

Regarding excel spreadsheet for pricing. This seems to be for a “project or prototype.” Again, our device is already developed and commercially available would we only be required to submit per system pricing with our proposal?

See Gov't response under no. 6.

Does DOD intend to procure the downstream 1,137 portable ultrasound systems through this same procurement vehicle?

No.

Will the 3500 units mentioned in the RPP that the DOD intends to purchase ‐ be recompeted in a separate

Request for Proposal?

No, it will be a direct award. Refer to Section 1.1 of the RPP and

Attachment A ‐ Statement of Objective, Section 3.

General Questions

Request for Project Proposal (RPP) No. HT9425‐23‐R‐0065 for “Ultrasound Field Portable (USFP) Assessment &

Development Efforts” for

“Ultrasound Field Portable (USFP) Assessment & Development Efforts”

Amendment No. 0002 ‐ Q&A

Date Posted to SAM.gov: 10 Aug 23

In section 2.1 Acquisition Approach: Will the same company be down selected for Objectives 4 AND 5, or will there be a down select for each Objective?

USAMRAA intends to make multiple awards, from this RPP to qualified performers for completion of Objectives 1, 2 and 3. After completion of

Objective 3, only one (1) awardee will be selected for completion of

Objective 4 (optional objective to be exercised for the one Performer who advances).

In section 3.4 Vol II‐ Administration and Cost Volume/4.3.1

Technical and Management Approach Factor 3: Will the

Government accept historical prices paid to substantiate fair and reasonable pricing for commercial fixed‐price acquisitions?

Yes.

Are the questions and RPP submission confidential? Offeror questions and Gov't respondances will be posted to SAM.gov via amendment. Proposal submission are confidential.

Please provide additional details on fixed amount and cost reimbursement provided via monthly payments for objectives 1‐3, 5. Attachment F Section 3: 3. This

Agreement is a combination fixed‐price and cost reimbursable OT. For Objectives 1 ‐ 3 and 5, the Performer shall be paid a fixed amount. The monthly payments provided under this Agreement for objectives 1 ‐ 3, and 5 are not intended to compensate the Performer on a cost basis for performance under this Agreement. For

Objective 4, the Performer shall be paid for costs incurred based upon documented progress towards completion of the Objective and its tasks.

Objective 1: Firm Fixed Price (FFP) ‐ equal fixed monthly invoicing/payments

Objective 2: Firm Fixed Price (FFP) ‐ 1 invoice/payment

Objective 3: Firm Fixed Price (FFP) ‐ equal fixed monthly invoices/payments

Objective 4: Cost plus fixed fee (CPFF) ‐ Cost reimburshment. Monthly invoices/payment

Offeror Question Government Response

What is the length of time the performer will be required to support the replacement/refurbished parts requirement in Deliverable 19?

The performer will be required to support the replacement/ refurbished parts requirement for the lifetime of the devices ‐ estimated to be 7 years for each USFP system ‐ or until the device is upgraded.

Are there any preferences or specifications desired for the viewing platform? For example: operating system, size, etc.?

In the SOO, under Objectives, see table labeled with "RECOMMENDED":

The attribute "Size" states "The complete USFP system (screen & transducer(s)) should be a cube of no more than 280 cubic inches"

Our current system is cleared for Compressibility measurement under FDA product code LXC. But this product code is not cleared for FAST, eFAST and MSK currently but is capable of FAST, eFAST and MSK.

Furthermore, the components of the system required for

FAST, eFAST and MKS are cleared by the FDA under a different product code. We expect to get FDA clearance for the prototype to fulfill this OTA requirement within the next six months. Would this still meet the scope of this

RFP?

The Ultrasound system must be FDA cleared for use in the abdomen, for cardiac use and for muskuloskeletal use; and must be capable of performing FAST, e‐FAST and MSK/MSKI exams.

RPP Questions

How do you expect us to demonstrate the capability of doing FAST, eFAST and MSK exams? In the absence of FDA clearance, can the requirement be fulfilled with clinical data/ real world evidence?

Pls refer to response in #3 (RPP questions)

“Have a 95% probability of completing 24 total run time hours within a 3‐day timespan without a System Abort

(SA), which equates to 468 hours Mean Time Between

System Abort (MTBSA)" – Question: Are you referring to a specific standard here? If yes, please indicate the standard.

The reliability requirement is not based on a standard. Reliability requirements are based on an analysis of a system’s Concept of

Employment and are documented in the requirement document. The reliability requirement for any system the Army acquires is unique to that system.

We expect to fully meet the reliability criteria: The USFP system should have a 95% probability of completing 24 total run time hours within a 3‐day timespan without a

System Abort (SA), which equates to 468 hours Mean Time

Between System Abort (MTBSA). However, we need additional time to conduct and submit the results of these tests. Is that allowed?

