Leveraging digitalization to accelerate production lead time and secure the quality of traceability – The MicroPort case

Product: Opcenter
Industria: Medicine

High performance is critical

MicroPort CRM (Cardiac Rhythm Management) is a business unit of MicroPort Scientific Corporation that manufactures pacemakers, implantable defibrillators, pac­ing leads and Holter monitors for patients with cardiac rhythm disorders. MicroPort CRM’s solutions are Class III products, that means they are strictly regulated by regulatory authorities and must have the highest level of quality.

Moving beyond a paper-based system

Before the introduction of MES in 2014, traceability was fully manual and all the test systems recordings that were used to check the electronic features of the devices, the lot numbers and materials used for product manufacturing were managed and signed in a separate and parallel way by the operator.

It was a huge amount of work spent to perform paper-based traceability activity.

This was the impetus for imple­menting Opcenter™ software, a manufac­turing execution system (MES). It is part of the Xcelerator™ portfolio, the comprehen­sive and integrated portfolio of software and services from Siemens Digital Industries Software. And today many machines in the MicroPort CRM production facility receive information from Opcenter MES.

Opcenter enabled us to control production: to record all production-related data and search, retrieve and consume a massive amount of data but it also allows us to con­trol and avoid errors during the manufacturing flow,” – says Federico Carnovale, information technology (IT) Manager at MicroPort CRM.

Carnovale continued highlighting the importance of traceability – “If we don’t have full traceability into one product, we cannot sell that prod­uct so we need to scrap it. Today, with a system that drives the execu­tion of manufacturing, we can avoid this kind of issue and the related scrap

Opcenter pays off

One of the benefits that we had with this system was with the massive amount of data collected in a single digital repository, we added the possibility to do analytics reportingBefore Opcenter it was more difficult to create reports with live data coming directly from one factory” – says Carnovale.  

If you look at industrial plants, you can imagine that a big percentage of the timeline of the manufac­turing is spent signing, writing, losing, print­ing: removing all this means accelerating the production lead time and this is a bene­fit for digitalizing manufacturing” – says Fadi Fakhouri, IT Director at MicroPort CRM

We are often audited by certificate entities and recently received compliments from the notified body for our traceability system and stability strength. We can provide the auditors with information in real time, retrieve data as they want and are able to show the reliability of the data they want without delay.” – says Alessandro Starace, Manager, Data Management MicroPort CRM

Integrating Opcenter with other factory systems

Opcenter is integrated with the firm’s enter­prise resource planning (ERP) system and is interfaced directly with its testing and man­ufacturing machines and the automation systems, which interact in real time.

This integration is key because, for example, one machine that is needed to produce a part must get information on the manufac­turing instruction immediately in real time before executing the manufacturing. In turn, it needs to provide feedback to the system on the operation just carried out because the next operation might be a few seconds later. So it is necessary to have a way of communicating that is extremely fast.

Labeling is another key aspect in the medical device industry. The labeling of the product is done with a software that manages the labeling for all products in the MicroPort CRM system. In this case MES provides infor­mation that is consumed by the labeling software to produce labels.