Safe medical applications

With SCHURTER's expertise, BIOTRONIK develops safe medical applications

For more than fifty years, BIOTRONIK has been developing medical devices that improve the quality of life of patients suffering from cardiovascular and endovascular diseases. One of the company's products is the Renamic Neo, a control unit that communicates with a medical device implanted in a patient, such as a pacemaker. The control unit allows the physician or patient to read information such as battery status, heart rate and other parameters that are important for the functioning of the implanted device. Specific knowledge of SCHURTER played an important role in developing this application. In conversation with Willem Zoeten, account manager at SCHURTER, and product development engineer Paul Berning.

Communication between the Renamic Neo and the implanted device is wireless, via a low-power radio signal. It is essential that no interference occurs in the frequency range of this signal. When developing the application, EMC was an important topic from the start, says Paul: “In a special, emission-free EMC chamber of BIOTRONICS we tested a number of types of controllers to see which solution has the lowest emissions. We have also tested and optimized the other components, such as the LCD display, in this way. Ultimately, we developed prototypes using the best-performing components BIOTRONICS were tested. The verdict was very good.”

When the Renamic Neo went into production, early BIOTRONICS to SCHURTER to include an EMC test as standard in the production process. Paul: “BIOTRONICS wanted to officially measure that their products comply with the medical EMC standard EN 60601-1-2 and supplied the equipment for this. There is now a shielded cabinet here, where no radiation can penetrate from outside. The product is placed in the cabinet, connected with cabling and switched on. An antenna in the cabinet captures all signals around the frequency in question, and these are passed through a coaxial cable to a spectrum analyzer outside the cabinet, which measures the signals. An algorithm determines an average value of those signals, which must be between 3 and 20 dB. lie."

Willem: “Thanks to the knowledge we have of EMC, in combination with our expertise in the field of control panels, we were able to make a significant contribution to this project. BIOTRONICS has a lot of in-house knowledge about EMC, we have contributed a lot of expertise to achieve a manufacturable product. Based on the requirements BIOTRONICS We redesigned the entire PCB. All to ensure that emissions are affected as little as possible.”

The application has now been in production for two years. Willem: “We currently supply 1,500 to 2,000 pieces per year, we will eventually reach a production size of 3,000 per year. Now it is a matter of fine-tuning the production process, with a particular focus on the cost structure. Can we improve anything in terms of production technology? Can we use other materials or production methods to reduce costs? Any savings are passed on directly to BIOTRONICS. We have already been able to reduce production costs by more than twenty percent per unit in the last two years and we are still working on further improvements.”

Continuously optimizing materials and production processes is a permanent fixture at SCHURTER, says Willem: “We have to offer these types of products competitively, but at the same time the risk is high in the beginning. Then it makes a difference if we know in advance that we can gradually make efficiency improvements.”