Medical Device Development Instructor- Led Training

SOURCES SOUGHT NOTICE / REQUEST FOR INFORMATION (RFI) Proposed Period of Performance: November 2 3, 2026 (Two-Day Training) Place of Performance: Constitution Center, Washington, DC Product Service Code (PSC): U004 Education/Training Scientific/Management NAICS Code: 611430 Professional and Management Development Training Size Standard: $15 million NOTE: All prospective contractors must be registered in the System for Award Management (SAM.gov) to be eligible for contract award. 1. Purpose The Biomedical Advanced Research and Development Authority (BARDA) is conducting market research to identify potential contractors capable of providing an in-person, instructor-led course on Device Development for Scientists. The course will focus on the regulatory, scientific, and commercial considerations involved in developing medical devices, obtaining U.S. Food and Drug Administration (FDA) clearance or approval, and successfully bringing medical devices to market. The Contractor shall provide qualified instructor(s) and all required course materials. The proposed training will be conducted over two days, November 2 3, 2026, at the Constitution Center in Washington, DC. Alternative dates may be considered based on instructor availability and mutual agreement. A copy of the Statement of Objectives (SOO) is attached to this Sources Sought Notice/RFI. 2. Scope The Contractor shall provide in-person, instructor-led training on Device Development for Scientists for up to 30 participants at the Constitution Center in Washington, DC. The Contractor shall be responsible for developing and providing all course materials, including presentation slides, workbooks, handouts, and other instructional materials. All electronic course materials shall comply with applicable Section 508 accessibility requirements. Final course materials shall be submitted to the Contracting Officer (CO) at least two business days prior to the start of the training. 3. Learning Objectives The training should address, at a minimum, the following topics: Discovery Pathways Diagnostics Therapeutics Software as a Medical Device (SaMD) Target identification and validation Device Discovery and Concept Development Preclinical development Decision milestones and go/no-go criteria Target product profile Nonclinical studies Investigational Device Exemption (IDE) and Clinical Studies IDE studies and exemptions Stages/phases of clinical studies Types of data generated during clinical studies and how the data inform subsequent study design Labeling Drafting medical device labels and package inserts Academia and Industry Key differences between medical device development in academia and industry Intellectual Property U.S. patents and exclusivity considerations Regulatory Pathways Understanding the FDA regulatory pathway Device risk classifications: Class I Low Risk Class II Moderate Risk Class III High Risk De Novo Classification Regulatory submissions: 510(k) De Novo Premarket Approval (PMA) Expedited/accelerated programs: Breakthrough Devices Program Safer Technologies Program (STeP) Post-Market Considerations Medical device recalls and the post-market process Coverage, Coding, and Reimbursement FDA and Centers for Medicare & Medicaid Services (CMS) coordination Relevant pilot programs, including RAPID and TEMPO, as applicable Coding and reimbursement considerations 4. Instructor Qualifications Proposed instructor(s) shall have: A minimum of five years of relevant experience in medical device development; Demonstrated experience with the regulatory, scientific, and commercial topics identified in this notice; Relevant educational and professional experience; and A master's degree or higher in a field related to the course subject matter. Respondents should provide resumes or curricula vitae (CVs) for proposed instructor(s) demonstrating the required qualifications and experience. 5. RFI Questions Interested parties are requested to address the following questions in their response:…