a better way to develop
MEDICAL PRODUCTS

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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

an industrial engineer illustrating a medical device. ona drawing tablet

Device Development

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

image of the stratasys j750 3d printer with lid lifted to show. the printer head

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

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

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StingRay Medical

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