Last Updated | November 7, 2024
As medical device manufacturers, you need a solution that automates your core operations, optimizes the supply chain, and organizes your data in a single place, all while helping you achieve compliance. Read on to learn how ERP for medical device manufacturers is an all-in-one solution that can handle all your concerns.
Overview – ERP for Medical Device Manufacturers
The ERP medical device industry has grown exponentially over the past few years. The U.S. healthcare ERP market touched a height of USD 1.81 billion in 2023 and is expected to hit approximately USD 3.19 million by 2033, at a CAGR of 5.84% from 2024 to 2033.
Operating in such a highly regulated industry brings numerous growth opportunities and tremendous competition for medical device manufacturers. The medical device sector often faces challenges and disruptions like any other industry. Setbacks slow the pace at which medical device manufacturers operate, from supply chain to finance operations.
Therefore, to maintain their competitive positioning, medical device manufacturers need to eradicate challenges like complex supply chains and high development costs to continue seamlessly creating innovative solutions. This makes the adoption of an ERP for medical device industry important.
By implementing an ERP system, manufacturers can improve time to market, traceability, product quality, and adherence to regulatory compliance, all of which are critical for success.
So, how does an ERP system meet the dynamic needs of medical device manufacturers?
Let’s take a closer look at the ERP system- its benefits and features- to find out how it can meet the needs of manufacturers.
What is ERP, and Why do Medical Device Manufacturers Need it?
Enterprise resource planning (ERP) refers to a business management technology or a suite of integrated applications that consolidate core business processes. An ERP system is a business management solution that manages processes in real time and documents, collects, and interprets data from many business activities. For example, medical device manufacturers can use ERP systems to create flexible supply chains and improve demand and supply forecasting by using external data.
ERPs are available in two types: on-premise and cloud-based.
On-premise or traditional systems are now considered legacy technology. Meanwhile, cloud systems have become rapidly popular because they make information readily accessible in any location with internet availability.
The ERP system’s applications collect information from various departments (accounting, manufacturing, sales, marketing, etc.) and make it available to teams that need it. As a manufacturer, the ERP system can help you track resources such as tech components, cash, production capacity, order status, purchase orders, and payroll.
With the help of an ERP system, you can regulate information flow throughout the company and manage connections to stakeholders. They keep processes integrated, facilitate automation to ensure error-free production and enhance data management, which increases your company’s efficiency.
The Benefits of ERP for Medical Device Manufacturers
You can make the most of medical device ERP in many ways.
Fundamentally, an ERP for medical device is a central management system that operates at the center of the business and takes care of your concerns. Here are the tasks they take care of:
1. Compliance
Without sophisticated technology, your teams may have to manually enter data across disparate systems, a time-consuming task that can put you at risk of errors or omissions. Any dips in quality or failure to stick to strict compliance standards can lead to hefty fines and fewer sales.
To meet the quality standards, your business needs the robust management functionality of an ERP system. The quality management module in medical ERP software tracks your product for quality and provides comprehensive traceability to simplify audits and recalls.
It also maintains electronic records of all important data—from raw components to the production of full-fledged technology—for compliance documentation.
2. Cost Reduction
Manufacturers run businesses on low margins, and increasing material costs and R&D expenses put extra load on your bottom lines, making matters worse.
ERP systems can help you cut down costs and increase revenue.
Medical device ERP systems offer a unified approach to managing complex medical device manufacturing processes. By integrating multiple systems, ERP for medical devices streamlines operations, boosts efficiency, and reduces the risk of errors. However, the initial implementation costs can be a significant barrier, particularly for smaller manufacturers.
Without an ERP, your teams may face challenges like accessing critical data from multiple systems, leading to delays and inefficiencies. Additionally, your IT team may be burdened with maintaining and updating various systems, diverting valuable resources. As a result, operations across the business can suffer from slowdowns as employees wait for necessary information or approvals.
This costs your business a lot more than an initial ERP payment.
As a unified platform, ERP combines several features and modules into a single system, providing a hub of all essential data. As a result:
- Your employees can quickly access important data and reports from its intuitive dashboards.
- Your IT crew will have one system to worry about.
- ERP becomes your one enterprise-wide system, connecting all processes to ensure better control and process automation and significantly reducing costs.
3. Supply Chain Control
As a medical device manufacturer, you are responsible for introducing innovative solutions that transform patients’ lives worldwide.
