Our Therapeutic Experience
Orthopedic & Neuro-Musculoskeletal
Neuro-musculoskeletal and orthopedic technologies are at the core of MCRA's 150+ years of combined experience. Led by the former Branch Chief of the US FDA's Orthopedic Devices Branch 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. 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
Spine
Spinal technologies have been a focus for MCRA's integrated service offerings since inception. Guided by decades of experience and industry know-how, in combination with firsthand US FDA experience, MCRA Spine is the leader in assisting clients in the entire technology life cycle, from research and development, through commercialization. MCRA's spine expertise has been strengthened through projects with over 500 clients in the past 10 years. Common spine consultants for MCRA include the following technologies:
- Cervical/Lumbar Disc Replacements
- Posterior Stabilization
- Annular Repair
- Combination Devices
- Interbody Cages
- Pedicle Screw Systems (Occiput - Sacral Spine)
- Anterior Cervical/Lumbar Plates
- Instrument Navigation Systems
- SI-Joint Screws
- Vertebral Body Replacements
- Vertebral Augmentation (e.g., Kyphoplasty)
- Laminoplasty Plates
- Bone Void Fillers
Cardiovascular
MCRA Cardio is at the forefront of one of the most robust and innovative therapeutic areas in medical technologies. Our mission is to provide best-in-class regulatory, clinical, and reimbursement services to help our clients achieve their product development and commercialization goals. We have structured our approach to navigating the regulatory and commercial landscape to align with the FDA's focus on the Total Product Life Cycle, a regulatory framework that integrates all aspects of product development. The battery of services in MCRA Cardio's portfolio therefore enables us to partner with our clients through the various stages of the innovation process, from conception, through pre-market development and FDA approval, to widespread market use and payor reimbursement. As stewards of technologies intended to treat the leading cause of death in the United States, MCRA Cardio's social responsibility is woven into the fabric of what we do, and fuels our passion to bring the most advanced medical therapies to those in need.
MCRA Cardio has decades of combined cardiovascular experience and direct oversight from a former FDA Branch Chief in cardiovascular devices, and is capable of taking on projects of any complexity, including (but not limited to) those within the following product areas:
- Cardiac Diagnostics Devices
- Cardiac Electrophysiology Devices
- Circulatory Support Devices
- Interventional Cardiology Devices
- Implantable Electrophysiology Devices
- Structural Heart Devices
- Vascular Surgery Devices
Woundcare
The extremely diverse nature of wounds make the treatments associated with them exciting and ever-changing. Woundcare technologies can range from the simplest to the highest classification and include tremendous variation in both use and complexity. MCRA's proprietary system of combining our integrated services in clinical trials lends itself very well to the woundcare technology lifecycle. Common woundcare consultations include technologies ranging from:
- Tissue Adhesives
- Films
- Gels
- Sutures
- Hemostats
- Combination Products
Biologics & Combination Products
Equipped with a superior knowledge base and deeply experienced management team, MCRA is well-positioned to help clients overcome the scientific and manufacturing complexities of biologic product development.
- Recombinant Proteins for Bone Growth
- Platelet Rich Plasma
- Cellular Products for Regenerative Medicine
- Hyaluronic Acid
- Adhesion Barriers
- 361 HCT/Ps
MCRA Device
In addition to core therapeutic experience, MCRA has played a pivotal role in the technology lifecycle for numerous innovations within other specialties. The diverse technical and scientific background of our team, in conjunction with centuries of combined experience have allowed our specialized approach to have widespread success. MCRA Device experience includes, but is not limited to:
- Dental
- Opthalmology
- Urology
- Robotic and Surgical Instruments
- Neurology
- Diagnostic Assays
- Radiation Therapy
- Obesity
- Imaging