Usability Engineering for Medical Devices
Clinical Performance Studies under the IVDR – What’s required, what has changed?
General Background
Usability is an important requirement for medical devices under the European Union’s Medical Devices Regulation (EU MDR). The EU MDR requires medical devices to be designed and manufactured in such a way that they are safe and easy to use for their intended purpose, including by their intended user groups.
When it comes to medical devices, usability is not only considering ease of use. It’s more about enabling and ensuring the safe use of the device. In fact, the industry standard for usability engineering of medical devices is IEC 62366-1, which defines usability as a characteristic of the user interface that facilitates use, increases effectiveness and efficiency, and leads to user satisfaction in the intended use environment.
But what exactly is the usability engineering? It is a process that allows manufacturers to assess and mitigate risks associated with correct use during normal use. It is an essential part of the design control and risk management processes that ensure the safety and effectiveness of medical devices.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key steps for usability under the EU MDR include:
Manufacturers must identify and document the user needs and requirements for their medical device, including the characteristics of the intended user groups and their use environments. By understanding these factors, you’ll be able to identify what can go wrong with regards to safety and the user interface of the device.
Once you have your use specification, you can analyze the risks related to the user interface. Remember, the user interface is much more than just the screen of the device. It includes all kinds of accompanying documentation and anything with which the user interacts. This is where usability engineering interacts with risk management.
Now, you’ll need to select the scenarios that need to be tested and included in your evaluation. This will help you identify potential hazards and user errors that could occur during normal use.
This is where you will define requirements that aim to reduce the occurrence of user risks. These can be seen as risk control measures. Additionally, you will need to consider the use environment and the user’s tasks to ensure the device is satisfactory for use and effective. This is where usability engineering intersects with design control.
Next, you will implement the requirements into a design prototype and test it through formative evaluation iteratively until you have no user errors at the end. Manufacturers must perform usability testing on their medical device to ensure that it meets the user needs and requirements and is safe and effective for its intended use.
Finally, you will perform a summative evaluation with the final product. This is where you will validate your safe user design of the device.
In summary, the EU MDR requires medical devices to be designed and manufactured with usability consideration, including user needs and requirements, user interface design, usability testing, labeling and instructions for use, and post-market surveillance. By complying with these requirements, manufacturers can ensure that their medical devices are safe, effective, and easy to use by their intended user groups.
Our Services
Training
AKRA TEAM offers training on drafting usability documentation to meet the expectations of the legislation and applicable standard. This would avoid delays during technical documentation assessments by notified bodies.
Process and Templates Development
AKRA TEAM has proven procedure and document templates available for all aspects of the usability documentation including:
- Usability procedure/process
- Device usability plans
- Formative usability testing protocols and reports
- Summative usability testing protocols and reports
- Device usability summary reports
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of usability documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of medical writers, clinicians, regulatory and quality experts available to write all aspects of usability documentation and support change assessment for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates and review of usability documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of the applicable legislation.