Single Source Justification.doc

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source

Attachment 1: Single Source Justification for SAP under the SAT

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: 36C250-26-AP-0810

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Richard L. Roudebush (RLR) VA Medical Center (VAMC), 1481 West 10th Street, Indianapolis, IN 46202-2803. 2237#: 583-26-1-156-0003

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The RLR VAMC Prosthetic & Sensory Aid Services (PSAS) submitted this new requirement to renew MIMICS Innovations Suite Software License. The software is currently in use at the facility and licensed permission for its use expires on 11/11/2025.

The Mimics Base System software is a medical 3D image-based engineering software that efficiently goes from image to 3D models and enables scaling from Research and Development (R&D) to high volume clinical operations. The software allows PSAS and the Innovation Lab staff to generate medical and anatomical models by additive manufacturing methods. The technology is designed to support streamlined workflows for increased productivity and will be used as a visual tool for case planning, reference in the OR, patient specific implants and models, and perform surgical simulations. The software required includes:

· MIMICS Base - Subscription Renewed / Local Hospital Limited License – 12 Months – Quantity of 1

· MIMICS C&V Segmentation - Subscription Renewed / Local Hospital Limited License – 12 Months – Quantity of 1

· MIMICS Design - Subscription Renewed / Local Hospital Limited License – 12 Months – Quantity of 1

· Review Module - Hospital Limited License Subscription – 12 Months – Quantity of 1

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: To address the increase in output for medical modeling the Mimics Base 3D software provides the compatibility needed to support the Stratasys J5 3D Medijet Printer. It meets the required Digital Imaging and Communications in Medicine (DICOM) imaging (CT/MRI) standards. It is TRM compliant. No other manufacturer examined possessed the capabilities of the Mimics Innovation Suite. After extensive collaboration and analysis of other software suites, it was determined that the Mimics Base 3D Innovative Software Suite was the most compatible with, and best satisfied the requirements of the VA for the 3D J5 Medijet Printer.

Materialise MIMICS software is consistently identified as the industry leading “gold standard” software for medical image segmentation. The VAMC uses the software in manufacturing FDA regulated medical devices. These processes are strictly controlled and regulated. A change in software would require the development of new design processes as well as verification and validation testing, staff training and a new application to the FDA at an estimated cost of $2 Million, and at least 6 months downtime.

The requested software items are already established. Due to proprietary licensures this requirement is available only from the original equipment manufacturer (OEM) large business, Materialise USA, LLC, who exclusively sells and supports the Mimics system and accessories.

4. Description of market research conducted and results or statement why it was not conducted: Market research queries were conducted using NAICS 513210 and keyword “Mimics.” Searches of DSBS, VA NAC, NASA SEWP, ADDS UP, GSA Advantage, and FPDS-NG databases found multiple contract holders and items manufactured by the OEM; however, none of the contract holders/items found were capable of satisfying the needs of this requirement. Multiple contracts awarded to the OEM for this software by other VAMCs were found under the ADDS UP’s simple search option. The items were identified as manufactured in the United States of America (USA).

An email was sent to the OEM and a reply received on 10/28/2025. The OEM confirmed they are the sole source provider, there are no SDVOSB/VOSB or other authorized resellers, and that the items are sold with open market pricing. The OEM is the only firm capable of providing the software and support described in the above section without the Veterans Health Administration experiencing unacceptable delays in providing 3D-printed products or substantial duplication of cost that could not be expected to be recovered through competition.

The product is not in the NMR Class Waiver Database. There are no SD/VOSB resellers available. The VA and SBA Rules of Two cannot be obtained. A sole source open market award to the large business OEM will satisfy this requirement and provide the best value to the Government.

Revision: 01

Effective Date: 11/15/2024 Acquisition ID#