JA-Brand Name Acquisition-ReActiv8 generators_Redacted.pdf

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

DHA PGI 213.5, Attachment 1 (06-21-2018)

ATTACHMENT 1

JUSTIFICATION AND APPROVAL (J&A) TEMPLATE

for

Sole-Source (Including Brand-Name) Acquisitions of Commercial Items Conducted Pursuant to FAR Subpart 13.5

(June 21, 2018)

Justification and Approval for Other than Full and Open Competition Brand Name Acquisition

1. Identification of the agency and contracting activity: Naval Medical Center San Diego, (NMCSD), Western Healthcare Operations Contracting Division (WHCO-CD), Defense Health Agency Contracting Activity (DHACA).

2. Nature and/or Description of Action being approved: This is a request for one-time, fixed price supply purchase to procure Reactiv8 implantable pulse generators for Naval Medical Center San Diego.

3. Description of Supplies/Services: The required Reactiv8 implantable neurostimulation pulse generator is the only medical device of its kind in the marketplace, based on its restorative therapy, mechanism of action, and patent portfolio. Reactiv8 is indicated for bilateral stimulation of the spine as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.

Required Items:

Model 8145-ReActiv8 Implantable Lead (3 EA) Model 7000-ReActiv8 Patient Activator (6 EA) Model 4000-ReActiv8 Patient Magnet (3 EA) Model TUN1-Mainstay Tenneler (3 EA) Model AP071GW2-BX5-Percutaneous Introducer (Box of 5) (2 EA)

Deliver By: 1 June 2024

Type of Funding: Operations and Maintenance (O&M)

Estimated total contract value: $79,926.00

4. Statutory Authority Cited permitting other than full and open competition: Acquisition of commercial item(s) conducted pursuant procedures in FAR Subpart 13.501 and 41 U.S.C.

1901, Simplified Acquisition Procedures were used.

DHA PGI 213.5, Attachment 1 (06-21-2018)

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

5. Rationale Justifying Use of the Statutory Authority Cited: The subject matter experts conducted market research on available disinfection systems. After an extensive review of the details of performance characteristics, testing throughput, configuration, and compatibility with current DoD laboratory and hospital information systems, the research has demonstrated that only the ReActiv8 implantable pulse generator will satisfy the needs and requirements of the facility. The ReActiv8 implantable neurostimulation system is the only medical device of its kind in the marketplace, based on its restorative therapy, mechanism of action, and patent portfolio (intellectual property protections). Additionally, MML US, Inc. (Mainstay Medical, the Original Equipment Manufacturer – OEM) authorizes two (2) small businesses Veterans Health Supply Solutions (VHSS), and Marathon Medical as distributors of the ReActiv8 pulse generators.

Marc Arnold, Director-Government Accounts of MML US, Inc. confirmed that they are the only authorized sources of the ReActiv8 implantable pulse generators. Market research did not identify any other companies that could provide the required equipment.

6. Efforts to Obtain Competition: Contract specialist conducted a mandatory search throughout April 2024 and determined via internet searches that equipment of this nature is customarily available in the commercial marketplace. However, exhaustive searches for ReActiv8 generators were conducted in AbilityOne, UNICOR, ECAT/MMC, SBA Quick Search, and GSA Advantage, all resulting in negative results under NAICS code 339113 and search terms “ReActiv8 pulse generators”. OEM authorizes two (2) small businesses: VHSS and Marathon Medical as distributors of the ReActiv8 generators. Market research has determined this requirement will be solicited as a Brand Name: ReActiv8 100% total small business set-aside.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price found reasonable on previous purchases and a comparison of the price to the Independent Government Cost Estimate (IGCE) provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research: As stated above, several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online search engines reviewed by Naval Medical Center San Diego and DHA Western Markets Contracting Division in April 2024. Contract specialist reached out to the Original Equipment Manufacturer (OEM), Marc Arnold, and he confirmed that there are two (2) authorized distributors of the ReActiv8 generators: VHSS and Marathon Medical. See Market Research Report for details.

9. Other Facts: None

10. Interested Sources: As identified, there are (3) authorized distributors of the the ReActiv8 generators: OEM MML US, Inc., VHSS, and Marathon Medical.

11. Actions to overcome barriers: Naval Medical Center San Diego and the DHA Western Markets Contracting Division will continue to survey and engage the market of any potential vendors that can provide ReActiv8 pulse generators and will consider competing future

DHA PGI 213.5, Attachment 1 (06-21-2018)

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104 requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for ReActiv8 pulse generators.

COORDINATION:

12. Technical/Functional Representative:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

APPROVAL:

13. Contracting Officer:

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