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 workflows and ensures a smoother path to market.
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.
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.
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..
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.
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.
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..