We craft products that elevate the human experience and enhance product value.

Our team’s unique ability to uphold design vision throughout the regulated landscape of medical device development leads to product solutions that exceed our partners’ expectations, driving their businesses forward.

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.

Engineering De-Risking
Sub-System Integration
Prototype Design
Embedded Systems Development
Alpha & Beta Prototyping
Prototyping Testing & Refinement
Formative Usability Studies
Design Failure Modes & Effects Analysis
Verification & Validation Planning

Phase 4 – Production Design

Art meets engineering.

We determine how to produce your groundbreaking product at scale. Design for manufacturing (DFM) principles guide our analysis of each part for material selection, manufacturing technique, and finish.

Design for assembly (DFA) principles guide our detailing of sub-assemblies. Our engineers break an assembly down into its component parts to produce a CAD database and bill of materials ready for production.

Our embedded systems engineers conduct hardware and firmware testing to perfect the product functionality and ensure adherence to safety standards.

With production intent prototypes we complete production verification perform product certification with testing labs and manufacturing validation with our supply chain, to arrive at a production-ready design that meets cost and quality constraints. We work with your team to validate the product. Our design controls process is guided by our Quality Management System which leads to a Design History File and Device Master Record to support submission to regulatory bodies.

Tasks & Activities:

Production De-Risking
Production Design Engineering
Embedded Systems Production Refinement
Production Intent Prototypes
Manufacturing Documentation
Completion of Risk Management File
Design Verification & Validation
Design History File and Device Master Record
Design Transfer

Phase 5 – Manufacturing

From One to Many

We right-size the manufacturing solution for your product and business. We provide low-volume manufacturing services in the heart of Toronto for initial pilot production and can support ramping volume manufacturing with domestic and overseas suppliers and factories.

We manage the entire manufacturing journey to ensure product specifications are met, manufacturing procedures are followed and quality is maintained. Our knowledge of your product ensures we manufacture the best product possible.

Tasks & Activities: