Overview
Misalignment between clinical and regulatory strategy is one of the most common (and costly) sources of delay in IVD development. In this presentation, Emily Friedland, VP of Clinical Research at DCN Dx, introduces a practical 360° framework for aligning claims, evidence, study design, and regulatory expectations from the earliest stages of development through submission.
Delivered at AMP 2025, the talk draws on real-world case studies where otherwise promising diagnostics stalled or failed due to siloed decisions, unclear intended use, weak claim-to-evidence mapping, or late-stage corrections. Rather than focusing on theory, the presentation shows how early, integrated planning across clinical, regulatory, data, and usability disciplines can reduce rework, minimize risk, and improve submission quality across the IVD lifecycle.
Why You Should Download
1. Understand why clinical–regulatory misalignment causes programs to fail
See how common breakdowns—vague intended use, disconnected evidence strategies, or delayed human factors work—create downstream problems that are difficult to recover from.
2. Learn the 360° Alignment Framework for IVD development
The presentation outlines a structured approach to aligning claims, clinical evidence, biostatistics, usability, and regulatory strategy into a single, cohesive plan.
3. Explore real case studies and failure modes
From rejected FDA submissions to failed clinical trials, these examples show exactly where programs went wrong and what could have been done differently.
4. Design studies for the label you intend to submit
Evidence should be generated intentionally to support regulatory claims, not retrofitted late in development.
5. Reduce late-stage surprises and rework
Learn how early cross-functional planning can prevent amendments, resets, and last-minute strategy shifts that cost time and momentum.
