6515--cochlear Implant Recompete

DEAPARTMENT OF VETERAN AFFAIRS REQUEST FOR INFORMATION This is a SOURCES SOUGHT NOTICE / REQUEST FOR INFORMATION (RFI); not a pre-solicitation notice or solicitation for proposals/quotations. This RFI is being issued as a means of conducting market research to identify parties that have an interest in and the resources to support this requirement. Responses to the information requested will assist the Government in determining the appropriate acquisition method. The Department of Veterans Affairs (VA) Denver Logistic Center (DLC) and Commodities and Services Acquisition Service (CSAS), in support of the Veterans Health Administration is seeking approved Food and Drug Administration (FDA) suppliers of Cochlear Implants and associated sound processors, accessories and parts. The objective is to ensure availability and consistency of products for nationwide usage and to obtain volume-based pricing. The VA anticipates awarding two or more fixed price indefinite delivery, indefinite quantity (IDIQ) contracts for a base year, and four, one (1) year option periods to qualified manufacturers. Items will be for delivery worldwide, f.o.b destination. It is anticipated these contracts will be utilized by both VA and Department of Defense (DoD). Manufacturers must be approved by FDA to supply Cochlear Implants and all items must be commercially available. The VA anticipates the following line item requirements: Cochlear Implant System Kit, which includes a stand-alone cochlear implant and sound processor kit with two processors; Cochlear Implant Standalone; Sound Processor Kit with One Processor; Sound Processor Standalone; Accessories & Replacement Parts The anticipated minimum technical requirements are as follows: Cochlear Implant system must be FDA approved. Internal device: Internal components must be biocompatible. Stimulation rate of at least 14,400 pulses per second available on standard electrode array. At least 12 channels available in standard electrode array. Telemetry available to assess impedance of electrode array. Sound Processor. Microphone characteristics are as follows: Directional or omni-directional microphone. Minimum input frequency range of 150- 8000Hz. Input Dynamic Range of at least 70dB. Accommodate at least 3 maps. Ear level or body-worn options. Internal telecoil on at least one processor model. Wireless accessory option line. Low battery indicator. Capability of non-user to check microphone function on at least one processor model. Verification of the implant by the processor to prevent inadvertent use of wrong processor. Waterproof capability on at least one processor model. The results of this RFI will be utilized to determine if any Service-Disabled Veteran Owned Small Business/Veteran Owned Small Business (SDVOSB/VOSB) opportunities exist. However, this RFI is also being used to identify potential and eligible firms, of all sizes, prior to determining the method of acquisition and issuance of a solicitation. All Small Business, Socioeconomic contracting programs (8(a), HUBZone, WOSB) will be considered. This requirement is assigned a NAICS code of 339113, Surgical Appliance and Supplies Manufacturing. The size standard for this NAICS code is 750 employees. As a result of this RFI, the VA DLC/CSAS may conduct a competitive procurement and subsequently award a contract(s). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. INFORMATION REQUESTED AND QUESTIONS TO BE ADDRESSED: All interested parties shall submit with their response the following information name of organization, corporate address, DUNS number, point of contact name, title, phone and email, and socioeconomic category, as it relates to NAICS 339113, as well as its responses to the questions below. QUESTIONS We are requesting interested parties submit answers and/or provide responses to the following: Does your company manufacture FDA approved cochlear implant systems (internal cochlear implant and compatible sound processor) and wireless systems compatible with cochlear implant systems? - If you are in the process of receiving FDA approval for your cochlear implant system, please provide steps currently being taken and anticipated timelines for FDA approval. Please submit a copy of your commercial retail pricing for cochlear implant systems, standalone cochlear implants, sound processor upgrade kits, standalone sound processors and compatible wireless accessories. Please provide your commercial order forms for a new, initial implant kit and for sound processor upgrades. Describe your company s familiarity with using SFTP and your ability to implement this file transfer protocol What steps could you take to provide VA and Veteran specific customer service? What are your company s current and future plans regarding CI sound processor and hearing aid compatibility? What are your company s current and future plans regarding CI sound processor wireless compatibility? What remote programming options does your company currently offer &/or are in development? Please describe any CI compatible apps that your company currently offers &/or has in development. Interested parties are encouraged to submit this information electronically to Caroline West and Kristin Decker, email addresses below, or by mail to Dept. of Veterans Affairs, Denver Logistics Center (003A4D1), Attn: Caroline West, 555 Corporate Circle, Golden, CO 80401. Questions may be directed to Caroline West at contact@example.gov and Kristin Decker at contact@example.gov. Responses are due by 3:30 pm Mountain Standard Time on November 20, 2020. E-mail communication must include the company name, address, point of contact name and title, e-mail address, and telephone number. DISCLAIMER: This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. Additionally, this RFI does not obligate the Government to the issuance of a Request for Proposal. All information received in response to the RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. In accordance with FAR 15.202 (e), responses to this notice are not an offer and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.