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FBO DAILY ISSUE OF MARCH 05, 2003 FBO #0458
SOLICITATION NOTICE

A -- Catheter Engineer

Notice Date

3/3/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, MD, 20892-7902
 

ZIP Code

20892-7902
 

Solicitation Number

NHLBI-PS-2003-042
 

Response Due

3/13/2003
 

Archive Date

3/28/2003
 

Point of Contact

Michael Clarkson, Contract Specialist, Phone (301) 435-0366, Fax (301) 480-3345, - Debra Hawkins, Chief, Procurement Section, Phone (301) 435-0366, Fax (301) 480-3345,
 

E-Mail Address

mc526x@nih.gov, dh41g@nih.gov
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is NHLBI-PS-2003-042, and the solicitation is issued as a request for quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2001-08. This acquisition is issued as a small business set aside. The North American Industry Classification System (NAICS) Code: 541511, size Standard: $21 million is applicable to this requirement. The National Heart, Lung, and Blood Institute (NHLBI) Cardiovascular Intervention Program (CIP) is seeking to purchase 2,080 direct labor hours of a Mechanical (Catheter) Engineer to design, prototype, and manufacturer catheter interventional cardiovascular devices to be used in animals under investigational real-time magnetic resonance imaging (MRI) applications. The engineer will modify existing devices and will build new devices. The Statement of Work: The NHLBI, Cardiovascular Intervention Program is developing new clinical applications for investigational real-time MRI. The work involves hardware development for magnetic resonance imaging (MRI) applications. The hardware will consist of cardiovascular interventional devices specifically altered to serve as safe intravascular MRI receiver coils. Development will include design, prototyping, recording, and iterative development in animals for ultimate translation into human use. The applications will include guidewire, angioplasty balloons, stents, covered-stents (Endografts), bifurcated endografts, recanalization catheters, suture catheters, staple catheters, and percutaneous valves. The Contractor will provide technical assistance in the design, prototyping evaluation, and iterative development of "Active" radiofrequency receiver devices integrated into interventional hardware for testing in animals. At the conclusion of the project, several devices will have been designed, prototyped, and tested in animals. Specifically, the Contractor shall: 1. Have or gain working knowledge of radiofrequency (RF) coil design for magnetic resonance imaging (MRI). 2. Have or gain working knowledge of safety and imaging considerations for intravascular RF coils. These considerations include hardware and software interfacing into clinical high-performance MRI scanners. 3. Have a working knowledge of design, prototyping, testing, and manufacturing of minimally-invasive transcatheter cardiovascular interventional devices including guidewires, balloons, stents, endografts, and/or valves. 4. Have a working knowledge of "Knowledge of Good Manufacturing Processes" (GMP). 5. Communicate with the clinicians and the Government's Project Officer to determine requirements for specific projects. These communications include careful project management. 6. Understand the requirements and translate them into development plans for discussion with the Government's Project Officer and clinicians. 7. Perform the necessary hardware development including coordinating the appropriate procurement and outsourcing as necessary. 8. Improve, modify, and further develop the devices as required. 9. Coordinate the requisitioning and ordering the materials and equipment. 10. Oversee contract manufacturing and other key vendors. 11. Write patent disclosures, procedures, and test protocols. 12. Assembles engineering records to support a U.S. Food and Drug Administration (FDA) Investigational Device Exempt (IDE) or 510(k) filing. 13. Generate documentation of experimental and development path. 14. If requested, perform data analysis using tools such as Matlab, spreadsheets or image processing packages. The Government expects that the Contractor will be responsive to the needs of the clinicians, and produce hardware applications which achieve the desired functions. A high level of competence is expected, such that the Contractor determines how to achieve the desired functions, makes it perform efficiently, and fixes any problems during development. The requirements are expected to change over time, as research often produces unexpected results. The Contractor must be able to work well in such an environment. At the conclusion of the project, data will be generated to support scientific manuscripts and investigational device exemptions or other regulatory applications for the FDA for investigational human use. At least one device must be ready for manufacture and testing in humans. The Government will provide the Contractor access to a machine shop, appropriate instrumentation, office space, and shared access to the MRI scanner which is the target of the applications. The Government's Project Officer will monitor the performance of the Contractor on a weekly basis. On a monthly basis, or as needed, the Contractor will meet with the Government's Project Officer to assess progress and technical direction. If it becomes clear that the proficiency level of the technical direction is not being achieved, the contract will be terminated. The period of performance is twelve (12) months from the date of contract award. The delivery and acceptance point is Bethesda, Maryland. The provisions of FAR Clause 52.212-1, Instructions to Offerors-Commercial Items, applies to this acquisition. The provisions of FAR Clause 52.212-2, Evaluation - Commercial Items is applicable to this acquisition. The Contractor selected for the award will be evaluated on their documented experience with interventional catheter, guidewire, balloon, and/or stent design and construction. Documented experience with radiofrequency (RF) coils design and construction for magnetic resonance imaging (MRI). Documented experience with regulatory filings. The award will be made to the lowest priced, technically acceptable offeror meeting the Government's specifications. The offeror must submit documented experience as a catheter engineer with product development construction experience and background, as described above. The offeror must propose a loaded hourly rate. The loaded hourly rate includes, salary, overhead, general & administrative expenses, and profit) The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-4, Contract Terms and Conditions -Commercial Items, applies to this acquisition. The FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to this acquisition. (1) 52.222-26, Equal Opportunity (E.O. 11246). (2) 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans (38 U.S.C. 4212). (3) 52.222-36, Affirmative Action for Handicapped Workers (29 U.S.C. 793). (4) 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era (38 U.S.C. 4212). (5) 52.225-3, Buy American Act - Supplies (41 U.S.C. 10). (6) (I) 52.225-21, Buy American Act - North American Free Trade Agreement Implementation Act - Balance of Payments Program (41 U.S.C 10, Pub. L. 103-187). (6) (ii)Alternate I of 52.225-21. (7) 52.239-1, Privacy or Security Safeguards (5 U.S.C. 552a). Individuals, Sole proprietorship, Partnership, Corporate business entities may submit a proposal. The above reference FAR clauses may be obtained from http://www.arnet.gov/far/ . Quotations are due ten (10) calendar days from the publication date of this synopsis or March 13, 2003, whichever is later. Contact Mr. Michael Clarkson, at (301) 435-2605 or clarksom@nhlbi.nih.gov for information regarding the solicitation. Proposals may be submitted by fax to (301) 480-3345, electronically to clarksom@nhlbi.nih.gov or by mail to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, 6701 Rockledge Drive, Rockledge Building 2, Suite 6042, Bethesda, Maryland 20892-7902, Attention: Michael Clarkson. An acceptable proposal includes: documentation of relevant experience, a loaded hourly rate, and the completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items. All responsible sources may submit a proposal, which if acceptable and timely received, shall be considered by the agency.
 

Web Link

Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NHLBI/NHLBI-PS-2003-042/listing.html)
 

Place of Performance

Address: Bethesda, Maryland

Zip Code: 20892

Country: USA
 

Record

SN00269520-F 20030305/030303220848 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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