TAG3 Product Development Journey

Idea

Whether you are a physician or individual with an idea for a new medical device, a start-up company or large corporation, we can help you navigate the process for designing, developing and manufacturing your product.

We can support you from concept to commercialization or mix and match to help you with any aspects of this process.

Design

Transform your ideas into innovative, functional medical devices using our expert team.

  • Concept Generation
  • Clinical Need Assessment and Definition
  • Clinical System FMEA
  • Product Concept Design
  • IP Assessment / Development
  • Preliminary Hazard Analysis
  • Rapid Prototyping (including 3D printing)
  • 3D Modeling
  • In-house Machining
  • Finite Element Analysis
  • Mechanical Design
  • Electrical Design
  • Concept Verification Testing
  • Requirements Development
  • Risk Management Plan

Develop

From concept to prototype to manufacturable product, we streamline regulated and compliant development for faster, efficient solutions.

  • Detailed Product Design
  • Preliminary Process Development and Documentation
  • Design and Process FMEA
  • COGS Estimates and Review
  • Component and Assembly Specifications
  • Packaging and Labeling Specifications
  • Design Control System
  • Development Plan
  • Regulatory Strategy and Filings
  • Supply Chain Development
  • Clinical Builds
  • Simulated Use Model / Testing
  • Human Factor Engineering and Formative Testing
  • Feasibility Studies
  • Functional Testing
  • Packaging Design and Development
  • Design for Manufacturability
  • 3D Modeling and Design

Manufacture

Scale your production with our ISO 13485 and GMP-compliant manufacturing processes.

  • Catheter Development, Extrusion, Braiding, Coil Winding, Laminating & Coating
  • Balloon Development
  • Assembly
  • Packaging
  • Process Validations (IQ, OQ, and PQ)
  • Design, Verification and Validation Testing
  • Transfer to Manufacturing
    • At TAG3 or into your Facility
  • Manufacturing Process and Test Method Verifications / Validations
  • Manufacturing Tooling
  • Regulatory Filings
  • Commercial Readiness Planning
  • Commercial Production

Launch

TAG3 can support you with your product launch as your contract manufacturing partner.