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FBO DAILY ISSUE OF SEPTEMBER 08, 2008 FBO #2478
SOLICITATION NOTICE

70 -- Finite Element Analysis Software or EQUAL

Notice Date

9/6/2008
 

Notice Type

Modification/Amendment
 

NAICS

541519 — Other Computer Related Services
 

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-SOL-08-1047288
 

Response Due

9/11/2008 1:00:00 PM
 

Archive Date

9/26/2008
 

Point of Contact

Rafael Taylor,, Phone: 301-827-7169, Jody L. O'Kash,, Phone: 301-827-5094
 

E-Mail Address

Rafael.Taylor@fda.hhs.gov, Jody.O'Kash@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

(i) This is a combined/synopsis solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. (ii) This is solicitation number FDA-SOL-08-1047288 and this solicitation is being issued as a Request for Quote (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-12. This is a total small business set-aside. (iv) The NAICS code is 541519. The size standard $25M. (v) The following is a Brand Name or EQUAL RFQ with the following list of minimum essential salient characteristics: An integrated Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) is a computational analysis tool that can be used to predict the mechanical safety of medical devices. Currently, this computational tool is used by regulated industry to help demonstrate the safety of their medical devices. Therefore, a great need exists at FDA for expertise in the implementation of integrated FEA and CFD for medical devices, its strengths and its limitations. A core thrust of the CDRH/OSEL/DSFM Mechanical Engineering Program is to analyze medical device failure and mechanical performance. As such, the DSFM Mechanical Engineering program is requesting to purchase software with the following characteristics: Solves large scale models (> 1 million elements), Wide range of linear and non-linear analyses, Sophisticated material models (elastic, hyperelastic, shape memory, plastic, etc.) as well as user-defined material models, Predefined and user-define contact definitions, Simulation software is capable of projects for biomedical applications that span multiple aspects of physics, Software with efficient exchange of data between simulations of different physical phenomena. An example is fluid structure interaction where two way data exchange is required to correctly capture the behavior of a system where fluid forces and pressures affect the structural response of the system and vise versa, Software that possesses a unified and common working environment to handle both fluid and solid analysis capabilities, Software that possesses advanced geometry integration, manipulation and computational mesh creation tools, and Complex computational fluid dynamic capabilities, such as laminar flow, turbulent flow, pulsatile flow, includes analysis using Newtonian and non-Newtonian fluids. (vi) DESCRIPTION OF REQUIREMENTS: STATEMENT OF WORK: A. An integrated Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) is a computational analysis tool that can be used to predict the mechanical safety of medical devices. Currently, this computational tool is used by regulated industry to help demonstrate the safety of their medical devices. Therefore, a great need exists at FDA for expertise in the implementation of integrated FEA and CFD for medical devices, its strengths and its limitations. A core thrust of the CDRH/OSEL/DSFM Mechanical Engineering Program is to analyze medical device failure and mechanical performance. B. A core thrust of the CDRH/OSEL/DSFM Mechanical Engineering Program is to understand the failure mechanisms of medical devices. By using this engineering stress analysis software, we will be able to better understand failure mechanisms of medical devices that cannot be performed with our existing experimental testing capabilities. In addition, this software will aid in providing recommendations to companies during the submission process to insure that accurate stress analyses are performed. This software will be installed on a stand-alone scientific workstation. It is not intended to be enrolled in the FDA Scientific Network, and is NOT to be connected to the FDA Administrative Network. C. Currently there are very limited methods in CDRH/OSEL/DSFM to perform localized stress analysis of complex medical devices. Experimental testing can only provide global information regarding the failure properties of these complex devices. However, integrated FEA and CFD software is necessary for estimating the local distribution of stresses/strains within a device. This type of computational analysis is imperative to determining stress concentrations and insuring the safety of devices from pre-mature mechanical failure. D. Overall, we anticipate this software will aid in better evaluations of safety against failure in a variety of medical devices. For example, we plan to investigate the effects of vessel deformations on stent mechanical integrity. The only method to accomplish this task is using integrated FEA and CFD software to estimate the local stress distribution within the stent. In addition, this software will help us further participate in standards working groups, such as ASTM F04, that investigate methods to characterize the failure of medical devices and write guidance on the use of integrated FEA and CFD to predict device safety. E. Solves large scale models (>1 million elements), Linear analyses, Non-linear analyses, Sophisticated Material Models, Contact definitions, Complex computational Fluid Dynamics Capabilities, and Integrated Fluid-Solid Interactions capabilities are the product outcome required by the software. F. Research projects for biomedical applications require a simulation software tool kit that spans multiple aspects of physics. These include fluidic and structural/mechanical. For each aspect, high end technology is required to capture the complex, non-linear behavior and response of the system and the materials involved. The geometry of the system to be considered can also be highly complex. G. This simulation technology should be composed of the advanced geometry integration, manipulation and computational mesh creation tools available. H. In addition, the project demands the efficient exchange of data between simulations of different physical phenomena. An