Cell Salvage Supplemental RFI.docx

Request for Information

(RFI)

RFI Number: FA800326SS004 Operational Medicine Test and Evaluation Cell Salvage Supplemental

Table of Contents

Disclaimer THIS IS A SOURCES SOUGHT AND REQUEST FOR INFORMATION (RFI) FOR MARKET RESEARCH PURPOSES ONLY. IN ACCORDANCE WITH (IAW) FEDERAL ACQUISITION REGULATION (FAR) 15.201(e), THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT.

ALL INFORMATION INCLUDED IN THIS RFI IS CONFIDENTIAL AND ONLY FOR THE RECIPIENT’S KNOWLEDGE AND MARKET RESEARCH PURPOSES. NO INFORMATION INCLUDED IN THIS DOCUMENT OR IN DISCUSSIONS CONNECTED TO IT MAY BE DISCLOSED TO ANY OTHER PARTY.

Introduction and Purpose of the RFI

This supplemental market research will help identify solutions that can safely bridge the time to surgery in austere environments.

The purpose of this RFI is to request information to determine your company’s services and capabilities to meet our government requirement for a device to perform cell salvage, blood conditioning, and autonomous return with flow rate control of blood delivery to include prototypes.

The information gathered from all companies that answer the RFI will be analyzed against the requirements to effectively identify capabilities that are available in the marketplace/industry. Both large business concerns and all categories of small business are encouraged to respond to this request.

The following North American Industry Classification System (NAICS) code(s) may possibly be used for this requirement:

· 339112 – Surgical and Medical Instrument Manufacturing.

Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

Background Description of Information Requested The Air Force Medical Service (AFMS) provides medical care throughout a wide range of environments including the various roles of care in the military theater. Survival rates for warfighters suffering major blood loss and hemorrhagic shock are poor. The lack of transportable, on-demand blood or blood components provides a significant obstacle when providing care efficient and safe enough when a patient's needs exceed surgical capability.

To address this critical capability gap, a Request for Information (RFI) was previously submitted in 2025 seeking viable market solutions; this current effort serves as a supplemental market research request to further expand and refine those initial findings.

The solution will enhance the United States Air Force's (USAF) ability to safely bridge time to surgery while providing adequate care in a timely manner that mitigates the lack of appropriate blood supply. The implementation of this product will provide a new capability within the initiatives of austere surgical stabilization, damage control resuscitation, and far forward blood transfusions to adequately treat severe blood loss in the field.

Scope AFMS is focused on the capability to provide adequate treatment for significant blood loss and hemorrhagic shock in the field with a device that can efficiently repurpose the blood lost without the need of using donor blood or blood components. Specific information is requested according to the forms below. Please complete as much information as possible.

Context in which the product or service will be used Statement of need

AFMS lacks the capability of providing on-demand blood, or blood substitutes/components for an expeditionary environment that are portable and shelf-stable without cold-chain logistics. The product is needed to directly support AFMS by allowing safe far-forward blood transfusions to enhance the efficacy of patient stabilization.

Requirements

The response should describe the company’s capability to provide, field, and sustain the product as characterized by the requirements addressed in this RFI. If unable to provide a product capable of meeting all requirements, the respondent should provide trade-off considerations to meet the requirements addressed in this RFI.

A total of 23 Essential Characteristics (EC) were identified along with 5 preferences. The EC and preferences are listed in the attached document (Form #2).

Note: Manufacturers are encouraged to submit a response to this RFI, even if the system does not meet all the requirements currently. For requirements that are not met, please provide commentary as trade-off considerations will still be reviewed.

Acronym List AFMS: Air Force Medical Service DOD: Department of Defense EC: Essential Characteristic FAR: Federal Acquisition Regulation FDA: U.S. Food and Drug Administration IAW: In Accordance With NAICS: North American Industry Classification System RFI: Request for Information USAF: United States Air Force Instructions to Respondents

To answer this RFI, please complete the attached forms (RFI response Form #1 and Form #2 [attached Excel Requirements Spreadsheet]). The contact person listed below is available for assistance, if needed.

The answers to this RFI will be evaluated by staff from different functions in Operational Medicine Test and Evaluation (OMTE).

Response to this RFI must be submitted via email to:

Mr. Aaron Nelson, Market Research Director / Director of Operations Email: usaf.detrick.afmra.mbx.sg5t-market@health.mil Email responses should be no larger than 10 MB in size. If larger attachments are required, please notify Operational Medicine Test and Evaluation (SG5T) at the above listed email address.

Please include a point of contact, phone number, email address, and website information; indicate whether the company is a foreign or domestic entity in the contents of the email. Each RFI response will receive a confirmation email; if a confirmation is not received, please call 301-619-8600.

The Government will not pay for any information submitted or for any costs associated with providing the information.

How to deliver the answer Send the attached Word and Excel forms (format unchanged) by email to: usaf.detrick.afmra.mbx.sg5t-market@health.mil Timeframe This is the timeframe for Q&A’s and responses 16 October 2026 – The RFI is sent out 2 November 2026 No later than 5:00PM CST – Last date for questions & answers 16 November 2026 No later than 5:00PM CST – Last date for response Point of Contact For questions regarding this RFI, you are welcome to contact:

Mr. Aaron Nelson Market Research Director Operational Medicine Test and Evaluation 1270 Montevue Lane (Area B) Fort Detrick, MD 21702 Phone: 301-619-8601 Email: usaf.detrick.afmra.mbx.sg5t-market@health.mil

RFI Response Form #1

Company name

Company address

Company web page

Main products/services

Main market/customers

Ownership structure with ownership status in percentage

Structure of mother corporation, joint ventures, subsidiaries, partnerships or other relevant relations

Number of years on the market

Company location(s)

Environmental management system(s)

Quality management system(s)

Describe your business continuity management

Contact person and responsible for answering this RFI

Telephone

Email

Conditions listed in the RFI that cannot be met

Description of products or services that are already delivered to customers today, and could be comparable to what is requested in this RFI

Reference customers using comparable products or services (including contact information)

Reference customers using your products or services today, although they are not comparable to what is requested in this RFI (including contact information)

Locations available for delivery, if not worldwide.

Availability of spare parts and support worldwide

RFI Response Form #2 See attached Excel document titled: 20261015_Cell Salvage Supplemental_RFI_Response Form_2