Evp,Strategic Development
Current• Responsible for ensuring Paradigm Spine is in Compliance with “Regulations” and “Standards” and the “Quality Management System Manual”;• Responsible for identifying appropriate surgeon candidates for different Advisory Boards (Corporate, Scientific, Consultants and other Vendors);• Responsible for coordinating all activities of these Board Members and facilitating interaction with the Chairman and CEO; • Responsible for scientific and technology due diligence, and identifying new products and technologies through industry analysis and surgeon interaction;• Responsible for portion of post-market surveillance which includes gathering feedback from the field (e.g., information from conferences, FDA Warning letters, surgeons and Orthopaedic / Spine Journals);• Responsible for R&D of acquired technologies and technologies to be developed internally;• Responsible for reviewing and understanding all IP and patents for all technologies;• Responsible for interacting closely with Regulatory Consultants for the design and implementation of all IDE’s and 510(k)s. including clinical as well as testing;• Responsible for primary oversight in running clinical studies both in the USA and OUS; and• Responsible for directing and advising Company interactions with surgeons.• Responsible for new product development and research activities for “non-fusion technologies:➢ coflex™ : Interlaminar-Interspinous Dynamic Stabilization System for Spinal Stenosis ➢ DSS Spinal Stabilization System™, a posterior pedicle screw-rod dynamic system for DDD ➢ Paradigm Spine Interspinous Plating System for stabilization of interbody fusions ➢ Dynamic Cervical Implant, a metallic nucleus-like dynamic implant ➢ Orthobiom, a non-fusion Scoliosis system for growth in adolescent scoliosis ➢ Growing Spine Profiler, a non-fusion device for congenital scoliosis especially for Thoracic Insufficiency System
