MTEC Pre-Announcement: Autonomous Closed Loop Control Mechanical Ventilation (ACLCMV)

Description

The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) in support of the Department of the Air Force. This effort focuses on the development of an autonomous closed loop control (ACLC) mechanical ventilator (MV). This device is expected to use advanced algorithms to automatically adjust ventilation settings for closed loop Positive End Expiratory Pressure (PEEP) based on the patient's physiological responses, minimizing the need for manual intervention. The goal is to create a lightweight, durable, and power-efficient ventilator that enhances patient safety and frees up medical personnel for other critical tasks during aeromedical evacuation and prolonged field care scenarios. ____________________________________________________________________________________ Background: The Department of the Air Force requires a next-generation mechanical ventilator to support casualties in austere, resource-limited, and prolonged-care environments. Current ventilators require frequent, manual adjustments by highly trained medical personnel, a demand that is unsustainable during en-route care or when managing multiple patients. The purpose of this effort is to reduce the technical risk associated with the ACLC/MV system by focusing on the design, development, and demonstration of the core Physiological Closed-Loop Control (PCLC) algorithms and the definition of the system�s hardware architecture. A PCLC algorithm is essentially a �smart autopilot� for patient care, continuously adjusting treatment based on real-time physiology to keep patients stable. This one-year project will demonstrate the feasibility of the autonomous control concept and mature the system design to a level sufficient to support activities related to milestone B (Engineering & Manufacturing Development (EMD)). Technical Objective: This upcoming RPP focuses on the research, design, development, and testing of a ACLC/MV over a 12-month period. Proposed solutions should focus on both of the following: PCLC Algorithm: Develop and demonstrate a PCLC software algorithm capable of receiving physiological inputs and making autonomous adjustments to ventilator settings. System Architecture and Hardware Definition: Define the hardware architecture, including the assessment of candidate components and interfaces necessary to meet the environmental and performance requirements of military operations. This effort will result in a system demonstration(s) and review(s), providing the Government with the technical data needed to validate the proposed solution, culminating in a Go/No-Go decision point for follow-on funding. Additional details on the technical requirements and objectives are expected to be provided in the upcoming RPP. Potential Funding Availability and Period of Performance: The USG expects to make one award to a qualified Offeror for a period of performance not to exceed 12 months. Acquisition Approach: This upcoming RPP is expected to utilize the Enhanced White Paper approach. In Stage 1, current MTEC members are invited to submit Enhanced White Papers using the mandatory format contained in the upcoming RPP. The Government will evaluate Enhanced White Papers submitted and will select those that best meet their current technology priorities using the criteria in the upcoming RPP. Offerors whose proposed solution is selected for further consideration based on the Enhanced White Paper evaluation will be invited to submit a full cost proposal in Stage 2 (and may be required to submit additional documentation or supplemental information). Notification letters will contain specific Stage 2 proposal submission requirements. The upcoming RPP will be posted to the MTEC website (mtec-sc.org) and a summary version will be available on SAM.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a proposal preparation period of approximately 30 days. MTEC membership is required for the submission of a proposal in response to the upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/. MTEC: The MTEC mission is to assist the Department of Defense (DoD) U.S. Army Medical Research and Development Command (USAMRDC), the Defense Health Agency (DHA), and other Government agencies by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters� health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the Defense Health Agency Contracting Activity (DHACA). For more information on the MTEC mission, see the MTEC website at mtec-sc.org. Point of Contact: For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Chuck Hutti, MTEC Senior Technical Program Manager, chuck.hutti@mtec-sc.org.