medical device design

Turning your medical device innovation into reality

Each of the design stages plays a crucial role in manufacturing a finished device. At NextPhase, we have the design engineering experience to develop your next-generation medical device. We can help you with cost, quality, and performance improvements for current devices.


NextPhase can lead concept development or collaborate with your design team to provide a sounding board for design performance, manufacturing costs and processes.

  • Participate in concept ideation
  • Assist with parallel design paths and selection
  • Prototype generation for proof of concept feedback and testing

Feasibility is a critical stage for our joint teams to develop value with design and manufacturing insights.

  • Design for manufacturability and assembly, quality, cost, service (DFx)
  • Human factors and use analysis
  • Finalizing product requirements
  • Define critical to function and critical to quality features of the design
  • Packaging identification and design
  • Identification of materials and suppliers
  • Perform product hazard analysis and early risk analysis
Design & development

Design & Development is where we help you refine your product design to meet your customer and design inputs.

  • Assist with DFMEA mitigation or completion
  • Development and identification of manufacturing processes and equipment
  • Engineering builds for early verification testing
  • Test protocols and fixture development
  • Create drawing packages and Bills of Materials
  • Component and supplier qualifications
Design verification & validation

Design V&V is the stage where we help our customers make sure the product meets the intended use for the application.

NextPhase Medical Devices offers a comprehensive set of product design verification services in its product development life cycle including:

  • Design Verification
  • Functional and Performance Verification
  • Environmental Testing
  • Biocompatibility Verification
  • Sterility Verification
  • Electrical Safety and Electromagnetic Compliance per IEC 60601
  • Packaging Transit Verification per ASTM or ISTA standards
  • Software Validation

 Design Validation activities mostly focus on Human Factors support that includes:

  • User needs analysis & creation
  • Formative & summative studies
  • Use flow & task maps
  • User research
  • Interface design
  • Usability testing
  • Prototyping and simulations
  • Usability studies
  • Pre-clinical study engineering and product support
  • Clinical study engineering and product support
Design to manufacture transfer

We utilize the following key elements in conducting a proper design to manufacturing transfer:

  • Process and equipment validation
  • PFMEA development
  • Documentation release
  • Commercial launch

Want to learn more about the importance of having a design project in place?