SUCCESS STORY

Beyond Statistics: Using the Totality of the Evidence to Gain Medical Device Approval

Using the totality of the evidence is key for gaining medical device approval. To successfully execute a strategy that tells the whole clinical story, given the available data, Bright leveraged the expertise of — and relationships built between — Bright, the client, the study's national PI, and the FDA. In the end, this approach contributed to the ultimate success: PMA approval.

SUCCESS STORY

Bright’s Novel Endpoint Proposal Creates Success for Med Device Start-Up

Opting for a rare clinical event endpoint meant that a medical device company’s proposed clinical trial would require thousands of subjects and a years-long enrollment period. Options were limited as all prior device studies in this therapeutic space had used this same rare endpoint, too.

SUCCESS STORY

A Two-Study Strategy for an Emergent-Use Device

A medical device company developed a brilliant solution for a rare but life-threatening situation that could be encountered during standard percutaneous coronary interventions (PCIs). Due to the complexity of PCIs and the infrequent but very serious nature of the clinical situation where this device would be needed, gathering data on device safety and efficacy was going to be difficult. With the FDA requiring a robust, prospective clinical trial, the client needed to figure out a way to overcome this data-gathering challenge and get their device on the market. It was Bright’s time to shine.

Bright Success Stories

SUCCESS STORY

Beyond Statistics: Using the Totality of the Evidence to Gain Medical Device Approval

SUCCESS STORY

Bright’s Novel Endpoint Proposal Creates Success for Med Device Start-Up

SUCCESS STORY

A Two-Study Strategy for an Emergent-Use Device