Inactive

Aeromedical Transport Litter Immobilization and Stabilization (ATLIS) Request for Information This announcement represents a Request for Information (RFI) by the Humans Systems Division/Aeromedical Br... Aeromedical Transport Litter Immobilization and Stabilization (ATLIS) Request for Information This announcement represents a Request for Information (RFI) by the Humans Systems Division/Aeromedical Branch, WPAFB, OH to determine potential sources for the ATLIS with extensive leveraging of commercial off-the-shelf components to improve patient transportability from the point of injury (POI) in the En Route Care (ERC) environment to definitive care locations. The USAF Air Mobility Command Surgeon’s Modernization Division (AMC/SGR) is investigating a replacement for the two existing devices which include the Stryker Wedge Turning Frame (SWTF) and the Vacuum Spine Board (VSB). The litter upgrade will significantly improve the ability to move critical patients with spinal cord injuries & pelvic fractures, enhance skin integrity during transport, and provide flexible options to medical personnel without severe weight limitations and space liabilities for ground or air movement. PURPOSE: This notice is part of USG Market Research, a process for obtaining the latest information on the ‘art of possible’ from industry with respect to their current and near-term abilities. All company proprietary information contained in the response shall be separately marked and properly protected from unauthorized disclosure. The USG will not use proprietary information submitted from any one firm to establish the capability and requirements for any future systems acquisition so as to not inadvertently restrict competition. THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This request for information does not commit the Government to contract for any supply or service whatsoever. Further, the Air Force is not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised that the USG will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it will be synopsized on https://SAM.gov under Contract Opportunities. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement. OBJECTIVES: The objectives of this RFI are to identify responsible sources and interested parties who have proven solutions that can meet requirements. For the purpose of this RFI, the term “proven” means solutions at a Technology Readiness Level (TRL) of 8/9 in accordance with the Technology Readiness Assessment Guide dated February 2020. Please provide justification for hardware TRL that your company claims. BACKGROUND: The two devices currently being utilized in the field: Stryker Wedge Turning Frame (SWTF) and the Vacuum Spine Board (VSB) are no longer being supported by the manufacturer or have notable shortfalls. Therefore, the AMC/SGR has identified a need for an improved ATLIS for use in transporting critical patients through AE. The device must be able to adequately immobilize the spine in critically injured patients, be easily applied at field hospitals (level 2 or 3 roles of care) and be capable of moving with the patient through patient staging and AE platforms. Provide flexible options to medics without severe weight limitations and space liabilities for ground or air movement. Consideration should be made for preventing skin breakdown on patients immobilized by the device for long flights. AMC/SGR prefers commercial off-the-shelf (COTS), government off-the-shelf (GOTS), or foreign off-the-shelf and research and development (R&D) options that fulfill the capabilities outlined below. REQUIREMENTS: The response should describe the company’s capability to offer, field, and sustain the device as characterized by the requirements addressed in this RFI. If unable to provide a device capable of meeting all requirements, the respondent should offer trade-off considerations. The requirements below are mandatory key performance parameters the spinal immobilization transport device must meet. Device must be able to meet the safe-to-fly (JECETS) criteria for all commonly used fixed and rotary wing aircraft used for ERC Device must have U.S Food and Drug Administration (FDA) Class I Registration (including exemptions) Must be able to provide cervical/thoracic/lumbar/sacral spinal immobilization These Key Performance Parameters and other key system attributes are listed in Form #1. RFI RESPONSE Form 1: RFI Response Form Company: Product: POC: Email: Phone: Address: Requirement Meets Requirement (Y/N) Comments/Details (Mandatory) Must be able to provide cervical, thoracic, lumbar, and sacral spinal immobilization Capable of passing air-worthiness testing IAW with JECETS Device must be “approved for market” (PMA), “cleared to market” (510k), or “legally marketed” (as defined in the Code of Federal Regulations - 21 CFR807.92(a)(3) for class I and II devices) Device must provide mechanism to be secured to