Once a new product is ready for commercialization it yet needs market access to the targeted geographies. On the one hand, regulatory approval is required, like, for instance, CE-conformity in EU-countries or FDA-approval in the US. On the other hand, reimbursement needs to be approved by the healthcare system of a respective target country. Both approval processes are complex, and expensive, and present critical challenges for medical device Start-ups and SMEs. These challenges will further increase as in-country reimbursement continues to be more and more subject to a Health Technology Assessment (HTA).
Too often, particular technical specifications and documentation standards that present key requirements of achieving regulatory approval and reimbursement are being managed insufficiently along the product development process. Consequently, a medical device company may create a well differentiated and competitive product that meets clinician’s needs, but misses optimal regulatory approval and reimbursement. As a result, MedTech entrepreneurs fail to accomplish their market share-, profitability- and sales goals.
Experts:
Dipl.-Volksw. Michael Weisser Chief Operating Officer & Authorized Representative of AiM GmbH Assessment in Medicine - Research and Consulting
A graduate in economics, with specialization in hospital management and social security systems, Mr. Weisser has 8 years’ experience in reimbursement affairs and Health Technology Assessment (HTA) in Europe. He has been the authorized representative and chief operating officer of the consulting company AiM GmbH, Lörrach since early 2016. AiM’s field of work includes reimbursement-related HTAs of diagnostic and therapeutic procedures based on the use of medical devices. In particular this relates to evidence-based benefit dossiers and submissions to health care coverage authorities. In this context, M. Weisser also plans and holds international workshops as well as making conference contributions related to these topics.
Dr. Martin Braun
President of Dr. Martin Braun GmbH – Health Care Management
A physician and a post-graduate in healthcare management Dr. Braun started his career as a clinician specialising and further graduating in internal medicine, gastroenterology and Diabetes care. Being a senior registrar at Klinikum Ansbach, he joined the federal government’s institute for hospital reimbursement (InEK GmbH), leading their medical department from 2003 to 2010. In this role he was instrumental to introducing the DRG reimbursement system in german healthcare. In 2011 he started his own business and serves as a consultant and expert reviewer in the healthcare sector. Dr. Braun works as a consultant in hospital reimbursemt for leading medical device and pharmaceutical corporations.
Dr. Hans-Joachim Lau
Founder & Owner, MedDevConsult
A graduate and Ph.D. in physics, Dr. Hans-Joachim Lau started his own business MedDevConsult, Hamburg, in 2011. He serves a an advisor and consultant to medical device companies entering the german healthcare market. Focus areas are reimbursement in the statutory health insurance, submission and management of clinical studies, and serving as an authorized representative (Regulatory Affairs/Bevollmächtigter) for non-european medical device companies launching in Europe. He started his medical device industry career in 1987 at Philips Medical Systems as International Product Manager, and finally worked as Vice-President Regulatory & Clinical Affairs at KRAUTH medical KG. Dr. Lau is a member of the german medical device industry association‘s (BVMed) expert working groups for Regulatory & Public Affairs, DRG und HTA.
Dipl.-Ing. (FH) Alexander Fink
Managing Director, Metecon GmbH
After graduating in biomedical engineering Alexander Fink started his career through several contract research and development projects in the medical device industry. Since 1999 he is co-founder and managing director of Metecon GmbH in Mannheim. Metecon is specialized in regulatory approval and documentation for medical devices, and in development of automated complex Testing-Systems for medical devices. The Metecon team currently includes 15 staff – with specializations in hardware and software development, planning of clinical trials and testing, and documentation/approval. All Metecon R&D processes are certified according to DIN EN 13485 and ISO 9001.
