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Why ERP is Essential for Medical Device Manufacturers? Learn in this Guide

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    Posted in Companion App

    Last Updated | May 8, 2024

    Executive Summary – ERP for Medical Device Manufacturers

    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 medical device industry has seen exponential growth over the past five years. As of 2021, the global market for medical device manufacturing was valued at USD 488.98 billion.

    Operating in such a highly regulated industry brings numerous growth opportunities and tremendous competition for medical device manufacturers.

    However, like any other industry, the medical device sector is often faced with challenges and disruptions.

    The setbacks slow the pace at which medical device manufacturers operate- from supply chain to finance operations.

    To maintain their competitive positioning, medical device manufacturers need to eradicate challenges and disruptions to continue creating innovative solutions seamlessly.

    This makes the adoption of an ERP system important in the industry.

    When the success of manufacturers hinges on optimal time-to-market, traceability, product quality, and compliance with regulations, an ERP system can add loads of value to each process.

    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?

    what is ERP

    Enterprise resource planning (ERP) refers to a business management technology or a suite of integrated applications that consolidate core business processes.

    As a business management solution, an ERP system manages processes in real-time and documents, collects, and interprets data from many business activities.

    ERPs can be on-premise or 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 applications that make up the ERP system collect information from across various departments (accounting, manufacturing, sales, marketing, etc.) and keep it available to teams who need it.

    The ERP system can help you, as a manufacturer, track resources- tech components, cash, production capacity- and the status of orders, purchase orders, and payroll.

    With the help of ERPs, you can regulate information flow throughout the company and manage connections to stakeholders.

    ERPs keep processes integrated, facilitate automation to ensure error-free production, and enhance data management, the processes that increase your company’s efficiency.

    Medical Device Software

    The Benefits of ERP for Medical Device Manufacturers

    Benefits of ERP for Medical Device Manufacturers

    You can make the most of ERPs in many ways.

    Fundamentally, an ERP is a central management system that operates at the center of the business and takes care of your concerns.

    Here are the tasks that ERPs take care of:


    Any dips in quality or failure to stick to strict compliance standards can lead to hefty fines and fewer sales.

    Without sophisticated technology, your teams may have to enter data manually across disparate systems. This time-consuming task can put you at risk of errors or omissions.

    But, you cannot afford errors in the production of any medical device since it will have a severe impact on the end users (medical professionals or patients).

    To meet the quality standards, your business needs the robust management functionality of an ERP system. The quality management module in ERP 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 production of full-fledged technology- for compliance documentation.

    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.

    As we have already touched on, ERPs combine the processes of multiple systems. Without them, your business has to manage disparate systems, which costs the efficiency of your company.

    However, many of you, especially small-scale manufacturers, dread ERPs because of their implementation cost.

    Consider this scenario:

    To access critical data, your teams may have to log into multiple systems, sometimes never finding what they need.

    So, your IT teams get to fix glitches and perform updates across the enterprise.

    Meanwhile, operations across the business pause as employees wait for necessary information or approvals.

    This costs your business a lot more than an initial ERP payment.

    ERP, as a unified platform, 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 and connects all processes to ensure better control and process automation, and significantly reduces costs.

    Supply Chain Control

    Being a medical device manufacturer, you are responsible for introducing innovative solutions to transform the lives of patients across the world.

    As your business develops sophisticated technologies, your supply chain complexity increases.

    Designing complex technology requires you to be in full control of your supply chain – from order to delivery.

    With an ERP system, you can instill agility, automation, and visibility into each step of the supply chain.

    ERPs also come 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.

    Global Operations

    Many manufacturing companies operate in global markets, which require them to manage various subsidiaries, currencies, and regulations.

    The right ERP for medical device manufacturers can bridge the gap between global sites and operations.

    A cloud-hosted ERP scales as businesses expand.

    When hosted on the cloud, ERP stores data on the cloud and makes it accessible from any location. Plus, the data you enter on one site becomes easily accessible across your business through the cloud.

    Some ERPs are specially built to withhold the pressures of the global marketplace. They help you keep track of international compliance and taxes, so you never lose sight of international markets.

    How ERP can Help with Quality Control and Regulatory Compliance

    Quality control and regulatory compliance come with close monitoring of manufacturing processes and product traceability.

    EPR system provides a comprehensive set of tools for managing product innovation with data management, process controls, and traceability.

