Your partner for medical product design and development

The “D2” design and development team at GCMI facilitates medical product development through all phases – from initial concept generation through transfer to production manufacturing. We guide and execute along a strategic pathway, focusing on both product excellence and regulatory compliance. Our team works with a variety of innovators: individual physicians, researchers and engineers, start-up companies and publicly traded industry leaders.

Our Services

We call this “Phase 0.” Read more about feasibility testing here.

  • Clinical Literature Review
  • Intellectual property landscape
  • Regulatory Analysis
  • Reimbursement Assessment
  • Functional Feasibility / Prototyping
  • User Needs & Design Inputs
  • Design Outputs
  • Risk Analysis
  • Quality Strategy
  • Verification & Validation
  • Regulatory Support
  • Pilot Manufacturing and Manufacturing Transfer
  • Supply Chain Assessment
  • Production Support

GCMI has a practicing surgeon on staff embedded in the development process. Insights on the following save time and money for our customers:

  • Clinical literature review
  • Risk mitigation
  • Care pathway insight
  • User experience
  • Resource allocation / budget management
  • Schedule & timeline creation and management
  • Team communication
  • External resource / ecosystem engagement
  • Device Design and Product Development
  • Rapid Prototyping
  • Protocol Development and Documentation
  • Product Bench Testing
  • Human Factors Testing and Voice of the Customer Input
  • Component Fabrication – 3D printing, machining, elastomer casting, external vendor management
  • Device Assembly
  • Quality System Compliance and Guidance