Delfi Tourniquet system for BFR

SOURCES SOUGHT SYNOPSIS THIS IS A Sources Sought Notice ONLY. The U.S. Government currently anticipates to award a contract for four (4) Delfi Personalized Tourniquet Systems (PTS) for Blood Flow Restriction (BFR) on an SOLE SOURCE basis, but is seeking vendors that may be able to perform this requirement in order to support a competitive procurement. Accordingly, the U.S. Government highly encourages all interested businesses (large and small) to respond to this sources sought synopsis. In addition, small businesses, in all socioeconomic categories (including, 8(a) Business Development Program, Small Disadvantage Business, Historically Underutilized Business Zone, Service-Disabled Veteran-Owned, Women-Owned Small Business concerns), must describe their identifying capabilities in meeting the requirements at a fair market price, i.e., information which may help support a set-aside. The proposed sole source is for a firm-fixed type contract to Owens Recovery Science for four (4) Delfi Personalized Tourniquet Systems (PTS) for Blood Flow Restriction (BFR) systems with equipment/components that will tie into Fort Campbell current unit's THOR3 Human Performance Training Center (HPTC) and Physical Therapy (PT) clinic. The equipment below is what is being requested. See below requirement. The following characteristics are required of the Blood Flow Restriction (BFR) Tourniquet System purchased for the THOR3 program. The size restrictions are to allow this system to be incorporated with current rehabilitation equipment and be available for OCONUS use if necessary. 4- DELFI Personalized Tourniquet System-BFU units 4.7"W x 70"H x 3"L Must have cuff pressure range of 50-350mmHg. Must have a pressure that is adjustable in 1mmHg increments, automatically regulated to within +/- 10mmHg of the selected pressure. Must have a BFR pressure application timer of 1-30 minutes, adjustable in 1 minute increments. Must possess Reperfusion timer for BFR of 1-10 minutes, adjustable in 1 minute increments. Must Inflation speed capable of inflating typical thigh cuff within 5 seconds. Must possess safety alarms with audio and visual alarms to warn of cuff over and under pressurization. Must be capable of operating with personalized pressure settings using limb occlusion pressure (LOP) technology that allows patient specific limb occlusion pressure to be measured and automatically calculates the patient's personalized tourniquet pressure as a percentage of the LOP. Must have advanced pressure regulation that maintains cuff pressure near selected tourniquet pressure during limb movements. Must possess integrated tourniquet cuff testing capable of testing cuffs, tubes, and connectors for leaks before or after use. Tourniquet system must be listed with the FDA as class I medical device and be specifically indicated for BFR use as such. Must possess a battery back-up with up to 3 hours of operation capabilities on back-up. Must possess a BFR system must not be larger than 8" x 6" x 6" and must not weight more than 40 ounces. Each unit must consist of a minimum of one (1) personalized tourniquet system for BFR with 3 pressure cuffs of 18", 24", and 34" for use on different size limbs with all tubing and connections required for operation. The statutory authority for the sole source procurement is statutory authority, 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii), (Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements). This notice does not constitute a Request for Quote (RFQ)/Invitation for Bid (IFB)/Request for Proposal (RFP) or a promise to issue an RFQ, IFB or RFP in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, bids or proposals at this time and will not accept unsolicited proposals in response to this sources sought notice. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. However, if a competitive solicitation is released, it will be synopsized on the Government wide Point of Entry. It is the responsibility of potential offerors to monitor the Government wide Point of Entry for additional information pertaining to this requirement. The anticipated NAICS code(s) is/are: 339112-Surgical and Medical Instrument Manufacturing Small Business Size Standard is 1,000. In response to this sources sought, please provide: 1. Identify any condition or action that may be having the effect of unnecessarily restricting competition with respect to this acquisition and identify alternatives or solution solutions. Also contact the MICC-HQ Small Business Programs and Advocate for Competition, Rosa Elmore, at rosa.p.elmore.civ@mail.mil at (270)798-7812, if you believe that this action is unreasonably restricting competition. Include the subject of the acquisition, this announcement, and the MICC POC information from the Sources Sought Synopsis. Provide the specific aspects that unreasonably restrict competition and the rationale for such conclusion. 2. Name of the firm, point of contact, phone number, email address, DUNS number, CAGE code, identify business size (large business or a small business), and if applicable, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. 3. Identify whether your firm is interested in competing for this requirement as a prime contractor or not. Identify subcontracting, joint ventures or teaming arrangement that will be pursued, if any. 4. Information in sufficient detail regarding previous experience (indicate whether as a prime contractor or subcontractor) on similar requirements (include size, scope, complexity, timeframe, government or commercial), pertinent certifications, etc., that will facilitate making a capability determination. 5. Information to help determine if the requirement (item or service) is commercially available, including pricing information, basis for the pricing information (e.g., market pricing, catalog pricing), delivery schedules, customary terms and conditions, warranties, etc. 6. Identify how the Army can best structure these contract requirements to facilitate competition, including competition among small business concerns.