Designing complex technology requires you to fully control your supply chain—from order to delivery. As your business develops sophisticated technologies, your supply chain complexity increases. This is where an ERP system steps in and instills agility, automation, and visibility into each supply chain step.
Med device diagnostic ERP also comes with product configurators and scheduling tools to enable instant changes, helping you avoid gaps in production and meet customer demand. Their process automation streamlines manual, recurrent tasks to expedite processes and drive accuracy.
Another powerful tool is the material requirements planning (MRP) module, which helps you achieve optimal supply chain performance. Being tightly integrated with the ERP interface, MRP can process your Bill of Materials (BOM) to align your machinery and raw materials before pushing them for production. This feature allows you to use resources based on demand.
4. Global Operations
Medical device manufacturers operating globally face challenges like managing multiple subsidiaries, currencies, and regulatory compliance. Cloud-based ERP systems offer a solution by providing scalability, accessibility, data centralization, and global compliance features. These systems can help manufacturers streamline operations, improve efficiency, and mitigate risks associated with international expansion.
How ERP can Help with Quality Control and Regulatory Compliance
ERP for medical device manufacturers helps assure data quality and adherence to regulatory compliance. By providing a comprehensive set of tools for data management, process control, and traceability, ERP systems enable close monitoring of manufacturing processes and product traceability.
With automated audits and checks on incoming resources, ERP ensures that production meets quality standards. Additionally, the system’s strong reporting capabilities offer valuable insights into business performance and compliance.
By increasing visibility into resources, production, and procedures, ERP empowers manufacturers to maintain control over the entire supply chain, facilitating adherence to regulations and quality requirements.
The Key Features of an ERP System for Medical Device Manufacturers
ERP systems offer powerful data management solutions and are ideal for automating data analysis and complete infrastructure integration for medical device manufacturers.
However, with increasing demand, multiple solutions are available in the market, making it overwhelming to filter out the right system. Modern ERP systems provide a mixture of on-premise and cloud modules, which are loosely coupled and easily replaceable. They keep your processes connected; however, if a specific module does not work, you can easily replace it without affecting other processes.
Let’s zoom in on the key functions while selecting an ERP for medical device manufacturers:
1. Integration
Integration in ERP in medical devices can achieve real-time visibility and optimize resource utilization to make informed decisions. This increases efficiency, reduces costs, and, ultimately, product quality. This step helps medical device manufacturers meet their key performance indicators (KPIs) and stay competitive in the industry.
2. Tracking and Traceability
Every step of the manufacturing process generates a high volume of valuable data that an ERP system can easily handle. They can track, control, and document the information in a centralized location, allowing better traceability and tracking.
Additionally, ERPs are good at collecting data in highly automated, fast-moving processes. Their trace functionality monitors everything from receiving orders to utilizing the material and delivering the products.
3. Quality Management Module
Every market has specific requirements for the product it demands. The quality management module in the ERP is designed to help you inspect and maintain the quality of healthcare devices and equipment you develop to ensure they match industry standards.
Some ERPs have comprehensive quality assurance tools that tie together all your processes and give you tight quality control.
This provides you with deeper insight and greater efficiency, enabling you to optimize your business’s performance and improve product quality.
4. Automation
An ERP system automates routine business tasks and stores data in a centralized hub. Data remains available for all users whenever they need it to perform tasks.
This enables automated communication between silos in your company.
Healthcare ERP Market in the U.S. 2024-2033
How to Choose the Right ERP System for Your Business?
Now that you know how ERP can help your business streamline processes and meet your needs, you are ready put the knowledge into action.
When selecting an ERP system for your manufacturing business, here are the steps that will guide you all the way to getting your hands on the right ERP:
1. Identify the Problems to Solve
Before solving the problem, you need to know where the problem is.
This requires conducting a review of your processes:
- Does your business has areas where your teams do manual or double entry?
- Can your operations improve with automation?
- Do you need faster reporting?
- Or are you struggling with meeting compliance requirements?
Whatever issues you spot, summarize the results into analysis and jump into the next step to find out the technology that solves these issues.
2. Evaluate the Technology Fit
Understanding how a potential system will fit into your existing infrastructure is important. Besides looking for a system that aligns with your existing systems, find an ERP that is resilient enough and grows with your company. A flexible, scalable, open, and modular system will be a good choice.
