A.02. JA Sole Source Brand Name VirtaMed Training Devices (rev 20230802)KOredacted.pdf

CUI//SP-PROCURE

Solicitation Number: W91YTZ23Q0170 Control Log Number: 23-RHCO-A-462

Sole Source Justification Brand Name for Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Medical Readiness Contracting Office – East (MRCO-E) Fort Bragg Health Contracting Cell 9275 Doerr Road, Building 1221 Fort Belvoir, VA 22060

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: DHP Total Dollar Value: XXXXXX

Name of Intended Contractor: Virtamed Inc.

Street Address: 16144 Churchview Dr STE 101 City, State, Zip: Lithia, FL 33547-3851

Phone: (844) 746-4357

Delivery Date: Four to Six weeks after date of contract.

3. Description of Supplies/Services: Womack Army Medical Center is requesting a purchase order for additional learning modules for existing VirtaMed Surgical Simulator products.

4. Authority Cited:

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

Controlled by: USAHCA CUI Category: SP-PROCURE

Limited Dissemination Control: FED ONLY POC: Mr. Jonathan D. Long (816) 325-0016

(d) FAR 8.405-6(a)(1)(i)(B): Only one source can provide the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: This is a sole source requirement with the OEM (original equipment manufacturer) recommended as the only authorized vendor and has no authorized resellers of these products. The VirtaMed simulator allows for training of various orthopedic, urology, OB/GYN and Laparoscopic general surgery procedures and techniques in a safe and realistic environment. This allows trainees to acquire and improve skills before performing surgery on a live patient. The products include a quantity of one (1) each of the following: VirtaMed ArthroS™ Knee Module, VirtaMed ArthroS™ Knee AANA Meniscectomy Module, VirtaMed ArthroS™ Knee ACL Reconstruction Module, VirtaMed ArthroS™ Knee Meniscal Repair Module, VirtaMed ArthroS™ Shoulder Module, VirtaMed ArthroS™ Shoulder Rotator Cuff Repair Module, VirtaMed ArthroS™ Hip Module, Platform upgrade to VirtaMed Ergonomic Platform, and simulator installation & initial training. Simulator Installation and Initial Training are considered incidental services to be provided to the Government.

The total estimated cost for this acquisition is .

The simulator is unique in the marketplace as it combines the rubber model of each relevant discipline with the benefits of virtual reality. The rubber model provides immediate and realistic feedback as opposed to any sort of robotic devices. The simulator also incorporates adapted original instruments, another feature that is not available on any other simulator. These features as well as the engine that generates the photo realistic graphics needed to ensure the realism of the system are all under lP protection and proprietary to VirtaMed AG. If training tools are not purchased to use on the existing equipment, the mission to train surgical staff members prior to real-life surgery would not be met.

6. Actions to Increase Competition: A sources sought was posted on SAM.gov from 12-19 July 2023 in accordance with DFARS 206.302-1 (d) that will allow the Government to identify interested sources capable of meeting the requirement and the potential for competition. This notice yielded responses only from VirtaMed stating VirtaMed AG is the unique provider of this equipment and has no vendor or third-party companies that provide this equipment to the hospital training market in the USA. All sales and support functions are done directly with VirtaMed and its sister entity, VirtaMed Inc. located in the USA. No additional responses were received. The Soliciation will be posted out on SAM.GOV for electronic notification; however, no further action will be taken to increase competition based on the proprietary nature of the equipment and services.

7. Market Survey: Market research was conducted in accordance with FAR Part 10. The end-user search ECAT and GSA Advantage for the required equipment with zero results. The contract specialist also reviewed of the Dynamic Small Business search based on NAICS code 339113 and key words for VirtaMed. The search showed that there was no small business that met the search criteria. VirtaMed is the OEM of these products as stated.

8. Procurement History:

Previous Contract or Purchase Order Number: or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: N/A

9. Technical / Requirements Certification: I certify that the supported data under my cognizance which are included in this mini-J&A is accurate and complete to the best of my knowledge and belief.

I certify the required products are not available using mandatory sources and delivery cannot be made by the required delivery date.

Submitted By: Dan Morasse Position Title: Chief, HTMB

Email address: daniel.m.morasse.civ@health.mil Date: 20 July 2023

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: Donna Blossom Position Title: Contracting Officer

Email address: donna.l.blossom.civ@health.mil

BLOSSOM.DONNA.L.1102273970 Digitally signed by BLOSSOM.DONNA.L.1102273970 Date: 2023.08.01 11:43:43 -04'00'