On January 29-30, 2014, CTTI’s QbD Project held a workshop focused on clinical trials that evaluate medical devices (diagnostic and therapeutic). The objectives for this workshop were similar to previous QbD Workshops:

• To develop understanding of risk-based Quality by Design (QbD) for clinical trials, from general principles, real-world examples, and hypothetical case studies;
• Gain confidence in the application of such concepts to clinical trials;
• Identify obstacles to the adoption of this approach;
• And identify opportunities for dissemination of these principles and practices to a broad array of stakeholders.