Executive Summary:Conducting of Clinical trials and approvals by MHLW /Reimbursement obtaining: 1. Renal Area:Establishment of Research Group of leading nephrologists and negotiation with MHLW to conduct clinical Trials including approval by MHLW and delivery of devices and solutions to home patients. 2. Contrast Media: non-ionic contrast media was used. Prof. Hiramatsu of Keio Univ.,Dr.Takamiya of NCVC and Prof.Uchida of Nara Univ.et al were participated in the study. 3. Intravascular Ultrasound System: In cooperation of a leading company. Kokura kinen Hospital and Sakakibara kinen Hospital were joined in the trials. Approval and Reimbursement were given successfully. 4. Several Critical Stents were evaluated successfully to obtain approvals and reimbursements by MHLW. 5. A major device: Transferd from Asahi Pentax ;MHLW gave to us the approval and reimbursement 6. Prostate Stent: Due to lack of patients enrollments, clinical study was abandoned. 7. RF Generator :Liver cancer ablation was studied. Submission of files for import approvals: 1. Catheters related :many key catheters products were successfully approved by MHLW and now still are in the key products lines. 2. Stent Graft: Priority review was used to get approval and reimbursement. 3. Esophageal stent and Biliary Stent could avoid clinical trials. Approval and Reimbursement were obtained successfully. 4. Transfers:Two IVUS systems, electrophysiology catheters, Artificial Vessels, Cerebral coils were transferred to us Post Market Surveillance: 1. Recall dispositions 2. Post Market Surveillance after clinical trials Product Development (R&D)and OEM 1. OEM of Hemodialysis system 2. R&D of Contrast medias warmers(bottles and boxes) and OEM 3. R&D of 4F catheters for brachial approach 4. R&D of Tip curving device for angiography 5. Drug delivery from drug port Contracts made 1. A major catheter company on OEM of catheters 2. Two Major Japanese companies for distributorship 3. A Major Pharmaceutical company: Drug for Drug Eluting Stent 4. Drug Eluting Stent by Tokyo Univ. Industry activities 1. Devices Committee 2. ACCJ 3. ACCJ RA Meeting 4. Medical Devices Industry Group
Work Experience:* Over 35 years Medical devices Experience on sales, marketing, Clinical/Regulatory Affairs and management
* Start-up of new companies from small to big(Four major companies)
* Clinical trials :more than 10 products:
* Obtaining of Major Reimbursement works: Major critical products
* Medical Devices Industry activities: Devices committee chairman, RA Leadership meetings, reimbursement system development w/ MHLW
* Transfer of other companies’ products to ours
² Complaint Processing:Recalls
Speciality:1. A lot of experience with Start-up companies from small stage
2. Bilingual in English and Japanese
3. Keep strong relationship with many key opinion leaders in cardiology , Radiology and Nephrology
4. Keep strong network among Regulatory Managers & Directors in the field
5. Can take advantages of capability of regulatory or Clinicals in sales and marketing field.
6. Liaison officer at a major company US for 18 months
Detailed Resume:company as Sales Engineer for Hemodialysis
-Sales Rep. 1972 Transferred to the technical section as marketing assistant
- Catalog and sales tools development
- MHW application documentation development
- OEM Coordination for Hemodialysis system 1978 Transferred to U.S. Head office as a technical liaison
-Technical coordination between Japan and US for product development and Complaint processing
-Interpretation for Japanese customers 1979 Transferred back to Japan ( HQ)as Marketing Assistant Manager
-Marketing of Hemodialysis products
-Established patients society of hemodialysis for tours for Hawaii 1980 Transferred to Nagaya sales office as the office manager
-Establishment of presence of the company in Nagoya area through sales and Management
1981 Transferred to HQ marketing as Marketing Deputy Manager
-Establishment of PRODUCT delivery system for home patients
-In charge of MHW for PRODUCT system penetration in Japan 1984 Joined another company as Osaka Sales Office Manager
-DSA catheter sales with the help of Dr.Makoto Takamiya of CVDC of Osaka
-DSA catheter development:4F
Promoted to National sales Manager
-Sales promotion and management
-Clinical Trial for X-ray contrast media
-Regulatory support for catheters and Contrast media 1990 Joined another company as National Sales Manager
-Recruited key managers and sales people
-Established the fundamentals for Organization
-In charge of Sales, Marketing , Regulatory and Clinicals 1992 Transferred to Director of RA/CA/QA(Executive Director)
-In charge of MHW
-Got approvals on import license for Key products through Clinical trials
-Industry activities through ACCJ and Advamed
2001 Joined a company as COO
2002 Transferred to RA/CA/QA Executive Director
2003 ・Parent company went into bankrupt and the subsidiary was merged by another company
・Established RA consultant company 2004 Joined a company as General Manager/CEO
-Established –Legal Entity,
-Established the company fundamentals
-Established strong relationship with KOL
-Established the penetration of new diagnostic concept into Japanesea market
-Established good partnership with Japanese leading company 2005 Transferred to RA/CA Executive Director
-Submission of New device to PMDA
-Help Partner to submit a new device
-Preparation of transfer of Shonin Approval to the company
2006 August Establish my own company to present
-Medical Device regulatory consulting
-Selling “ stationary “through internet and at a major department store
Other Info:1) Strong people management by showing my own style to my subordinates
2) Strong relationship with many KOL in medical field in Radiology and Cardiology
3) Strong relationship with MHLW , PMDA and Industries
4) Many experiences and Knowledge how to get Reimbursement
5) Many experiences with clinical trials
6) Long experience with sales and marketing
7) Many experiences with small start-up companies
8) Healthy and diligent
9) Self motivation
10) High Humor Sense
Education:University
Degrees:B.S. Engineer Dept. Chemistry
Project Wanted:Market entry support for foreign capital companies.
Project Length:6~ months
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