HT942524D0001 JA Redacted.pdf

Control Number: JA-23-09-1439

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

2. Description of Action: The U.S. Army Aeromedical Research Laboratory (USAARL) requests approval for a new, sole source, firm-fixed price (FFP), Indefinite Delivery Indefinite Quantity (IDIQ) contract with Prevent Biometrics, Inc., located at 4600 W 77th St Suite 275, Edina, MN 55435.

3. Description of Supplies/Services: USAARL has a need for head impact/acceleration monitoring capability in a mouthguard form factor in support of ongoing Research, Development, Test & Evaluation (RDT&E) projects. The hybrid IMM and associated equipment and software are developed by Prevent Biometrics Inc. The hybrid IMM is used to investigate head impact/acceleration exposures in military training environments and ultimately to correlate with neurophysiological performance deficits. The Hybrid IMM is a small sensor incorporated into a molded mouthguard capable of measuring linear acceleration and rotational velocity (or rotational acceleration) of the head. The mouthguard can store up to 100 events locally and transmit events to a computer, tablet, or phone via Bluetooth Low Energy (BLE). The mouthguard sensor provides time-trace data from each impact event. The mouthguard sensor classified each impact event as a "true event" (e.g., resulting from head motion) or "false event" (e.g., resulting from non-head motion). The mouthguard sensor is fully self-contained and does not have any component outside of the mouth during normal operational use. It is capable of less than ±5% measurement error. Each individual mouthguard sensor is calibrated to provide the best possible data. Associated hardware includes individual charging cases for each mouthguard and a "Team Case" that provides storage and charging capability for the individual charging cases. The Team Case can hold up to 27 individual charging cases for storage and charging. The individual storage cases have a light indicator for charging and sanitation status.

The estimated ceiling value of this effort is Fiscal Year 2023 RDT&E funds are anticipated for the first delivery order. It is anticipated that each subsequent order will also be funded with RDT&E funds; the FY for funds will vary depending on when each delivery order is awarded. The IDIQ contract awarded as a result of this requirement will include a five-year ordering period.

FEB 2023

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501 (a), sole source under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: USAARL has performed research in the area of head impact exposure monitoring since 2007, has extensive experience in the field head impact exposure monitors and has conducted several projects involving head impact exposure monitoring. Through a review of available trade journals, literature, web resources, and industry knowledge, USAARL identified multiple companies capable of providing head impact exposure monitors including Prevent Biometrics, HitlQ, ORB Innovations, BioCore-Football Research lnc/DTS/Opro Mouthguards, Black Box Biometrics, BAE Systems, GForceTracker, Riddel, and Simbex. Comparable devices are also manufactured by Academic institutions (e.g., Stanford and Wake Forest University); however, they are not commercially available, and they do not fully meet the minimum essential characteristics of this requirement. Current commercially available instrumented mouthguards are either fully custom molded (e.g., BioCore/DTS) or do not have additional proximity-based sensors (or comparable technologies) to determine when the device is worn and on the teeth. The Prevent Biometrics mouthguard sensor has been identified for evaluations in military training environments because it is the only mouthguard-based sensor compatible with existing personal protective equipment while also providing false-event rejection algorithms, sufficient sampling rate, and access to data.

Prevent Biometrics, Inc. is the Original Equipment Manufacturer (OEM) and sole distributor of their manufactured products. There are no licensed authorized third-party distributors.

6. Efforts to Obtain Competition: In accordance with FAR 5.2 - Synopses of Proposed Contract Actions, a Notice of Intent (NOi) to award a sole source contract will be published on the www.sam.gov website for 15 days. All capability statements received in response to the NOi to Sole Source, by the due date specified, will be considered by the Government solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

7. Actions to Increase Competition: USAARL and USAMRAA will periodically conduct future market research and analysis to determine if other potential sources emerge that are capable of providing the required head impact/acceleration monitoring capability in a mouthguard form factor. Additionally, all future requirements will be synopsized in accordance with FAR 5.201 and if other potential sources do emerge, USAMRAA will assess whether competition for future requirements is feasible.

