SOURCES SOUGHT
A -- Biomedical Engineering Support Services
- Notice Date
- 1/5/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 1066759
- Archive Date
- 2/9/2010
- Point of Contact
- Jaclyn Stielper, , Doreen Williams,
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- 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 (541711). 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. Background. FDA regulates the safety and effectiveness of active (electrically powered) medical devices that may be put at risk from the emissions of radio transmitters, cell phones, security systems, and a variety of wireless devices. The Electromagnetics and Wireless Laboratory, in the Center for Devices and Radiological Health (CDRH), is frequently called on to confirm the normal and safe functioning of medical devices in the presence of potential electromagnetic interference (EMI) from a wide variety of sources including Magnetic Resonance Imaging (MRI) systems. The Lab also participates with international standards groups in the development and maintenance of standard test methods for electromagnetic compatibility (EMC). Purpose and Objectives. The purpose of this contract is to maintain the continuity of our ongoing test programs. The services required to maintain our test programs are assistance in the design, conduct and documentation of medical device EMC and medical device MRI safety tests; and with computer modeling to support those tests. In order to maintain continuity over the course of this contract the services should, to the maximum extent possible, be provided by a single individual with at least a Masters degree in an applicable field of science or engineering. Project requirements. This contract will provide services to CDRH’s Electromagnetics and Wireless Laboratory in all phases of EMC and MRI safety testing of medical devices. Description of Work. Task 1: Design of experiments to be performed with implanted and other medical devices exposed to electromagnetic fields. Consult with FDA project officer regarding identifying and obtaining implanted medical devices (i.e. cardiac pacemakers, defibrillators, spinal cord stimulators) and externally worn devices to be studied in the FDA white Oak MD labs. The devices and all equipment and supplies will be provided by the FDA. Design experiments to test the effects of exposure to specific electromagnetic fields and the resulting unintended stimulation, electromagnetic interference, and radiofrequency (RF) heating by intense magnetic fields from Magnetic Resonance Imaging (MRI) systems including Gradient fields and RF fields emitted by simulated and actual clinical MR systems on certain implanted medical devices identified above. Design experiments to test the effects of exposure to specific RFID systems on certain implanted and non-implanted medical devices identified above. Deliverables: Experimental design approved by project officer. Estimated level of effort: 250 hrs. Technical factors: The contractor shall demonstrate knowledge of, and experience with: active implantable medical devices, RFID systems, and MRI RF subsystems. Task 2: Develop experimental protocols for testing medical devices in intense electric and magnetic fields. Develop detailed written experimental protocols for developing tests of the devices identified in task 1. Prepare a written test protocol for conducting said experiments the protocols will include all technical details, test equipment identification, and methods needed to ascertain if electromagnetic interference caused failures in the electronics of these devices produces potentially harmful conditions in physical and computer models of patients. Deliverables: Develop written experimental protocols to be approved by FDA project officer. Estimated level of effort: 300 hrs. Technical factors: The contractor shall demonstrate knowledge of, and experience with: making electrical measurements in intense electric and magnetic fields, design of experimental protocols, and failure analysis of electronic devices. Task 3: Develop and calibrate experimental MR exposure systems obtained by FDA for testing medical devices. Prepare the FDA labs for power, cooling, measuring SAR distribution produced by FDA’s dual frequency 3T MRI RF body coil. Design, develop calibrate and use the new exposure systems to simulate MRI gradient and radiofrequency (RF) fields. These systems include the FDA’s newly ordered dual frequency 3 Tesla (3T) RF whole body coil and a new MRI gradient field simulator. Set-up, test, and calibrate the FDA’s 3T RF whole body coil and gradient field simulator in the FDA White Oak lab. Learn to operate these complex systems, calibrate them, validate the performance specifications including spatial maps of the RF E field, B1 (RMS) and gradient B fields using the FDA’s computer controlled, on-site Dasy5 robotic scanner, FDA’s Easy-4-MRI measurement systems and E and H field probes. Deliverables: Complete and ensure the operational status of the systems in task 3. Write detailed laboratory reports with plots, charts, and tables of the specified parameters of this task. Estimated level of effort: 600 hrs. Technical factors: The contractor shall demonstrate knowledge of, and experience with: MRI RF and