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SaMD in Japan:
Navigating Opportunities
in Software as a Medical Device for 2024

The global market for Software as a Medical Device (SaMD) is rapidly expanding, with projections indicating a growth to US$86.5 billion by 2027. Japan, recognizing the potential of SaMD, has implemented policies to foster the development and commercialization of these innovative medical solutions. This presents a lucrative opportunity for European medtech and digital health companies looking to enter or expand in the Japanese market.

Join our webinar to gain comprehensive insights into the Japanese SaMD landscape, including market potential, regulatory framework, health insurance reimbursement, and effective localization strategies. Discover how Kobe's Biomedical Innovation Cluster, a leading life sciences ecosystem in Japan, can support your business's growth and success in this dynamic market.

Date & Time
March 27, 2024, from 9:00 to 10:15 AM CET (5:00 to 6:15 PM JST)
Cost:
Complimentary
Partnership:
Details and Registration
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Agenda

1. Welcome and Introduction
Overview of the MAGIA/FBRI Collaboration
Presenter: Sarah Niemann, Manager International Affairs, Life Science Nord Management GmbH
2. Exploring the Kobe Biomedical Innovation Cluster
Insights into Japan's premier life sciences ecosystem
Presenter: Takako Yokochi, Senior Coordinator, Medtech Group, FBRI
3. Understanding SaMD in Japan: Market, Regulation, and Reimbursement
A comprehensive guide to navigating Japan's regulatory landscape
Presenter: Tadanori Yasuda, Group Leader, Medtech Group, FBRI
4. Innovation in Bio-Pharma and Regenerative Medicine
Latest trends and developments
Presenter: Keiko Kobayashi, Chief Coordinator, Drug Discovery & Biomedicine Group, FBRI
5. Case Study: Dürr Dental's Success in Japan
A firsthand account of entering and thriving in the Japanese market Presenter: Uwe D. Haul, CEO, Dürr Dental Japan K.K.
6. Fostering EU-Japan Business Collaborations
Opportunities for partnering in Japan
Presenter: Daniel Gralki, Consultant, EEN, EU-Japan Centre for Industrial Cooperation

Speakers

Sarah Niemann, Manager International Affairs, Life Science Nord Management GmbH

Sarah brings a wealth of international experience to her role, having significantly contributed to global partnerships and networks. Prior to joining Life Science Nord, she has worked as an International Account Manager at XING SE and for the German American Chamber of Commerce of the Midwest in Chicago.

Takako Yokochi, Senior Coordinator, Medtech Group, FBRI

With a rich background in international sales within the medical device sector, Takako has exported products to over 80 countries and represented her company in numerous international exhibitions. Her expertise is now channeled into supporting the international business development and operations of FBRI's cluster member companies.

Tadanori Yasuda, Group Leader, Medtech Group, FBRI

Tadanori is an adept strategist in regulatory science, leveraging his extensive background in marketing supervision to provide nuanced advice on regulatory differences between Japan and other nations. His global experience in project formulation and partnership establishment is invaluable for companies navigating the Japanese market.

Keiko Kobayashi, Chief Coordinator, Drug Discovery & Biomedicine Group, FBRI

Keiko's role at FBRI involves leveraging her international business experience and extensive network to support the overseas expansion of KBIC member companies. With a focus on the drug discovery and biopharma sectors, she plays a pivotal role in connecting Japanese innovations with global opportunities.

Uwe D. Haul, CEO, Dürr Dental Japan K.K.

Uwe's journey in Japan, spanning over two decades, showcases his versatility, transitioning from a technical expert to a sales leader, and now, as the CEO of Dürr Dental Japan K.K. His leadership has been instrumental in establishing the company's strong presence in the Japanese dental market.

Daniel Gralki, Consultant, EEN, EU-Japan Centre for Industrial Cooperation

Daniel's extensive experience in Japan includes facilitating European and Japanese business exchanges in the biotechnology and advanced materials sectors. At the EU-Japan Centre for Industrial Cooperation, he organizes trade fairs and matchmaking events, showcasing his language skills in English, German, Japanese, and French to foster international collaborations.

About the Webinar Series

This event is part of a series aimed at fostering collaboration between European and Japanese companies in the life sciences sector, organized by the MAGIA Alliance and the Kobe Biomedical Innovation Cluster (KBIC).

About the Organizers

MAGIA Alliance: A European consortium committed to the international expansion of innovative MedTech SMEs. The alliance is formed by key clusters from four countries: the bioPmed Cluster, represented by Bioindustry Park Silvano Fumero SpA in Italy; BioWin in Belgium; Life Science Nord in Germany; and Lyonbiopole in France.

Kobe Biomedical Innovation Cluster (KBIC): Japan's largest biomedical cluster, fostering innovation among a network of companies, universities, research institutes, and hospitals to advance the biomedical industry.

Foundation for Biomedical Research and Innovation (FBRI): FBRI, the core support entity of KBIC, provides comprehensive assistance to enterprises, facilitated by a team of dedicated coordinators with diverse medical backgrounds, aiming to boost international business's growth in Japan through tailored services and extensive partnerships.

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