example is fluid structure interaction where two way data exchange is required to correctly capture the behavior of a system where fluid forces and pressures affect the structural response of the system and vise versa. I. Software that possesses a unified and common working environment to handle both fluid and solid analysis capabilities. J. Data Rights - The Government will maintain ownership and “unlimited rights to all applications, source codes, and data generated in the performance of and at the end of the task. "Unlimited rights" means the rights of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so. (vii) Place of Performance: Government facility, White Oak building 62 Lab 2233, 10903 New Hampshire Avenue, Silver Spring, MD 20993-002, software installed on government owned computer operated by government personnel, no contactors. Deliverables – Software shall be delivered 15 calendar days after award. Technical Support shall be provided by phone or email for one calendar year from date of delivery. Software updates shall be provided as they become available within one year from date of delivery. (viii) The provision at 52.212-1, Instructions to Offerors (APR 2008) -- Commercial, applies to this acquisition and is available at website: http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P257_45709. (ix) The provision at 52.212-1, Evaluation -- Commercial Items (Jan 1999) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will offer the best value to the Government. This is a competitive best value source selection in which the Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price, and other factors considered. Contractors shall furnish as part of their quotation all descriptive material necessary for the government to determine whether their service meets the technical requirements. The Government is more concerned with technical understanding capability rather than lowest overall price. However, the Government will not make an award at a significantly higher overall price to the Government to achieve only slightly superior technical capabilities. Overall price to the Government may become the ultimate determining factor for award, as offers become more equal based on the other factors, as determined by the Government. Technical understanding in offerors proposals will be evaluated and assigned one of the following scores: “Acceptable” and “Unacceptable” For Technical Understanding and Expertise, the offeror shall discuss their technical understanding of the statement of work (SOW) and their expertise in evaluating Finite Element Analysis (FEA) software. Mere restatement of the Government’s requirements is not acceptable. Factors to be considered are: 1) The offeror’s proposed solution to meet the requirements of the SOW, 2) The offeror’s proposal adequately addresses the timeline for completion, and3) The offeror’s proposal adequately addresses the safety and security of the use of FEA for predicting the mechanical safety of medical devices. For these factors, an acceptable proposal will demonstrate the contractor’s experience and ability in successfully using Finite Element Analysis (FEA) software for predicting the mechanical safety of medical devices. The Government intends to issue one firm fixed award for this requirement. The Government reserves the right to make award without discussions. (x) Vendors shall complete FAR 52.212-3, Offerors Representations and Certifications - Commercial Items (JUN 2003). This can be done electronically at http://orca.bpn.gov. The contracting officer will review the vendor’s online certifications at http://orca.bpn.gov to ensure that they are accurate and complete. If the vendor does not have active representations and certifications registered online they will be disqualified from being considered for award. (xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (FEB 2007), applies to this acquisition. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JUNE 2007), applies to this acquisition as well as the following clauses cited therein: 52.219-6, Notice of Total Small Business Set-Aside (JUN 2003) (Alternate I OCT 1995), 52.222-3, Convict Labor (JUN 2003)(EO 11755); 52.222-19, Child Labor - Cooperation with Authorities and Remedies (JAN 2006)(EO13126); 52.222-21, Prohibition of Segregated Facilities (FEB 1999); 52.222-26, Equal Opportunity (MAR 2007)(EO11246); 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era and other Eligible Veterans (SEP 2006)(38 USC 4212); 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998)(29 USC 793); 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era and other Eligible Veterans; 52.222-50, Combat Trafficking in Persons (AUG 2007); 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003), 52.225-1 52.225-13 Restriction on Certain Foreign Purchases (FEB 2006), 52.239-1 Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a). Full text of clauses and provisions can be accessed at www.arnet.gov/far. (xiii) In order to comply with Section 508 of the Rehabilitation Act, the Government asks vendors to complete a Voluntary Product Accessibility Template (VPAT) and submit it with their quote. The technical standards applicable to this requirement are: 1194.21 Software Applications and Operating Systems, 1194.25 Self Contained, Closed Products, 1194.31 Functional Performance Criteria, and 1194.41 Information, Documentation, and Support. The 508 technical standards are available at http://www.section508.gov/. All questions must be submitted in writing to Rafael.taylor@fda.hhs.gov or Jody.O’Kash@fda.hhs.gov no later than Tuesday, September 9, 2008 at 1pm EST. Answers to all questions will be posted as an amendment to the solicitation. Proposals, Technical proposals, and VPAT may be submitted electronically at Rafael.taylor@fda.hhs.gov and/or Jody.O'Kash@fda.hhs.gov no later than Thursday, September 11, 2008 at 1pm EST.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=ddc3c374c68efbbd2ed61168d934858c&tab=core&_cview=1)
 

Place of Performance

Address: 10903 New Hampshire Ave. Bldg W062, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN01661994-W 20080908/080906213747-df6361feb8f94eba913c101c28d132d4 (fbodaily.com)
 

Source

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

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