Brainsway Justification.pdf
PDF 212 KB Posted
- Attached to
- 6515--BRAINSWAY TMS Helmet Federal contract opportunity
- Solicitation number
- 36C24624Q0619
About this file
This document is a Justification for Single Source Awards under Simplified Acquisition Procedures (SAP) for a requirement at the Chesapeake VA Medical Center.
The requirement is for a BrainsWay 104 System with H1 Coil, a noninvasive neurostimulation treatment system that uses Transcranial Magnetic Stimulation (TMS) to treat mental health disorders. The estimated value is $. BrainsWay is the sole provider of this FDA-approved equipment with unique capabilities, and market research confirmed no other vendors can meet the requirement. A Sources Sought and Intent to Sole Source were posted with no responses received. The Contracting Officer has approved the single source justification in accordance with FAR 13.106-1(b).
This document also references a related Federal Contract Opportunity for this requirement, Solicitation 36C24624Q0619, a Special Notice for a sole source award to Brainsway for the Chesapeake VAMC. The NAICS code is 339112 Surgical and Medical Instrument Manufacturing. Responsible sources were invited to submit capability information by July 12, 2024 to potentially compete, but the Government reserves the right to proceed with the sole source award to Brainsway.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Intent to Sole Source Brainsway.docx | DOCX document | |
| 36C24624Q0619_1.docx | DOCX document |
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Text version
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT
Last Updated: 02/01/22 Page 1 of 2
DEPARTMENT OF VETERANS AFFAIRS
Justification for Single Source Awards IAW FAR 13.106-1 For
Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)
Acquisition Plan Action ID:____36C24624AP2891_________________
1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 06, located at 100 Emancipation Drive, Hampton, VA 23667 in support of the Chesapeake VA Medical Center located at 70 Knells Ridge Blvd Chesapeake, Virginia, 23320
Purchase Request 590-24-3-2474-0167
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Hampton VAMC has a requirement for BrainsWay 104 System with H1 Coil. BrainsWay is a noninvasive neurostimulation treatment system that uses Transcranial Magnetic Stimulation (TMS), a series of magnetic pulses that stimulates precise neurons in the brain to treat mental health disorders such as major depressive disorder and anxious depression.
The estimated value of the proposed action is $
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
The BrainsWay system is FDA approved and has several unique capabilities such as deeper and broader stimulations, flexible, head conforming coils, and is able to treat multiple conditions in one session. These unique features allow for efficient, specialized patient care. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (MDD) / anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction.
The OEM, BrainsWay USA Inc. (SB) is the sole provider of the equipment.
4. Description of market research conducted and results or statement why it was not conducted:
Market Research from recent award 36C24624P1329 dated 6/6/2024 NCO6 indicated that the OEM Brainsway (Small Business) is the sole provider of the TMS equipment. Verified letter from OEM uploaded to ECMS briefcase. A Sources Sought under 36C24624Q0619 was conducted on 3/19/2024 with zero responses from vendors.
An Intent to Sole Source was posted on Contract Opportunities on 5/29/2024 with a closing date of 6/3/2024 for RFQ 36C24624Q0911 for recent NCO06 award 36C24624P1329 for exact product. The NCO 6 Contract Officer received zero responses.
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT
Last Updated: 02/01/22 Page 2 of 2
Additional Market Research was conducted on FPDS, GSA Elibrary, GSA Advantage, and VetCert which revealed multiple awards to OEM Brainsway and no other recent awards to other vendors.
Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.
Jerry Mann Contracting Officer Date
File details come from the government source that posted it. Updated .