Sole Source Justification (Redacted).docx

SINGLE SOURCE JUSTIFICATION AND APPROVAL

USE OF OTHER THAN FULL AND OPEN COMPETITION – FAR PART 13 UNDER SAT

1. Contracting Activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Hospital (NH) Oak Harbor and Marine Corps Recruit Depot (MCRD) Parris Island requirements.

2. Description of the Action Being Approved.

The proposed action is for two (2) dental prosthesis design/manufacturing systems, computer- aided [25-104] (CAD/CAM) for Naval Hospital (NH) Oak Harbor and Marine Corps Recruit Depot (MCRD) Parris Island. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Imagine Milling Technologies, Inc. (Imagine Milling) of 14225 Sullyfield Cir Ste E Chantilly, VA 20151.

Description of Supplies/Services.

The Naval Medical Logistics Command has a requirement for two (2) dental prosthesis design/manufacturing systems, computer-aided [25-104] (CAD/CAM) for Naval Hospital (NH) Oak Harbor and Marine Corps Recruit Depot (MCRD) Parris Island.

The CAD/CAM systems shall each include a dental implant milling unit. Each CAD/CAM system shall include a dental milling unit and CAM software. The milling unit shall be capable of dry and wet milling and shall be capable of milling via five (5) axes with up to 30 degrees of axis adjustment. The milling unit shall have a minimum of ten (10) tool positions. The milling unit shall process 98 and 98.5 mm blank CAD/CAM blocks. The milling unit shall be able to machine zirconium dioxide, Poly-methyl methacrylate (PMMA), wax, plastics, glass ceramics, cobalt chromium, and titanium. The milling unit shall have adaptable holders capable of carrying pucks, prefabricated titanium blanks, and glass ceramic blocks. The milling unit shall process these materials to fabricate dental restorations to include crowns, inlays, onlays, copings, bridge frameworks, full-contour bridges, custom abutments, dentures, and implant components. The milling unit shall be capable of holding pucks in an open or c-shaped holder for denture milling. The milling unit shall be capable of milling implant level connections from PMMA, zirconia, and titanium. The milling unit shall be capable of reproducing tool paths generated by user- defined manufacturing protocols, or templates, incorporated in the CAM software. The CAD/CAM system shall include consumables, including cutting tools, material pucks, implant components, and coolant. The consumables shall include autoclavable scan bodies. The vendor shall include installation and operational training. The system shall be able to directly interface with currently-installed Sirona CEREC Omnicams. The power requirement is 110 V, 60 Hz.

The CAD/CAM systems shall each include a light scanner that shall be able to scan models and impressions into software to be used for planning of orthognathic surgeries, in surgical guides for reconstruction, and for implant planning. The light scanner shall have 2 axes and an accuracy of at least 10 microns. The light scanner shall use two (2) cameras to scan multi-unit implant frameworks and create 3D digital images. The light scanner shall be capable of impression scanning and shall be able to scan full size articulators. The light scanner shall use calibrated articulator scanning. The light scanner shall utilize a static scan table that does not require rotation or inversion of the model, yet allows for manual cast removal during the scan process without disrupting the scan workflow. The light scanner shall not require fixtures, jigs, or adhesives to secure the cast to the scan table when scanning models. The system shall allow for the scanning and exporting of Standard Triangle Language (STL) files for CAD/CAM milling. Each system shall include CAD design software and CAD software capable of collecting data from the light scanners. The CAD software shall be able to integrate the data sets from the light scanner into one digital implant model. The system shall include a computer, monitor, keyboard, and mouse.

The CAD/CAM systems shall each include a 3D printer that utilizes non-contact membrane digital light printing (DLP) technology for printing dental models. The 3D printer shall be capable of printing orthodontic models, crown and bridge models, long-term temporaries, pressable wax restorations, surgical guides, splints, night guards, and dentures. The 3D printer shall include a touch screen. The 3D printer shall include a ultra-violet (UV) curing unit, a material mixer, a resin tray kit, and a printer pedestal.

