Six-Step Medical Device Design Process

Six-Step Medical Device Design Process

Medical Device Design Process - Concept to Finished Product

Our well-established Six-Step Medical Device Design Process will advance your product idea through all the necessary stages to produce a finished product ready for testing and further evaluation. Our process produces high-quality prototypes that performs according to their functional requirements. We also take into account regulatory considerations, design for manufacture (DFM) principles, and commercialisation objectives.

The steps in our Six-Step Medical Design Process include:

  • Requirement stage – define user requirements, functional requirements, specifications, project goals, and targets.
  • Concept stage – group ideation to create multiple concepts and solutions for evaluation.
  • Development stage – select a preferred design, create a 3D model, and review manufacturing methods and materials.
  • 1st prototype stage – produce physical models of the device for bench testing, evaluation, and review of size, fit, and ergonomics.
  • Refinement stage – select a design and review design for manufacture and design for assembly considerations.
  • 2nd prototype stage – fabricate a high-quality prototype based on the refined design.
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