BNJ.pdf

Brand Name Justification

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

U.S. Food and Drug Administration (FDA) and Office of Acquisition and Grants Services (OAGS) federal agency and contracting activity.

b. Sponsoring organization.

Center for Devices and Radiological Health (CDRH)/Office of Science and Engineering Laboratories (OSEL)/Division of Biomedical Physics (DBP)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Crystal McCoskey

ii. E-mail address: crystal.mccoskey@fda.hhs.gov

iii. Telephone number: 870-814-7578

2. Nature and/or description of the action being approved.

The nature and purpose of this document is to delineate in writing the justification and approval (J&A) of a Brand Name acquisition for FEKO Electromagnetic Modeling (EM) and simulation software maintenance, licenses, and services in accordance with the Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i). This is a brand name justification for the FEKO EM and simulation software maintenance, licenses, and services, currently FDA uses FEKO EM and simulation software in CDRH’s OSEL DBP lab, where the user employs Method of Moment (MoM), Finite Element Method (FEM), and Finite Difference Time Domain method (FDTD) methods to analyze EM problems associated with the Magnetic Resonance (MR) safety regulatory science.

Procurement of FEKO brand software, licenses, maintenance and services is critical for the Agency to meet its regulatory mission. CDRH is responsible for protecting and promoting public health by ensuring patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. In support of this mission, FDA requires FEKO brand software to continue the research needed to maintain the experimental and theoretical methods continuity CDRH has been working on for over a year. To that end, in 2023, FDA procured the FEKO software commercial off the shelf (COTS). FDA requires continued maintenance of these software licenses because the FEKO software supports numerous ongoing studies.

a. Acquisition purpose and objectives.

mailto:crystal.mccoskey@fda.hhs.gov

The purpose of this procurement is to continue EM modeling and simulation of the Magnetic Resonance Imaging (MRI) scanner environment to assess the safety patients and efficacy of the equipment. Patients with implantable medical devices are now being routinely allowed to go under MRI examinations and the implants pose risks for patients ranging from heating, burn, mechanical force, torque and vibrations that are extremely dangerous to patients and medical personal working under and with the MRI scanners. By using the EM modeling software these adverse effects can be accurately predicted and prevented.

b. Project background.

The purchase of this FEKO software maintenance and licensing is required for continuity of studies being performed at CDRH. The initial software purchase was in August 2023 as Order No.

75F40123P00294 ($20,501.00) using full and open competition procedures. FEKO software is designed and proprietarily owned by Altair Engineering, Inc.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

CDRH requires the FEKO software maintenance and licenses to support a continuing need for a 1-year base period plus up to four (4) 1-year option periods. The FEKO EM modeling software is a fast, efficient, and comprehensive approach to model and assess MRI safety of patients under MRI examination. It allows for the regulatory science team involved in MRI safety research at the DBP, OSEL at CDRH to pursue regulatory science research on MRI safety. The software must perform numerical simulations in reasonable amount of time (within minutes to less than 48 hours for large problems) and accuracy verifiable by experiments, using appropriate numerical techniques suitable for the EM problem at hand. The annual cost is estimated at $27,360.00 with a total contract value of up to $136,800 for all five (5) years.

a. Project title.

FEKO software maintenance and licenses

b. Project Description.

The Contractor shall provide Electromagnetic (EM) modeling and simulation software using and performing the following techniques and functions:

1. CAD modeling environment

2. Method of Moments – MoM

3. Finite Element Method – FEM

4. Finite Difference Time Domain method – FDTD

5. Applying surface and volume equivalence principles

6. Optimization algorithms

7. Scripting capability for post processing

8. Availability anatomical models

9. shall be compatible with Windows 10 - 64 bit operating system

10. Thermal analysis

11. Computer Aided Design (CAD) file formats (IGES, STEP, Parasolid, DWG, DXF)

12. 1-Year of Support and Updates

c. Total estimated dollar value and performance/delivery period.

The annual cost is estimated at $27,360.00 with a total contract value of up to $136,800 for all five (5) years.

4. Identification of the statutory authority permitting other than full and open competition.

Federal Acquisition Regulation (FAR): 13.106-1(b)(1)(i)

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Altair FEKO, 1820 E. Big Beaver Road, Troy, MI 48083

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

• Compatibility: Altair Engineering is only known source that utilizes all the electromagnetic techniques (FEM, FDTD, Method of Moments, Surface Equivalence and Volume Equivalence principles), scripting capability, optimization algorithms, anatomical models needed to meet the needs of the FDA. The software renewal of Altair FEKO will enable CDRH to continue the work in DBP/OSEL, where the user employs Method of Moment, FEM, and FDTD methods to analyze EM problems associated with the Magnetic Resonance (MR) safety regulatory science.

• Experimental Continuity: Prior work has been done using FEKO Method of moment and FEM and the researcher needs to maintain the experimental and theoretical methods continuity. Changing to another software would incur not only time to learn new software but also way too much comp and redo the computational models already created but also increase the computational time to several days and weeks that could be done with FEKO within few minutes and hours. If CDRH changed to another software that does not use the same numerical algorithm it would increase the computational time for e.g. 20X to 100 X more depending on the complexity of the problem. This increase computation time would delay work, publication time of papers and regulatory science tools that are the current products of the OSEL/CDRH of the FDA. Second, the user would have to learn a new software from scratch which takes time to master to solve complex problems the labs are dealing with at the DBP/OSEL/CDRH. It will take several months to a year to remaster which would be compounded by increase in computational time with unsuitable numerical methods for CDRH’s electromagnetic problem. The rework and remaster costs would be estimated at around $200,000.00.

• Direct Replacement: These are direct replacement parts/components for existing equipment and no substitutes exist. This renewal is a direct replacement of the software that was acquired in Aug 2023.

• No known distributors: FEKO software is not available from any authorized distributors. As the developer and proprietary data owner, Altair is the sole provider of it’s software.

6. Any other facts supporting the justification.

No additional input.

7. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The Government will ensure that available competition, if any, among Altair FEKO software resellers is obtained.

8. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for this brand justification, are accurate and complete.

Signature:____________________________________

Crystal McCoskey

COR

July 3, 2024

Signature:____________________________________

Ananda Kumar Requiring Activity POC

July 3, 2024

9. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Signature:____________________________________

Sephora Calderon Contracting Officer

July 8, 2024