UPSTREAM SERVICES
03. Concept Definition & Requirements
Knowing your user’s needs is useless if they don't survive the transition to engineering. We convert them into conceptual solutions and test them with real users to de-risk development before expensive tooling begins.
TRANSLATE “WHAT IF” TO “HOW TO”
“We translate abstract user needs into tangible concept visions and traceable design inputs.”
KEY OUTPUTS & DELIVERABLES
Concept Visualization Sketches
Professional renderings and storyboards that bring abstract ideas to life for stakeholder review.
Low-Fidelity Prototypes
Rapid "look-and-feel" models (paper/foam/digital) used to test form-factor and basic interaction logic.
Stakeholder Value Consensus
A formal record of shared priorities - clinicians, payers, and engineers - ensuring the "Win-Win" for all parties.
Ideation Output Gallery
A descriptive catalog of generated product concepts, serving as a creative repository for your R&D pipeline.
03.a
Innovation & Co-Creation Workshops
Harness collective intelligence to align your vision before you build.
We facilitate structured design sprints that unite clinicians, patients, and engineers in a collaborative environment. By using rapid prototyping and design thinking, we transform stakeholder friction into a unified product vision that is technically feasible, clinically relevant, and commercially viable.
I was very impressed with Ergonomics Factory's understanding of their client's needs.
Barbara, Head of Drug Product Development
Swiss Pharma Company.
KEY OUTPUTS & DELIVERABLES
Traceable Requirement Matrix
A rigorous map linking every requirement back to a user need or clinical pain point (User Needs → Design Inputs).
Validation Criteria
A framework defining how each requirement will be tested during design validation to prove safe and effective use.
Interface Scope
Requirements covering the complete user experience, including hardware, software, packaging, labeling, and training.
03.b
User Requirements Definition
Systematically convert clinical "Needs" into engineering "Requirements".
This is where the regulatory trail from user needs continues. We translate qualitative insights into formal, unambiguous User Requirements (per 21 CFR 820.30 and ISO 13485). By providing clear targets for your R&D team without restricting the solution space, we create the basis required for a robust Design History File (DHF).
KEY OUTPUTS & DELIVERABLES
Early-Stage Friction Analysis
A diagnostic of intuitive vs. non-intuitive interactions to refine the product’s logic and flow.
Workflow Simulation Testing
Confirmation that the concept integrates seamlessly into the established clinical routine without creating new overhead.
Mental Model Mapping
Observations on whether users intuitively understand the product’s architecture and operational "story."
Design Rationale & Evidence Record
A documented history of why specific design directions were chosen, providing the critical "Why" for your regulatory submissions.
03.c
Concept User Studies
Fail fast and learn faster - before your design is "frozen".
We use early-stage models to put your ideas in front of users long before the cost of change becomes prohibitive. This iterative testing identifies usability flaws and value gaps while the design is still fluid, providing a "Go/No-Go" technical gate that prevents expensive late-stage redesigns.
What does it take to replicate real-world clinical conditions?
The Strategic Outcome
Your Engineering Blueprint for Clinical & Commercial Success.
The ‘Concept Definition & Requirements’ services move your project from "possibility" to "specification”, ensuring that your DHF is populated with technical requirements derived from iterative testing. By de-risking the concept early, we create a seamless hand-off to R&D that accelerates time-to-market and ensures your final product is built to succeed.
Lifecycle Navigator
Exploring Upstream Phase