Building a Medical Device is Hard. We’re here to help.
Cortex Design supports bring your new medical technology to market by tackling user, technical, and regulatory challenges through our design-led process, guiding you as a trusted partner from concept to commercialization.
Phase 0 – BaseCamp
BaseCamp by Cortex™
We ask the question “Should we build it? to validate and de-risk the solution as described to us by you. We consider the business case, technology stack, product use-case and workflow, manufacturing concerns, and regulatory and quality implications. We evaluate the risk of each element before we undertake the full development of a solution.
BaseCamp allows both teams to establish a strong and collaborative relationship while de-risking the development process by creating a go-to-market framework which creates a roadmap to predictable product development outcomes.
Tasks & Activities
Human Factors Research & Exploration
Technical De-Risking
Regulatory Pathway
Manufacturing Analysis
Strategic Product Planning
Phase 1 – Discovery & Definition
Immersion into the culture of the user
We dive into the work you have performed to absorb the information and get the team up to speed on the project quickly. We become intimately familiar with your intent, target market and project objectives by experiencing the world from the customer’s perspective. User Needs are defined and initial product requirements are crafted.
This phase is the foundation on which the entire design process is built.
Tasks & Activities:
- Development of Factbase
- Ethnographic & Workflow Research
- Market Research & Brand Language Definition
- Product Architecture Definition
- Initial Engineering De-Risking
- Initial User Journey Definition
- Used Needs & Product Requirements
Phase 2 – Concept Exploration
Visualizing solutions
With a clear design intent, we begin to define the project constraints with brainstorming sessions, sketching, and mock-up prototypes. Our objective for this phase is to refine the ideation and conceptualization into a focused, clear, strong direction to carry forward into the prototype design phase. Product safety risks are considered to inform our creative process.
By the end of this phase, the product champion will be able to show the design to stakeholders and build excitement, momentum, and buy-in.
Tasks & Activities:
- Concept Exploration
- Refined User Journey
- Concept Refinement
- Product Life Cycle Definition
- Concept Engineering
- Embedded Systems Architecture & Planning
- Visual Asset Generation
Phase 3 – Prototype Design
Learning through building.
Now with a strong concept direction, we translate the product concept into the CAD environment to start making it real. Our focus is breaking down a product into sub-systems, perfecting each before re-integrating into the whole. Using iterative prototypes created with our in-house prototyping lab, we take the design from the computer to the real world and test and refine.
We we resolve product functionality, we create “looks-like, works-like” Alpha and Beta prototypes with external prototype partners to showcase the product in it’s final form. These prototypes are field-tested for usability, given to your target market for valuable user feedback, and exhibited to key stakeholders for their buy-in. Our team starts planning verification & validation using these prototypes.
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