JA_KLSMartin_FY2025_v2 -JS-ACO signed_1.pdf

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

FY ‘25 1

JUSTIFICATION & APPROVAL FOR USE OF OTHER THAN FULL & OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

This Justification and Approval (J&A) is executed by Naval Medical Research Command (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, on behalf of the requesting agency, Naval Medical Research Unit San Antonio (NAMRU-SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234.

2. Nature and/or description of the action being approved.

Award of a contract on a sole source basis will be made to KLS-Martin Limited Partnership for a supply agreement for SonicWeld Rx consumables and accessories. SonicWeld Rx is the only product that meets all the requirements set by the government: 1) is US Food and Drug Administration (FDA) approved, 2) holds broken bones in place in the face, 3) is resorbable by the body, and 4) utilizes ultrasonic vibrations to adhere material to the bone. KLS-Martin L.P. is the manufacturer and sole source provider (letter attached) of SonicWeld Rx. The period of performance for this contract is anticipated to be a period of 12-months for a single order. The proposed source is:

KLS-Martin L.P.

11201 Saint Johns Industrial Pkwy S Jacksonville, FL, USA, 32246-7652

(904) 641-7746 / (800) 625-1557 www.klsmartinnorthamerica.com

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The requirement is for a contract to provide the shipping and supplies for a device/system that: 1) is US Food and Drug Administration (FDA) approved, 2) holds broken bones in place in the face, 3) is resorbable by the body, and 4) utilizes ultrasonic vibrations to adhere material to the bone. The SonicWeld Rx system is the only product that meets all these requirements. The contract should supply NAMRU-SA with 19 individual, sterile mesh pieces, 18 5-packs of sterile pins, 10 2-packs of sterile pins, 10 twist drills, 14 sterile battery packs, and 2 handpieces with cables.

Estimated Dollar Value

The estimated total value of this contract is $26,333.36.

http://www.klsmartinnorthamerica.com/

FY ‘25 2

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C.

2304(c) (1) as implemented by FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of theacquisition requires use of the authority cited.

The SonicWeld Rx system is the only product that meets all the requirements set by the government: 1) is US Food and Drug Administration (FDA) approved, 2) holds broken bones in place in the face, 3) is resorbable by the body, and 4) utilizes ultrasonic vibrations to adhere material to the bone. These specifications are needed to act as a predicate device to support the approval of a novel product being tested by NAMRU-SA researchers.

KLS-Martin L.P. is the manufacturer and sole source provider (letter attached) of SonicWeld Rx.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202. No other known sources have expressed an interest, and no other source is expected to express interest in this effort. KLS-Martin L.P. is the manufacturer and sole source provider (letter attached) of SonicWeld Rx.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer will perform a cost and price analysis to determine that the anticipated quotes received by the Government for the services cover by this J&A will be within fair market value and reasonable. Fair and reasonable pricing has been determined by researching FPDS-NG for the same or similar items. In addition, the market research showed that KLS-Martin L.P.’s prices are comparable to vendors with similar products, but which do not meet all the requirements set by the government.

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted by technical experts from September – October of 2024. This research consisted of market survey through contacting military SMEs, reviewing past market summaries, obtaining source lists from government and academic search engines, reviewing catalogs, and contacting salespeople. Search engines utilized include Google, FDA “Establishment Registration & Device Listing”, and FPDS-NG, using the following search terms: resorbable, biodegradable, bone, implant, plating system. Five companies (KLS-Martin L.P.; Inion Inc; Stryker Sales, LLC; Johnson and Johnson MedTech / DePuy Synthes; Zimmer Biomet) were contacted to inquire into their resorbable bone fixation devices/systems. The proper department, Microfixation, of Zimmer Biomet did not respond after multiple attempts to contact by phone and online form, demonstrating poor costumer service. Johnson and Johnson MedTech / DePuy Synthes demonstrated technical issues and never placed us in contact with a salesperson. Stryker Sales, LLC and Inion Inc provided quotes, but their devices do

FY ‘25 3

not meet the requirement of utilizes ultrasonic waves to adhere material to bone. KLS-Martin L.P. is the only company with a device/quote that meets all the requirements set by the government: 1) is US Food and Drug Administration (FDA) approved, 2) holds broken bones in place in the face, 3) is resorbable by the body, and 4) utilizes ultrasonic vibrations to adhere material to the bone.

9. Any other facts supporting the use of other than full and open competition.

NA

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.203. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point Of Contact.

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

FY ‘25 4

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 Cognizance SIMECEK.JOHN. Digitally signed by

SIMECEK.JOHN.W.1134323473

W.1134323473 Date_: 2025.02.12 14:47:11 -06'00'

Dr. John W. Simecek, DDS, MPH Date Director, Craniofacial Health and Restorative Medicine Naval Medical Research Unit San Antonio

Requirements Cognizance

CDR Nicholas J. Hamlin, DC, USN Date Acting Commanding Officer Naval Medical Research Unit San Antonio

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

Office of Counsel Date

CONTRACTING OFFICERS CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. The Contracting Officer’s signature below also represents approval of the J&A.

Contracting Officer Date Naval Medical Research Command