SOURCES SOUGHT
R -- MRI Compatible Device and Radio Frequency Consulting Services
- Notice Date
- 6/9/2016
- Notice Type
- Sources Sought
- 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)-2016-160-KMA
- Archive Date
- 7/1/2016
- Point of Contact
- Kevin Alvarez,
- E-Mail Address
-
kevin.alvarez@nih.gov
(kevin.alvarez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- A.Sources Sought Notice: NHLBI-CSB-HB-2016-160-KMA B.Title: MRI Compatible Device and Radio Frequency Consulting Services C.This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) their size classification relative to the North American Industry Classification System (NAICS) code 541990 for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Kevin Alvarez, Contract Specialist, at kevin.alvarez@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by June 16, 2016 9:00 AM, EASTERN TIME under Solicitation Number: NHLBI-CSB-HL-2016-160-KMA. FAXES ARE NOT ACCEPTED. D.Information: 1.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. 2.Purpose and Objectives 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.  3.Project Requirements a.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. b.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 c.Assess and document service contracts for the facility. d.Document existing suppliers for the facility. e.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. f.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. g.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. h.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. i.Design and manucature RF safe optical base transmission line for active MRI catheters during collaboration with Dr. Degertekin's Lab at Georgia Tech University. 4.Contractor Requirements a.Contractor must have experience in clinical-grade manufacturing of cardiac catheters, combined with extensive experience in design and manufacture of MRI catheter antennas and experience in heat testing catheters during MRI. b.Contractor must have experience working in the NHLBI environment. 5.Anticipated Period of Performance/Delivery Date 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 6.Capability Statement Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: a.A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. b.Information as needed in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. c.The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the North American Industry Classification System (NAICS) code: 541990, All Other Professional, Scientific, and Technical Services, Small Business Size $15.0 Million. d.Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. e.The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. f.All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. 7.Closing Statement All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Kevin Alvarez, Contract Specialist, at kevin.alvarez@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by June 16, 2016 9:00 AM, EASTERN TIME under Solicitation Number: NHLBI-CSB-HB-2016-160-KMA. FAXES ARE NOT ACCEPTED. This Sources Sought Notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Quote (RFQ). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
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