the floor of identified DoD aircraft commonly used for medical missions. See figure 1, 2 below and 3 below. Device must not cause additional heat or cold stress to the patient Must be manually operated Patients may remain on device for long periods of time so significant consideration for prevention of pressure ulcers must be made Reusable, easily cleaned to meet standard infection control guidance as prescribed by CDC and AF guidance Must provide a platform to accommodate patient medical equipment during all phases of device use Must be able to support patients from 75 lbs to 400 lbs (Total weight 400 lbs., to include equipment) Man-portable Can elevate head at 30 degrees while maintaining spinal immobilization Must be easily assembled without the use of tools Must minimize vibration Must be compatible with existing AE aircraft without aircraft modification Must be compatible with standard ground patient movement vehicles Must be serviceable far forward in limited austere environments Must not require proprietary tools for repair Must be packaged and easily palletized for non-patient care related shipping Product should be compatible with SMEED adapter Figure 1: C-17 Two Litters Figure 2: KC-135 Two Litters Figure 3: AC-130 One Litter Any proposed solution must meet all Operational, Safety, Suitability and Effectiveness (OSS&E) requirements mandated by the Department of Defense. Must pass safe-to-fly criteria for all commonly used fixed and rotary wing aircraft used for ERC and obtain Air Worthiness Certification. INSTRUCTIONS TO RESPONDENTS Interested parties should provide capabilities, qualification statements, and complete Form #1 to demonstrate their ability to satisfy the requirements detailed in the REQUIREMENTS paragraph of this announcement. Companies or parties are to submit responses in Adobe Acrobat compatible electronic format. The maximum page limit for responses is 30 pages, 8.5” x 11”, including attachments, figures, and/or drawings, and no smaller than size 12 font. Responses must include: Company Name, Address, CAGE Code, Industry Point of Contact (POC) for technical and contractual issues to include name, position, telephone number, and e-mail address Complete Description of the Device Overall capabilities of the device as compared against the REQUIREMENTS section of this announcement Hardware TRL maturity levels along with justification (see attachment of Technology Readiness Assessment Guide dated February 2020) Reponses to this RFI must be submitted no later than 3 Feb 2024 and shall be transmitted electronically to Mr. James D. Connell IV james.connell@us.af.mil and Ms. Stephanie Haveron stephanie.haveron@us.af.mil DISCUSSIONS One-on-one information gathering sessions with respondents are currently not contemplated. The USG may elect to conduct one-on-one discussions with industry based on its analysis of the RFI responses, the quality of submission and the specifications in the information provided. The USG is under no obligation to conduct these sessions. The USG does not commit to providing a response to any comment or questions. Any revision to this RFI based on comments received remains solely at the USG’s discretion. These initiatives may ultimately result in the USG developing and issuing an RFP for respondents. The above information is for sources sought only. SPECIAL NOTICE Respondent’s attention is directed to the fact that contractor consultants and advisors to the USG will review and provide support during review and evaluation of submittals. When appropriate, non-government advisors may be used to objectively review a particular functional area and provide comments and recommendations to the USG. All advisors shall comply with procurement integrity laws and shall sign Non-Disclosure and Rules of Conduct/Conflict of Interest statements. The USG shall take into consideration requirements for avoiding conflicts of interest and ensure advisors comply with safeguarding proprietary data. Submissions in response to this RFI constitute approval to release the submittal to Government Support Contractors. Per FAR 52.215-3, Request for Information or Solicitation for Planning Purposes (Oct 1997): (a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation. (b) Although “proposal” and “offeror” are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. (c) This solicitation is issued for the purpose of collecting Government Market Research, a process for obtaining the latest information on the ‘art of possible’ from industry with respect to their current and near-term abilities Contracting Office Address: AFLCMC/WNU Aeromedical Branch Attention: Mr. James D. Connell IV 1981 Monohan Way Bldg 12 WPAFB, OH 45433 Phone: 937-904-3488 Primary Point of Contact: Mr. James D. Connell IV Contracting Officer James.connell@us.af.mil Secondary Point of Contact: Ms. Chloë Voisard Program Manager Chloe.voisard@us.af.mil Phone: 937-257-5900