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.
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 Areas
Orthopedics & Spine
Hundreds of successful device trials
Overview
BSC has supported hundreds of orthopedic and spine device trials, establishing us as a leading statistical partner in musculoskeletal research. Our expertise spans spinal fusion systems, joint replacement devices, fracture fixation products, and soft tissue repair technologies.
Specialized Capabilities
Composite endpoint design combining radiographic and clinical success criteria. Handling of surgeon and site variability through hierarchical modeling. FDA panel meeting experience for Class III orthopedic devices. Expertise in pain and function endpoints (VAS, ODI, WOMAC, SF-36). Historical control methodologies for rare orthopedic conditions.
Regulatory Experience
We understand the orthopedic division's expectations for imaging core labs, independent radiographic assessment, and durability. Our team has successfully navigated complex discussions around equivalence margins, non-inferiority designs, and superiority claims for next-generation devices.
Representative Studies
Lumbar fusion systems (TLIF, ALIF, posterior instrumentation).
Total joint arthroplasty (hip, knee, shoulder).
Spinal cord stimulation devices.
Bone graft substitutes and biologics.
Extremity fracture fixation systems.
Design
We use innovative approaches — Bayesian design, adaptive clinical trial design, and Propensity Score Matching — to reduce costs, overcome limited data access, and minimize 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 – the good, bad, and ugly.”
• Vice President, Clinical Operations
• Former FDA Regulator
• CEO, Medical Device Company
Featured Resources
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from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
Featured Resources
Get regulatory insights
from BSC®
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®