Our Approach

Research. Creativity. Breakthroughs.

Touchpoints

Systematic &
Rigorous.

Our approach is grounded in thorough research, risk analysis, and usability engineering. Great design begins with understanding—users, the regulatory landscape, and opportunities for innovation.

Human-centered.

Human-centered design is at the heart of our work, enhanced by creative problem-solving to identify and address real pain points. This allows us to simplify complexity and make technology serve the user.

How we work

Working within regulation,
standards, and design controls.

Our process bakes in adherence to regulatory guidelines and standards- IEC 62366 for usability engineering, ISO 14971 for risk management, and ISO 13485 and 21 CFR 820 for design control. HE75, ISO 9241 and other standards and best practices also guide designs to ensure safety and usability.

Knowing what to build,
for whom, and why.

We draw insights from healthcare professionals, patients, and stakeholders to gather user needs and understand their challenges. Through research, observation, and interviews, we explore how users will engage with the product in their environments, ensuring the UX is safe, tailored to them, and provides real benefit.

Discovering where to innovate.

Through market research and evaluating current solutions, we identify gaps, understand people’s pain points, and discover opportunities where innovation can make a real difference.

Collaboration

Collaboration at the Core

We believe in collaboration, not working in silos. We work closely with internal teams, clinicians, patients, and stakeholders to bring diverse perspectives together, align goals, and enhance problem-solving. This interdisciplinary approach streamlines development, and ensures a smoother path to market.

Usability Foundations: Identifying users, risks, and needs.

Early usability engineering work includes defining the use specification, research into existing solutions, identifying critical tasks and hazard scenarios, and deciding what to test for in summative evaluations.

By observing users, conducting interviews, and analyzing workflows, we identify user needs that directly inform the user interface specification. This allows us to align the design with users' behaviours, environments, challenges, and goals.

Throughout the research phase, we begin exploring how different interaction modalities can fit into existing workflows and environments.

Design. Evaluate. Repeat

With the user interface specification in place, we create a user interface evaluation plan to assess its safety and effectiveness through formative tests and a final summative validation study.

Through multiple iterative cycles of designing, evaluating with users, and refining—from rough sketches to polished functional prototypes—we verify that all design inputs are met and identified risks are controlled.

The primary goal here is to refine the user interface until we’re confident that all critical tasks can be performed safely and effectively before engaging in a summative evaluation. Once all requirements and safety measures are verified, we advance to the next phase.

In parallel, we work with industrial designers and human factors experts to craft a visual language that mirrors the polished, refined aesthetics of consumer products. This fusion of functionality and thoughtful design demonstrates that medical devices can be both effective, beautiful, and engaging.

Final Validation. Safe, Effective. Efficient

The last phase is a final validation study to evaluate all aspects of the user interface that relate to safety and effectiveness under realistic simulated conditions. This includes assessing information for safety such as IFUs, warnings, and labeling.

The aim is to confirm that users can safely perform critical tasks and that risks identified in earlier phases have been mitigated.T his culminates in a usability validation report to demonstrate regulatory compliance and design readiness..

Usability Foundations: Identifying users, risks, and needs.

Early usability engineering work includes defining the use specification, research into existing solutions, identifying critical tasks and hazard scenarios, and deciding what to test for in summative evaluations.

By observing users, conducting interviews, and analyzing workflows, we identify user needs that directly inform the user interface specification, aligning the design with their behaviors, environments, challenges, and goals.

Throughout the research phase, we begin exploring how different interaction modalities can fit into existing workflows and environments.

Design. Evaluate. Repeat

Final Validation. Safe, Effective. Efficient