Model-Based Systems Engineering (MBSE) is an increasingly popular approach for verifying medical devices. By using a digital model as a single source of truth, MBSE can help medical device companies gain clarity in their product development processes and improve the quality of the products they bring to market. In this article, we will discuss the advantages and challenges of verifying medical devices with MBSE.
Advantages of MBSE in Medical Device Verification
Using MBSE in the verification of medical devices provides a number of benefits. First, it can help companies automate the verification process, reducing the need for manual testing. This can in turn reduce the time and cost associated with verifying medical devices. Additionally, by using digital models as the single source of truth, companies can keep an accurate and up-to-date record of all the changes made to the device throughout the development process. This can help ensure that all the necessary steps have been taken to ensure the device’s safety and efficacy.
Another advantage of using MBSE is that it can help companies better visualize the development process and the device itself. By visualizing the device’s architecture, the relationships between its components, and the interactions between them, companies can gain a better understanding of the device and identify potential areas of risk. Finally, MBSE can help companies streamline the approval process, as regulators can access the MBSE model to more quickly evaluate a device’s safety and efficacy.
Challenges of Verifying Medical Devices with MBSE
Despite the advantages of using MBSE for medical device verification, there are also a number of challenges to be aware of. One challenge is the need for companies to invest in the necessary tools and resources to effectively use MBSE. Additionally, creating an accurate MBSE model is an involved process that requires expertise and experience, and can be costly and time-consuming. Finally, companies must also ensure that their MBSE models are properly maintained and updated to reflect any changes that have been made to the device.
In summary, MBSE provides a number of advantages for verifying medical devices, including automation of the verification process, improved understanding of the device’s architecture, and a streamlined approval process. However, companies must also be aware of the associated challenges, including the need to invest in the necessary tools and resources, the need for expertise in creating an accurate MBSE model, and the need to regularly maintain and update the model.
