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.

Our Phase Process & A La Carte Services

Device Development

Providing expertise and services for the creation and improvement of medical devices.

Rapid Prototyping

Offering quick and efficient physical modeling to improve medical device designs.

Manufacturing

Producing medical devices efficiently and effectively, while adhering to quality standards.

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
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