The Government will test devices against this criteria and that information will be used along with the other "Recommended" criteria in the down‐ selection process.

The documents contained in the RPP/RFI appear to be for a “prototype” device that may not have been developed yet. Is this correct?

Please refer Section 1.1 Purpose of the RPP and Sections 2. Background and 3. Scope of Effort of the SOO.

We have a commercially available FDA‐approved device that meets many if not all the requirements. Of all these documents, which ones do we return?

Please refer to Section 3. Proposal Submission Instructions of the RPP

Please provide additional details on testing protocol/methodology to measure reliability. Attachment

A: Reliability ‐ The USFP system should have a 95% probability of completing 24 total run time hours within a

3‐day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort

(MTBSA).

The reliability requirement is not based on a standard. Reliability requirements are based on an analysis of a system’s Concept of

Employment and are documented in the requirement document. The reliability requirement for any system the Army acquires is unique to that system. The Government will test this devices against this criteria and that information will be used along with the other "Recommended" criteria in the down‐selection process.

Please provide detail on power source lasting for 2 hours and explanation on highest setting. Attachment: Request for Prototype Proposal Desired setting:

Power source should last for two hours at the highest setting.

Continual use for 2 hours for the ultrasound system, while the viewing platform is at it's brightest setting. If a specific mode requires more power, that mode should be used.

Please clarify maintenance: defined as in field maintenance or probe/system back to manufacturer.

Mean Time Between Maintenance (MTBM) (Deliverable

10 of SOO)

The question is unclear. If the question is referencing the types of maintenance for the system, we anticipate that no field level maintenance will occur. All maintenance, such as software updates, will be sent back to the depots.

Please define length of operational use at 49 C. The fully functional USFP system should be operational at all settings at 49°C.

Please refer to Attachment I ‐ MIL‐STD‐810

Under “recommended parameters” specifications, will you accept a system that is 6 lbs?

In the SOO, under Objectives, see table labeled with "RECOMMENDED":

The attribute "Weight" states "The complete USFP system (screen & transducer(s)) should not weigh more than three pounds"

Is it the DOD’s intention and goal to purchase a commercially available portable ultrasound system or to develop a new protype?

Please refer to Section 3. Scope of Effort of the SOO. The goal is to field a non‐networked ultrasound system.

Our system consists of an application and transducer set that loads onto a 3rd party viewing screen/tablet. Is this what you intend to procure?

Please refer to Objective 2 in the SOO for the components expected to be supplied.

Could you explain what would be considered the protype component for development?

Please refer to Section 2. Background in the SOO. The goal is to field a non‐ networked ultrasound system.

Would the DOD require a specific brand or model for their

3rd party viewing screen/tablet?

No. Please note in the SOO, under Objectives, see table labeled with

"RECOMMENDED" for size and other attriubtes. The requirement is to have a non‐networked total ultrasound system.

Regarding RMF/ATO will the ultrasound systems transducers and application require an approval or just the connecting 3rd party viewing screen/tablet?

The whole system will undergo an RMF assessment.

Does the DOD have a fleet management process planned to update and service these devices, whether it is within the DOD process or third party periodically?

If the question is referencing the types of maintenance for the system, we anticipate that no field level maintenance will occure. All maintenance, such as software updates, will be sent back to the depots.

As a hand ‐held Ultrasound manufacturer and partner to the DOD, how can we best service your portable devices to keep them compliant and safe over the span of the product?

We are unable to respond to this question, since the prototype product hasn’t yet been developed.

Does the DOD plan to continue to use Samsung tablet devices to connect Ultrasound HH transducers?

There are no viewing screen requirements in the solicitation for specific name brands. Please see both the "REQUIRED" and "RECOMMENDED" tables in Objectives in the SOO.

Has the DOD collaborated with Samsung or any other third party to develop a tablet to meet the desired criteria for the DOD to connect the Ultrasound transducers for safe and compliant operation in the field?

There are no viewing screen requirements in the solicitation for specific name brands. Please see both the "REQUIRED" and "RECOMMENDED" tables in Objectives in the SOO.

Does the network removal include WIFI and Bluetooth connection between the probe and monitor? Or just the

DICOM PACS portion of the software?

See "REQUIRED" table in the Objectives of SOO. The ultrasound system connect to a network or store data. If the intention is to connect via

Bluetooth or wireless, the permissions need to be locked down so that unintentional connections are not allowed. It may require additional assessment when going through the RMF assessment. It must not be able to connect to anything other than the components in the ultrasound system.

Can you share the specific use case mix (e.g., % or #'s of specific exam types being performed).

See "REQUIRED" table in the Objectives of SOO.

