The US market for medical technology has been growing steadily for decades. Currently, the market has developed into one of the most lucrative sectors within the US healthcare sector. With a total market volume of approximately US$ 150 billion (2017), the USA is not only the largest manufacturer of medical devices on the global market (40% share), but also is the largest importer of medical devices with annual imports of over US$ 55 billion.
The US medical technology industry is home to some of the largest medtech companies in the world. Although German manufacturers can expect strong competition, there are still many opportunities for successful expansion in the US medical technology market. However, despite the market potential, businesses should not underestimate the unique challenges associated with market entry, particularly with the FDA approval process and protection against possible product liability issues. The FDA issues a complex regulatory and equipment classification system, where manufacturers and distributors are required to register their business operations and equipment.
The "Medical Technology" workshop will highlight current opportunities for German medical technology manufacturers and navigate through the various challenges in the medical technology industry. Participants of the workshop will have the opportunity to learn from representatives of German companies who have successfully entered and expanded their business in the US market.
Dr. -Ing. Arne Dethlefs
CEO, Garz & Fricke GmbH
Dr.-Ing. Arne Dethlefs is CEO of Garz & Fricke Inc. located in Minneapolis, Minnesota and Head of Production at Garz & Fricke GmbH in Hamburg. In this role, he is responsible for both, the company's own electronics production and equipment assembly for Human Machine Interfaces and components for vending machines, as well as industrial engineering. Previously, he worked as a senior engineer at the Institute of Machine Tools and Factory Operation of the Technische Universität Berlin and as a project manager at the Fraunhofer IPK. He studied mechanical engineering at the Hamburg University of Technology and received his doctorate in 2015 with a thesis on the basics of vibratory finishing at the TU Berlin.
General Manager, Berlin Heart
Mr. Friedel studied economics in Fulda and Berlin. He has been involved in the development of Berlin Heart since the start-up phase. Initially, Mr. Friedel was Head of Finance for various international VC financings. In 2006 he participated in the sale of Berlin Heart to today's partner. After the establishment of the US subsidiary, Berlin Heart Inc., he took over the management of Berlin Heart as well as the commercial management of ECP Entwicklungsgesellschaft mbH. ECP pursued the development of a highly innovative percutaneous assist system for applications in cardiology. In 2014 Mr. Friedel helped facilitate the successful sale of this business, along with an extensive IP portfolio, to Abiomed Inc. Since October 2014 he manages the business of Berlin Heart together with Dr. Ares K. Menon.
Founder & CEO, Kalms Consulting GmbH
In 2012, he founded Kalms Consulting, focusing on European market access for international medical device, diagnostic and bioscience companies. Marco has more than 25 years of experience in operational, strategic and market access leadership positions in the healthcare industry. As a long-time Sales Manager, Country Manager Germany and Managing Director Europe, he contributed significantly to the growth of American Medical Systems, Inc.
In his role as Managing Director Europe, Marco developed market access strategies to open up new markets in the EMEA regions.It is this mixture of operational business and market access experience that is an essential part of the expertise the Kalms Consulting team offers to support healthcare companies.
CQO, Head of Quality and Regulatory Affairs, Löwenstein Medical Technology
CEO, Löwenstein Medical Americas
Thomas Weber has been active in the medical device industry for more than 15 years. Since 2012 he has been assigned responsible for all regulatory activities to support the Löwenstein Medical Technology (formerly Weinmann Geräte für Medizin) internationalization strategies within the Löwenstein Group as CQO, Head of Quality and Regulatory Affairs. With his team, he handles medical device approvals in more than 40 countries, including particularly challenging markets such as China, Japan and the US. Since 2018 he has also been assigned CEO of the Löwenstein Medical US branch, where he is driving the expansion of the Löwenstein Group into the North and South American markets.