Does darwinism work in the medical device industry?
Tuesday 7 July 2020 17:00 CEST
"It is not the strongest of the species that survives, not the most intelligent that survives. It is the one that is the most adaptable to change" Charles Darwin
- Ms. Kathleen A. Marshall, President & CEO MAXIS LLC, San Jose, California and MAXIS Medical GmbH, Frankfurt am Main, Germany
- Dr. Bassil Akra, CEO & CO-OWNER QUNIQUE GmbH, Wohlen, Switzerland and Greifenberg, Germany
Ms. Kathleen Marshall and Dr. Bassil Akra discuss the impact of recent global turmoil on the medical device world in a one-on-one interview.
- MDR Implementation
- COVID-19 and clinical research
- Survival strategies
Ms. Marshall created MAXIS, LLC, in 2003 after nearly twenty years as a significant strategic contributor to the overall success of multiple medical device start-up companies. She holds a B.A. from Amherst College and an M.S. in Regulatory Affairs from Northeastern University. She is an experienced senior executive, skilled in clinical research, market development and commercialization of new medical technology. During her career in medical device start-ups, she has established a proven track record in conducting international clinical studies, building global markets, branding emerging technologies and leading start-up ventures. She has successfully established and managed teams that have created lasting clinical value and financial returns. Kate holds dual citizenship in the USA and Ireland.
Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.).He spent the most recent years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system. Bassil was the Vice President of strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has extensive experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. He spent the last decade at the biggest notified body in Europe and represented notified body associations in various European discussions on a global scale.