Research Services Reports Comparing Hip Prosthesis Device Development

Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source firm fixed price purchase order for a three-month period with Medical Device Development, 2390 Mission St., Suite 8, San Francisco, CA 94110, to support the US Department of Veterans Affairs (VA) research office.

This requirement is for Medical Device Development, a small business, to provide an evaluation and reports comparing the subject and predicate prostheses in laboratory tests, using synthetic bones ( sawbones ) and human cadaveric bones for the San Francisco VA Healthcare System, research department. The FDA requires the evaluation of the predicate and subject prostheses in both a synthetic bone model and in human cadaveric bones before allowing clinical use of the subject prostheses.

Medical Device Development was awarded the previous contract for evaluation of the predicate and subject prostheses in human cadaveric bones using competitive procedures. This requirement is a continuation of the previous contract and part of a larger research project. To maintain continuity in this project, the recommendation is to sole source this three-month requirement to Medical Device Development.

Contracting out to a different source will delay the project and lead to discordant outcomes between the results for synthetic bones and human cadaveric bones. Since the intent is to procure this on a sole source basis, no solicitation will be posted on SAM.gov (Contract Opportunities). The applicable NAICS code is 541720 with a $28MIL standard. The PSC is AN11. The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy agency requirements.

Interested persons may contact the Contracting Officer via email at annmarie.stewart@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.