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 perform according to their functional requirements. We also take into account regulatory considerations, design for manufacture (DFM) principles, and commercialization 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.