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FDA Advisory Committee Preparation: Devices

Situation

A small start-up medical device company with no previously approved devices, worked for more than 15 years to develop and clinically evaluate their novel, first-of-a-kind technology. This technology was indicated for patients who were not candidates for any other drug or surgical therapy. The company had a challenging history with FDA due to a revolving door of statistical reviewers over the 15-year process, and a medical reviewer who publically stated that he didn’t believe the technology worked, even before reviewing the results of the clinical trial.

Approach

3D worked closely with the company on strategy, scripting, slide development, panel packet review, Q&A practice, and speaker training. In addition, when the company received an extremely negative FDA draft panel pack, 3D quickly developed a revised strategy to proactively discuss the issues with FDA management and revise the company’s core presentation to directly address every major negative point made in the FDA panel pack. This strategy pre-empted the FDA presentation and provided the panel members with the company’s perspective BEFORE the Q&A started.

Results

The FDA advisory panel voted 11-0 recommending approval. Although still awaiting final approval, the FDA has indicated that they want to work quickly and interactively to bring this critical therapy to patients.