Biologics and Biological Implants

The Department of Veterans Affairs established this Master IDIQ for biologics and biological implants on September 28, 2018, with ordering authority ending September 26, 2023. The vehicle is now closed to new orders and has issued 395 task orders as of September 2024, though recent activity has slowed sharply to just 4 orders in 2024 after 94 orders in 2023.

The contract procures FDA-approved human allografts (bone and soft tissue from cadavers) and xenografts (animal-derived bone and soft tissue, typically porcine and bovine) for use in VA surgeries and medical procedures. Deployed products include vascular grafts and stents, abdominal aortic aneurysm endoprostheses, shoulder and hip implants, penile implants, surgical mesh, and peripheral nerve stimulation systems. All products must be tracked from source to implantation and labeled per ISBT 128 standards. Task orders are firm fixed price with completion windows typically ranging from two to twelve months.

Era Health LLC dominates the vehicle, holding 274 of 395 orders (69% of total) and accounting for $7.3 million of the combined $11.2 million potential value across the awardee base. Zimmer US Inc., Davol Inc., and Academy Medical Inc. are the secondary suppliers, with combined potential values of $1.4 million, $734 thousand, and $705 thousand respectively. The top five primes capture 92 percent of all task orders and 93 percent of combined potential value.

The Veterans Health Administration within VA placed virtually all orders, with Veterans Integrated Service Network 2 (80 orders, $2 million) and VISN 20 (60 orders, $1.5 million) accounting for 36 percent of ordering activity across the portfolio. Set-asides are minimal; 98 percent of orders carry no set-aside designation, with only 4 service-disabled veteran-owned small business sole-source orders.

Combined task-order potential value stands at $11.2 million with $10.6 million obligated (95 percent), indicating substantial execution of the vehicle's initial scope. The most valuable individual order was a Zimmer hip kit delivery to a VISN facility in February 2023 for $814 thousand, with typical orders ranging from $10 thousand to $40 thousand.

The Department of Veterans Affairs (VA) Prosthetics Sensory Aid Service (PSAS) requires the acquisition biologics and biological Implants. The objective of this IDIQ is to ensure availability and consistency of products for nationwide usage and to obtain volume-based, standardized pricing. The commodities to be acquired are various types of biologics and biological implants, which include any human cell, tissue, or cellular or tissue-based product or animal product inserted or grafted into the body for prosthetic, therapeutic purposes. The goal is for the implant to restore or replace a body function, or restore appearance.