TÜV SÜD Product Service
Dr. Max Singh is the Global Director of the Orthopedic Focus Team at TÜV SÜD Product Service. Prior to this role, he spent about 15 years in the medical device industry, mainly working in the orthopaedic sector. He held several positions in R&D, where he was in charge for de-signing medical devices for knee, hip, trauma, and spine surgery. He also has strong experiences in computer-assisted surgery (CAS) and surgical robotics. Besides R&D, he was also responsible for product management and marketing of large amounts of product portfolios. Through global launch activities, he was exposed to the international regulatory requirements in the medical de-vice industry.
Dr. Singh holds academic degrees in medical engineering and business administration. In his doctoral research, he investigated various aspects of spine surgery technologies in the U.S. medical device industry. Within TÜV SÜD, he is strongly involved in the matter of spinal classification according to the Medical Device Regulation (MDR).
Quality in Product Innovations for Start-Ups, SME, and Incumbent Medical Device Manufacturers Through the New EU Medical Device Regulation
Medical device innovation under the new Medical Device Regulation (EU MDR 2017/745) will become a challenge for manufacturers, since more stringent requirements need to be met. This will affect, amongst others, quality in product innovations. Since the EU MDR will become fully applicable in May 2020, there is also not much time left for all stakeholders to fully comply with the new regulation. Furthermore, large manufacturers might have an advantage over small- and medium sized enterprises (SME) and start-ups due to their evolved processes and the availability of larger amounts of resources within their organisations. Since SME and start-ups account for more than 90% of all types of manufacturers in the EU medical device industry and because these types of firms are generally related to innovative healthcare products, the competitiveness of European MedTech market might be challenged compared to other regions in the world.
Initially, this presentation aims to provide an overview of the EU MDR including its implications for manufacturers. The main drivers in the evolvement of the new EU MD, which has the multiple size compared to the existing directives, will also be presented. Then, important timelines and changes will be shown to highlight the consequences for the different types (sizes) of medical device manufacturers. In the end, chances for innovation under the scope of the MDR will be discussed.