BARDA Device Development for Scientists Training

The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response seeks a qualified contractor to deliver a two-day, in-person Device Development for Scientists training course for up to 30 participants, with quotations due October 21, 2026, at 1:00 p.m. Eastern Time. This is a total small business set-aside under NAICS 611430 with a $15 million size standard.

Training is scheduled for January 11-12, 2027, at the Constitution Center in Washington, DC, with core hours from 9:30 a.m. to 3:30 p.m. The Government will provide the facility and coordinate participant logistics.

Instructors must hold a master's degree or higher in a field related to medical device development and demonstrate a minimum of five years of relevant professional medical device development experience. Non-U.S. citizen instructors require security vetting information submitted at least ten business days before training commencement. Multiple qualified instructors are permitted; substitutes require prior written Contracting Officer approval.

The curriculum must address five subject areas: Medical Device Discovery and Development (including Context of Use, preclinical development, target product profiles, and nonclinical studies); Clinical Development (Investigational Device Exemption studies and clinical investigations); Regulatory Pathways (FDA device classifications, submission pathways including 510(k), De Novo, Premarket Approval, and accelerated programs including Breakthrough Devices and Safer Technologies Program); Commercialization and Intellectual Property (patents, exclusivity, and coding/coverage/reimbursement); and Post-Market Considerations (post-market surveillance and recalls).

All quotations must be firm-fixed-price, covering preparation, instruction, materials, travel, and expenses with no separately reimbursable costs. Electronic course materials must comply with Section 508 accessibility requirements and be delivered two business days before training. Evaluation weighs technical approach and instructor qualifications (combined, more important than price) against price. Questions are due October 6, 2026, at 10:00 a.m. Eastern Time.