Wendi Young-Asao

Wendi T. Young-Asao is a procurement professional specializing in the acquisition of advanced medical and diagnostic equipment, playing a critical role in ensuring the agency’s access to high-integrity healthcare technologies. She manages complex contracting actions for Class II and Class III medical devices, in-vitro diagnostics, and electromedical systems, aligning acquisitions with federal regulatory standards including FDA clearance pathways and ISO 13485 compliance. Her work supports mission-critical healthcare delivery by securing reliable, clinically validated instrumentation essential for patient care and public health surveillance. Her contractor relationships are primarily with manufacturers and distributors of surgical instruments, diagnostic reagents, and electromedical apparatus, including both large-scale industrial suppliers and specialized niche vendors. She engages with vendors that demonstrate robust quality management systems, traceable supply chains, and compliance with Unique Device Identification (UDI) requirements. Her procurement approach emphasizes performance-based specifications and lifecycle cost analysis, fostering long-term partnerships with suppliers capable of sustaining technical support and regulatory updates. Young-Asao’s contracting portfolio is overwhelmingly non-set-aside, with 95.1% of awards issued under full and open competition, reflecting a focus on technical merit and product suitability over socioeconomic preferences. Nevertheless, she consistently allocates 4.9% of opportunities to total small business set-asides under FAR 19.5, demonstrating a measured but intentional commitment to small business participation without compromising mission readiness or clinical efficacy. Her technical domain centers on NAICS 339112 (surgical and medical instrument manufacturing) and 325413 (in-vitro diagnostic substance manufacturing), with significant activity in surgical supplies, electromedical devices, and pharmaceutical preparations. She possesses deep familiarity with FDA classification rules, sterilization validation protocols, and biocompatibility standards, ensuring all procured products meet stringent safety and performance benchmarks for clinical environments.