Situation
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.
Solution
Bright proposed a unique two-study strategy: one study would focus on the product’s general application to help the client get their device on the market sooner (Study 1), and the other study would help the client obtain additional market authorization for a more clinically specific indication (Study 2):
Study 1 (get the device on the market):
Goal:
Evaluate safety and procedural success of the device when used in standard PCIs, using a straight-forward study design with standard enrollment processes.
Expected Result:
With a robust dataset, the client could aim to commercialize the device with a general indication for use.
Study 2 (pursue the specific indication):
Goal:
Evaluate safety and procedural success of the device when used in emergent clinical scenarios occurring during PCIs, using enrollment processes specific to emergency research (e.g., “exceptions from informed consent” [EFIC], subject to regulatory approval).
Expected Result:
Because of the additional regulatory burden and the sporadic nature of emergent situations, this study would likely require a longer timeline compared to Study 1, even with leveraging much of the same infrastructure. While the timeline would be longer, this path would help the client seek the desired specific indication.
The client agreed to the strategy and planned to launch both studies in parallel.
Significance
Bright’s innovative two-study strategy has played out successfully thus far. Study 1 has wrapped up enrollment, and the client is executing the regulatory process to commercialize their device for use in PCIs. Once Study 2 is completed, the client plans to request the specific labeling claim they ultimately desired, elevating their essential device to a potentially life-saving product.
Learn more about partnering with Bright for creative solutions to your clinical research needs.