gradient field subsystems and measurements of electric and magnetic field produced by these subsystems. Task 4: Develop computer models and analyses of results for MHD modeling for cardiac disease diagnoses techniques initiated and partially completed by FDA in prior years. Complete the analyses of results of MHD computer modeling. Write detailed laboratory reports with plots, charts, tables of the specified parameters of this task. Deliverables: Complete detailed laboratory reports detailing results of the specified requirements of this task. Estimated level of effort: 200 hrs. Technical factors: The contractor shall demonstrate familiarity with, and experience using, SEMCAD or other software programs specifically intended for bio-electromagnetic modeling. Task 5: Hearing Aid Compatibility (HAC) with cellular phones. Implement methods for mapping measured electromagnetic emissions and evaluating the undesired effects of these emissions from nearby, test-enabled cellular phones on hearing aids. Mapping will be performed with the FDA’s DASY5 automated system by SPEAG AG Deliverables: Write detailed laboratory reports on the results of these measurements and tests. Estimated level of effort: 270 hrs. Technical factors: The contractor shall demonstrate knowledge of hearing aids and basic electromagnetic compatibility measurements including mapping electromagnetic emissions near cellular phones using the DASY5 automated system by SPEAG AG. Task 6: Prepare written manuscripts, as assigned, for tasks 1 – 5. Perform analyses, determine critical factors and parameters affecting performance, and develop manuscripts of research results suitable for submission to technical journals (i.e. IEEE or biomedical engineering online). Deliverables: Detailed manuscripts of findings from tasks 1-5. Estimated level of effort: 300 hrs. Technical factors: The contractor shall demonstrate experience with analysis and documentation of complex experimental data and developing manuscripts of research results suitable for submission to technical journals. Anticipated period of performance. Base Contract: 03/01/2010 – 12/31/2010 Option Year1: 01/01/2011 - 12/31/2011 Option Year 2: 01/01/2012 - 12/31/2012 Deliverables Deliverables: Experimental design. Task 1: Design of experiments to be performed with implanted and other medical devices exposed to electromagnetic fields. Due at completion of task. Experimental protocols. Task 2: Develop experimental protocols for testing medical devices in intense electric and magnetic fields. Due at completion of task. Laboratory test reports. Task 3: Develop and calibrate experimental MR exposure systems obtained by FDA for testing medical devices. Due within 10 business days after completion of laboratory tests. Analysis report. Task 4: Develop computer models and analyses of results for MHD modeling for cardiac disease diagnoses techniques initiated and partially completed by FDA in prior years. Due within 10 business days after completion of analysis. Laboratory test reports. Task 5: Hearing Aid Compatibility (HAC) with cellular phones. Due within 10 business days after completion of laboratory tests. Manuscripts Task 6: Prepare written manuscripts, as assigned, for tasks 1 – 5. Due within 30 business days after assignment. Deliverables will be submitted to the Electromagnetics and Wireless Laboratory, Laboratory Leader. Materials and resources to be supplied by FDA The Electromagnetics and Wireless Laboratory, Division of Physics will supply the laboratory facilities, instruments, test items, and expendables necessary to perform the EMC tests required under the terms of the contract. In addition, office space, computers, printing capability, telephone, and office supplies will be provided. Capability statement /information sought. Respondents must provide, as part of their responses, a capability statement and estimated costs. This is not a Request For Proposal and pricing will be used solely for planning purposes. Respondents may also include: i. respondents’ opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition ii. information regarding 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; iii. general information regarding the respondent’s estimate or rough order of magnitude of the effort or time that may be required for completion of the work. iv. respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code; v. any other information that may be helpful in developing or finalizing the FDA’s acquisition requirements. Information should be provided electronically to Jaclyn Stielper at Jaclyn.Stielper@FDA.HHS.GOV. Telephone and facsimile responses will not be accepted. Information should be provided in Adobe PDF and must not exceed 30 pages in Times New Roman (size 12) font, single spaced. Pages must be numbered and only one copy must be submitted. Responses are due by 4:00 PM EST on January 25, 2010. Be sure to include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. 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/FDA/DCASC/1066759/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02035539-W 20100107/100106000823-5824c14c02e7c9c843be31a896b4b08c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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