Advanced Development of Next Generation Portable Ventilators

The purpose of this Request for Proposal (RFP) is to enter into a contract for domestic manufacturing to support advanced development of next generation portable ventilators with accessory components at a cost of <$2000/fully kitted unit that will advance the technology to meet the needs for an expected overwhelming number of respiratory infectious disease patients during a pandemic influenza outbreak or in an all-hazards (chemical, biological, radiological, nuclear (CBRN))event in which mass casualties may be expected. Characteristics recommended for the new technology should include the following: a basic volume flow-control; a filtration device to protect against exposure during a CBRN event; light weight battery with extended battery life exceeding the current industry standard of 4-12 hours with a rechargeable battery that is capable of recharging within 2-4 hours; flexibility to accommodate a wide patient population from neonate to adult; intuitive user interface for ease of use in a clinical setting so that inexperienced health care providers with no respiratory support training could safely and easily use the device; small, lighter weight than current portable ventilators and easily transportable to clinical sites and for storage in the Strategic National Stockpile (SNS); a closed-loop inspiratory pressure control system that can operate with minimal time and attention from staff; accommodate a universal breathing circuit and connectors; adequate shielding for radio frequency interference (RFI), electromagnetic interference (EMI), and conductive interference; software must be easily upgradeable to the state-of-the-art to extend the product life-cycle; real time monitoring of O2 saturation, CO2, and respiratory rate; stable shelf life and ease of maintenance for stockpiling and use; recognizable and operational audible and visible alarm system; and should accommodate a heat and moisture exchanger (HME) or a humidifier and a pulse oximeter. The Offeror must be able to ramp up production in an emergency to supply at least 1700 fully kitted ventilators in one month to meet a capability goal of at least 10,000 fully kitted units within 6 months. All aspects of manufacturing and distributing capabilities for the ventilator and subcomponent parts/accessories shall be compliant with FDA Quality System Regulation requirements and must meet all applicable American Society for Testing and Materials (ASTM) and American National Standards Institute (ANSI) standards for ventilators. The outcome of the contract is to develop a domestically manufactured next generation portable ventilator that has FDA premarket clearance. The anticipated period of performance will be two years or 24 months. Additional details and requirements will be described in the solicitation. RFP-HHS-BARDA-08-20 will be available electronically through FedBizOpps on or about December 12, 2008. Proposals will be due a minimum of 45 days after RFP issuance. Any responsible Offeror may submit a proposal that will be considered by the U.S. Government (USG). This notice does not commit the USG to the award of a contract. Only written or email requests directly from the requestor for this solicitation will be accepted. No collect calls will be accepted. No facsimile transmissions will be accepted. See U.S. Government - Wide Numbered Note 26. All responses to this notice shall be identified with RFP-HHS-BARDA-08-20, name of the firm, name of requestor, mailing address, telephone number, FAX number and email address and should be submitted to the Contracting Office address identified in this notice. Multiple awards may result from this solicitation with an estimated award date of May 2009. This requirement will be full and open competition for both large and small businesses. Small businesses are encouraged to respond.