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a better way to develop
MEDICAL PRODUCTS

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.

Signing Contract

Our Phase Process & A La Carte Services

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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

plastic surgeon pouring an implant from the implant tray into the brekka medical device
Brekka Medical

 

The Brekka device is intended to facilitate the delivery of implants by providing a shell-tissue ... 

StingRay Medical's implant delivery device shown with an implant resting on top of it, in preparation for implant delivery
StingRay Medical

 

StingRay™ is intended to facilitate the delivery of silicone gel implants by providing ... 

ASK US ABOUT ... DEVICE & TISSUE-TO-SKIN ANIMATIONS. 

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