What level of user do you anticipate will be operating the device in the operational environment? (e.g., never/rarely used, novice, expert)

The user will have training in how to use/read an ultrasound but the level of experience will be varied.

Will prolonged patient field care be required? If so, how will patient information be stored and shared as they proceed through the care path?

Yes it will be used in prolonged care. This system will not connect to any network, therefore no patient data will be stored or transmitted/ shared.

Does data from the device need to be integrated into the electronic health record, joint trauma system, or other casualty tracking system?

This system will not connect to any network, therefore no patient data will be stored or transmitted/ shared.

The viewing aspect is open and may lead to an invention or novel display type. Is there a viewing device (android or iOS) already available to the end user that we can access or is it mandatory to have a self‐contained USFP?

Per the Objectives in the SOO, a non‐networked viewing device must be provided as part of ultrasound system. If no vendor can produce this requirement, Objective 1 will allow for selected vendors to develop a non‐ networked viewing screen.

If a self‐contained USFP is it desired that the viewing device be integrated into the probe or would you rather have it be separate?

Based on the "REQUIRED" table in the Objectives section of the SOO, there is not a preference for it to be integrated or separate but it needs to meet the "REQUIRED" attributes and as many of the "RECOMMENDED" attributes as possible

Are there specific visibility requirements (e.g., is there a need to hide the visible footprint or is a brighter screen desired to clearly see the image)?

It must be operational in the operational environment. Please refer to

Attahcment I ‐ MIL‐STD‐810.

Are there any other preferred specification for the viewing device (e.g., tablet vs. phone, portrait vs. landscape orientation, screen size)?

The viewing screen must not connect to any networks and there are size and weight attributes listed in the SOO, under Objectives, see table labeled with "RECOMMENDED".

Are there specific durability requirements (drop, IP67…) for the USFP?

The system will undergo environmental testing according to MIL STD 810.

No other durability requirements specified.

33 Will remote repair or troubleshooting be required? No.

Attachment H p2, it states “Shall be capable of performing

MSK exams” as the threshold and “Shall be FDA cleared for performing MSK exams” as the Objective. We currently have a probe capable of performing MSK exams, and we are in the process of obtaining FDA clearance, which we expect to receive by the end of the year. Could you please confirm whether our submission is valid?

The Ultrasound system must be FDA cleared for use in the abdomen, for cardiac use and for muskuloskeletal use; and must be capable of performing FAST, e‐FAST and MSK/MSKI exams.

Does the TLR 7 device have to be FDA cleared for MSK? See Section 3. Scope of Effort of the SOO and refer to the TRL attachment.

If Objective 1 is required for the TLR 7 work, an we start objective 2 as soon as LTR 7 is achieved rather than wait the full 15months?

The Objective 1 period of performance can be shorter than what is listed.

Attachment A p2 states that between TRL 6 an TRL 7 "NO

OTHER DEVELOMENT EFFORTS WILL BE PREMITTED." Does this include normally updated commercial items like IQ improvements, bug fixes and new feature development?

See Deliverable 11 ‐ the update cycle will need extension out to 18 months. Updates are not considered development work.

To help understand the update process, how would you prefer to manually upgrade the probes in the field (esp.

given that there are 3,500)? Would a software management system be used vs. an over the air software push?

Since the device will not be able to connect to a network, it will not able to be done "over the air". Deliverable 11 is for the vendor to provide a software update plan.

If multiple probes are required, is each included in the 3lb weight limit?

Yes

Can you share more details about how these systems will be deployed in the field?

Please refer to Section 1. Purpose and Section 2. Background of the SOO.

Could you share why 1,137 was chosen as the number of units for objective 5?

No longer applicable. Please reference updated SOO.

What is the timing of the of 3,500 units? Could you share why that specific number?

The estimated 3,500 units will be spread out over a 5‐year period estimated from 2025‐2030.

Will there be an expectation of recurring systems, or is this a onetime purchase?

The estimated 3,500 units will be spread out over a 5‐year period estimated from 2025‐2030.

Would training materials be delivered at the point of care?

We have novel training tools in place, could they be shared as part of the submission?

The training plans will be developed in Objective 4 for the down‐selected ultrasound system.

Attachment H p3 states the Low Temperature threshold at

‐1°C and the objective at "26°C." The objective (26°C) seems too high and may be a typo, if so, what is the low temperature objective?

Correction made to attachment H. Objective low temperature is ‐26°C

Can you confirm this request is for a laptop ultrasound system? If not, would you prefer a tablet system or hybrid, partial laptop/partial tablet? If so, what quantities for both?

Please refer to the "REQUIRED" and "RECOMMENDED" tables in the

Objective section of the SOO.

Will a side by side demo of the systems be offered? We are unable to respond to this question, since we do not know what this question is in reference to.