Epicor® ERP for Medical Device Manufacturing 

Medical device manufacturers are all about creating innovative tools to help people get healthier. But where do these businesses go when their own processes and bottom lines are unhealthy? For this industry, the cure for inefficiencies and excess costs is enterprise resource planning (ERP) software. Below, we go through some of the key benefits of implementing ERP for medical device manufacturing success.  

Compliance  

There’s no room for error in medical device manufacturing. Any dips in quality or failure to adhere to regulations could have you seeing major fines and fewer sales. Without a sophisticated software solution, businesses find themselves manually entering data across multiple systems, a time-consuming task that puts you at risk of omissions and errors.  

To meet strict compliance standards, your business needs the robust quality management functionality of an ERP system. Quality management modules include cradle-to-grave traceability to simplify audits or recalls. ERP software also maintains electronic data essential for audits and compliance documentation.  

Epicor® includes a particularly robust quality management module to help users adhere to a variety of standards across the FDA, ISO, GMP and more. Among Epicor®’s quality and compliance features include the following: 

• The Automation Tool for Epicor (ATE), which allows companies to build electronic validation scripts required to follow FDA regulations 
• Comprehensive change logs with time and date stamps to support certification and auditing 
• Robust product lifecycle management (PLM) tools that allow users to manage extensive electronic documentation 
• Full radio frequency (RF) capability in warehouses and plant floors to track products in process alongside finished goods, supplied products and inventory 
• Serial and lot traceability to maintain quality and generate reports and audits  

Following regulations and upholding your products’ integrity will only get more difficult as standards become stricter. With ERP, you cut down on the risk of human error and simplify compliance by leveraging your system’s process automation and traceability for end-to-end visibility and precision. 

Cost Reduction 

Medical device manufacturers operate on low margins. Making matters more difficult, rising raw material costs and R&D expenses put an extra strain on their bottom lines. ERP can help these businesses reduce expenses and increase revenue. Manufacturers, particularly SMBs, often fear ERP implementations because of the initial cost, but the long-term savings and boost in productivity far outweigh the price tag.   

As we’ve already touched on, without ERP, you’re likely to manage processes with multiple systems. This method hurts your company’s efficiency. To access critical data, users must log into various platforms, sometimes never finding what they need. IT teams are stuck fixing glitches and performing updates across several systems. Operations are held up as employees wait for approvals or necessary information.  

By joining a range of features and modules into a single solution, ERP provides a central hub for enterprise data. Users can instantly access essential data and reports from intuitive dashboards. Your IT department only has to worry about one system. Automated workflows streamline the supply chain to accelerate lead times. Some vendors such as Epicor also include Kanban functionality and lean metrics to help users detect areas of wasted resources and avoid overproduction or surplus inventory. Managing your enterprise out of one solution saves time and money to help you widen profit margins and gain substantial ROI.  

Supply Chain Control 

Innovations in medical device manufacturing are transforming the lives of patients around the world. However, with new developments come supply chain complexity. Designing intricate products and ensuring they reach customers on time requires full control from order to delivery. ERP software instills automation, agility and visibility in every step of the value chain. Product configurators and scheduling tools enable on-the-fly changes, so you can avoid production line interruptions and keep up with customer demand. Process automation streamlines manual, repetitive tasks to drive efficiency and accuracy.  

One powerful tool for achieving optimal supply chain performance is your material requirements planning (MRP) module. Tightly integrated with your ERP interface, the MRP system processes the Bill of Materials (BOM), ensuring machinery and raw materials are in place before gearing up production lines. This feature helps you procure resources in line with demand.  

Supply chain control also requires a great deal of flexibility. Following purely MTO manufacturing processes, for example, probably isn’t the answer to meeting the highly specific needs of your industry and customers. That’s why ERP systems should enable users to configure workflows and provide the functionality to support distinct business requirements. Epicor supports an array of manufacturing strategies, such as MTO, MTS, CTO, ETO and a combination of various methods to achieve optimal performance.  

Global Operations 

The international market for medical devices requires many manufacturers to manage multiple sites, currencies and regulations. Bridging gaps between global locations and processes is possible with the right ERP solution. When hosted in the cloud, ERP can easily scale as your business expands. Plus, data entered at one site can become instantly accessible across your enterprise through the cloud.  

But additional functionality is required to fully manage worldwide operations. Epicor is uniquely built to withstand the pressures of the global marketplace. Global engines and Country Specific Functionality (CSF) help users keep track of international compliance and taxes. Epicor also includes multi-currency management to automate buying and selling in foreign currencies. Furthermore, multi-management functionality enables users to access relevant metrics throughout all your locations from a single login. ERP ensures that medical device manufacturers never lose sight of their international processes.  

Wrap Up 

Technical innovation has made medical devices more advanced than ever, but these developments as well as strict compliance standards and global demand make supply chains more complicated than ever. Medical device manufacturers can only meet these needs with ERP software. Epicor proves especially adept at handling the concerns of multiple manufacturing verticals. With robust modules and advanced functionality, Epicor ERP comprehensively addresses changing medical device manufacturing processes. 

To truly leverage your software for specific business needs, it’s essential to team up with ERP experts. Datix has provided solutions and services to a variety of manufacturers and distributors for over 20 years. With our experience in multiple industries as well as ERP, CRM, and eCommerce systems, we serve as a one-stop shop for enterprise software. From implementations and upgrades to integrations and customizations, our consultants do whatever it takes to align your software to your unique business goals. 

Ready to boost your medical device manufacturing operations? Get in touch with Datix today to start your ERP project!