SOURCES SOUGHT
A -- Medical Device Production through 3D Printing of Radiation Crosslinked Polymers
- Notice Date
- 7/22/2011
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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
- FDA-1092096
- Archive Date
- 8/11/2011
- Point of Contact
- ZetherineGore, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
(zetherine.gore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Research and Development (R & D) Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement." Background. The Food and Drug Administration (FDA) has been tasked under Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the America people by establishing the foundational elements that will support medical countermeasure availability and utilization. 3D printing has emerged as a technology that will allow for dispersed manufacturing capability of complex parts in the event of a mass medical emergency (pandemic, chemical, biological, radiological, or nuclear (CBRN) event, or natural disaster). However, the properties required in a polymer to be printable result in poor mechanical properties in the finished product and preclude medical devices from being manufactured by this method. The FDA is pursuing the development of a 3D printable polymer system that is cross linkable post printing and robust enough to produce highly complex parts/devices and in an emergency would insure an uninterrupted supply of items ranging from respirator parts, emergency medical devices, and pedestrian but vital medical devices. Project Purpose and Objectives. The Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Solid and Fluid Mechanics is requires research to support its Medical Counter Measure (MCM) Initiative titled "Expanded Emergency Capacity of Medical Device Production through 3D Printing of Radiation Crosslinked Polymers." The project calls for the development of a printable (low molecular weight polymer) that can be radiation cross-linked after being printed. This requires expertise in polymer synthesis, chemistry, and radiation crosslinking. This project will result in a greater understanding of the challenges and viability of using 3D printing manufacturing for medical devices and equipment. Project requirements. This research project includes the design, synthesis, and optimization of a 3D printable polymer system that can be radiation cross linked post printing along with supplying the FDA radiation cross linked polymers for mechanical characterization. This includes polymer synthesis and optimization and polymer design to support the Medical Counter-Measure Initiative project. The work to be conducted is highly specialized and requires demonstrated expertise in polymer design, radiation cross-linked of polymers, and polymer characterization. Expertise in the following four critical elements is required: (1) with the design of radiation crosslinking polymers, (2) utilizing novel and cutting edge polymer chemistries and techniques for advanced polymer systems, (3) with the needs and requirements for thermal and mechanical testing of advanced polymers, (4) optimizing polymer chemistry and structure for use in bulk manufacturing processes. Anticipated period of performance: Twelve (12) months. Capability Statement. Sources interested in this requirement must a provide statement of capabilities in sufficient detail to determine if the requirements of this request can be met. Responses should provide a description of the services which can be provided by its organization. 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 capability and qualifications to perform the work. The Government is requesting information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training relative to this specific requirement; (b) current in-house capability and capacity to perform the work; (c) previous projects of a similar nature. Respondents are requested to provide 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. Statements should not exceed 10 pages. Contractors are requested to provide their capability statement in pdf format. 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. However, responses to this notice will not be considered adequate responses to a solicitation. "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/FDA-1092096/listing.html)
- Record
- SN02508692-W 20110724/110723014824-8398baefdf57428b2f618754eedb7d4d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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