Primordial Soup is a product development firm with deep experience in healthcare.
We are mechanical engineering centric. This means we speak the language of design, electrical engineering and manufacturing. Mechanical engineering is the translator for other engineering disciplines. We're very effective in balancing user needs with manufacturing needs. Our clients achieve unified products. In short, we're crushing it.
Human Factors Engineering
Contextual Inquiry | User Needs Definition | Use Specification | Design Input Development | Use-based Risk Analysis | Formative Usability Testing | Summative Testing
Industrial design
Brainstorming | Sketching | Concept Development | Prototyping | CAD Modeling | Surface Modeling | Product Rendering | Color Material Finish Design | Packaging Design
Engineering
IP Generation | System Design | Device Design | Design For Manufacture (DFM/DFA/DFX) | Tolerance Stack Analysis and GD&T | Material Specifications | Process Development | Component and Assembly Drawings | Bills of Material | Packaging and Labeling Design/Specifications
Analysis & Testing
Finite Elements Analysis | Failure Analysis | Tensile and Compression Testing | LabVIEW Testing | Cycle Testing | Verification And Validation
Manufacturing
FDA Registered and ISO 13485 Certified QMS | Rapid Prototypes | 3D Printing | CNC Machining | Assembly | Pilot Production | Project Management | Sourcing | Vendor Management | Regulatory Adherence
Project Management & Documentation
Project Plans and Schedules | Product Specifications | Risk Management and Analysis (FMEAs) | Design Control and Technical Documentation | Design Verification and Validation Planning | Design Transfer | Regulatory Submission Support (including FDA 510k and PMA)