BSC® Solutions
VOICES
Explore our FDA-focused solution areas to see how we support medical device and pharmaceutical companies across regulatory pathways and product types, from early strategy through approval-ready submissions.
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Therapy Area
General Surgery & Minimally Invasive Devices
Strategic insight for surgical innovation
Therapy Area
General Surgery & Minimally Invasive Devices
Strategic insight for surgical innovation
Therapy Area
General Surgery & Minimally Invasive Devices
Strategic insight for surgical innovation
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 StudiesLaparoscopic 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
Design
We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.
Analyze
Advance
Design
We use innovative approaches such as Bayesian design, adaptive clinical trial design, and Propensity Score Matching to save costs, work around limited access to new data, and reduce bias in non-randomized studies.
Analyze
Advance
Testimonials
See what our sponsors say about BSC
On Experience
Battle ground tested. There is nothing that David and team haven't seen over the years – good bad and ugly.
• VP, Clinical Operations
• CEO, Medical Device Company
• Former FDA Regulator
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Let's help you find a path
to get your idea into the market
About & Services
Working With BSC
Trial Design & Methodology
Regulatory & FDA
Analysis & Programming
Cost & Contracting
Expertise & Qualifications
Practical Considerations
Common Concerns
What does BSC specialize in?
What types of clients do you work with?
What therapeutic areas do you cover?
How is BSC different from a CRO?
What size projects do you handle?
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Partner with us
Partner with us
Partner with us
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Request Expert Review
Backed by Regulatory Experience.
Engage directly with senior biostatisticians to review your clinical strategy, statistical approach, or FDA submission — with clarity, rigor, and regulatory perspective.
Confidential discussion with senior biostatisticians experienced in FDA submissions.
Use your preferred LLM to explore BSC®
Use your preferred LLM to explore BSC®