We employ a user-centered discovery & design process to understand the needs, challenges and opportunities within in each unique program. We think broadly and learn rapidly through a process of creating, prototyping, testing and refining.
Our Product Development Process
Translating User and Business Needs Into Innovative Product Solutions
Driving Development Efficiency Through our Integrated Service Model
Our integrated design, development & manufacturing model streamlines communication, eliminates handovers and drives efficiencies in every stage of medical device development.
Design Research
With your business and product objectives as the foundation, our strategic process draws from a wide range of research tools and methodologies to create actionable insights to guide design development.
- User Persona Development
- Usability Plan
- Risk Analysis & UFMEA
- Ethnographic Studies
- Contextual Interviews
- Online Studies
- Protocol Development
- Testing Recruitment
- Formative Usability Testing
- Workflow Analysis
- Journey Mapping
- Design History File Documentation
Industrial Design
From the clarified business, product, and user experience objectives, our creative and technical teams collaborate to explore, visualize, test and iterate a range of design solutions.
- User Experience (UX) Task Flows
- UX Storyboarding
- Brainstorming
- Concept Ideation
- Product Architecture
- Form Development
- Visual Brand Language
- Iterative Prototyping & Refinement
- Color, Material & Finish
- Rendering Visualization
- Packaging Design
- Design History File Documentation
Engineering
Clarify product requirements and collaborate in development, prototyping, testing and iteration to ensure fit to specification and DFM/ DFA efficiency.
- Conceptual Engineering
- Risk Analysis & DFMEA
- Iterative Engineering &Prototyping
- DFM/ DFA
- Breadboarding
- Bench Testing
- Prototype/Build Development & Management
- BOM and Initial Cost Development
- Vendor Management
- Functional Testing
- Production Drawings and Specifications
- Design History File Documentation
Prototyping
Our process is hands-on, with rapid prototyping as an essential tool for visualization and discovery. Low-fidelity prototypes allow us cover a lot of ground in the early stages. As development matures, we draw upon a wide range of resources to suit the needs.
- Hand-Sculpting
- 3D Printing
- CNC Machining
- Soft Goods Prototypes
- Clickable UI Prototypes
- Breadboard Prototypes
- PCB Fab & Assembly
- Appearance Prototypes (Looks-like)
- Functional Prototypes (Looks-like / Works-like)
- Development Builds
UI/UX Design
Explore, visualize, test and iterate to create intuitive and elegant interface solutions.
- User Persona Development
- UX Task Flow Development
- Risk Analysis
- UFMEA
- Wireframing
- Interactive Prototyping
- Usability Testing
- Visual Design
- UI Specification
- Design History File Documentation
Realization & Manufacturing
Finalize the frozen design and guide it through sourcing, verification testing, validation testing, documentation, assembly, quality, and production.
- Design History File
- Vendor Sourcing
- Testing Plans
- Final Manufacturability
- Final Assembly Refinement
- Document Controls
- ISO/IEC 62366 Compliance
- Quality Plan
- Full Turn-Key Manufacturing