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
  • 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 (original equipment manufacturer). 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 and Consulting

BIC GROUP regulatory and quality

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

 

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

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

Miyasaka-san
Tsuyoshi Miyasaka

Managing Consultant

Read Bio

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.


Atsushi Hirayama

Regulatory Consultant

Read Bio

Atsushi holds a strong background in regulatory affairs, quality assurance, safety, clinical and medical writing, having worked for foreign based Medical Device companies in Japan for over 40 years. He is responsible for delivering regulatory affairs consulting solutions to BIC Medical device and IVD clients.

Atsushi has developed a strong and close working ties with regulatory bodies and authorities. He has submitted well over 140 submissions to the PMDA (MHLW) and obtained regulatory approvals for numerous devices from ME devices to implants in all classes. Also, he has been engaged in planning of protocols for clinical trials and monitoring the progress of trials and results for many years.

He has served as a consultant or adviser to many organizations like Johnson & Johnson, P&G, St. Jude Medical, Philips Medical, Medtronic, Alcon, Carl Zeiss Meditec, Zimmer, Kao, Fukuda Denshi, Pentax and Hoya Glass in Japan.

Atsushi is a licensed General Marketing Compliance officer and Responsible Engineer. He speaks English and Japanese. He received his bachelor’s degree from Meiji Gakuin University in Japan.

Our Work / Case Examples

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

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