P03 VAIPM JA FE_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Office of Procurement, Acquisition and Logistics (OPAL)

Strategic Acquisition Center (SAC) 5202 Presidents Ct, Suite 103

Frederick, MD 21703

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND 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 sole source justification for certain commercial items is executed by the Strategic Acquisition Center (SAC), on behalf of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Office of Healthcare Innovation and Learning (OHIL), VHA Innovation Ecosystem, VHA Innovators Network (iNET).

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

This activity proposes to negotiate a non-competitive award (sole-source) with Harbor Designs and Manufacturing, LLC to provide specialized product design support, regulatory and compliance support, prototyping design support, and manufacturing services support resulting in Design Analysis / Discovery roadmap.

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

The VHA Innovators Network will partner with Harbor Designs and Manufacturing, LLC to utilize their unique and extensive experience and expertise to support the purpose of this requirement, which is in product design, development, engineering, and manufacturing. The following services will be required.

Design Analysis / Discovery:

o Based on the discovery session and understanding of immediate and long-term goals, the Contractor shall generate a proposed roadmap to satisfy the immediate goals and, when applicable, full roadmap to US Food and Drug Administration (FDA) compliance and commercialization. This roadmap, sent in Microsoft Word, will include, but is not limited to, an initial Rough Order of Magnitude estimate or cost target per unit which would include the anticipated cost of both the number of units to be produced and the time and materials necessary to prototype and then produce them. The roadmap will further include recommendations on which of the following task(s) (Task Categories 2-6 as described below) will be required within the 12 months following Task 1, with an estimation of when each task would begin for the products:

Design Support / Design for Manufacturing Prototyping Quality Assurance / Regulatory Support Packaging Design Licensing Strategy / Evaluation

Strategic Acquisition Center (SAC)

The total estimated value of this firm-fixed price contract is $63,000.00, and the period of performance (PoP) is one (1) 12-month base period.

(4) The statutory authority permitting sole source.

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(2) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source”.

(5) A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring use of the authority.

The contractor, Harbor Designs, has unique qualifications, expertise, and knowledge to support the Department of Veterans Affairs. Harbor Designs has direct experience with VA employee-designed products.

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

Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements.

VA issued a Sources Sought notice and published in the System for Award Management (SAM) as a Request for Information (RFI) to Contract Opportunities on June 7, 2023, ID#36C10X23Q0171.

RFI submissions were reviewed by a team of innovation subject matter experts. Upon review, it was determined that one of the respondents had the required knowledge, experience, or expertise to provide the services to the level and schedule required. This respondent was Harbor Designs and Manufacturing, LLC.

Strategic Acquisition Center (SAC)

(7) The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the contracting officer that the anticipated cost to the government will be fair and reasonable.

No award shall be made until the Contracting Officer determines the cost to the Government to be fair and reasonable. This determination will be based on a comparison of current contract pricing, an Independent Government Cost Estimate, past proposal submissions (if available), and other information as made available.

(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.

In accordance with Class Deviation from VAAR 810.001-70, the Small Business Administration VETCERT, SBA Veteran SB Cert Program, was queried on June 6, 2023, using NAICS code 541618.

The iNET team dedicated to the VA Intrapreneurial Product Marketplace (VAIPM) contacted knowledgeable individuals within the Government regarding the market capabilities to meet the requirement of the VAIPM. These individuals included but were not limited to: Contracting Officers and Specialists, Innovation Specialists, Tech Transfer Specialists, Minneapolis Adaptive Design and Engineering (MADE) Program engineers, Richmond VA Medical Center Assistive Technology Design Center engineers, VHA Office of Advanced Manufacturing leadership, VHA Innovation Ecosystem leadership, and VHA Office of Healthcare Innovation and Learning leadership.

The iNET team dedicated to the VAIPM participated in interactive, on-line communication among industry, acquisition personnel, and customers. The interactive, on-line communication included information on the VA Intrapreneur Marketplace Day, which was sent to businesses working in product development, businesses in healthcare product sales, and made available at

Strategic Acquisition Center (SAC) a larger scale as it was highlighted as part of the VHA Innovation Experience.

The iNET team dedicated to the VAIPM obtained lists of businesses in product development and healthcare product sales. These businesses were included in the VA Intrapreneur Marketplace Day to learn more about the needs of the VAIPM.

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

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

Harbor Designs and Manufacturing, LLC. (SDB)

(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.

All future requirements will be handled on a case-by-case basis. The Government will continue to conduct ongoing market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

Strategic Acquisition Center (SAC)

(12) Technical and Requirements Certification.

I certify that the supporting data under my cognizance, which are included in this J&A, are accurate and complete to the best of my knowledge and belief.