Full digitization of the medical device lifecycle to optimize quality, traceability, and data management, with a focus on efficiency and regulatory compliance.
Mectron S.p.A
PTC
Reduced development costs
The “single source” approach to data management has led to a significant reduction in development costs, with savings of 30% to 40% compared to traditional methods.
Reducing time-to-market
Adoption of Digital Thread reduces both design and launch times, improving process efficiency with an estimated reduction in time-to-market of 30% to 40%.
Increased efficiency
Integration of new powders The simulation system has improved powder handling efficiency and device performance, allowing new formulations to be integrated with greater accuracy.
Mectron is an Italian company operating in the high-tech medical device sector. For over 40 years, it has been developing innovative solutions for the healthcare sector, combining research, engineering, and quality. It is internationally recognized for its technological excellence.
Managing medical device data was a significant challenge for Mectron, with fragmented processes and predominantly paper-based documentation. This led to delays in audit management and increased difficulty in ensuring regulatory compliance.
Goal: Develop a Digital Thread to integrate and digitize all product lifecycle data, enhancing quality control, reducing development time, and boosting competitiveness in a rapidly evolving sector.
The project was developed in five key phases:
Defining business requirements: analysis of PLM system functionalities required by key users.
Test environment implementation: Configuration of a Product Lifecycle Management platform in a pilot environment, with simulations of powder prophylaxis devices.
Digital Twin development: Creation of a digital model to predict medical device behavior throughout its lifecycle.
Production release: Full implementation of the PLM platform, integrated with CAD and ERP for business process management.
Integration of a dedicated application for validating new component or product requirements.
Significant reduction in development time and time-to-market.
Improved quality control and compliance with regulatory standards.
Complete digitalization of technical documentation, reducing paper usage.
Enhanced collaboration through centralized data access.
