Compiere Profile

NameCompiere, LLC
Address1-10-22-1104 Nakameguro, Meguro-ku, Tokyo, Japan
EstablishedMarch 16, 2007
PresidentMichiko Masaka
Business OperationsRA Consulting
ISO9001/13485, QMS Consulting
Professional Seminars
Management Consulting
Designated Marketing Authorization Holder

Compiere is an Italian word which means "to accomplish" or "to complete." This name was chosen to emphasize the fact that the various forms of support provided are not limited to just preparing regulatory documents, but such support continues until the product gains the commercial success envisaged by the client.

A wealth of Experience

With over two decades of combined experience at such notable companies as Bristol-Myers Squibb, Medtronic and Roche Diagnostics, Dr. Michiko Masaka has a wealth of experience in dealing with the Japanese regulations that need to be cleared for obtaining inroads into the Japanese medical device and pharmaceuticals market.

Working for nearly a decade in the Diagnostics and related fields as a Marketing Director and Senior Manager of R&D, Dr. Masaka educated herself on how to approach key physicians and negotiate with government officials upon obtaining approval in an expedited fashion. Success was gained by switching the marketing direction from clinical laboratory staffers to real key decision makers in the hospital through physician’s seminars or academic associations. What I was done was to introduce the products to targeted physicians so they can understand how important these items are.

Another success was achieved in the following five years: a 25% increase in sales revenue was maintained for all those years, instead of the 10% increase over the previous five years based on a switch in marketing direction from Nurse to Physicians for Wound Care Marketing through face-to-face meetings and academic congresses, quite an innovative method at that time. In most cases, Nurses in Hospital take care of patients and are interested in wound dressing as well as wound care, yet they are not the real decision makers. Focusing on key opinion leaders and key decision makers leads to an added market share, ranging on average from 40% to 60%.

She also had the most exciting experiences of working with the government officials to establish harmonization of medical device regulation via Global Harmonization Task Force (GHTF) and revision of the Pharmaceutical Affairs Law (PAL) in Japan. During the 2000-2004 period, as a member of the Medical Devices subcommittee in American Chamber of Commerce in Japan, which works closely AdvaMed in the US, she talked about the down regulation and reimbursement issues with MHLW officials. Since 2004, she has been working as an independent consultant, not only for regulatory issues but also for the medical field generally, such as developing a clinical protocol and case report form, not to mention negotiating with physicians involved in clinical studies, arranging study meetings and so forth. In March of 2007, she established Compiere, LLC to further build on her experience.

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