Overview

BSC supports surgical device development across general surgery, including laparoscopic systems, robotic surgery platforms, surgical staplers and sealants, energy-based devices, and surgical navigation systems. Our experience spans both open and minimally invasive surgical techniques.

Specialized Capabilities

Surgical outcome composite endpoint design. Handling of surgeon learning curves in statistical models. Non-inferiority designs for surgical device equivalence. Complication rate analysis with appropriate risk adjustment. Economic endpoint integration (length of stay, resource utilization).

Regulatory Experience

We understand FDA expectations for surgical devices, including appropriate concurrent controls, handling of surgeon variability, and demonstration of device safety across skill levels. Our team has experience with both substantial equivalence (510(k)) and PMA pathways.

Representative Studies

• Laparoscopic and robotic surgical systems.

• Surgical staplers and closure devices.

• Energy-based surgical devices (electrosurgery, ultrasonic).

• Surgical mesh and fixation products.

• Surgical navigation and guidance systems.