SPECIAL NOTICE
66 -- Supplies, Bifurcated Lead Development/Materials-Research, CLE
- Notice Date
- 6/24/2022 11:55:14 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25022Q0787
- Archive Date
- 07/24/2022
- Point of Contact
- Christopher A. Callihan, Contracting Officer, Phone: 216-447-8300, Fax: NA
- E-Mail Address
-
christopher.callihan@va.gov
(christopher.callihan@va.gov)
- Awardee
- null
- Description
- The VISN 10 Network Contracting Office (NCO) 10, Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, Ohio intends to negotiate a sole source contract with Ardiem Medical, Inc. the manufacturer. This is for the acquisition of the iSens system components required by the Louis Stokes Cleveland Veterans Affairs Medical Center Research Department at 10701 East Boulevard, Cleveland, Ohio 44106-1702. The North American Industry Classification System Code (NAICS) is 334516. The Government believes that Ardiem Medical, Inc. is the only contractor that can satisfy the current requirement of the agency. Therefore, the Government intends to proceed with a sole source for the required equipment. This procurement is for: 1 EA *NRE-Bifurcated lead development (Mold design, fabrication of mold pin, design Y branch/yoke and mold. New 8ILF molding pin, fabrication of Y branch yoke mold) 1 EA *NRE-Materials (Materials to build 12 devices) 1 EA Bifurcated Lead Prototype (Salvage parts from MDT connector) 5 EA Bifurcated Lead Assembly; Distal leads 8ILM 1.3mm MDT pitch 1 EA *NRE-DFT Wire (35N LT DFT-41%Ag, PFA coating) The items are expected to be delivered within 30 days ARO / ASAP. utilizing FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). To the best of our knowledge, Ardiem Medical, Inc. is the only source that can provide the required equipment. This is to provide a new bifurcated lead development for the Dustin Tyler iSens system. Ardiem is uniquely qualified to develop this clinical grade component due to their familiarity with this type of lead as well as iSens system and regulatory requirements. These are custom-built specific to the intended human implant application, requiring specialized manufacturing techniques already approved by the FDA for the Tyler study. Any other company not knowledgeable in the specific techniques needed to produce these components would require extensive upfront development NRE, significant time to engage, and extensive costs to obtain FDA approval. The Government s technical experts conducted market research by reviewing the market and querying the manufacturer of the existing solution. This market research is an ongoing process and continuously being conducted, as recently as June 2022. Based on continued market research, the Government s technical experts determined that fitment and function requirements limit the requirement to the system described above. The VA Subject Matter Experts regularly review industry trade publications and conduct internet research to ascertain if any other solutions are available. Based on all of these market research efforts, the Government s technical experts have determined that only the Ardiem Medical, Inc. can meet all of VA s needs. This notice of intent is not a request for competitive quotes. No solicitation document is available; however, any firm that believes it can meet these requirements may give written notification to the Contracting Officer within five (5) business days from the date of publication of this synopsis. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirements. Information can be sent to the Contracting Officer via email at christopher.callihan@va.gov. Responses received will be evaluated however a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, on or before COB July 01, 2022, the VA will proceed with the sole source award to Ardiem Medical, Inc. for the Louis Stokes Cleveland VA Medical Center. THIS SYNOPSIS DOES NOT COMMIT THE GOVERNMENT TO CONTRACT FOR ANY SUPPLY OR SERVICE. THE GOVERNMENT WILL NOT PAY FOR ANY INFORMATION OR ADMINISTRATIVE COSTS INCURRED IN RESPONSE TO THIS SYNOPSIS.
- Web Link
-
SAM.gov Permalink
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- Record
- SN06368288-F 20220626/220624230056 (samdaily.us)
- Source
-
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