
PHASE DEVELOPMENT TIMELINE
Phase Overviews & Deliverables


Phase 0
Exploration
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Brainstorm
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Ideation
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Explore Competitors
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Problem Definition
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Market Assessment​
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Technology Research
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Concept Development
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IP Strategy
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User Research
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Sketch Prototypes​
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Video Animations
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Videos Pictures Weekly
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Weekly Prototypes
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Database Development

Phase 3
Design for Manufacturing
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Design for Manufacturing (DFM)
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CAD to DFM Files
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Regulatory Development
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Regulatory Costing
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Regulatory Timing
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Mold Flow Analysis
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Die Mold Devleopment
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Die Mold Manufacturing
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Functional Prototypes
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Pre DV Testing
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Supply Chain Confirm
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BOM Development
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Design Freeze
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DHF Files Frozen
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DFM Files Frozen
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Compile Documents QMS

Phase 1
Prototyping
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Concept Refinement
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Low-Fidelity Prototypes
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Bench Testing
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Database Refinement
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User Assessment
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Regulatory Pathway
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Regulatory Risk Analysis
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Manufacturing Ballparks
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Business Strategy
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Roadmap for Development
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CAD File with Labeled Parts
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CAD File Parts Measured
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Business Plan & Investor Docs
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Anatomy Animation Video

Phase 4
Manufacturing & Regulatory
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Design Verification Units (DV)
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Manufacturing Documentation
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Supply Chain Approval
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Tooling & Small Runs
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Dial-in Specs Small Runs
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Verification & Validation Testing
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510K Regulatory Testing (3 months)
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Quality Documentation
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Quality Management System
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QMS build-out 100 documents
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Compile Certificates
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Sterilization Protocol
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Engineering & Validation Runs
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510K Document Writing
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510K Regulatory Submission
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FDA 510K Response

Phase 2
Refinement & Testing
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Concept Downselection
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High-Fidelity Prototypes
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User Testing (UT)
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Clinician Feedback
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Functional Testing
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Specification Development
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CAD Reconfigurement with UT
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Vendor Sourcing
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Vendor QMS Confirmation
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Vendor Qualification
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Vendor Costing
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Vendor Meetings (10+)
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Concept Freeze
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CAD File Freeze
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Design History File
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Compile Documents QMS

Phase 5
Business Operations & Sales
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Business Operations
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Distribution Strategy
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Device Commercialization
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Production Orders
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Sterilization Regular Runs
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Marketing Pictures & Videos
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Website Creation
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Marketing Literature Creation
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Document Control
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QMS Management
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Bi-yearly QMS Audits
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FDA Complaint Handling
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Distribution Plan
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Warehousing Space
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Shipping Protocol
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Inventory Management
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Sales Strategy
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