SOLICITATION NOTICE
R -- MRI-Compatible Device and Radio Frequency Consulting Services
- Notice Date
- 6/16/2016
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(HL)-2016-176-KMA
- Archive Date
- 7/9/2016
- Point of Contact
- Kevin Alvarez,
- E-Mail Address
-
kevin.alvarez@nih.gov
(kevin.alvarez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Bogazici Universitesi, Guney Kampus Bebek Besiktas, Istanbul (Europe), 34342, Turkey, to procure the services of an experienced senior scientist in the field of medical device design and RF engineering that is required by the Cardiovascular Intervention Program (CIP) within NHLBI's Department of Intramural Research (DIR). BACKGROUND The National Heart, Lung, and Blood Institute's Cardiovascular Intervention Program is developing cardiovascular catheterization procedures to be conducted entirely under MRI guidance. Catheters are designed and built for novel pre-clinical and early-stage clinical catheter procedures. These catheter devices require an unusual combination of mechanical and electrical engineering skills to accomplish the clinical catheterization requirements as well as embedding radiofrequency (RF) antennas for visibility under MRI as well as avoiding hazardous heating of conductive structures during MRI. The laboratory needs an experienced senior scientist in the field of medical device design and RF engineering to develop new interventional devices addressing the above interventional MRI challenges, and implementing custom engineering and testing to allow FDA Investigational Device Exemption (IDE) approval. The laboratory includes a catheter fabrication facility including cleanroom, as well as a combined X-ray MRI clinical interventional suite. PURPOSE The purpose of this acquisition is to procure the services of an experienced senior scientist in the field of medical device design and RF engineering to develop new interventional devices addressing the above interventional MRI challenges, and implementing custom engineering and testing to allow FDA Investigational Device Exemption (IDE) approval. TASKS TO BE PERFORMED The contractor shall perform the following tasks: •Work with NHLBI Catheter Fabrication Staff to design, perform, analyze, and summarize all mechanical, in-vitro, and in-vivo tests for the TST-35 guidewire FDA Investigational Device Exemption. •Work with NHLBI Catheter Fabrication Staff to design, perform, analyze, and summarize all mechanical, in vitro, and in vivo tests for the Segmented Nitinol Guidewire FDA 510k application. •Assess and document service contracts for the facility. •Document existing suppliers for the facility. •Design clinical grade detachable hub active guidewire with following options: 128cm active guidewire (TST-35DH) otherwise unmodified from the current version (TST-35) 128cm active guidewire with 1.7m passive extension. •Design and manufacture 5 and 6Fr deflectable guiding catheter with inductively-coupled MRI markers. The guiding catheter should have a non-metallic braided shaft, at least 100 cm long, with 0.035" guidewire compatible inner lumen. The application is to cross congenital heart defects including ventricular septal defect. •Design and manufacture 4Fr long active needle with 0.035" guidewire compatible inner lumen. The active needle may have multiple coils to indicate insertion length under MRI. •Design and manufacture 10 Fr bidirectional steerable and MRI compatible volumetric intracardiac echo catheter prototypes during collaboration with Dr. Degertekin's Lab at Georgia Tech University. •Design and manufacture RF safe optical base transmission line for active MRI catheters during collaboration with Dr. Degertekin's Lab at Georgia Tech University. ANTICIPATED PERIOD OF PERFORMANCE Base Year: July 1, 2016 - June 30, 2017 Option Year 1: July 1, 2017 - June 30, 2018 Option Year 2: July 1, 2018 - June 30, 2019 Option Year 3: July 1, 2019 - June 30, 2020 JUSTIFICATION The sole source determination is based on the fact that this is a follow-on to an existing contract and Bogazici Universitesi is currently providing an experienced senior scientist to assist with these services. Due to their specific experience and expertise with the projects outlined above, only Bogazici Universitesi would be able to complete any significant fraction of the work within the project interval. If another contractor were to take over, there would not only be a lapse in services in order to train the new contractor on the processes and procedures of the lab, but there would be an expensive and duplicative investment in analysis, training, and implementation. This loss of productivity and substantial duplication of costs is unacceptable to the Government. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 541990, All Other Professional, Scientific, and Technical Services, and the Small Business Size Standard is $15.0 Million. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 (June 15th, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by June 24, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-(HL)-2016-176-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to kevin.alvarez@nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
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