
Must-Have ERP Capabilities Medical Device Manufacturers Should Look for in their ERP Systems
Significant advances in wireless technology, miniaturization, and computing power are fueling the development of new connected medical devices that can generate, collect, analyze, and transmit data
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CIO Applications Europe | Friday, October 01, 2021

The smart device revolution is radically altering manufacturing and customer experience, while subscription services, device rental, and leases are reshaping the industry's business model. Manufacturing technology enables a successful pivot of the business model.
Fremont, CA: Significant advances in wireless technology, miniaturization, and computing power are fueling the development of new connected medical devices that can generate, collect, analyze, and transmit data. Consumers are increasingly adopting smart healthcare technology such as connected inhalers, smart insulin pens, and asthma monitors, which enable them to better manage their own health.
The smart device revolution is radically altering manufacturing and customer experience, while subscription services, device rental, and leases are reshaping the industry's business model. Manufacturing technology enables a successful pivot of the business model.
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Medical device manufacturers have always had to meet a slew of stringent manufacturing standards. They must build complex products to exact specifications and tolerances that are highly regulated, and they must operate for a long period of time – potentially for the rest of a patient's life.
However, with smart devices, manufacturing is only the beginning of the journey because customers may spend far more on services for a device over its lifetime than they will on its initial investment.
Here are key capabilities that medical device manufacturers should search for in their ERP systems to support shifting business models and requirements:
Quality management: This is crucial for medical device manufacturers in order to reduce risk, monitor in-process quality, and ensure regulatory compliance. FDA regulations require tracking and monitoring of in-use products. Manufacturers must implement a Corrective and Preventive Action (CAPA) process when a potential problem is discovered. Quality management must also be in sync with the quality management processes of suppliers. An automated system ensures that quality best practices are integrated into operations and that organizations can address the full range of quality and compliance mandates.
Traceability: Advanced ERP toolsets allow for serial control from the cradle to the grave – from component level to assembly and shipping finished goods – providing manufacturers with complete end-to-end traceability. This enables manufacturers to track the origins of a specific part of an entire product batch throughout the supply chain.
Traceability is frequently performed outside of the ERP system, which makes it very difficult to track the components inside the device or fully comprehend which customers received the device or specific components. Traceability as an integrated function of the ERP system ensures that commercial and quality flows are in sync.
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