8. Market Research: Market research conducted in accordance with FAR Part 10 was multifaceted and was undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Product, 2) if two or more small businesses exist that can meet the government's requirements, and 3) if there is more than one source capable of meeting the government's requirement.

Market research examined if the required equipment met the FAR definition of a commercial product, which is a product, other than real property, that is of a type customarily used by the general public or by nongovernmental entities for purposes other than governmental purposes and (i) has been sold, leased, or licensed to the general public; or (ii) has been offered for sale, lease, or license to the general public.

Market research determined that the required equipment does meet the definition and is commercially available; thus, standard commercial terms and conditions will apply.

Market research conducted in accordance with FAR Part 10 does not support that a minimum of two or more capable small business could potentially satisfy this requirement. Therefore, this requirement is not appropriate for a small business set aside. However, it is noted that Prevent Biometrics is registered as a small business.

Lastly, market research examined if there are other sources capable of providing the required mouthguards. It was also determined that although there are multiple vendors in the market providing the capability to measure head impact exposures, the other devices are not capable of being boiled and fitted to a subject (e.g., they require fully custom molding) nor do they include proximity-based sensing (or comparable technologies) to determine when the device is on the teeth. The mouthguards manufactured by Prevent Biometrics are the only devices in the market capable of meeting the government's minimum essential characteristics. Further, Prevent Biometrics does not have any authorized resellers. Therefore, Prevent Biometrics is determined to be the only vendor capable of providing mouthguards meeting the government's minimum essential characteristics.

9. Interested Sources: The synopsis required by FAR 5.201 will be posted on the System for Award Management (SAM) website as this requirement meets the threshold stipulated in FAR 5.101 (a)(1 ). Any written inquiries, bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of all awarded contracts for these same requirements.

Blanket Purchase Agreement (BPA) W81XWH17A0010 was awarded to Prevent Biometrics, Inc. on 17 August 2017 for head impact monitors in a mouthguard form factor. The BPA was awarded with a five-year ordering period and a cumulative ceiling amount for all orders issued against the BPA of $1,105,000.00.

(2) The competitive status of these actions.

BPA W81XWH17A0010 was awarded to Prevent Biometrics, Inc. as a result of a sole source procurement.

(3) Authority previously cited if less than full and open competition was used.

W81XWH17A0010 was awarded in accordance with 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501 (a), sole source under the authority of the simplified procedures for certain commercial items.

(4) Justification to Support Procurement - Summary of Actions to Increase Competition.

Per the sole source justification approved on 06 April 2017, at the time competition could not be increased due to Prevent Biometrics, Inc. being identified as the only vendor capable of producing a mouth guard sensor that is fully contained in the mouth and usable for testing without a facemask or helmet. At the time, there were no other available opportunities for the creation of competition for the required mouthguards as Prevent Biometrics, Inc. was the only source capable of providing a mouthguard meeting the Government's minimum requirement.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Not applicable.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

Not applicable.

(7) Justification to Support Procurement - Circumstances Justifying Procurement and any significant changes.

Prevent Biometrics, Inc. is the only company that can perform this work because they have developed and own the mouth guard sensor, software, and hardware necessary to meet the Government's requirements of a mouth guard contained fully inside the mouth. This requirement exists since all the Personal Protective

Equipment (PPE) in use by USAARL involves helmet or head protective equipment that has no face mask. There is no place to mount an impact sensor on USAARL's current equipment, therefore a sensor interior to the mouth is needed. If we were to compete this requirement among all sensor manufacturers, the Government would have to procure new PPE in order to purchase external sensors, increasing the overall cost of the procurement and study. The Prevent Biometrics, Inc. mouth guard sensor is being evaluated by the Army for inclusion in Garrison Training environments as Prevent Biometrics, Inc. mouth guard does not have any components that need to be outside of the mouth (e.g., attached to a face mask or helmet). Prevent Biometrics, Inc. mouth guard sensors are fully compatible with all the current equipment in use by the Government.

There have been no significant changes since the previous contract was awarded. Prevent Biometrics, Inc. remains the sole source vendor capable of providing head impact monitors in a mouthguard form factor meeting the government's minimum essential characteristics.

b. Other facts. Not Applicable.