Arthrex, DJO, NuVasive, Aesculap, Wright Medical, Globus Medical, ConMed, Orthofix, Exactech and Acumed range in annual revenue from $250 million to $2 billion and account for ~16% of the orthopaedic market's $48.1 billion. Unlike the Top 5, they each specialize within one or two segments of joint reconstruction, spine, arthroscopy/soft tissue and extremities.
To prepare for a VAC, it helps to think like a VAC. Device companies have experienced success in establishing their own market access advisory panels, with representatives who have previous VAC experience.
Tim Hunter of Musculoskeletal Clinical Regulatory Advisers shared tactics that medical device companies can use along the road to product commercialization, easing the reimbursement challenge and building cross-departmental solidarity.
More than 20 companies from 11 countries received their first 510(k) in 1H17. Of the clearances, 40% were for trauma products, 30% for spine, with the remainder addressing joint reconstruction, arthroscopy equipment and biologics.
EU Medical Device Regulation, Additive Manufacturing, Raw Materials, QMS, FDA Updates, DFM. These subjects and more are covered in presenter slides, available now.
Combined, the companies would offer products for bone and soft tissue regeneration based on CellRight's human-derived bone grafts and Tissue Regenix's dCELL decellularization platform.
ConMed will acquire the ExoShape Anterior Cruciate Ligament fixation system, as MedShape seeks to focus growth on its core foot and ankle products--including new investments.
Zimmer Biomet announced preliminary 2Q17 revenue and the departure of David Dvorak, its CEO of ten years, as well as resignation of Adam Johnson, Group President for the Spine, Dental, Craniomaxillofacial and Thoracic group.
