Bringing Orthopedic Products to Market

Orthopedic medical device companies are in the business of improving quality of life for millions of patients around the world. However, bringing the newest technologies to market is not always easy. There is a long and hard road ahead of anyone seeking to introduce new ortho devices and other MedTech solutions. 

In addition to the intricacies of the clinical trial phase, other considerations include navigating the regulatory environment and satisfying insurance providers’ requirements for reimbursement. Unfortunately, not all orthopedic device companies have the resources and bandwidth necessary to overcome all these obstacles. This is where MCRA’s expertise in orthopedic device consultation can be an invaluable resource.

Our Experience in Orthopedics

Led by the former Branch Chief of the US FDA's Orthopedic Devices Branch and the most experienced orthopedic team in the world, and with over 160 site and 350 surgeon relationships within the US neuro-musculoskeletal space, MCRA is skillfully positioned to take on any orthopedic projects. 

Partnering with manufacturers within the orthopedic specialization, our experts provide a wealth of knowledge and market savvy that ensures the smoothest journey to market. Our expertise makes it possible for new orthopedic products to reach the people who need them the most as quickly and successfully as possible. 

MCRA's highly-specialized approach has culminated in expert-level knowledge of, but not limited to:

  • Joint Reconstruction

  • Spine

  • Trauma

  • Arthroscopy/Soft Tissue Repair

  • Orthobiologics

Our mission is to ensure orthopedic medical device and biologic companies have all the support they need to bring their newest products to market. We provide global regulatory expertise, full clinical research organization capabilities, reimbursement and market access experience, quality assurance, healthcare compliance knowledge, and cybersecurity assistance. We’re committed to delivering best-in-class services in every regard, helping our clients achieve their product development and commercialization objectives in the most effective and efficient manner. 

The sheer depth of our services with regard to orthopedic consultation enables us to help our clients throughout every stage of the innovation process. We assist orthopedic manufacturers in guiding their new technologies through conception, pre-market development, regulatory approval, and finally widespread market use and payer adoption. In everything we do, our goal is to ensure that the latest medical technology reaches the people who need it the most, the patient. 
 

Contact an Orthopedic Expert

 

Our Team

Everything we do for our clients is made possible only through the expertise and dedication of our team. The orthopedic specialization of our experts means we can provide the companies we serve with comprehensive knowledge across all aspects of our services. Meet the members of our team below.

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Hollace Rhodes

Hollace Rhodes

Vice President, Orthopedic Regulatory Affairs
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Dave McGurl

Dave McGurl

Vice President, Regulatory Affairs
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Hannah Irwin

Hannah Irwin

Director, Regulatory Affairs
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Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA

Mehdi Kazemzadeh-Narbat, Ph.D., PMP, CQA

Director, Regulatory Affairs
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Veronica Downen, M.S., RAC

Veronica Downen, M.S., RAC

Director, Regulatory Affairs

Orthopedic Medical Devices Services