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Spencer Shunt – Request for Information (Market Research) General Introduction: This announcement constitutes a Request for Information (RFI) only. Air Force Life Cycle Management Center (AFLCMC) Huma... Spencer Shunt – Request for Information (Market Research) 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 is not a request for competitive proposals. Respondents are advised that the Government will not pay for any information or administrative cost 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. AFLCMC/WNU is not seeking proposals at this time and will not accept unsolicited proposals. Not responding to this RFI does not preclude participation in any future solicitations/Request for Proposal (RFP), if any is issued. Large and small businesses are encouraged to provide responses to this RFI in order to assist the AFLCMC/WNU Program Office in determining potential levels of competition available in the industry, as well as helping to establish a basis for developing any subsequent subcontracting goals. Acquisition strategies are still being determined. Market research results will assist the Air Force in determining whether this requirement will be a full and open competition, a small business set-aside, a sole source acquisition, or another contracting method. If there is sufficient demonstrated interest and capability among small business contractors, then it may be determined that a small business set-aside is appropriate. A key factor in determining if an acquisition will be a small business set-aside is that two or more potential small business prime contractors must be capable of performing at least 50% of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, “Limitations on Subcontracting”. Note: The Non-manufacturer Rule exception applies to this acquisition (see FAR 19.102(f) for more details. 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. It is the responsibility of the interested parties to monitor the Beta.SAM.gov site for additional information pertaining to this RFI. Respondents are solely responsible for all expenses associated with responding to this inquiry. This announcement is not to be construed as a formal solicitation. It does not commit the Government to reply to the information received, or to later publish a solicitation, or award a contract based on this information. Companies 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. 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, conduct validation testing of the Spencer Shunt, and provide data and documentation to support an FDA 510(K) submission for the Spencer Shunt. RFI Vendor requirements for the Spencer Shunt are the following: Vendors must be Registered Device Manufacturers with the FDA. The Spencer Shunt is a Class II temporary implantable medical device which will require pre-market approval by the FDA prior to human use. Vendors must have facilities suitable for the manufacture and assembly of a temporary implantable Class II medical device. Facilities infrastructure and internal company procedures should satisfy all testing requirements for cleanliness and reduced bioburden on the Spencer Shunt. Vendors must have a quality management system compliant to 21 CFR Part 820 – Quality System Regulation and FDA current Good Manufacturing Practice (cGMP). Additionally, Quality management systems registered to ISO 13485 or ISO 9001 are highly desired. Of particular interest within the vendor’s quality management system are procedures for documentation control, material traceability, control of non-conforming materials, failure analysis and corrective action(s). Vendors must be able to manufacture the Spencer Shunt using the parameters of U.S. Patent 8,251,943 B1 (attached). Where specifically identified, design features (embodiments) and materials should be maintained. Experience extruding / molding polydimethylsiloxane (PDMS) is highly desired. Vendors are encouraged to describe recommended design changes preferably within the scope of the patent and describe manufacturing approaches to produce the Spencer Shunt. Detailed drawings are available upon request and completion of a non-disclosure agreement. Note that the patent is not currently licensed to any entity. Vendors must have the ability to coordinate validation testing for product sterilization, product validation testing per ISO 7198 – Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubular vascular grafts and vascular patches, Bioburden testing, Human Factors testing, and Shipping / Distribution testing. Testing support and direction can be provided by the 59th Medical Wing which will be the sponsor of a future FDA 510(k) submission for the Spencer Shunt. Vendors must have design and process engineering support from a minimum of one employee with a Bachelor’s degree from an ABET accredited engineering program OR an engineering degree from a non-ABET school AND a Professional Engineering (PE) license. Design engineering experience is desired to support anticipated design improvements and process engineering experience is desired to support the development and improvements to the vendor’s internal manufacturing processes and associated work instructions and inspection and test methods. Vendors must have company business process that support development, manufacturing, packaging, quality control and shipping/distribution operations. Those business process should include the ability to order materials, manage raw materials, in-process parts and finished goods inventory, the ability to manufacture, assemble, inspect, test, package, and label product, and the ability to supply finished product to designated locations. Also desired is the ability to provide after-sales adverse event reporting support for the evaluation of customer complaints as well as periodic trend analysis of customer complaints. Vendors must have the production capacity to produce approximately 2,000 Spencer Shunts during the product development period to support initial product sample approvals by the 59th Medical Wing, support process validation efforts internal to the vendor’s manufacturing operation, and support external sterilization, packaging, physical attribute and biocompatibility validation testing. Note: Product produced as part of the external sterilization validation effort may be production representative product further utilized for the product validation testing per ISO 7198 testing, the biocompatibility testing per ISO 10993, the shipping / distribution testing, human factors testing, and initial fielded product for military user inventories. Vendors are being requested to provide, as part of this market research, a rough order of magnitude (cost/price estimate) for the level of effort required to manufacture 2,000 Spencer Shunts (Patent No. US 8,251,943 B1) for initial product sample approvals and a rough estimate of the time (in months) required from project initiation through the delivery of the Spencer Shunts. RFI Responses: Submittals shall provide information describing the respondent’s capabilities in all required elements defined above. 1. Provide your Request for Information responses to david.bathgate@us.af.mil and steve.bauer.5@us.af.mil by 9:00am EST 20 Oct 2020. Title e-mail responses in the subject line of the e-mail as follows: “Response to Spencer Shunt Request for Information #WNUK-20-019.” 2. Responses shall include the following information: Company/Institute name Address Point of Contact Cage Code DUNS Number Phone Number E-mail Address Web page URL 3. All prospective contractors must be registered in the System for Award Management (SAM; https://beta.sam.gov/) database to be awarded a DoD contract. The North American Industry Classification System (NAICS) code for this requirement, if applicable to the company’s capabilities, should be included in the company’s NAICS code listing in SAM. 4. The NAICS Code for this action is 339112 size standard 1,000 employees. Based on the NAICS Code, state whether your company qualifies as a: Small Business (Yes/No) Women-Owned Small Business (Yes/No) Economically Disadvantaged Small Business Women-Owned Small Business (Yes/No) 8(a) Certified (Yes/No) Date certified: ____________________ HUB Zone Certified (Yes/No) Veteran-Owned Small Business (Yes/No) Service Disabled Veteran-Owned Small Business (Yes/No) Statement as to whether your company is domestically or foreign owned (if foreign owned, please indicate country of ownership). 5. Please limit your responses to no more than 10 pages, to include supporting information as related the questions above; and, identify a representative to support further Government inquiries and requests for clarification of the information provided, if needed. Marketing materials are considered an insufficient response to this Request for Information (market research). 6. Respondents should indicate which portions of their responses are proprietary and mark accordingly. All information received in response to this RFI that is properly marked as “proprietary” will be handled accordingly. Proprietary information must be clearly marked on the outside container and on the materials inside. The Government shall not be liable for, or suffer any consequential damages, for any proprietary information not properly identified.