RWE-Driven MedTech: Meeting Clinical Evidence Needs of Higher Risk Devices

Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a globally acting consultancy company based in Germany. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has vast experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG) and International Standards. He spent the last years of his career at TÜV SÜD training and educating various stakeholders on EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving relevant designation ensuring continuity of the healthcare system in the interest of patient populations.

Dr. Ziskoven is a clinical expert at TÜV Rheinland LGA Products GmbH (NB 0197) and a board licensed physician for trauma and orthopedic surgery. He participated in the evaluation and drafting of guidelines and position papers in the context of Team-NB, and is an auditor for ISO 13485, MDD and MDR.

Amelia Hufford, PhD, is the Senior Vice President of Clinical and Regulatory Science and Co-Founder of 3Aware, a clinical data solution serving the real-world data needs of healthcare and medical device manufacturers. Dr. Hufford has 20 years of experience in scientific and clinical research including 10 years within the MedTech industry. She has led teams in regulatory and clinical affairs and has guided the approval and continued market access of many medical products. Dr. Hufford and 3Aware have pioneered methods of uncovering key elements of patient outcomes following treatment, negating the need for costly study investment and revealing a product’s value for patients.

David Breiter is the Vice President of Clinical Research, Medical Sciences, Regulatory Affairs, and Health Economics, Policy, and Reimbursement (HEPR) at Medtronic's Cranial and Spinal Technologies division. In this role, he oversees clinical research initiatives, medical science strategies, regulatory affairs, and health economics policies to support the development and approval of medical technologies in the cranial and spinal sectors. His extensive experience in clinical research, regulatory affairs, and medical sciences has been instrumental in advancing medical technologies and therapies in the cranial and spinal fields.