Lessons Learned From the Mistakes of Others

Transcription

1 Lessons Learned From the Mistakes of Others Keisuke Kaye Suzuki March 30, 2007

2 Basic Market Entry Models Direct Operation Market Penetration Operational Expenses Commercial Investment Risk + Joint Venture Share and Board Balance Transfer Price Distributorship Distribution Strength Purchasing Commitment -

3 Additional 2 C s Direct Operation Cultural Investment Risk Commercial Investment Risk Compliance Investment Risk + Joint Venture = = Distributorship + - +

4 Basic Model - Kaye s View Direct Cultural Code of Conducts Core Value Communications Compliance Regulatory (PAL) Pre-clinical (GLP) Clinical (GCP & GPSP) Quality (GQP & QMS) Vigilance (GVP) Joint Venture Distributor Capability Commitment Channels Commercial

5 Seizou-Hanbai Shonin (Market Release Approval) 1. YOUR distributor is the applicant - usual Apply as the Market release Authorization license Holder (MAH, Seizou-Hanbai Gyosha) for the product Changing distributor is a potential challenge as Shonin is granted to distributor, not YOU 2. YOU can be the applicant - alternative Apply directly under the Foreign Special Exemption Approval System (PAL article 19-2) Appoint distributor as Designated MAH (Sennin MAH) delegated on GVP compliance Changing distributor is not prevented by regulatory issue Can you have the distributor be your outsource? Market Release = To originate Manufacturing, Importation, Distribution, Sale, Rent and/or Present

6 Lesson 1 1. What are important criteria that Ace should evaluate and watch out for, during their selection process to identify the right-fit partner in Japan? 2. What can Ace do besides finding their distributor in Japan to speed up the market entry?

7 Assumptions Japanese market (size, growth, therapy acceptance, competitors and price) is very attractive US still needs continuous resource focus Distributor candidates are identified with background check completed All distributor candidates hold Class 1 Device MAH Model A ventilator is classified as Controlled Medical Device without Approval Standard Implantable breath assist device is first of its kind, classified as Highly Controlled Medical Device with Clinical data necessary

8 Criteria - Commercial (1) Management Value & Vision Key Decision Maker Sales Structure Incentives Training Marketing Launch Strategies Processes Product Positioning Monitoring Metrics Alignment Strategies Customer Handlings Customer Segmentation English Capabilities Customer Preferences Market Intelligence

9 Criteria - Commercial (2) Workforce Diversity Age Gender Supply Chain Inventory Management Dealer Management Voice of Stakeholders Customers Competitors Dealers Turnover Tenure Labeling Operation After Service Regulators Present Manufacturers Past Manufacturers

10 Criteria - Compliance & Cultural (1) Demand and Observe Alignment on Shonin strategy Bilateral satisfaction of WHY before any action Peer review on all documents PRIOR to submission Participation on all meetings with MHLW/PMDA Biweekly conference call to align on next step Quarterly face to face meeting Offer and Observe Full dossier submitted to FDA and CE tified Body Training and Testing on products and dossiers Drafting English respond to all inquiries as a base

11 Criteria - Compliance & Cultural (2) Conduct an AUDIT on PAL & Ethics compliance Just like FDA and/or CE notified body will to YOU Audit the system, procedures, controls and records Observe how the distributor, handles the audit; accepts the findings and observation; develops CAPA plans; reach for your advise; and executes CAPA Compare with YOURSELF How you will handle this situation if you were on their shoes?

12 Lesson 2 1. What are important criteria that Ace should evaluate and watch out for, during their selection process to identify the right-fit partner in Japan? 2. What can Ace do besides finding their distributor in Japan to speed up the market entry?

13 Basics for Quality 5 S Seiri, Seiton, Seisou, Seiketsu, Shituke Arrange, Order, Clean, Neat, Habit 5 MU Muri, Muda, Mushi, Muchi, Mura Overstressed, Waste, Ignorance, Untrained, n-uniform 5 GEN Genba, Genbutsu, Genjitsu, Genri, Gensoku On Site, Actual Thing, Reality, Theory, Principal

14 Good Preparation (1) Understand PAL, GLP, GCP, GQP, QMS, GVP and GPSP Understand the Shonin application review process Organize FDA and CE Review History and Records Obtain Copies of Similar Device Shonins Compose Compelling Explanations on Safety & Efficacy Conduct GCP Documentation Quality Check Develop Detailed CRF Spreadsheet

15 Good Preparation (2) Develop Detailed Material/Component List Compile into A Product Master File Review Complaint Records and MDRs Review Field Actions and Associated CAPA Conduct R&D Documentation Quality Check Prepare for Foreign Manufacturer Accreditation Application Prepare for Detail Oriented Audit by PMDA

16 Draft YOUR Thesis (1) Medical Device Market Release Shonin Application Japan Medical Device Classification Japan Medical Device menclature Applied Product Name Intended Use, and Efficacy Description of Shape, Dimensions, Structure and Mechanism Detailed Raw Materials and/or Components Specifications Instruction for Use and/or Operation Basic Manufacturing Processes Storage and Shelf Life Designated Manufacturers Designated Raw Material and/or Component Manufacturers tes and Remarks

17 Draft YOUR Thesis (2) Shonin Application Attachments Controlled Highly Controlled Highly Controlled New Approval Standard Clinical necessity Development Background (Origin & History) Usage in Foreign Countries Comparison with Similar Devices Descriptions on Specifications and their justification Justifications on Stability and Durability Documentation on Basic Requirements Conformity Declaration Justifications on Basic Requirements Conformity (MHLW PN122, 03/29/2005) Supporting tests & results on Performance and Safety Supporting tests & results on Efficacy Supporting tests & results on Handling and Usage Explanations on Risk Analysis Implementation System Justifications on Potential Critical Hazards Explanations on Manufacturing Process and Equipments/Facilities Explanations on Sterilization Explanations on Quality Control Clinical Trial Reports Post Marketing Study Execution Plan (draft)

18 Summary YOUR distributor represents YOU; NOT ONLY your products to the stakeholders - Become Dynamic Duos with your distributor! YOU need to be PROACTIVE, NOT REACTIVE; define and take the lead YOU have to shift your perception; Japan is not fundamentally different from YOU - YOU need to take away your sunglasses YOUR Compliance Risk is the same; Distributor, Joint or Direct YOU need to invest time and money, do your homework to gain access to attractive Japan market; nothing come for FREE YOUR overall cost will be higher later, if you compromise now; deal with it upfront

19 Quotes Your most unhappy customers are your greatest source of learning. - Bill Gates The Quality is mental; Overall Functionality versus Sum of Individual Component Functionality The difficult part is to understand the true WHY? (min. 3 layers deep), then the rest if fairly easy!