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The US market for medical technology has grown steadily for decades and has developed into one of the most lucrative sectors in the healthcare sector. With a total market volume of approx. USD 150 billion (2017), the USA is not only the largest manufacturer of medical devices on the world market (40% share), but also the world's largest consumer of medical devices with annual imports of over USD 55 billion. USD.


The US medtech industry represents some of the largest medtech companies in the world. German manufacturers can therefore expect strong competition. There are many opportunities in the US medical technology market, especially for innovative newcomers, but the strong competition and the sometimes considerable market entry barriers should not be underestimated. This applies above all to the demanding FDA approval process and possible product liability issues. The FDA has a complex regulatory and device classification system that requires manufacturers and distributors to register their businesses and register their devices, among other things.


The "Medical Technology" workshop addresses current opportunities for German medical technology manufacturers in the USA and addresses possible challenges and barriers to market entry. Workshop participants can learn from experienced German company representatives who have already successfully entered and expanded in the US market.

Our speakers

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dr -Ing. Arne Dethlefs

CEO, Garz & Fricke GmbH

Dr.-Ing. Arne Dethlefs is CEO of Garz & Fricke Inc. based in Minneapolis, Minnesota and production manager at Garz & Fricke GmbH in Hamburg. In his function as production manager, he is responsible for the company's own electronics production, device assembly for human-machine interfaces and components for vending machines, and industrial engineering. Before that, he worked as a senior engineer at the Institute for Machine Tools and Factory Management at the TU Berlin and as a project manager at the Fraunhofer IPK. He studied mechanical engineering at the TU Hamburg and received his doctorate in 2015 with a thesis on the basics of vibratory finishing at the TU Berlin.

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Sven René Friedel

Owner and Managing Director, Managing Director, Berlin Heart

Mr. Friedel studied economics in Fulda and Berlin. He has known the development of Berlin Heart since the start-up phase. Initially, Mr. Friedel was responsible for various international VC financings as head of finance and also accompanied the sale of Berlin Heart in 2006
the current shareholder. After setting up the subsidiary Berlin Heart Inc. in the USA, he took over the management of ECP Entwicklungsgesellschaft mbH in 2008 in addition to the commercial management at Berlin Heart. ECP pursued the development of a highly innovative
percutaneous assist system for applications in cardiology. In 2014, Mr. Friedelderen realized a successful sale together with an extensive IP portfolio to Abiomed Inc. Since October 2014, he and Dr. Ares K. Menon the business of Berlin Heart.

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Marco Kalms

Founder & CEO, Kalms Consulting GmbH

Marco Kalms has over 25 years of experience in various management positions in the
healthcare industry. As a long-standing Sales Manager, Country Manager Germany and Managing Director Europe, he made a significant contribution to the growth of American Medical System, Inc., a US medical device manufacturer that now belongs to Boston Scientific. In 2012 he founded the company Kalms Consulting GmbH, which supports start-ups and established companies in medical technology, diagnostics, health IT and life sciences in all phases of market access in Germany and international markets. The KalmsConsulting team consists of senior consultants with many years of practical experience in the industry.

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Thomas Weber

CQO, Head of Quality and Regulatory Affairs, Löwenstein Medical Technology

CEO, Lowenstein Medical Americas

Thomas Weber has been working in medical technology for over 15 years and has been responsible for regulatory activities for the implementation of the company's internationalization strategies within the Löwenstein Group since 2012 as CQO, Head of Quality and Regulatory Affairs at Löwenstein Medical Technology (formerly Weinmann Geräte für Medizin). . With his team, he processes medical device approvals in over 40 countries, including particularly challenging markets such as China, Japan and the USA. He has also been CEO of the US subsidiary since 2018, where he drives the Löwenstein Group's expansion into the North and South American markets.


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Susan Rehse

Branch Manager, AHK USA-Philadelphia

Susanne Rehse has been with the AHK USA-New York since February 2011. On January 1, 2019, she took over as Executive Director of the Philadelphia office. Previously, Ms. Rehse worked as a senior manager in business development consulting at the AHK USA-New York and was responsible for market entry consulting in the north-east of the USA. Here she successfully supported various German SMEs in entering the US market, carried out a large number of business travel programs, delegation trips, projects and events and wrote countless market analyses. Ms. Rehse studied economics at the Cologne University of Applied Sciences and the University of Wisconsin-Whitewater. She also completed an apprenticeship as an office communications clerk at Deutsche Telekom AG.

This workshop is sponsored by:

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