Request for Information - Spencer Shunt

General Introduction: This announcement constitutes a Request for Information (RFI) only. Air Force Life Cycle Management Center (AFLCMC) Human Systems Program Office (AFLCMC/WNU) is conducting market research to identify potential sources and companies that may possess the expertise, capabilities, and experience to respond to the requirements listed in this document. AFLCMC/WNU is issuing this RFI to explore the cost-effective options to provide this capability and obtain valuable feedback in regard to the requirements for development and production of the Spencer Shunt (Vascular Shunt - Patent US 8,251,943 B1) listed within this RFI. This RFI is issued solely for information and planning purposes and may be considered to determine the acquisition strategies as well as potential future solicitations. This announcement is not to be construed as a formal solicitation. AFLCMC/WNU is not seeking proposals at this time and will not accept unsolicited proposals. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. Respondents are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI. Please be advised that all submissions become Government property and will not be returned. All costs associated with responding to this RFI will be solely at the responding party's expense. Vendors may be contacted if additional information is needed to fully understand the marketplace and/or comments to the requirements presented below. Purpose: The purpose of this RFI is to gather information on the current state and availability of vendors capable of developing and producing the Spencer Shunt. The device may prove to be pivotal in addressing injury patterns identified in recent battle campaigns. In such a time critical situation, the shunt has proven to save limbs and lives. Spencer Shunt Requirements: The Government is requesting feedback on the requirements contained below and gain an understanding of the capabilities of vendors to manufacture the Spencer Shunt. Interested parties are asked to review the attached patent, Attachment 1, and respond to this announcement by using the Excel document entitled RFI Respondent Spreadsheet, Attachment 2. RFI Vendor requirements for the Spencer Shunt are the following: Vendors must be, or can achieve, Food and Drug Administration (FDA) clearance as a registered device manufacturer. The Spencer Shunt is a Class II temporary implantable medical device which will require pre-market approval by the FDA prior to human use. The vendor-manufactured Spencer Shunt must be able to maintain patency. The vendor-manufactured Spencer Shunt must be easily inserted and secured with hemostatic junctions. The vendor-manufactured Spencer Shunt must support distal perfusion. Vendors are being requested to provide [1] a Spencer Shunt unit cost estimate; [2] an estimated extended cost estimate required to manufacture 2,000 Spencer Shunts; and [3] a rough estimate of the time (in months) required from project initiation through the first deliveries of the Spencer Shunts. RFI Responses: Submittals shall provide information describing the respondent's capabilities in all required elements defined above using Attachment 2, RFI Respondent Spreadsheet, and any other supplemental documentation/narratives. 1. Provide your Request for Information responses to david.bathgate@us.af.mil by 9:00am EST on 12 Nov 2020. Title e-mail responses in the subject line of the e-mail as follows: - Response to Spencer Shunt Request for Information # WNUK-21-001. 2. Please limit your responses to no more than 10 pages, to include supporting information as related the requirements. 3. Respondents should indicate which portions of their responses are proprietary and mark accordingly.