UPSTREAM SERVICES
02. User Research & Insights
Users can't always articulate needs, but they always reveal struggles. Watch the friction and let real-world clinical pain shape your engineering blueprint.
UNCOVER THE INVISIBLE
“We move beyond surface-level feedback to map the latent behavioral needs that define market success.”
KEY OUTPUTS & DELIVERABLES
Environmental Stressor Audit
A mapping of physical constraints - lighting, noise, and space - that dictate the real-world boundaries of safety.
Workflow Workaround Analysis
Identification of "MacGyvered" shortcuts that signal where current technology has failed.
Workload & Decision Mapping
A diagnostic to pinpoint where interfaces must be invisible - and where they must provide maximum guidance.
"Day-in-the-Life" Video Artifacts
Curated visual evidence providing teams with a visceral understanding of the "Clinical Why."
02.a
Contextual Inquiry & Ethnography
The "Micro-View": Identifying the Moments of Friction.
Interviews reveal what users think; observation reveals what they do. By uncovering "Silent Workarounds" in the field, we capture the unarticulated design inputs that traditional research misses. We provide a deep-dive diagnostic of the clinical environment to ensure your product solves the problems users have learned to ignore, but cannot afford to repeat.
KEY OUTPUTS & DELIVERABLES
Pain Point & Opportunity Heatmap
A visual diagnostic of where current solutions fail and frustration is highest. This identifies the commercial tipping points where your technology can most effectively overcome market inertia.
Critical Touchpoint Matrix
A prioritized isolation of high-stakes interactions identified in the field. This ranks user moments by their impact on the product lifecycle, ensuring R&D resources are focused on the "make-or-break" design requirements.
Emotional & Physical Journey Map
A correlation of clinical stages with user anxiety, cognitive load, and pain. This provides the human context for empathetic engineering, ensuring safety and usability in high-stress clinical environments.
Clinical Service Blueprint
A "Single Source of Truth" mapping the user journey against "backstage" hospital workflows and IT systems. This ensures operational compatibility by aligning technical specs with existing care infrastructure.
02.b
Patient & User Journey Mapping
The "Macro-View": Contextualizing the Ecosystem of Care.
A product is just one aspect in a complex journey. We visualize the end-to-end stakeholder experience to pinpoint the "Critical Touchpoints" where your product either drives breakthrough or risks failure. By mapping the lifecycle from diagnosis to disposal, we align Clinical, R&D and Commercial on the timing, context, and emotional stakes of product use.
KEY OUTPUTS & DELIVERABLES
Attribute Utility Scores
A statistical ranking of product features (e.g., battery life vs. weight) using Discrete Choice Experiments (DCE).
Benefit-Risk Trade-off Analysis
Quantitative "Patient Voice" data - utilizing Best-Worst Scaling (BWS)—required for FDA/MDR submissions.
Regulatory PPI Dossier
A formal evidence package designed to justify clinical outcomes and streamline the path to approval.
Market Choice Modeling
Predictive analysis simulating how feature changes impact clinician and patient adoption.
02.c
Patient Preference Information Studies
The "Value-View": Quantifying Clinical Trade-offs.
Regulatory bodies and payers demand quantitative evidence of what patients value. We measure the risk tolerance and benefit-risk trade-offs associated with your specific journey touchpoints, providing the statistical data required to support clinical trial design, labeling claims, and regulatory benefit-risk determinations.
KEY OUTPUTS & DELIVERABLES
Goal-Oriented User Needs
High-level, verifiable statements that define what stakeholders require to ensure safety and effectiveness.
Environmental Context Specification
Formal documentation of the actual physical conditions - derived from the Environmental Stressor Audit - where the product must perform.
Intended User Profiles
Detailed summaries of the cognitive and physical characteristics of all potential user groups, defining the "Human Factors" boundaries of the design.
Use Error & Risk Inputs
Preliminary identification of potential hazards based on field observations, feeding directly into Risk Management (ISO 14971) and ensuring appropriate scope.
02.d
User Needs Definition
The "Regulatory-View": Hardening Insight into User Needs.
The bridge between research and engineering. As the foundation of your Design History File (DHF), we translate field insights and quantified trade-offs into regulatory-grade user needs in line with ISO 13485 and IEC 62366-1. This ensures your intended use is perfectly aligned with operational realities - preventing late-stage design changes.
The organizational skills & flexibility of Ergonomics Factory ensured that the project was completed within the pre-defined time frame & budget.
Alberto, Head of R&D. Italian Pharma Company
The Strategic Outcome
Your Evidence-Based Foundation of Adoption-Driven Design.
The ‘User Research & Insights’ services move your project from assumption to reality, ensuring that your strategy is rooted in traceable, real-world human behavior rather than speculation. By identifying environmental stressors and mental constraints early, we ensure your technology is engineered to be clinically indispensable - solving the adoption barriers that regulatory compliance alone cannot address.
Lifecycle Navigator
Exploring Upstream Phase