Spinal Medical Device Consultants

Bringing Spinal Devices to Market

Companies that manufacture medical devices for spinal health are under pressure on numerous fronts when it comes to bringing their product to market. Not only do they need to be aware of regulatory considerations, they also need to ensure reimbursement and quality assurance is handled correctly to keep the flow of innovation moving in the right direction. 

Meeting all these challenges is only made more difficult by the fact that many of these organizations lack the necessary resources and expertise in key areas. Even as the technology accelerates into new areas of capability, spine device companies may find themselves lagging behind the rest of the industry. It requires specific expertise and knowledge to bring new products into the spinal medical device market with any success.

Our Experience in Spinal Technology

Fortunately, MCRA is here to provide companies within this sector expert spinal device consultation to help them find their spot in the marketplace. Guided by decades of experience and industry know-how, in combination with firsthand global regulatory experience, MCRA Spine is the leader in assisting clients in the entire spinal medical technology life cycle, from research and development, through commercialization. Standing by their side every step of the way, our consultants make sure clients’ spine products meet all internal and external criteria so they will have the smoothest and most successful launch. 

MCRA's expertise with spinal devices has been strengthened through projects with over 500 spine medical device companies in the past 20 years. These projects range from regulatory strategies for design concepts all the way through FDA Pre-Submissions and the ultimate marketing submissions, including 510(k)s, De Novos, and PMAs.

MCRA’s team has extensive experience with spine devices including the following technologies:

• Cervical/Lumbar Disc Replacements
• Posterior Stabilization
• Annular Repair
• Nucleus Augmentation
• Combination Devices & Fusion Biologics
• Interbody Cages
• Pedicle Screw Systems (Occiput - Sacral Spine)
• Nonfusion Scoliosis Correction & Stabilization
• Anterior Cervical/Lumbar Plates
• Instrument Navigation Systems
• SI Joint Fixation
• Facet Fixation
• Vertebral Body Replacements
• Vertebral Augmentation (e.g., Kyphoplasty)
• Laminoplasty Plates
• Bone Void Fillers
• Spinous Process Plates

MCRA is routinely at the forefront of the MedTech industry, helping clients navigate the ever-changing guidance across the globe for all device types, manufacturing processes, and materials in the spine industry. MCRA understands and believes in the total product lifecycle to foster device generation changes and will assist clients with design strategy, including consideration of the regulatory value of design iterations and real-world evidence collection.

As a leading advisor to spine device companies, we offer a wide range of capabilities designed to serve our clients. These include our global regulatory expertise, comprehensive CRO services, reimbursement and market access, quality assurance, healthcare compliance, and cybersecurity. 

No matter what we do for our clients, our goal is always to provide the best services to help them achieve their goals with regard to product development and commercialization. Our portfolio of services for spinal technology manufacturers ensures we can assist our clients through every stage of their innovation process. From ideation to pre-market development to regulatory approval and widespread market use, we serve as stewards of technology. Our strong sense of social responsibility is a core component of what we do, and it fuels our drive to bring the most advanced medical technologies to those who need them the most. These are the qualities that have carried us to a position of leadership within the industry. 
 

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