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Regulatory Strategy: FDA Medical Device Approval

Situation

A device start-up company spent nine years in product development and had yet to receive IDE approval to begin clinical trials in the United States.  The company had secured a critical pre-IDE meeting with FDA to discuss steps towards approval.  Previous meetings with the agency had not gone well, and the company wanted to ensure that their scientists and engineers had a focused strategy and could clearly and succinctly address the agency’s concerns.

Solution

3D Communications assigned a scientific lead and a communications lead to the project to review all submissions, publications, and communications between the agency and the sponsor.  We then conducted a messaging session, which became the cornerstone for the discussion and presentation with the agency. To ensure speakers could confidently deliver their messages and handle objections from the FDA, we conducted speaker training with realistic on camera role-plays.  Our focus was on making sure messages were directly linked to the overall strategy, and that the team was repeatedly and credibly bridging back to these key messages throughout the meeting.

Results

The CEO and VP of Clinical & Regulatory deemed the meeting a success, and used it as a springboard for submission of the IDE response, and continued communication with the FDA to move the application forward.

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