PERFORMANCE WORK STATEMENT_Amend 0002 10-14-26.pdf

Revised PWS — Amendment 0002

PERFORMANCE WORK STATEMENT (PWS)

BARDA Device Development for Scientists Training

1. Background

The Biomedical Advanced Research and Development Authority (BARDA) requires commercial training services to enhance participants' understanding of the scientific, regulatory, clinical, intellectual property, and commercial considerations associated with medical device development. The training is intended to provide participants with an understanding of the medical device development lifecycle and the key considerations associated with progressing a medical device from discovery and concept development through regulatory review, commercialization, and post-market activities.

2. Objective

The objective of this requirement is to obtain a qualified Contractor to provide a two-day, in-person, instructor-led training course on Device Development for Scientists. The training dates are 11-12 January 2027

The training shall provide participants with an understanding of the scientific, clinical, regulatory, intellectual property, and commercial considerations involved in medical device development and bringing medical devices to market.

3. Scope

The Contractor shall provide a two-day, in-person, instructor-led training course for up to 30 participants at the Constitution Center in Washington, DC.

The Contractor shall provide qualified instructor(s) and all course materials necessary to conduct the training.

Course materials may include presentation slides, participant workbooks, handouts, case studies, exercises, or other instructional materials appropriate for the course.

The Contractor shall ensure that the course addresses the learning objectives identified in Section 4.

4. Training Requirements and Learning Objectives

The Contractor shall provide training addressing, at a minimum, the following subject areas.

4.1 Medical Device Discovery and Development

The training shall address:

• Discovery and development pathways applicable to diagnostics, therapeutics, and Software as a Medical Device (SaMD);

• Context of Use (COU) Medical device discovery and concept development;

o Preclinical development;

o Development decision milestones and go/no-go criteria;

o Target product profiles; and o Nonclinical studies.

4.2 Clinical Development

The training shall address:

• Investigational Device Exemption (IDE) studies and applicable exemptions;

o Clinical investigations applicable to medical devices;

o Types of data generated during clinical studies; and o How clinical study data inform subsequent study design and development decisions.

4.3 Regulatory Pathways

• The U.S. regulatory pathway for medical devices;

• Medical device risk classifications, including:

o Class I – Low Risk;

o Class II – Moderate Risk;

o Class III – High Risk; and o De Novo classification, as applicable;

• Medical device submission pathways, including:

o 510(k) premarket notification;

o De Novo classification requests; and o Premarket Approval (PMA);

• Accelerated device programs, including:

o Breakthrough Devices Program; and o Safer Technologies Program (STeP); and

• Considerations associated with drafting medical device labeling and package inserts.

• Joint review by CMS and FDA (RAPID and TEMPO Pilot programs) in coding and reimbursement

4.4 Commercialization and Intellectual Property

• Key differences between academic and industry approaches to medical device development and commercialization;

• U.S. patents and exclusivity considerations relevant to medical device development; and

• Coding, coverage, and reimbursement considerations, including relevant FDA and Centers for Medicare & Medicaid Services (CMS) initiatives.

4.5 Post-Market Considerations

• Post-market considerations applicable to medical devices; and

• Medical device recalls and their role in the post-approval/post-market process.

5. Course Materials

The Contractor shall provide all instructional materials necessary to conduct the training.

Course materials may include presentation slides, participant workbooks, handouts, exercises, case studies, or other supporting materials.

Applicable Contractor-provided electronic course materials shall comply with applicable Section 508 accessibility requirements.

Final electronic course materials shall be provided to the Contracting Officer (CO), or Government representative designated by the CO, no later than two business days prior to commencement of the training.

6. Instructor Qualifications

The Contractor shall provide qualified instructor(s) with demonstrated expertise relevant to the subject matter of the course.

Proposed instructor(s) shall have:

• A minimum of five years of relevant professional experience in medical device development;

• Education and professional experience demonstrating knowledge of the subject areas identified in Section 4; and

• A master's degree or higher in a field related to the course subject matter.

7. Period of Performance

The Government’s training dates for this requirement are 11-12 January 2027. The training shall consist of two days of in-person instruction.

8. Place of Performance

The training shall be conducted in person at:

Constitution Center 400 7th Street SW Washington DC 20024 The Government will provide the training location.

8.1. Facility Access and Security Vetting

Contractor instructors who are not U.S. citizens shall submit all information required for security vetting through the Government-designated secure method, not by unencrypted email, no later than ten (10) business days before the scheduled training start date

9. Participants

The Contractor shall provide training for up to 30 participants.

10. Deliverables

11. Government Responsibilities

The Government will:

• Provide the training facility at the Constitution Center in Washington, DC;

• Coordinate participant attendance; and

• Provide the Contractor with appropriate facility access and logistical information necessary to conduct the training.