Simplyfing Complex Science for FDA Success

The Challenge:

CraniUS Therapeutics needed an animation and technical schematics to clearly communicate their device’s mechanism and intended use for a pre-submission meeting with the Food and Drug Administration (FDA). Their challenge was simplifying a highly complex product for regulators while ensuring that the principles of operation, fit, and function were conveyed effectively.

The Solution: 

We quickly aligned with their business objectives and distilled complex information into a concise narrative. Our team delivered:

  • A high-quality animation demonstrating how the device administers medication to the affected part of the brain.
  • Simplified engineering line drawings to showcase the device’s fit, form, and function.
  • A principle of operation schematic that clearly illustrated how the system works and its intended use for the target patient population.

The Impact:

With these assets, CraniUS effectively communicated the device’s functionality and intended outcomes during their FDA meeting. This resulted in a productive discussion and a clear understanding of the most likely regulatory pathway for their device.

Capabilities Delivered:

  • Concept development and animation
  • Technical schematic design
  • Principle of operation documentation
  • Regulatory communication support
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