Orthopedics & Spine
With nearly 40 years supporting orthopedic and spine device manufacturers, BSC has established unmatched regulatory expertise in musculoskeletal research. We've guided spinal fusion systems, joint replacements, and fracture fixation devices through complex FDA pathways, delivering efficient approvals and defensible statistical strategies.
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.
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
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