    It can increase your visibility into resources, production, and procedures to facilitate monitoring and control of the entire supply chain.

    You can set up automated audits and checks of incoming resources in ERP to ensure your production meets quality standards.

    Additionally, ERP includes a wide array of dashboards and reports that give you insight into the health and performance of your business.

    The more you are aware of what is happening in your business, the better you can keep everything in place, and the more prepared you will be to meet regulations and quality requirements.

    The Key Features of an ERP System for Medical Device Manufacturers

    ERP systems serve as powerful data management solutions. For medical device manufacturers, ERPs are ideal for automation, data analysis, and complete infrastructure integration.

    However, the market is a sea of ERP solutions with bells and whistles that make it overwhelming to filter out the right system.

    To escape from unnecessary features and zoom in on key functions while selecting an ERP, check out the list of some core features below:


    Integration of every part of your production allows you to transform your business and meet your key performance indicators (KPIs).

    ERPs have a wide range of modules to handle each part of your business.

    Modern ERP systems provide a mixture of on-premise and cloud modules, which are loosely coupled and easily replaceable. They keep your processes connected, but when a specific module does not work, they allow you to easily replace them without affecting other processes.

    Tracking and Traceability

    The manufacturing process generates tons of valuable data at every step. ERP can track, control, and document the data in a centralized location, allowing better traceability and tracking of data.

    ERPs are even good at collecting data in highly automated, fast-moving processes. Their trace functionality keeps an eye on everything from receiving orders to utilizing the material and delivering the products.

    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 standards.

    Some ERPs come with 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 to optimize the performance of your business and improve product quality.


    ERP system automates your routine business tasks and stores data in a centralized hub. Data remains at hand for all your users whenever they need it to perform tasks.

    This enables automated communication between silos in your company.

    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

    It is important to understand how a potential system will fit into your existing infrastructure.

    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 to go with.

    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.

    FAQs – ERP for Medical Device Manufacturers

    What are Healthcare ERP Systems & Solutions for Medical Device Manufacturers?

    ERP systems for medical device manufacturers are business solutions that streamline processes and automate repetitive routine tasks.

    By bringing automation into production workflow, ERPs reduce paperwork, organize data in a single source, and expedite supply chain performance.

    What is EMR in medical billing?

    Electronic medical records (EMR) provide a record of patient health. When patients receive services at any medical facility, the EMR stores information about their treatment, lab results, and diagnoses. When it comes to billing, EMR helps create a digital bill for all the services a patient receives.

    What real-time information do ERP systems provide?

    ERP software for medical device manufacturers provides real-time information on production status and performance to give you access to your company’s performance at any time and keep you on top of everything.

    Some ERPs even come with 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?

    An ERP comes in handy when it comes to ensuring compliance within healthcare administration. This is because ERPs increase data visibility, traceability, and security for healthcare organizations, keeping everything under control.

    Medical device manufacturing ERP software system also provides 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 chock-full of errors. ERP automates repetitive tasks to reduce errors in data and free up teams.

    By eliminating errors, ERP for medical device manufacturers improves compliance and automation of tasks, 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.

    What is a HIPAA compliance software checklist?

    HIPAA is a set of rules that define guidelines for protecting patient information stored in medical devices.

    Organizations that provide medical device software development, including medical diagnostic software and healthcare app development, must ensure HIPAA compliance.

    So, while developing a medical app, development companies need to keep a HIPAA checklist to ensure they meet all its requirements.

    The checklist includes the following actions:

    • Understanding HIPAA privacy and security requirements
    • Determining if the Privacy Rule applies to their business
    • Learning what type of data HIPAA wants them to protect and putting the right security measures in place to protect that
    • Taking preventative measures against HIPAA violations
    • Staying updated with HIPAA changes to ensure compliance

    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 can add great value to your manufacturing business by aligning your operations and helping you maintain the quality of the medical technology you develop.

    Since ERP integrates with the core infrastructure of your business, you need to select it wisely.

    Everything you learned above, including ERP benefits, features, and the right steps to choose a system has prepared you to jump into the market and look for an ERP for your business.

    But if you need ERP experts to help you implement one, you can bank on our support.

    At Folio3, one of the top healthcare IT companies, we take pride in building ERPs to help businesses yield efficiency and utilize team productivity to drive growth and revenue.

    Let us show you how a medical ERP solution can improve your operations.

    Schedule a free consultation right away.

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