Pharmaceutical & medical medical technology in T
transition: new requirements for connectors for medical devices
hat the Coronavirus crisis has changed the medical technology industry is indisputable. Fundamental market and competitive changes are also expected in the future, bringing with them
opportunities and challenges in equal measure, according to the “Medical Technology Trend Report” study by SPECTARIS. Accordingly, adjustments to the way companies work, expansion of digital sales channels and digital service solutions were described as the three most important effects. Likewise, corporate functions such as Research & Development and IT services are in particularly high demand - which poses renewed challenges for companies due to the shortage of skilled workers. The political demands of COVID left clear
traces in the healthcare system. A drastic shortage of healthcare and nursing professionals is driving the need for supportive processes. This increases the need to maintain productivity through the increased use of medical technology. The requirements for medical devices have changed significantly, and the focus is on the safety of patients and medical staff when operating medical devices. Added to this are the changed technical requirements. Possible sources of error due to human operator error should be reduced to a minimum. “This also increases the demand for robotics and automation to make medical devices even more powerful and safer,” says Mathias Wuttke, business development manager for Medical Europe at ODU. Particularly with regard to plug-in connections, this does not result in completely new products, but the detail requirements are increasingly increasing. From IEC 60601 requirements for MOOP and MOPP to product remanufacturing, extensive product testing is required. In addition, quality management controls are increasing, as defect-free, reproducible products are required more than ever. From a technical standpoint, one of the
biggest challenges ODU’s customers currently face is with regard to clearance and creepage distances. These take on a completely different meaning due to the new evaluation of the products based on the MDR. For example, the insulation diagram must be considered for the product, and all safety-relevant points from IEC 60601-1 must be observed. In addition, there are the adapted requirements from the MDR, which makes demand not only of the medical device manufacturers, but also of the suppliers. To implement the MDR, ODU
Instrumentation Monthly January 2023
maintains appropriate technical documentation, risk and change management, and CMR substance management. Furthermore, complete traceability is ensured and there is the option of applying the Unique Device Identification (UDI) by laser marking. The topics of patient and user protection (2 MOOP and 2 MOPP) are implemented in the products in compliance with IEC60601-1. In general, companies face difficulties in
procuring raw materials and correspondingly much longer lead times. Supply bottlenecks for raw materials and components are delaying production in all industries, and additionally rising costs for energy are making products more expensive. The supply chain crisis is forcing companies to increase inventories, cut investments and attract more suppliers. Due to ODU’s high vertical range of manufacturing, challenges in the supply chain can be better balanced. The company has manufacturing sites on different continents that support and complement each other. Collaboration has also changed due to
digitalisation. “Customer and supplier have moved even closer together, and digital communication and cooperation options make processes more effective and faster,” says Stefan Wittmann, application manager at ODU. Nevertheless, personal contact is important, especially during initial contact and project start- up, in order to define requirements concretely and discuss possibilities.
odu
odu-connectors.com 53
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82
