Request for Information for Endodontic Kit

REQUEST FOR INFORMATION (RFI) Endodontic Kit THIS IS NOT A REQUEST FOR PROPOSALS, NOR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NO CONTRACT WILL BE AWARDED PERSUANT TO THIS ANNOUNCEMENT. SUBJECT: The U.S. Army Medical Materiel Agency (USAMMA) is conducting market research for a supplier to configure a Deployable Endodontic System. Any vendor questions regarding this RFI are requested by 5:00 pm EST on 20 December 2018 to allow sufficient time for USAMMA to respond. Vendor responses to this RFI are due by 5:00 pm EST on 17 January 2019. DISCLAIMER: This RFI is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Any information provided in response to this RFI will be considered and treated as unrestricted information which can be used by the Government in any future planning or acquisitions. USAMMA does not anticipate awarding or modifying a contract in response to this RFI. All information comments and suggestions determined to be beneficial to USAMMA may be incorporated into future acquisition documents or contracts, without identifying the source or obtaining prior approval from the source. The Government shall not be responsible or liable for any costs incurred by any party in the preparation and submission of any response to this RFI. All information received in response to this RFI marked as "proprietary" will be handled accordingly. Information provided in response to this RFI will not be returned. USAMMA does not guarantee that any resultant acquisition action will result from this RFI. BACKGROUND: General Dentist trained in the last decade represent the bulk of the Army Dental Corp. The vast majority of these dentist have been trained to complete root canal therapy almost exclusively using rotary instrumentation. This is a departure from the way endodontics was taught a 15-20 years ago. New technology allows for rotary endodontic capability to be packaged in a light and easily transportable package. It is now possible to provide deployed dentist with a compact endodontic kit that possesses a high level of capability. Today, in the combat theatre, the Army Dental Corps has the capability to save soldiers teeth in a forward environment, where traumatic dental injuries and the need for endodontic care is common. Without the proper equipment, the current option for deployed dentists is to extract easily repairable teeth. Not only is this not optimal patient care, but adds significant post deployment cost upon returning home with the expense of prosthodontic rehabilitation. Providing deployed dentist with a compact endodontic system will enhance their theatre capabilities and allow them to provide significantly improved endodontic treatment using minimal amount of equipment and material, and reducing the overall dental care cost per soldiers. This RFI is an invitation to submit to USAMMA the following: Technical information and all related supporting documentation for a deployable endodontic system and associated components and accessories. Please provide detailed responses submitted on the Vendor Response excel spreadsheet (attached). Responses must be straightforward, clear, concise, and specific to the information requested. Vendors must provide the applicable page numbers in the supporting technical literature and additional options/features/items. Requested Essential Characteristics/Information Please submit, on the attached Vendor Response Spreadsheet, detailed responses addressing the below listed characteristics/information concerning the configured system as well as providing supporting technical literature and additional options/features/items. Responses must be clear, concise, and specific to the characteristic/information. To facilitate review, please reference applicable document and specific page/paragraph numbers for the specific characteristics/information. For a detailed explanation of the Integrated Product Support Essential Characteristics, vendors can go to the Defense Acquisition University website at https://www.dau.mil/acquipedia/Pages/ArticleDetails.aspx?aid=c9b84a4f-b25b-4315-8a66-8bd6c37f6ddd. 1. Durable and Expendable Items The deployable endodontic system shall contain the items outlined below. These durable items are essential and must be included in the configured system for the system to be considered acceptable. Durable Items Description Portable cordless endodontic rotary motor. (one motor) The system shall be powered by a rechargeable battery and capable of continuous rotation (T) and additional reciprocation function capability (O) Portable compact cordless battery powered Heat Carrier gutta percha condensation device. (one device) Device shall have a rechargeable battery, pen like shape with corresponding tip sizes .06, .08, and .10 taper (3 of each). (T=O) Apex locator that has the capability to measure in both wet and dry canal conditions with accuracy. (one apex locator) Shall be compact size, with LCD display screen with a clear, progressive display and high contrast. (T=O) Expendable Items Description Endodontic Rotary Files Quantity: Tip Size: Taper: Length: Purpose: 10 .20 .06 or variable 21 or 25mm Orifice Shaper 5 .17 .04 or variable 25mm Tight canals 10 .25 .04 or variable 25mm Small apical size 15 .30 .04 or variable 25mm Primary canals 10 .35-.40 .04 or variable 25mm Medium-Large Canals 5 .45 .04 or variable 25mm Large Canals Shall be Heat Treated Nickel Titanium with controlled memory, allowing for optimal pre-bending and flexibility. Tight flute structure and cross-section that provides higher resistance to fatigue and deformation. Non-cutting safety tip. File systems shall have matching sizes of gutta percha and absorbent paper points that correspond to the final file sizes greater than 25. Gutta percha and paper points should come with a wheel type organizer for greater accessibility. (T) and files should ideally be from the same manufacturer and capable of instrumenting canals with the least number of files possible and manufacturer recommended endodontic sealer. (O) K type files: Quantity: Tip Size: Taper: Length 15 .08 ISO .02 25mm 15 .10 ISO .02 25mm 15 .15 ISO .02 25mm 15 .20 ISO .02 25mm Surgical instruments used by dentists when performing root canal treatment. These tools are used to clean and shape the root canal, with the concept being to perform complete chemomechanical debridement of the root canal to the length of the apical foramen. Preparing the canal in this way facilitates the chemical disinfection to a satisfactory length but also provides a shape conducive to obturation (filling of the canal). 