Medical Device Business Consulting provides wide-range expert supports services to the medical device companies. Primary services include:

  • R&D, Licensing, Business Development
  • Distributor/Partner Searches Worldwide
  • Regulatory Affairs and Consulting
  • Designated Marketing Authorization Holder (DMAH) services
  • Strategy development and Implementation
  • Merger & Acquisition, Due Diligence (Scientific and Commercial)

Each service is customized to meet the unique needs of each client. So please contact us to learn how BIC could be a value addition to your business.

Distributor/Partner Searches Worldwide

Through our strong network of distributors & manufactures in Japan and the region, we can identify your potential local partner to your distribution / OEM.

Partner Selection Process

  • Partner search based on your Non Confidential information
  • Short list of target potential companies
  • Contact target potential companies on your behalf
  • Coordinate meetings with interested companies and follow up
  • Assist in negotiating agreements


Each search is customized to meet the unique needs of each client. BIC supports you whole way from identifying the right partner companies to the Deal-closure and Representation.

Contact us to learn more or to begin your search with BIC GROUP.

Regulatory Affairs Consulting and Services

BIC GROUP regulatory and quality

BIC offers customized Regulatory Consulting Services to Medical Device and IVD in the following categories:


Strategy and Registration
PMDA, MHLW Consultation and Meeting Support
Quality Management
Clinical Trials

Designated Marketing Authorization Holder (DMAH) services
BIC has First-Class (allowed to handle all classes ) Marketing Authorization Holder (MAH) licenses and Manufacture licenses (Packaging, Labelling and Storage) of Medical Devices and IVDs, which allow us to represent wide range of our client’s products in Japan.

Strategy development and Implementation

Our best in class team can help at every stage, from strategy development and implementation.

Business Development

BIC has a strong focus on Partnering, Licensing and Business Development. Our consultants all have decades of experience, and proven track record in business development in the areas of Medical device, IVD, Pharmaceutical/biotechnology, Consumer healthcare and bioscience industries. We can therefore provide you with a comprehensive insight into your needs.

Meet our Medical Devices leadership team

Akira Irie
Managing Consultant

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Akira is a managing consultant, Medical Practice at BIC GROUP. He is an established leader in the medical device industry. He has successful track record of managing foreign affiliated businesses in Japan and working in global organization APAC, USA and EMRA. He brings a strong background in sales, marketing and project management skills to the BIC team.

Prior to joining BIC GROUP, he held number of executive positions in Kodak Health Imaging, HOLOGIC Japan,  Edwards Lifesciences and St. Jude Medical.

He received a bachelor’s degree in Commercial Science from Meiji University. He is responsible for delivering solutions to our medical device clients.

Tsuyoshi Miyasaka

Managing Consultant

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Tsuyoshi is a managing consultant, Medical Practice at BIC GROUP. Tsuyoshi utilizes his extensive Business and scientific experience to support our medical device clients.

Tsuyoshi brings over 30 years of experiences in the industry. His background roles include, Executive Director, Vice President Sales & Marketing, Business Development and Project management in the areas of Interventional Cardiovascular, Ophthalmology, Orthopedics and Diagnostics.

Prior to joining BIC GROUP, he held executive positions in Otsuka Medical Devices, Medicon, Abbott Vascular Japan, Boston Scientific Japan, Getz Brothers (St. Jude) Japan and Pfizer Japan.

Tsuyoshi holds a BS in pharmaceutical science from the University of Meiji Pharmaceutical and he is a registered Pharmacist too.

Furthermore, he is an industry advocate and speaker.

Our Work / Case Examples

Development and Maintenance of Cortellis Regulatory Intelligence database – Clarivate Analytics (present)

“BIC group supported us in regulatory questions and in the strategy development for our presence in Japan. The consultants were specialists with many years of practical experience in Japan providing us with concrete answers to our practical and strategic answers.”
Director of Global Market Development, EU based leading manufacturer of medical equipment and solutions.

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