The BioFabUSA program is a public-private partnership between the Department of Defense (DoD) and the Advanced Regenerative Manufacturing Institute (ARMI), a member-driven, nonprofit organization whose mission is to make practical the scalable, consistent and cost-effective manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. Within the last decade, significant breakthroughs in cell biology, biofabrication and materials science have laid the foundation for the large-scale manufacturing and commercialization of engineered tissues. However, the field of tissue engineering remains fragmented and lacks a mechanistic framework through which to translate laboratory discovery into manufactured products. The goal of the institute is to close the gap in focus that inhibits the commercialization and translation of research and development. By removing existing regulatory hurdles, producing scalable, GMP-compliant processes, and establishing a commercial ecosystem, ARMI will help catalyze and foster the development of a new industry.