SPINE & ORTHOPEDIC MEDICAL DEVICE CONSULTING

Bringing transformative musculoskeletal technologies to market faster

Building on MCRA's longstanding regulatory leadership in orthopedics and spine, IQVIA MedTech helps innovators reduce risk, strengthen evidence strategies, and accelerate market success through integrated clinical, regulatory, and commercialization support.

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Sub Brands MedTech Homepage Therapeutic Areas Orthopedic, Spine & Musculoskeletal MedTech Consulting

Partner with the industry's premier spine and orthopedic device regulatory and clinical advisors

Innovation across spine and orthopedic technologies is advancing rapidly, with advances in motion-preserving implants, interbody fusion systems, patient-specific systems, joint replacement, biologics, robotic-assisted surgery, and navigation platforms driving more personalized care.

Building on MCRA's longstanding regulatory leadership in spine and orthopedics, IQVIA MedTech helps innovators navigate complexity, strengthen evidence strategies, and accelerate commercialization through integrated clinical, regulatory, and market access expertise.

Clinical Research
Clinical trials, registries, and evidence generation for orthopedic and spine technologies
Regulatory Services
Regulatory strategy, submissions, and global market authorization support for orthopedic and spine devices
Reimbursement & Market Access
HEOR, coverage, coding, payment strategy, and evidence development to support market access and reimbursement success
Commercialization
Market assessment, launch planning, competitive intelligence, and commercialization strategies to support growth and adoption
Quality & Compliance
QMS, risk management, manufacturing quality, remediation, and post-market surveillance expertise

Specialized expertise across orthopedic, trauma, and spine technologies

Orthopedic innovation spans implants, fixation systems, enabling technologies, and procedural solutions that require specialized clinical, regulatory, and commercial expertise. IQVIA MedTech supports a broad range of musculoskeletal technologies, including:

Beyond Traditional Devices: Orthobiologics, Robotics, and Digital Orthopedics

As musculoskeletal technologies become increasingly connected, data-driven, and multidisciplinary, innovators face challenges that extend beyond traditional device development. IQVIA MedTech helps companies navigate the clinical, regulatory, and commercial complexities associated with next-generation orthopedic innovations.

SECURED THE INDUSTRY’S FIRST-EVER ORTHOPEDIC GRANT FROM THE US FDA

SECURED THE INDUSTRY’S FIRST-EVER SPINE DE NOVO GRANT FROM THE US FDA

90+

ORTHOPEDIC AND SPINE CLINICAL TRIALS CONDUCTED

Translating strategy into commercial reality: A historic orthobiologics milestone

Innovative orthobiologics firm BONESUPPORT™ needed a comprehensive U.S. strategy to launch CERAMENT® G — a novel, antibiotic-eluting bone graft substitute — into the healthcare market. Facing extreme regulatory scrutiny with no clear market precedent, the company required specialized guidance to navigate this intricate drug-device combination product.

To ensure a successful commercialization timeline, BONESUPPORT™ engaged MCRA for end-to-end orthopedic medical device consulting. The goal was to simultaneously unlock a market-first FDA regulatory pathway and secure vital reimbursement metrics to drive hospital adoption.

CHALLENGE

Bringing a novel combination product into the U.S. musculoskeletal medtech sector presents massive regulatory and post-clearance adoption hurdles. The client faced an entirely unmapped clinical review pathway, demanding rigorous discussions and intensive technical negotiations with the FDA.

Hospital networks operating under fixed surgical bundles presented a strong barrier to adopting a premium, high-cost antibiotic bone graft. To protect their timeline and ensure long-term financial viability, the client needed an integrated approach addressing regulatory clearance and lucrative government reimbursement metrics at the same time.

Solution

The MCRA advisory team engineered a dual-pronged clinical, regulatory, and market access strategy utilizing specialized orthopedic device regulatory consulting alongside proactive public policy defense.

Leveraging deep orthopedic expertise, our regulatory specialists guided BONESUPPORT™ through the FDA De Novo pathway for combination products. Concurrently, our market access team leveraged the product's Breakthrough Device Designation to petition CMS, securing specialized new-technology payment models for inpatient and outpatient settings.

Results

CERAMENT® G achieved a historic victory as the first-ever drug-device combination product granted an FDA De Novo classification in its category. Securing Medicare’s NTAP (inpatient) and TPT (outpatient) status effectively eliminated financial barriers to hospital adoption at launch.

“We’ve worked with MCRA since 2016. MCRA’s integrated service divisions have been very helpful and supportive in providing valuable strategic guidance and project support to BONESUPPORT since that time. I have been extremely happy with our decision to work with MCRA in support of our US Regulatory needs which is evidenced by this De Novo achievement.”

—Emil Billbäck, Senior Advisor and Former CEO, BONESUPPORT

Download the full orthobiologics case study

MCRA IS NOW PART OF IQVIA MEDTECH

Orthopedic & Spine Expertise That Accelerates Innovation

From joint reconstruction and trauma to spinal implants and biologics, MCRA helps orthopedic and spine innovators navigate every stage of the product lifecycle. We help bring complex musculoskeletal technologies to market with confidence.

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Frequently asked questions about orthopedic medical device consulting

Unlike other domains, load-bearing implants face rigorous mechanical, wear, and fatigue testing standards (such as ASTM and ISO fatigue protocols) before clinical data can even be considered. Our specialized orthopedic device regulatory consulting team coordinates with mechanical testing labs early in development. This ensures that your bench-testing data meets the exact technical requirements set by FDA reviewers and European notified bodies.

MCRA is widely recognized as the industry's premier advisory force for orthopedics and spine care, having successfully led the pathways for the industry’s first orthopedic and spine De Novo grants. By embedding this specialized force within IQVIA's global trial footprint, clients receive direct support from former FDA CDRH Orthopedic Branch Chiefs, specialized biomedical engineers, and veteran biostatisticians who understand how regulatory bodies evaluate bone-anchored technologies.

Hospitals operate under highly constrained diagnostic-related group (DRG) payment models for orthopedic surgeries. If a novel device significantly increases procedural costs without clear economic data showing reduced rehabilitation times or lower revision rates, hospitals will not adopt it. Our market access team works alongside clinical designers to embed the specific health economics endpoints needed to secure sustainable, long-term reimbursement for orthopedic devices from global payers.

De-risk your development and claim your market position

Partner with our experts across clinical development, regulatory strategy, and commercialization to confidently accelerate your path to market.

TALK TO AN ORTHOPEDIC, SPINE & MUSCULOSKELETAL EXPERT

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