New Product Introduction TMP-C-014 Rev A

Process Effective Date: 08/18/2015

Portfolio Management Development and Launch

Do the right projects Do the projects right

_________________________________ _________________________________________________________________________________

Project 1 2 5
Phase Project Planning Project
3 4 Measurement
6
Implementation Production Measurement
Concept and Development Production
Gates Business Approval Project Input Review
Project Output Review Product Release
Committment Launch Readiness

ALIGNMENT
POST-MARKET
PROJECT PROJECT INITIATION DESIGN INPUT REVIEW DESIGN OUT REVIEW REGULATORY POST-MARKET
SURVEILLANCE
MANAGEMENT APPROVALS SURVEILLANCE
ASSESS BUSINESS CASE COLLECTION OF INPUTS DEVELOPMENT LAUNCH READINESS
MARKET RELEASE

6-12 MONTHS POST-LAUNCH REVIEW

DESIGN TRANSFER
FINANCE Technical feasibility: Relevant Inputs to allow a Cost of Goods checked:
detailed Product Drawings Created:
 Estimated Project Specification to be Verification/Validation: Product Evaluation:
 Full Scale
MARKETING Time Line created:  Prototypes Production
 Regulatory Pathway  Design Output Review  Product Trials  Ready for Volume
 Clinical Plan
 Exit Strategies  Market Analysis  Patents Filed  Instrument Case Production
supporting Claims
DEVELOPMENT  Initial Supply Strategy  Voice of Customer  Tooling and Fixtures Design Finalized  Cost of Goods
 Manufacturing  Marketing Plan  Value Stream  Design Freeze Checked
Capable  Target Costs  Identified  Design File  Fully Train
QUALITY  Process Technology Established  Prove Outs Preparation Operators
 Capital Expenditure  Estimated Cost of  Product Claims  Post Market  Hand over to Value
Goods Surveillance Plan Stream Engineers
REGULATORY  Critical Literature  Clinical Plan on
Identified Track
 Clinical Plan
SUPPLY CHAIN

MANUFACTURING

DESIGN
Phase 1: Phase 2: Phase 3: Phase 4: Phase 5:
CONTROL
CN-1004 Design Design Design DesignPage 1 of 4 Design
PHASE
Preparation Qualification Verification Transfer Validation
STAGES
 New Product Introduction TMP-C-014 Rev A
Process Effective Date: 08/18/2015

Project / Design Control

Deliverable Stage Comments
Stage I: Assess Business Case
Product Requirements and Planning & Inputs
Objectives Phase 1: Design Preparation
Stage I: Assess Business Case
Planning & Inputs
Initial Forecast Info Phase 1: Design Preparation
Stage I: Assess Business Case
Preliminary Project Plan (i.e. Planning & Inputs
Gantt Chart) Phase 1: Design Preparation Design Phase Review
Stage I: Assess Business Case
Planning & Inputs
Project Kickoff Meeting Minutes Phase 2: Design Qualification
Stage I: Assess Business Case
Initial Marketing Plan Phase 2: Design Qualification
Stage I: Assess Business Case
Planning & Inputs
Initial Manufacturing Plan Phase 2: Design Qualification
Stage I: Assess Business Case
Planning & Inputs
Initial Quality Assurance Plan Phase 2: Design Qualification
Stage I: Assess Business Case
Planning & Inputs
Initial Regulatory Plan Phase 2: Design Qualification
Stage I: Assess Business Case
Planning & Inputs
Risk Management Plan Phase 2: Design Qualification
Stage I: Assess Business Case
Preliminary Product Design Planning & Inputs
Specs Phase 2: Design Qualification
Stage I: Assess Business Case
Planning & Inputs
Initial Risk Review Phase 2: Design Qualification
Stage I: Assess Business Case
Approved I/O Matrix (Inputs & Planning & Inputs
Input Sources) Phase 2: Design Qualification
Stage I: Assess Business Case
Design Stage Gate Approval Planning & Inputs
Form: Section I Phase 2: Design Qualification
Stage II: Collection of Inputs
Approved Marketing Plan Phase 2: Design Qualification
Stage II: Collection of Inputs
Approved Manufacturing Plan Phase 2: Design Qualification
Approved Quality Assurance Stage II: Collection of Inputs
Plan Phase 2: Design Qualification
Stage II: Collection of Inputs
Approved Regulatory Plan Phase 2: Design Qualification
Stage II: Collection of Inputs
Risk Analysis D-FMEA Phase 2: Design Qualification
Stage II: Collection of Inputs
Update Forecast Phase 2: Design Qualification Design Phase Review

CN-1004 Page 2 of 4

Deliverable
Risk Management Report
Labeling & IFU (Draft)
FMECA & Process Risk
Assessment Summary
Approved I/0 Matrix
(Verifications and Outputs)
Mfg Specification (BOM & Job
Routers)
Marketing Literature
Product Design Specifications
Regulatory Submission as
applicable
Functional, Mechanical,
Performance Tests as Required
Sterility Validation/Assessment
Packaging/Shelf Life
Biocompatibility Testing
Approved Project Plan
Design Verification Summary
Control Plans/Quality Plans
Deliverables
Risk Analysis PFMECA & D-
FMEA Amendments
DMR Complete
Initial Regulatory Clearance
Approved Vendors
Approved Product Labeling
Draft IFU
Clinical Evaluations as Required
Updated Forecast
Approved DHF
Approved Post Market Review
Surveillance Plan
CN-1004
New Product Introduction TMP-C-014 Rev A
Process Effective Date: 08/18/2015
Project / Design Control
Stage Comments
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage II: Collection of Inputs
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage III: Development
Phase 3: Design Verification
Stage IV: Design Transfer
Phase 3: Design Verification
Stage IV: Design Transfer
Phase 3: Design Verification Design Phase Review
Stage IV: Design Transfer
Phase 4: Design Transfer
Stage IV: Design Transfer
Phase 4: Design Transfer
Page 3 of 4

Deliverable
Project Plans Updated
Clinical Evaluations Summary
Final Forecast
Approved IFU
Design Validation Summary
Process Validation Summary
Final Product Review
Final Marketing Literature
Regulatory Clearance USA -
510(k), PMA, etc.
Declaration of Conformity, C.E.
mark
Regulatory Clearance - Other
Markets
Product release to
Commercialization
Approved release Forms
Product Management:
Competitive Review
Product Management: Customer
Service Exp.
Regulatory Complaint History &
Defects
Quality: Product NC Reports
Product Development: Design
Changes Implemented
Manufacturing: Mfg.
Performance
Purchasing: Purchasing History
Data
Logistics & Planning: Actual vs.
Forecast, etc.
Design Stage Gate Approval
Form: Section VI
CN-1004
New Product Introduction TMP-C-014 Rev A
Process Effective Date: 08/18/2015
Project / Design Control
Stage Comments
Stage IV: Design Transfer
Phase 4: Design Transfer
Stage IV: Design Transfer
Phase 4: Design Transfer Design Phase Review
Stage IV: Design Transfer
Phase 5: Design Validation
Stage IV: Design Transfer
Phase 5: Design Validation
Stage IV: Design Transfer
Phase 5: Design Validation
Stage IV: Design Transfer
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation
Stage V: Market Release
Phase 5: Design Validation Design Phase Review
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Stage VI: Launch Readiness
Page 4 of 4