Our first step in the development process is recommending a plan unique to the needs of the project and client. We have the expertise to design a program from a design thinking approach – starting with emphasizing with the user to a lean startup model – quickly building, testing, and learning, to something in between. We bring the experts and run the process to simplify development and ensure success.
Our Product Development Process
We Bring the Teams to Discover and Translate User and
Business Needs into Innovative Product Solutions
We Know Medical Product Development
We specialize in the development of challenging medical products in the areas of wound care, cardiovascular, electrophysiology, peripheral vascular, catheterized, and electro-surgical. In addition, we routinely apply our process to many other challenging problems. We run an FDA-compliant, user-centered process, involving formative, summative, and usability studies, satisfying key components of the regulatory strategy.
Research & Strategy
Build a strong foundation for a project by incorporating different research techniques to gather and analyze user feedback and create actionable insights to guide development.
- Ethnographic Studies
- VOC User Research
- Competitive Analysis
- Customer Journey
- IP Generation
- Formative Testing
- Opportunity Scans
- Task Analysis
- Workflow Studies
- Brainstorming Workshops
- Exploration Models
- Summative Usability Testing
- Medical Procedure-Observation
Industrial Design
Design and imagine solutions that solve problems. Then bring those ideas to life and create the physical form, shape, and features to evaluate, test, and refine.
- Concept Sketching & Ideation
- Form Studies
- Material Studies
- 3D CAD Modeling
- Photo Realistic Rendering
- Mechanism Conceptualization
- Journey Mapping
- Storyboarding
- Visual Brand Language
- Brainstorming
- Color, Material & Finish
- Packaging
- Prototyping
- User Specification
Engineering
Refine concepts and add details and specifications to make them fully functional and reliable and to satisfy the product requirements while also being manufacturable at scale.
- Mechanical Engineering
- Mechanism Development
- Mechanism Breadboarding
- Design for Manufacturability
- Document Control
- Design for Injection Molding
- Design for Roto & Blow Molding
- Design For Thermo Forming
- Design for Sheet Metal
- Design for Assembly
- FMEA Analysis
- Developmental Testing
- Testing Plans
- Testing Rigs
- Engineering Spec. Docs
Prototyping
Create physical versions of concepts, starting with low fidelity models, then moving to higher fidelity functional prototypes, and culminating with looks-like works-like functional prototypes for testing and realization.
- Form Studies
- Material Studies
- Low-Fidelity Models
- High-Fidelity Models
- Breadboard Prototypes
- Semi-Functional Prototypes
- Looks-Like Works-Like Prototypes
- Development Builds
UI/UX Design
Apply the same user-centered design approach to the user interface of a product and conceptualizing, building, and testing to achieve a compelling, intuitive, and easy to use user experience.
- Heuristic Analysis
- User Research
- Wireframing
- Persona Development
- Workflow Studies
- Clickable Prototypes
Realization & Manufacturing Services
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