DS-PubRel-FY26-0088 - Autoinjector Platform RFI_JUL26_Final_v4 .docx

REQUEST FOR INFORMATION

DEVELOPMENT OF A FORMULATION-AGNOSTIC AUTOINJECTOR PLATFORM

This Request for Information (RFI) is for planning purposes only. It does not constitute a commitment by the United States Government (hereafter referred to as “Government”), nor will the Government pay for the requested information. Furthermore, the Government does not guarantee it will issue a solicitation as a result of this RFI.

Background:

The Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense’s (CPE CBRND) Joint Project Manager for CBRN Medical (JPM CBRN Medical) serves as the War Department’s (DoW) premier program management office for the development and acquisition of safe, effective, and innovative medical solutions to combat CBRN threats to service members. JPM CBRN Medical leads medical countermeasure (MCM) development for vaccines, diagnostics, and therapeutics, which are critical elements to a multi-layered defense strategy.

Objective:

JPM CBRN Medical seeks approaches to develop or leverage an already developed modular autoinjector platform(s) capable of delivering a single drug, single chamber, dual drug, dual chamber, or any combination thereof for, but not limited to:

· Atropine (2.1 mg/0.7 ml) and pralidoxime chloride (2-PAM, 600 mg/2 ml) in a single autoinjector

· Atropine (2 mg / 0.7 mL)

· Midazolam (10 mg / 0.7 mL)

· Naloxone (10 mg / 0.4 mL)

CPE CBRND desires the autoinjector(s) to be operationally suitable, commercially viable beyond the military use case, and able to rapidly incorporate new medical countermeasures (MCMs) while minimizing changes to the autoinjector design and production line. In addition, CPE CBRND wishes to have the option to leverage the autoinjector device platform(s) to deliver other chemical or biological agent exposure MCMs.

Respondents must include their most up-to-date research and designs. Respondents who participated in past industry days/technical presentations or submitted prior responses related to this requirement must update and resubmit their information.

As part of the market research process the Government may contact respondents who submit a qualifying response to arrange a follow-up meeting to discuss their white paper in greater depth. Expect contact within 4 weeks after the submission period end date. White papers must include, at a minimum:

· Company Overview & Experience: A summary of corporate capabilities and past performance in executing FDA-compliant medical device programs.

· Technical Solution: A description of the proposed autoinjector prototype or existing commercially available design, detailing the specific design elements that enable formulation-agnostic delivery (single chamber or dual chamber liquid-liquid, dual chamber solid-liquid reconstitution).

· Regulatory Pathway: A brief strategy outlining the planned FDA approval/clearance pathway for the combination product.

· Manufacturing Strategy: Overview of capabilities for producing the platform under strict cGMP environments and flexibility for incorporation of other medical countermeasures.

· Commercial Business Case Strategy: A comprehensive market viability plan outlining production scalability, unit cost economics, intellectual property management, and dual-use commercialization pathways to ensure long-term consistent utilization beyond Government procurement.

Desired Characteristics:

The Department of War (DoW) CPE CBRND, JPM CBRN Medical seek responses from private or public entities (academic, non-profit, and commercial organizations). Responses must detail a comprehensive product development plan, complete with scheduled milestones, to develop and deliver a formulation-agnostic autoinjector device platform.

Autoinjector Device Platform Performance:

· Ruggedization: Autoinjector design that complies with Military Standard (MIL-STD-810H) or is capable of being ruggedized to meet MIL-STD-810H.

· Shelf-Life: The product must achieve an initial controlled room temperature shelf-life of two (2) years (Threshold) and five (5) years (Objective).

Manufacturing:

· Reliability: The device must meet FDA reliability requirements of 99.999%. The Government highly recommends leveraging design-outcome predictive frameworks to systematically mitigate clinical risks, ensure continuous operational safety, and provide robust statistical validation throughout the product's entire lifecycle.

· Formulation Flexibility: Delivery may employ various mechanisms, including but not limited to dry (e.g., lyophilized or spray-dried powder), liquid only, liquid combinations, or co-formulated liquid/dry constituents.

· Delivered volume: Capable of delivering a minimum volume of 0.4 mL and a maximum volume of 2.0 mL (Threshold) up to 5.0 mL (Objective). With a potential broad range of fluid viscosities.

· Reconstitution: Devices featuring reconstitution capabilities must rapidly and fully reconstitute the drug prior to/during administration without requiring additional user steps (e.g., shaking).

· Delivery Mechanism: The prototype must deliver via the intramuscular (IM) route, which requires penetration through Mission Oriented Protective Posture (MOPP) and Army Combat Uniform (ACU).

Ergonomics & Safety:

· Tactile Differentiation: Must be able to identify the device by touch, easily distinguishing it from other fielded or developmental military-use autoinjectors.

· Ease of Use: The operation must allow self-administration during periods of reduced visibility and dexterity while minimizing the risk of inadvertent deployment.

RFI Response Instructions:

Respondents must address the following elements in their submission. The total response must not exceed a maximum of ten (10) pages.

1) Company Description, Background, and Data Rights (Two (2) page maximum)

· Company Profile: Describe the company’s history, strategic alliances, and funding structure, placing specific emphasis on relevant experience in medical device manufacturing.

· Regulatory Experience: Detail prior experience successfully navigating products through the FDA approval process or clearly demonstrate the capability or partnership strategy to act as the primary regulatory sponsor for this effort.

· Intellectual Property (IP): Outline any anticipated data rights assertions or restrictions related to autoinjector development. This must include discussions on freedom to operate, patent application statuses, and any issued or licensed IP.

2) Technology and Manufacturing Capability Description (Eight (8) page maximum) (Note: The Government welcomes innovative approaches that address the overarching program goals, even if they deviate slightly from the precise desired characteristics listed.)

Please provide the following information for ALL proposed configuration options:

· Formulation & Delivery Strategy: Detail the approach for formulation and delivery single drug, single chamber, dual drug, dual chamber, or any combination thereof. This must include a description of any reconstitution technology or the co-formulation of drug components.

· Performance Objectives Alignment: Describe how the proposed technology meets the capabilities outlined in the Desired Characteristics section above.

· Design Methodology: Identify and describe the specific design frameworks and methods that will be utilized during this effort.

· Technology Maturity: Discuss the current maturity of the proposed approach, including any previously demonstrated use-cases and relevant prior exposure to the FDA regulatory process.

· Development Schedule: Provide a high-level schedule detailing the path through initial 24-month technical development phase and ultimate FDA approval.

· Cost Estimate: Provide a Rough Order of Magnitude (ROM) cost estimate for proposed strategy and approach through FDA approval.

Administrative:

The Government will retain all comments and information received in response to this RFI. Respondents must clearly mark any proprietary information as "Company Proprietary." Do not apply Government security classification markings to any submission.

Submit all written responses via email no later than 1600 EST on 07 August 2026. Email submissions must be sent to ALL of the following recipients:

· Dr. Roberto Rebeil – roberto.rebeil.civ@army.mil

· Dr. Mary Addison – mary.m.addison2.civ@army.mil

· Dr. Jill A. Harvilchuck – jill.a.harvilchuck.ctr@army.mil

Do not submit material that is strictly promotional or advertising in nature.

Submission Formatting:

Emails must use the following Subject Line format: "[Responding Organization Name] - [RFI Title]".

Questions:

For any questions related to this RFI, please email: Ms. Imani Daiyaan, Imani.s.daiyaan.civ@army.mil