Our Development Timeline

Problem Definition​

Brainstorm​

Ideation​

Regulatory Investigation​

Market Assessment​

Technology Research​

Concept Development​

IP Support​

User Research   ​

Low-Fidelity Prototypes​

Video Animations​

Videos Pictures Weekly​

Weekly Prototypes​

Database Development​)​

Concept Down Selection​

Concept Refinement​

Higher-Fidelity Prototypes​

Bench Testing​

Database Refinement​

User Assessment​

Regulatory Pathway​

Manufacturing Ballparks​

Business Strategy​

Roadmap for Development​

CAD database​

Business Plan​

Investor One Pager​

Anatomy Animation Video​

Engineering Refinement​

High-Fidelity Prototypes​

User Testing (UT)​

Clinician Feedback​

Functional Testing​

Specification

Development​

Design for Manufacturing​

Vendor Sourcing​

Vendor QMS Confirm​

Vendor Qualification​

Vendor Costing​

CAD Database

Refinement​

Design History File​

Documentation Drafts​

Concept Freeze​

Final Design For Manufacturing (DFM)​

Regulatory Documentation​

Regulatory Costing & Scheduling​

Design Control Documentation​

Molding Design​

Mold Flow Analysis​

Die Mold Manufacture​

Functional Prototypes​

Pre DV Testing​

Supply Chain Confirm​

BOM Development​

Design Freeze​

DFM Files Frozen​

Oversee Tooling​

Manufacturing Documentation​

Design Verification Units (DV)​

Supply Chain Approval​

Tooling & Small Runs​

Assembly Line Setup​

Verification & Validation Testing​

Quality Documentation​

Quality Management System (QMS)​

Shipping Testing​

Biocomp Testing​

Performance Testing​

Usability Testing​

Aging Testing​

Sterilization Validation​

510K Document Writing​

510K Regulatory Submission ​

Creative & Marketing​

Distribution​

Commercialization​

Sterilization regular runs​

Marketing/Pics/Videos​

Website Creation​

Brochure Creation​

Document Control ​

QMS Management​

FDA Complaint Handling​

Warehousing Space​

Shipping Protocol​

Inventory Management​

Plug-N-Play W2 Sales Team​

Sales Training​