German expertise key to medtech safety, reliability, success

Quality control is vital for those who rely on medical technology. Medical equipment must always be safe and function as it is designed to.

Doctor is holding a presentation; Source: Photography
© Photography

As a leading global manufacturer of medical technology, Germany has a great deal of expertise in quality control and validation. Manufacturers are required to meet stringent standards as set out in norms such as ISO 13485.

Growth in the medical technology market has been well above-average in recent decades. Industry sources say this has been driven by the development of many new technologies for diagnosing and treating disease. Germany is no exception, wit HEALTH MADE IN GERMANY reporting increasing sector turnovers in the country from 2018 to 2020.

What is more, according to the business intelligence provider GlobalData, the global market for medical devices was estimated to be in excess of US$ 335 billion in 2021– which is higher than for pre-pandemic 2019 and reflects a more than 20 percent year-over-year growth. These trends have led many makers of medical devices to outsource production to ease pressure on their own manufacturing facilities.

The outsourcing has led to contract manufacturers offering electronic manufacturing services (EMS). Grundig Business Systems (GBS) is one such provider. The company’s medical engineering unit provides a range of services, such as ISO 13485 certified quality management, which includes painstaking process validation.

According to GBS quality manager Volker Seidel, the company decided to move into manufacturing and EMS for medtech products, because it followed on logically from its expertise in working in the automobile industry with the IATF 16949 quality standard. In close cooperation with one medtech contractor, GBS spent over a year first carefully analyzing, documenting and optimizing all the contractor’s processes. A master validation plan was set up, requiring all production activities with measurable results to be verified and documented.

Manufacturing steps with results more difficult to measure, said the master plan, must be validated. Seidel explained that further, special testing was needed in these cases. Using soldered joints as an example, Seidel said that during validation, x-rays are taken of the joints. What is more, platins sawed up, set in resin, and microsections are created for evaluation in the lab.

The quality testing procedure summarized above is just one among many, including Installation Qualification, Operation Qualification, Process Qualification and the validation of software. Producers in Germany’s medical technology sector, including contract manufacturers such as GBS, are subject to these standards. This systematic attention to quality and detail has helped to put Germany among the world leaders in the field of medtech.