General Surgery & Minimally Invasive Devices
BSC® supports surgical device manufacturers with statistical strategies that demonstrate procedural benefit while addressing FDA's safety expectations. From robotic systems to minimally invasive instruments, we help you build compelling evidence for both regulatory approval and clinical adoption.
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
- Surgical staplers and closure devices.
- Energy-based surgical devices (electrosurgery, ultrasonic).
- Surgical mesh and fixation products.
- Surgical navigation and guidance systems.
- Laparoscopic and robotic surgical systems.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"Battle ground tested."
"There is nothing that David and team haven’t seen over the years – the good, bad, and ugly.”
Vice President, Clinical Operations
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company