MEDICAL DEVICE DEVELOPMENT MANUFACTURING. EVERYTHING IN-HOUSE.
REDUCING R&D DEVELOPMENT FEES
We've been the inventor and we didn't like the development fees. We also didn't like all the outsourcing of specialties. We've built our business to reduce those pain points and to reward the inventor for their brilliant idea. Our inventors spend less, develop faster and commercialize easier than our competitors.
Our Phase Process & A La Carte Services
Phase Development Timeline
Phase 0 - Exploration
Problem Definition
Market Assessment
Technology Research
Concept Development
IP Strategy, FTO
User Research
Sketch Prototypes
Database Development
Phase 3 - Design for Manufacturing
Design for Manufacturing
Regulatory Development
Functional Prototypes
Pre DV Testing
Supply Chain
BOM Development
Design Freeze
Die Mold Analysis
Mold Flow Analysis
Die Mold Manufacture
Phase 1 - Prototyping
Concept Refinement
Low-Fidelity Prototypes
Bench Testing
Database Refinement
User assessment
Regulatory Pathway
Manufacturing Ballparks
Business Strategy
Roadmap for Development
Go-No-Go
Phase 4 - Manufacturing & Sterilization
DV Units
Manufacturing Documentation
Supply Chain Approval
Tooling & Low Volume Runs
Verification & Validation Testing
510K Regulatory - Documentation
510K Regulatory Submission
Sterilization Engineering & Validation runs
Phase 2 - Refinement & Testing
Concept Downselection
High-Fidelity Prototypes
User Testing
Functional Testing
Specification Development
Vendor Sourcing
Concept Freeze
Phase 5 - Distribution
Production Orders
Sterilization Regular Runs
Marketing
Inventory
Plug-&-Play Sales Team
Sales Training
Featured Projects & Portfolio
Brekka Medical
The Brekka device is intended to facilitate the delivery of implants by providing a shell-tissue ...
StingRay Medical
StingRay™ is intended to facilitate the delivery of silicone gel implants by providing ...
ASK US ABOUT ... DEVICE & TISSUE-TO-SKIN ANIMATIONS.
