SOURCES SOUGHT
R -- Guidewire for MRI-guided Cardiovascular Catheterization
- Notice Date
- 6/27/2017
- 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
- HHSN-NIH-NHLBI-SBSS-2017-254
- Archive Date
- 7/20/2017
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a small business sources sought notice. 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 small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Heart, Lung, and Blood Institute (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 sources sought 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 sources sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The NHLBI is seeking capability statements from all eligible small business concerns under the North American Industry Classification System (NAICS) code 541990 with a size standard $15.0M. Based on the responses received from this sources sought announcement, the proposed acquisition may be solicited as a total small business set-aside. All eligible small business concerns responding to this sources sought announcement must have the capabilities to provide the services as stated below. Background MRI catheterization is a promising, minimally-invasive approach to effectively diagnose and treat cardiovascular disease. It offers radiation-free guidance and tissue visualization for pediatrics and complex mechanical interventional procedures. The National Heart, Lung, and Blood Institute (NHLBI) Division of Intramural Research (DIR) created an investigational MRI catheterization suite dedicated to performing radiation-free heart catheterization in pediatric patients. More advanced catheter procedures having a more significant clinical impact will require the purchase of custom catheter devices. One of DIR's major goals for its MRI catheterization program is the incorporation of cardiovascular biopsy. Biopsy is an especially attractive application for children who require repeated endomyocardial biopsy for surveillance of rejection after transplant. Conventional endomyocardial biopsy targets only gross anatomic positions using X-ray but not focal myocardial pathology. The result of this approach is low diagnostic yields and an intractable risk of cumulative valvular injury and myocardial perforation. Studies have shown that MRI guidance can enhance yield and safety of such procedures. MRI-guided endomyocardial biopsy is one of the advanced catheter procedures that require specialized equipment. The DIR has dedicated many years to perfecting its design of an MRI bioptome system to facilitate MRI-guided endomyocardial biopsy. This system consists of multiple interdependent devices including a metallic guidewire. The DIR does not have the necessary resources to manufacture a metallic guidewire in-house. For this reason, the DIR must outsource the manufacturing of said guidewire. Purpose and Objectives The DIR requires a contractor to manufacture a metallic guidewire for MRI-guided cardiovascular catheterization per the DIR's design specifications. The DIR will use the guidewire to perform careful animal studies as part of its ongoing development of MRI catheterization as a safe alternative to treating cardiovascular disease in pediatric patients. Tasks to be Performed The contractor shall furnish all necessary labor, materials, supplies, and equipment not otherwise provided by the Government to manufacture twenty (20) metallic guidewires for MRI-guided cardiovascular catheterization at 1.5T per the Government's specific design/instructions. Said guidewires shall meet the following specifications: -Length 190cm and/or 260cm; -Outer diameter 0.035"; -Short non-resonant lengths (approximately 10cm) of metallic segments (such as nitinol) non-conductively coupled to each other using stiffness-matched couplers; -Coated with multiple discrete ferrous markers (approximately every 10cm) to impart conspicuity along shaft and at tip; -Tip configurations for cardiovascular catheterization including angled and J-curve, or user-shaped; and, -Suitable for transarterial and transvenous antegrade and retrograde cardiovascular catheterization and navigation into right ventricle, pulmonary arteries, and left ventricle. Capability Statement / Information Sought 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 general overview of the respondents' opinions about the difficulty and / or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. -Information 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. -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 with a small business size standard of $15.0M. -Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. Capability statements must demonstrate experience with similar projects and will be evaluated by the following criteria: -The capability statement includes the manufacturing processes including quality control and assurance. -The capability statement provides evidence of access to materials, supplies, equipment (both manufacturing and testing equipment), and facilities necessary to perform the work. -The capability statement provides evidence of past performance in similar projects relating to manufacturing of medical devices, specifically cardiovascular catheter devices. Closing Statement Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed five (5) single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. 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. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Jonathan Lear, Contracting Officer, at john.lear@nih.gov in either MS Word or Adobe Portable Document Format (PDF), by July 5 at 4:00PM, EST and must reference synopsis number HHSN-NIH-NHLBI-SBSS-2017-254. All responses must be received by the specified due date and time in order to be considered. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHSN-NIH-NHLBI-SBSS-2017-254/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04558969-W 20170629/170627235135-36d69e35ecb65225e7ffca88769cfd99 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |