MCRA’s Orthopedics team is at the forefront of one of the most robust and innovative therapeutic areas in MedTech.
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.
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.
Orthopedic Medical Devices Services
-
Orthopedic Medical Devices Clinical Research Organization (CRO)
Our proven integrated expertise, physician and site relationships, and dedicated team of experts all work together to help bring orthopedic products to market. We provide all the scientific expertise to lead the way for orthopedic manufacturers. Our knowledge of the research phase ensures their products meet all the most rigorous criteria.
-
Orthopedic Medical Devices US Regulatory
The FDA approval process can be complicated and challenging, but our expertise and deep understanding of the history and regulatory precedent makes it much easier for our clients to navigate it. With our long history of success in helping bring new products to market, device manufacturers won’t have to worry about being hung up in red tape.
-
Orthopedic Medical Devices Global Regulatory
When attempting to bring new devices to markets overseas, you need comprehensive regulatory and scientific leadership that we are uniquely positioned to provide. Competing in international markets opens new opportunities for medical device companies, and we leverage our orthopedic device consultation services to make it possible.
-
Orthopedic Medical Devices Reimbursement, Health Economics, and Market Access
With more than 50 years of experience in terms of reimbursement, health economics, and public policy services, you can count on us. We’re dedicated to ensuring our clients have all the available revenue streams they need to drive growth and further innovation.
-
Orthopedic Medical Devices Quality Assurance
We can help you manage your document control, R&D, risk management, software development, supplier evaluation, measurement equipment control, and other critical processes. We leave no stone unturned to provide our clients with absolute confidence in the quality and performance of the devices they create.
-
Orthopedic Medical Devices Healthcare Compliance
We know how to bring new devices successfully through even the most complex legal and regulatory obligations. There’s nothing worse than leaving a promising technology to wither on the vine due to compliance issues, which is why we’re committed to helping clients avoid that scenario.
Learn more about our orthopedic medical devices compliance assistance here.
-
Orthopedic Medical Devices Cybersecurity
Advanced medical technology needs to be protected against cybercriminals and data breaches, and we have the know-how to do so. Protecting patients’ most valuable information is of the utmost importance in today’s increasingly connected world, which is why we don’t rest until all gaps in cybersecurity are closed.