Smart Manufacturing 08/26/2022

The three main challenges for medical device manufacturers

The three main challenges for medical device manufacturers

Manufacturers of medical devices are still under pressure in the new year: In May, the MDR will be in effect for one year - and many companies are still working on implementing the new regulation. But how do you meet the requirements even in production, where cost pressure and complexity are increasing? Bernhard Marsoner, CEO of znt Richter, is already familiar with these problems for manufacturers from other industries and outlines, how to compete on the global market.

The essential safety and performance requirements for medical devices have not only grown with the entry into force of the MDR - just like those for the accompanying documentation. Changes in classification and approval and the doubling of the retention period to 10 years create additional work, as do technical and logistical problems. Many manufacturers must comply with multiple regulations such as FDA and 510K at the same time. Distributed development documents and Excel checklists have long since ceased to be suitable tools for managing this situation. That's why many companies have expanded their product data management to Product Lifecycle Management (PLM) and added Application Lifecycle Management (ALM). "Now many manufacturers face the dilemma of linking these systems to actual production requirements and processes," says Bernhard Marsoner. "If you let product development and production run side by side, you won't achieve efficient or flexible processes."

He identifies the second challenge in the increasing complexity of product development, production and assembly: "More components and higher intelligence of the products with sensors, electronics and software as well as increasing individualization are responsible for this," says Marsoner. "Especially the integration of new products into production is becoming more difficult and causes higher effort." The search for manufacturing information, its verification and the consideration of production-related changes and their documentation will not become easier in view of smaller batch sizes and customized products.

Finally, as a third challenge, many manufacturers are facing cost pressures that have long been familiar in other industries. "Those who meet the growing demands due to greater flexibility and transparency in manufacturing and eliminate the errors of paper-based processes with their manual changes can achieve significant savings at the same time," says Marsoner. "This requires an expandable manufacturing execution system (MES) to manage and control production in real time." With Opcenter Execution Medical Device & Diagnostics, znt Richter recommends the most comprehensive, leading solution for medical technology and diagnostics. "It enables relevant companies to get to market with their products faster and turn previous problem areas into competitive advantages."