All systems shall include an open source solution that allows for in-house use or exportable files to other Naval Medical Treatment Facilities (MTFs) for manufacturing custom guides, reconstruction plates, and bone graft matrices. The open source solution shall allow for data to be transmitted between all subcomponents. The system shall include all necessary software for transferring images from acquisition scanning units to the milling units. The system software shall allow for output of implant interfaces in designed restorations. The system shall be able to provide and apply manufacturing protocols for dental implants including crowns, bridges, copings, abutments, abutment bars, inlays, and onlays. The system shall have a preloaded template library of common dental implants connections including, but not limited to: standard hex, external hex, 3.25mm, 3.4mm, 4.1mm, 4.3mm, 5.0mm, 6.0mm, engaging, and non- engaging.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

5. Rationale Justifying Use of Cited Statutory Authority.

Market research was conducted in December 2019 through February 2020. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors that can provide dental design/manufacturing systems include 3D Natives, 3Shape, Custom Automated Prosthestics LLC, DAL DT Technologies, Dental Wings, Dentsply Sirona Imagine Milling Technologies, Inc. (Imagine Milling), Masterlink LLC, Medit, Inc., Pressing Dental, Renishaw, Inc., Schutz Dental Group, Inc., and Vorum Research Corp. Only Imagine Milling can provide a light scanner that utilizes a static scan table that does not require rotation or inversion of the model and does not require securing of the model to the scan table. Only Imagine Milling is capable of providing a milling unit with CAM software that can produce dental restorations required by the Navy.

Imagine Milling is the only vendor capable of providing a light scanner with a scan table that does not tip or invert. The Imagine Milling DOF light scanner is patented to utilize cameras that move up and down to record images of the cast while the cast itself remains upright on the scan table. This prevents the need for clinicians to secure the cast to the scan table using a separate fixture unit, seating jig, or adhesives. The cast can also be removed and replaced during the scan process without disrupting the scan workflow. This is a critical feature for young lab technicians and enables continuous handling of the model without having to start the scan over. Securing the cast to the scan table is technique sensitive depending on the clinician, time intensive, and requires breaking off existing mounting to mount a new model. An upright scan table that doesn’t move enables clinicians with varying techniques to scan all models exactly the same while also eliminating the time and supplies needed to secure the model. While other vendors can potentially distribute the DOF light scanner, no other vendor can provide the DOF light scanner with Navy-specific CAM software.

Imagine Milling is the only vendor capable of providing a milling unit capable of reproducing tool paths generated by user-defined manufacturing protocols, or templates, incorporated in the Imagine Milling CAM software. The CAM software from Imagine Milling includes milling templates that were designed with feedback form in collaboration with the Navy and are Intellectual Property of Imagine Milling. Imagine Milling designed the CAM software specifically for the Navy to include user-defined milling programs, implant libraries, implant manufacturing options, default settings, and specific materials parameters. The CAM software templates were designed to include the capability to mill PMMA and metal implant level interfaces for Navy-specific designed restorations. Imagine Milling developed and tested the CAM software templates with the Dental Corps, who contributed over 600 work hours over 7 years to collaborate on a solution that meets the specific needs of the Navy.

Purchasing milling units and CAM software from vendors other than Imagine Milling would result in the loss of the template development that took 7 years to cultivate; including the capability of designing specific restorations to mill PMMA and metal implant level interfaces. The current capabilities of the Navy sites would end until another company could develop and test de novo templates. The time it would take to develop a customized software solution would hinder the sites’ ability to provide customized milling, impacting clinical workflow and patient care. This would result in significant delays to patient care, increased cost to the Government, and increased time required from the Dental Corps to start over the collaboration of designing templates. No other vendor can provide a milling unit with dental prosthesis design/manufacturing software and pre-built implant templates for the Navy. No other vendor can provide a light scanner that utilizes a static scan table that does not require rotation or inversion of the model and does not require securing of the model to the scan table. Imagine Milling is the only vendor that can meet the minimum requirements of the Government.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

This requirement will be posted to FedBizOpps in accordance with FAR 5.202. Market research was conducted by technical experts from December 2019 to January 2020. This research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and the ECRI sourcebook catalog. No other vendors can provide a suspended body and face shield protection device.

7. Determination of Fair and Reasonable Cost. The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.

CERTIFICATIONS AND APPROVAL TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Technical / Requirements Cognizance:

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief.