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President & CEO

Kunihiko Mitsuda

Before founding Japan MDC, Kunihiko Mitsuda served as president of the Japanese subsidiary of leading medical laser company Lumenis, covering the fields of dermatology, plastic surgery, ENT, urology, ophthalmology and veterinary services. Before his appointment to president, he served as manager of sales and marketing at Lumenis Japan for 4 years with responsibility for about 150 employees. Significant achievements during his career at Lumenis included success in building sales of light/laser-based devices for dermatologists and plastic surgeons by developing a unique marketing strategy of direct appeal to patients through the creation of the Photofacial® aesthetic medical treatment brand. This received significant media attention, and Photofacial® has become the gold standard for non-invasive facial rejuvenation treatment.
Prior to joining Lumenis, Mr. Mitsuda served as chief sales and marketing executive in the Urology Division of Boston Scientific Japan for three years. He was highly successful in expanding sales of catheter disposables by focusing on the sale of equipment rather than on the catheter itself. This business model has been highly successful, and Boston Scientific Japan in fact decided to distribute Lumenis’ laser for benign prostatic hyperplasia (BPH) treatment during Mr. Mitsuda’s time as president of Lumenis Japan.
In addition to the above, Mr. Mitsuda has had a wide range of sales experience in large-scale medical equipment. He completed a ten-year stint with Nippon Eurotech as deputy sales manager, a role in which he handled the ESWL products of EDAP TMS S.A.
Mr. Mitsuda started with Nippon Eurotech as an after-sales maintenance engineer, and his natural skills as a salesman were quickly recognized. He soon became the top salesman for ESWL machines, frequently winning President’s Awards for outstanding performance. His secret was to act not only as a sales rep to his clients but also as an engineer and educational/clinical specialist, enabling him to support his customers effectively. Based on his experience in the medical device market, Mr. Mitsuda established Japan MDC in 2003. His customers are frequently impressed by his innovative sales methods.
His motto is “Stability through constant innovation”


1980-1982 : Kawasaki Heavy Industries, Ltd.
French interpreter in Algeria
1983-1987 : Art-Supply, Ltd.
Chief of Educational software of engineering section
1989-1996 : Nippon Eurotec Co., Ltd.
Chief of Engineering Division
Deputy sales manager for ESWL Division
1996-1999 : Boston Scientific Japan K. K.
Marketing manager for Urology Division
Sales and Marketing Executive Manager for Urology Division
1999-2001 : ESC Sharplan Japan K. K.
VP of Sales and Marketing
2001-2003 : Lumenis Japan K. K.
President & COO
2003-present : Japan MDC, LLC
President & CEO

Lectures/Presentations

September 5, 2004 : "Medical spa business marketing"
Academic Society of Beauty Forum
January 23, 2005 : "Medical spa marketing"
 Japan MDC, LLC
Jun 6, 2005 : "The Medical act and its business"
 Beauty Equipment Association
January 19, 2006 : "Medical practice and its business"
 Kanagawa Industrial Medicine Committee, Sanofi-Aventis
January 31, 2007 : "Cosmetic dermatology business and marketing"
 Japan Aesthetic Dermatology Symposium
May 13, 2007 : "The Pharmaceutical Affairs Law (PAL) and clinical practices with medical products imported under doctors’ license"
 Japan Advanced Medical Institute
February 27, 2008 : "The basics and safety of lasers/white lights"
 Beauty Equipment Association
August 6, 2011 : "The light and dark sides of Dermatological practice"
 Medical Women's Association of Tokyo eastern region
March 22, 2013 : "Work-Life Satisfaction"
 Japan Aesthetic Dermatology Symposium

Publications

  1. “Marketing Strategy for Treatment Using Lasers/White light”
    Japanese Society of Beauty Science, March 2006

  2. “Market Report, Medical Device Market Japan 2007”
    Edited & planned by the Embassy of Switzerland’s Swiss Business Hub Japan Issued by OSEC Business Network Switzerland

  3. “The Technical know-how for regulatory approval ”
    Edited & planned by Technical Information Institute Co., Ltd, September 2011

  4. "The Japan Medical Device Market and Regulatory Report"
    Issued by Japan MDC, LLC




Chief Regulatory Officer

Nobuko Matsunaga

Nobuko Matsunaga’s career has been exclusively focused in regulatory affairs for medical devices, over 20 years of experience in the medical device industries.

Ms. Matsunaga is one of the founders of Japan MDC and was appointed Chief Regulatory Officer of Japan MDC on July 14, 2003.
Prior to founding the company, Ms. Nobuko served as in charge of regulatory affairs of EDAP Technomed Co Ltd, a subsidiary of EDAP TMS France S.A., a medical device company.

At Japan MDC, she has worked on product registration for various types of medical devices.
In addition to the daily work of regulatory consulting, she contributes to improving the regulatory environment in Japan as a member of the regulatory sub-committee of the EBC (The European Business Council in Japan).

In 2008, MHLW set up  "the joint working committee".  It is composed of three major groups (MHLW, PMDA and Medical Devices Industry group).  The purpose of committee is to improve the Japanese regulatory system.  
Ms.Nobuko Matsunaga was selected as a member of the committee

She is one of the regulatory specialists for medical devices who are most trusted in Japan.


Lectures/Presentations

January 16, 2006 : "Japan’s New Medical Device Law"
 Clinical Device Group, Inc (USA)
July 11, 2006 : "GCP and Japanese specific requirements for clinical trial"
 Clinical Device Group, Inc (USA)
September 10, 2007 : "Conducting Clinical Evaluation in Japan"
 London, UK
January 14, 2009 : "Revision of Japan's GCP Regulations"
 Clinical Device Group, Inc (USA)
September 1, 2009 : "Workshop, Regulatory Challenges in the JapaneseMedical Device Market"
 Zurich, OSEC (Switzerland)

Publications

  1. “Market Report, Medical Device Market Japan 2007”
    Edited & planned by the Embassy of Switzerland’s Swiss Business Hub Japan
    Issued by OSEC Business Network Switzerland

  2. "The Japan Medical Device Market and Regulatory Report"
    Issued by Japan MDC, LLC

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