Digital Thread for Medical Devices (DTMD)
Company name
Mectron S.p.a
project title
Digital Thread for Medical Devices (DTMD)
dimension and location
Medium Enterprise - Carasco (GE)
PARTNER
PTC
technologies
Quality 4.0
Smart monitoring and control of industrial processes
The problem
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.
Objective: 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 solution
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.
Desired Impacts
- 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.
Benefits for the company
- Increased global competitiveness through more efficient, digitized processes.
- Better regulatory compliance management and streamlined audit processes.
- Optimized product information management and revision cycles.
- Reduced errors and production time through simulation and the Digital Thread.