2. Integrated Logistics Support (ILS) Elements These are areas of desired support including logistics, maintenance, training, parts, and others which allow for the sustainment of the system during storage, transport, and use. They allow for technical trade space and assist in best value determination. If these areas of support are met, they will be rated as strengths and if unavailable as weaknesses. ILS Element- Supply Support Definition Accessories and Consumables Support Vendor shall provide a full listing of consumables, expendables and all items packaged in the transport case. The list shall contain all part numbers. Configuration Part Number Vendors shall provide a single overarching part number for the system configuration so that the deployable endodontic system can be purchased as a whole with one part number. This part number must be maintained for a span of at least 10 years. (T) Ideally, this system will be placed on a procurement contract allowing for rapid purchase. Obsolescence The vendor shall notify the USAMMA and DLA that their system and/or parts are coming to the end of useful life, or that they are no longer available for procurement within 12 months of such date. System shall be supportable for a minimum of 10 years. Parts and Supplies Request Vendor shall allow DoD personnel, including maintenance and logistics, to contact manufacturer to request information, verify data, and order accessories, consumables, and spare parts as required to support the system throughout the useful life of the system. ILS Element - Package, Handling, Storage, Transportation Definition Transport Complete Deployable endodontic system, to include all parts and accessories, shall be packaged in a single hardened transport case. System Packaging The transport cases shall meet the appropriate handle and lifting requirements for the weight and cube of the proposed system, IAW MIL-STD-1472G. (O) Organized for immediate use and continuous storage (i.e. slots for individual items, closed cell foam inserts). Transport Case Labeling Each case shall have a permanent marked data plate with the following information: National Stock Number, Item Unique Identification (IUID), IAW DFARS 252.211-7003, Item Unique Identification and Valuation (MAR 2016), System Nomenclature, and Manufacturer Name. Loose Cargo Transportation The system shall be fully operational after being subjected to the shock and vibration encountered during military transport operation. This test will be conducted IAW MIL-STD-810G, Method 514.6 on the device in its packaged shipping container. RFI Response: Please complete the attached response spreadsheet with indicated information for Deployable Endodontic System, with specific, clear and concise answers, and provide a narrative response to the following (if applicable to the proposed system): Does the vendor have upgraded technology for this type of equipment that may be of interest to the Government? If so, provide detailed technical literature outlining this upgraded technology. Does the vendor currently have potential upgradeability of the system (as technology matures)? Include a discussion of upcoming new products and/or feature's over the next 12 months. What is the manufacturing lead time for the system, and how many systems can be produced and delivered yearly? Discuss any considerations or trade-offs the Government should consider including issues with the draft requirement above or any additional information that the Government should be aware of. Include any applicable product brochures, operating, and service manuals, technical specifications, videos, and maintenance information for the Deployable Endodontic System. Include any applicable Reliability, Availability, and Maintainability (RAM) characteristics/life cycle data for the system (historical information on parameters such as mean-time-between-failures, mean-time-to-repair, etc.) Address availability of spare parts from vendor including manufacturing sub-contractors and the company's global distribution partners/centers. Address the willingness of vendor to provide spare parts, accessories and consumables under any procurement to include availability to purchase using a DLA automated ordering system (i.e. ECAT). This should include discussion of the life of the product itself along with support after product is no longer sold in the commercial market. The Government may request vendor presentation and product demonstrations as part of this RFI at no cost to the Government. Please describe the kind of product presentation or actual product demonstration that could be provided in conjunction with this RFI. Include whether there is an actual system available for possible product demo. RESPONSE INFORMATION: Response to this RFI must be submitted via email to Erica Smith at Erica.k.smith5.civ@mail.mil and Casey Gilbertz at Johanna.gilbertz.civ@mail.mil. E-mail responses should be no larger than 5 megabytes (MB) in size. Responses should not be uploaded to the FedBizOpps posting. Each RFI response will receive a confirmation e-mail. Please include a point of contact, phone number, e-mail address, and website information. Vendor questions regarding this RFI are due by 5:00 pm EST on 20 December 2018. Vendor responses to this RFI are due by 5:00 pm EST on 17 January 2019. If larger attachments are required, additional methods to submit responses include: Sending documents separately due to size restrictions as long as each e-mail indicates how many total emails are being sent.