Sleep disorders affect millions of people worldwide. For many, this means daytime fatigue, health risks, and a significantly reduced quality of life. However, traditional polysomnography (PSG) in the laboratory is often cumbersome, time-consuming, and expensive.
Onera Health addresses this challenge with SleepMap. This software enables clinicians to request sleep studies for their patients to be conducted in the comfort of their homes, while providing a ready-to-review diagnostic report, allowing them to focus on accurate diagnosis and treatment rather than logistics.
Find out how we supported Onera Health in the implementation process through formative evaluation for optimised user interface design in this case study.
Initial situation & project
Onera Health developed SleepMap, a software platform that enables clinicians to review and overscore sleep study data efficiently. To optimize their user interface, it is crucial to involve end users in the development process at an early stage. Therefore, a formative evaluation was conducted with experienced sleep scorers and sleep physicians to gather crucial input and suggestions for improvement.
Custom Medical was brought in to bridge this gap — offering an expert team, a proven usability engineering process and the regulatory know-how needed to deliver
Custom Medical helped us in identifying the right independent experts and carried out the formative usability testing professionally and efficiently. What stood out to me was their deep knowledge of usability engineering and their extensive experience with FDA expectations, which made them a valuable partner in setting up the study.
They worked flexibly with the materials we provided, filled gaps where necessary and maintained full transparency throughout the project. Their combination of expertise, flexibility and clarity made the entire collaboration smooth and highly effective.
Nicoline Haisma
Senior Usability Engineer
Our approach
01
Project planning and kick-off
As part of the product development process for SleepMap, a formative evaluation was key to demonstrating that the user interface is intuitive, effective and aligned with the needs of its intended users.
Initially, we were provided with a comprehensive overview of the project’s objectives and challenges. The software was presented to us in detail, and expectations were clarified.
Based on this shared understanding, we structured a tailored project approach. We defined the focus areas of the formative evaluation, aligned on the intended user groups and outlined a clear plan for how the study would be executed. Our aim was to ensure that all preparation steps, responsibilities and decision points were fully transparent from the start.
02
Recruitment of participants
During the development of SleepMap, early feedback was gathered from Onera Health’s trusted network of sleep scorers and physicians, but for the formative evaluation in the United States additional independent experts outside this network were required.
We supported Onera Health by taking over the entire recruitment process. We defined the screening criteria, identified qualified U.S.-based sleep scorers and sleep physicians and handled all communication, scheduling and participant confirmations.
By coordinating the full recruitment workflow, we ensured that Onera Health had access to the independent user groups needed for the formative evaluation.
03
Preparing the formative evaluation
For the formative evaluation, Custom Medical assisted the Onera Health team in preparing the study. Based on the risk management process, Onera Health created the defined use scenarios and tasks into a clear study procedure that could be tested effectively with the intended user groups.
After receiving access to the software, we reviewed the system to ensure that all defined tasks could be
performed during the study sessions. We verified the relevant workflows, checked functional availability and ensured alignment between the study materials and the actual software behaviour.
In a pilot session, we tested the entire setup, refined the flow where needed and confirmed that the evaluation was ready for execution.
04
Conducting the formative evaluation
We conducted the formative evaluation remotely, testing the defined use scenarios and tasks with experienced sleep scorers and sleep physicians in an entirely online setup.
To match the U.S. participant group, the formative evaluation were led by a native English-speaking usability expert from our team, ensuring the effectiveness and high quality of the interviews.
Each session was made available for live observation, allowing the Onera Health team to follow the study directly and gain immediate insights into how participants interacted with the software.
05
Evaluation & Documentation
The results confirmed that the interaction with the user interface was free of critical use errors. Still, potential User Experience improvements were identified, helping Onera Health to further improve the User Experience of SleepMap.
Based on a lean, FDA compliant usability approach, the formative evaluation confirmed the absence of critical use problems as identified by Onera Health’s use-related risk analysis.
With our joint formative evaluation, Onera Health was ready to close the Human Factors Engineering activities for FDA submission.
I would recommend Custom Medical to companies that need part of the usability service, such as respondent recruitment and study facilitation, or a sparring partner during the process. I would also recommend them to companies that would like to outsource the full usability service.
Nicoline Haisma
Senior Usability Engineer
Let’s get started!
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