MTEC #MTEC-26-02-Ventilator

Development of Autonomous Closed Loop Control Mechanical Ventilator (ACLCMV) System for Military Use

This opportunity seeks innovative solutions for next-generation military medical technology: - Government Buyer: - Department of Defense - Defense Health Agency (DHA) - U.S. Army Medical Research and Development Command (USAMRDC) - Medical Technology Enterprise Consortium (MTEC) - Project Scope: - Design, develop, and demonstrate an Autonomous Closed Loop Control Mechanical Ventilator (ACLCMV) system - Focus on core Physiological Closed-Loop Control (PCLC) algorithm development and hardware architecture definition - Prepare and submit an Investigational Device Exemption (IDE) application for FDA review - Emphasis on maturing the ventilator design for use in austere and prolonged-care military environments - Requirements: - Offerors must be FDA-registered medical device companies with in-house ventilator manufacturing capabilities - Project duration is up to 12 months with a firm fixed price award - Total funding available is up to $1.9 million - Products/Services Requested: - No specific OEMs, part numbers, or commercial ventilator models are named; the solicitation is for R&D and demonstration of a new system - Unique/Notable Requirements: - Focus on autonomous, closed-loop control to reduce manual intervention and enhance patient safety - Deliverables include algorithm development, system design, testing, and FDA IDE application - Potential for non-competitive follow-on work based on project success

Description

This solicitation is a Request for Project Proposals (RPP) issued by the Medical Technology Enterprise Consortium (MTEC) in support of the Defense Health Agency (DHA) and the Department of the Air Force. The project aims to reduce technical risk associated with the ACLCMV system by focusing on the design, development, and demonstration of core Physiological Closed-Loop Control (PCLC) algorithms and defining the system's hardware architecture. The one-year effort will demonstrate the feasibility of the autonomous control concept and mature the system design to support a follow-on Engineering & Manufacturing Development contract. The project targets the development of a next-generation mechanical ventilator for austere and prolonged-care environments, emphasizing autonomous adjustments to ventilation settings to minimize manual intervention.

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