We turn your medical device innovations into a reality
Our design engineering technical expertise includes but is not limited to:
- Biomedical engineering
- Design for manufacturability
- Design for serviceability
- Electrical engineering
- Materials science
- Mechanical engineering
- Plastics engineering
- Quality engineering
- Risk management
- Software development
- Systems engineering
- Validation and verification
The design engineering process
The first step is understanding the inspiration of your device. Whether it’s an improvement of an established device or a whole new treatment option that promises to change patients’ lives, once the user needs are identified defining how the device is to be used, a foundation for the design can be established.
Design work starts with brainstorming concepts consistent with the use and technology of the device. CAD and analysis are applied to the ideas to achieve proof-of-concept designs and some looks-like/works-like prototypes.
Engineering is applied to the proof-of-concept prototypes to make functional prototypes. A combination of rapid prototyping, quick process development and craftsmanship renders a device that provides the customer with a device that can be assessed by gathering customer feedback and performing functional testing.
It’s a fast-paced process, and collaboration with the customer is a key to success. The process continues with more and more precise representations of the device with greater demands placed on each iteration until the parts, process and the customer’s idea are ready for manufacturing.
The NextPhase design engineers have extensive experience in the development and manufacture of medical devices. It’s our passion. We develop conceptual and detailed designs that ensure product functionality by drawing on our experience and tackling the scientific challenges. We help our customers bring their device to market by documenting our process and arming them with the materials they need to navigate their regulatory path.
We take you through the whole design control process in the following steps: Concept Development, Feasibility Stage, Design & Development, Design Verification & Validation, and Design to Manufacturing Transfer.