With a modular ERP, you can integrate different systems and add new functionality based on the latest manufacturing advances.
3. Make Sure the System is Easy to Use
The ERP system will have a wide range of users in your company- from machine operators and field engineers to accountants, quality control in charge, and research and development (R&D) teams.
So, look for an intuitive technology any of these users can operate on.
Make sure the interface of medical device ERP software is logically structured and easy to use.
A well-designed system will increase usability and employee satisfaction, resulting in efficient performance.
4. Understand the Total Cost of Ownership
Before committing to a particular system, learn about the potential cost associated with purchasing the software.
Also, be sure to uncover hidden costs such as the cost of implementation, software maintenance, hardware upgrades, and backfilling project teams.
When you know the cost estimate, you can develop a comprehensive project plan to understand the expenses and resources required to make the project a success.
By adhering to these steps, you will have a much better idea of what ERP can serve your needs to choose the right ERP for your manufacturing business.
Effortless ERP Integration With Folio3 Digital Health
We specialize in seamless ERP integration tailored to your specific needs. Our solutions are meant to make your daily operations hassle-free and increase workflow accuracy and efficiency. Our industry experts can help you build customized, scalable, seamless connections that address your goals. Take the next step and contact us for information, or book a demo to see how Folio3 Digital Health can improve your business.
Bottom Line: ERP for Medical Device Manufacturers
Implementing an ERP can help you as manufacturers automate tedious tasks, make employees productive and smarter, improve operations, and keep data organized and accessible across the enterprise. ERPs add great value to your manufacturing business by aligning your operations and helping you maintain the quality of the medical technology you develop. Since it integrates with the core infrastructure of your business, you need to select it wisely.
Frequently Asked Questions
What are Healthcare ERP Systems & Solutions for Medical Device Manufacturers?
An ERP system for medical device manufacturers simplifies manufacturing processes, reduces waste, improves inventory management and data visibility. By bringing automation into production workflow, ERPs reduce paperwork, organize data in a single source, and expedite supply chain performance.
Some of the ERP features include product lifecycle and quality management, manufacturing, supply chain, regulatory compliance, and financial management. Popular ERP solutions like Oracle NetSuite, SAP, and Microsoft Dynamics 365 offer industry-specific capabilities to drive growth in the medical device industry.
What Are The Best Examples of ERP For Medical Devices?
Some of the best ERP medical devices examples include NetSuite, Epicor, SAP, etc.
What Real-time Information Do ERP Systems Provide?
ERP systems improve decision-making capabilities by providing valuable, accurate reports based on real-time data. This allows you to access your company’s performance at any time and keeps you on top of everything.
Some ERPs even have advanced business intelligence (BI) that delivers up-to-the-minute, accurate information to facilitate expeditious and informed decision-making.
How Can ERP Help With Product Compliance and FDA Requirements?
A suitable ERP helps companies track materials along the supply chain and during product development. This tracking and secure data storage minimize the efforts required to navigate the drug approval process.
An ERP is handy when it comes to ensuring compliance within healthcare administration. ERPs increase data visibility, traceability, and security for healthcare organizations, keeping everything under control.
Medical device manufacturing software systems also provide inspection reminders, regular audits, mock product recalls, and compliance reports that help you meet healthcare administration requirements.
How Can ERP Help with Regulatory Compliance?
Proving compliance with regulatory requirements is challenging when your data is full of errors. ERP automates repetitive tasks to reduce data errors and free up teams. ERP consolidates information and automates key workflows for managing compliance. Leading ERP systems come with features to support compliance efforts, such as access controls and user permissions.
By eliminating errors, ERP for medical device manufacturers improves compliance and task automation, giving your team ample time to triple-check compliance requirements.
Either way, medical device manufacturing ERP software helps prepare for regulatory compliance without hiring healthcare compliance consulting services.
About the Author
Abdul Moiz Nadeem
Abdul Moiz Nadeem specializes in driving digital transformation in healthcare through innovative technology solutions. With an extensive experience and strong background in product management, Moiz has successfully managed the product development and delivery of health platforms that improve patient care, optimize workflows, and reduce operational costs. At Folio3, Moiz collaborates with cross-functional teams to build healthcare solutions that comply with industry standards like HIPAA and HL7, helping providers achieve better outcomes through technology.
