Success Story | Ergonomics Factory, Switzerland

Validating a new radiology solution’s readiness for CE marking

User Studies, March 2022

Business situation

In November 2021, a global medical device company engaged Ergonomics Factory to perform a human factors validation study. Conducted in Switzerland, the study aimed to verify that the client’s new radiology solution conformed with European health, safety, and environmental protection standards, thus making it suitable for CE marking approval.

The Challenge

During the design and development phase of this innovative radiology solution, the client had already conducted several formative human factors studies of their own. However, they required greater human factors expertise to plan a design validation strategy that would comply with EU and US regulatory requirements.

The next human factors validation study would need to be highly cost-effective. To prevent any misallocation of resources, notably time, stakeholders wanted absolute confidence that the final study would comply with regulatory requirements and expectations. We also agreed to grow their in-house expertise to prepare for future product development.

The client’s ideal study partner would need to:

Consolidate previous formative human factors studies’ findings.
Support the planning and preparation of the client's design validation activities.
Perform a highly cost-effective human factors validation study in Switzerland.
Support their team in completing risk assessment activities.
Deliver a report to support Class 1 medical device CE marking approval.

The Solution

Ergonomics Factory reviewed the client’s user interface, human factors, and risk-related documentation and consolidated the findings of previous formative human factors studies. We revised the risk assessment documentation with the client’s in-house quality and risk management representatives. Leading up to the study, we developed a human factors validation study protocol and participant screener.

The client recruited the participants in accordance with the participant screener and organized the test site at a local hospital. Ergonomics Factory’s [specialist title(s)] executed the study sessions while the client’s trained staff collected data using predefined note-taking sheets.

Our team then EFTY analyzed the study results and delivered a comprehensive study report. We supported the client’s risk assessment, including benefit-risk assessment, to successfully complete the human factors validation activities.

The Outcomes

The interaction and visual design concept includes all information and interactions required for performing the surgical procedure as per the system’s user requirements and intended use, and meets international standards and regulatory requirements for medical devices

The client has an interactive prototype of the interaction and visual design concept that allows the assessment of the systems feasibility and usability

The concept and its prototype were specifically defined and developed to support the client’s technology, i.e., the display’s resolution, dpi, screen size, and multi-touch capabilities

The sizes of buttons and fonts, as well as the spacing between elements, have been specifically designed for minimizing use-related risks and optimizing ease of use under the intended use conditions, including use of sterile gloves and supporting multiple operators from different user groups that may interact with the system at a time

Use of a clear and concise color coding system to facilitate distinction between different critical and non-critical system states and screen elements

A consistent button states system to ensure understanding of actions that are allowed, ongoing, or disabled during surgical procedure

The client’s human factors validation study was completed, with thorough and compliant human factors engineering design history file documentation. We achieved full traceability between identified use-related risks and proof of the effectiveness of the implemented use-related risk control measures. In [month] 2022, the client’s radiology device was officially approved for CE marking.

BENEFITS

First-time right human factors validation

Strengthened in-house competencies

Regulatory compliance and efficient approval

Increased speed to market

Updates

Now that the client has attained CE marking for their radiology solution, they continue to work with Ergonomics Factory on strengthening the core competencies of their in-house design and development team.