Case study: the importance of usability in the context of Regulation (EU) 2017/745 (MDR)

Di Eliana Russo - Head of Regulatory Affairs

With the introduction of the Medical Device Regulation 2017/745 (MDR), usability has become a crucial requirement for obtaining the CE marking of a medical device. Regulatory developments underline the responsibility of manufacturers, among others, to ensure that their products are not only effective but also safe for users. Analyzing and managing the risks associated with using a device is an integral part of the development process. It is essential that manufacturers identify and assess the risks associated with both the correct use of the device and possible misuse that could be foreseeable. 

Usability refers to the ease with which a device can be used for its intended purpose. This process not only aims to protect patients but also helps to improve the user experience, facilitating interaction with the product. 
According to the IEC 62366 standard, usability engineering is a step in the device development process. Manufacturers are required to define their requirements, and if these are implemented correctly, they can significantly increase the likelihood that users will use the device without making mistakes. Therefore, it is crucial to carry out targeted usability testing to evaluate, analyze, and improve the usability of the device

A practical example of a usability application is represented by a case study developed for a polyurethane breast implant. The implant is designed as a temporary replacement for the removed breast tissue and as a support for the growth of patients' autologous tissue. Intended for adult women undergoing breast conservative and reconstructive surgery, the implant should only be used by qualified medical personnel. To ensure the assessment that the prosthesis meets the usability requirements, a detailed questionnaire has been developed to be administered to the clinicians who use it. The questionnaire begins with questions related to the clarity of the information on the packaging label and the ease of opening.
Subsequently, the questionnaire investigates aspects such as the ease of extraction of the prosthesis from the packaging, as well as the feasibility of its hydration. These factors should be considered important, as they can affect the safety and effectiveness of surgery. The questionnaire extends to evaluate the usability of the prosthesis during the surgical phase. Questions are asked about the placement, fixation, and coverage of the prosthesis, along with the ease of removal or explantation. 

This detailed assessment allows the identification of potential areas for improvement, thus ensuring safer and more effective use of the device. A key section of the questionnaire collects opinions on the clarity of the information provided by the manufacturer in the instructions for use (IFU). This includes aspects such as packaging, sterilization, material handling, warnings, and potential risks. Clear and structured feedback from users is essential to further improve instructions and usage practices. The case study of polyurethane breast implants illustrates how the application of MDR regulations and usability standards can significantly improve the interaction between doctor and device. 

Through targeted usability testing, it is possible to verify that the information provided by the manufacturer on the label and in the IFU is clear and complete and misuse risks can be identified and mitigated, ensuring safe and effective use of the device. The integration of usability into the medical device development process not only facilitates the achievement of regulatory compliance but represents the way to avoid possible misuse of the medical device by the users for whom it is intended.