Medical device manufacturers operate in a highly regulated environment, where good manufacturing practices and industry standards are extremely high and require compliance with strict regulatory requirements. In 2020, the global medical devices industry's estimated worth was $456.80 billion. Despite challenges, the market continues its rapid growth and is expected to grow to around $671.49 billion by 2027.
This estimate means that precision in quality management, data accuracy, document control, and inventory management are vital for medical device companies to drive business growth while safeguarding patient safety.
Medical device manufacturers face unique challenges in managing their operations, from ensuring regulatory compliance to maintaining high-quality products. By leveraging industry-specific solutions, medical device manufacturers can improve operational efficiency, decrease costs, and enhance customer satisfaction.
For instance, MES solutions can help medical device manufacturers streamline their manufacturing operations, while ERP software can provide a centralized platform for managing business operations.
An enterprise resource planning (ERP) system, like a cloud ERP solution specifically designed for medical device manufacturers, typically provides key features allowing for comprehensive evaluation. It helps in comparing various functional and industry-focused criteria to find the most suitable solution for your business.
ERP software can provide a centralized platform for managing business operations in medical device manufacturing. By integrating an ERP system, medical device manufacturers can streamline their operations, improve communication, and cut costs.
ERP software can also provide real-time visibility into business operations, enabling manufacturers to make data-driven decisions and respond quickly to changes in demand or supply. Additionally, an ERP system can help medical device manufacturers comply with regulatory requirements.
Manufacturing execution systems (MES) are designed to optimize production processes and improve operational efficiency in medical device manufacturing. By leveraging MES, medical device manufacturers can streamline their production workflows, reduce errors, and improve product quality.
MES can also provide real-time visibility into manufacturing processes, enabling manufacturers to make data-driven decisions and respond quickly to changes in demand or supply. Additionally, MES can help medical device manufacturers comply with key industry regulations.
A tailored medical device manufacturing software delivers deep insights into your production, quality control, and supply chain operations, enabling full traceability, real-time transparency, and consistent regulatory compliance across your entire production process. With a proven track record of transforming manufacturing operations in highly regulated industries, Andea offers extensive experience and new technologies to effectively streamline your medical devices manufacturing.
Medical device manufacturers operate under a tremendous—and common for highly regulated industries—pressure to innovate existing processes while ensuring both product specifications and compliance requirements are met. Gaining a competitive advantage in this environment means delivering a cost-efficient yet seamless customer experience, embracing the next generation of technologies, and optimizing resource utilization and supply chain management.
To achieve their objectives, MedTech companies need to integrate internal systems with ERP software and MES for medical devices manufacturing. An ERP system will effectively bring together their business strategy and operations while a modern MES will help seamlessly enforce and execute the manufacturing processes using statistical process control to ensure quality control and manage errors.
Companies believe that transforming functions using digital technologies will be of high strategic priority in the next five years. Less than half of the MedTech companies responded that they are using digital technologies and capabilities to improve processes (44%). Surveyed MedTech leaders reported that the key objectives for their digital investments are to reduce costs (31%), gain insights into execution of business strategy (25%), and increase demand for products (25%).
This estimate means that precision in quality management, data accuracy, document control, and inventory management are vital for medical device companies to drive business growth while safeguarding patient safety.
Medical device manufacturers face unique challenges in managing their operations, from ensuring regulatory compliance to maintaining high-quality products. By leveraging industry-specific solutions, medical device manufacturers can improve operational efficiency, decrease costs, and enhance customer satisfaction.
MedTech manufacturers need new technologies and manufacturing execution solutions that are easily configured to their unique business models. A medical device company, like yours, can rely on MES for medical device manufacturing to offer insights into your production and manufacturing process, ensure quality control, and improve supply chain management, all while meeting stringent regulatory requirements. You will:
Consistently maintain reliable quality with robust custom reports, minimize design flaws and development issues, and limit customer complaints.
Gain end-to-end traceability and transparency across production, from raw materials to finished goods, ensuring every product meets mandatory regulations.
Meet the mandatory medical devices industry regulations, including FDA compliance, ISO standards, EU MDR, and other strict rules and legislations.
The medical device industry is an extremely demanding, challenging, and competitive environment for manufacturers. To succeed and outperform other medical device companies, you need to modernize your legacy internal systems and optimize your existing processes. Only then, you can successfully redefine the entire production process to ensure cost-effectiveness, and adherence to strict quality standards and regulatory obligations.
With DELMIA solutions, you can accelerate production, maximize resources, and reduce lead times for faster time-to-market. To support medical device manufacturers at every stage of the production process, we offer DELMIA Apriso MES for advanced planning and scheduling and DELMIA Ortems APS for medical device manufacturing.
DELMIA Apriso MES is designed to provide real-time visibility, control, and synchronization of your MedTech manufacturing operations.
DELMIA Ortems APS is designed to enhance production planning and scheduling of your MedTech manufacturing operations.
Learn how Neusoft Medical, a global leader in clinical diagnosis and treatment solutions, faced significant challenges in managing the documentation of its medical devices. Read the case study to find out about the importance of accurate documentation for FDA approval, and how Neusoft's reliance on paper-based device master records and device history records created inefficiencies and high costs in maintenance and repair.
The company needed a manufacturing execution system that could transform its device history and device master records. Neusoft's decision makers selected DELMIA Apriso hoping it was a modern MES system they needed.
DELMIA Apriso helps us in building a production traceability platform to improve management efficiency and information transparency.
With the arrival of emerging technologies, the medical device industry is reaping the rewards of Industry 4.0 but also faces increasing complexities in designs and development. Manufacturers deal with complicated designs, consisting of multiple systems with subsystems that require digital connectivity.
As a medical device company trying to redefine today's healthcare sector, you are under constant pressure to implement both preventive actions and corrective actions to mitigate risks and eliminate nonconformances. To address costly errors and design flaws effectively before physical prototyping further complicates the situation, you must move away from the traditional device design, testing, and validation method and embrace a simulation-driven approach.
You can use virtual twin technology to:
Connect lifecycle stages with virtual simulations for safer, superior products.
Perform detailed calculations to assess safety and quality before physical prototyping, reducing both time and costs.
Gain predictive insights through data collaboration for fewer recalls and enhanced patient safety.
As a medical device company operating in a highly regulated industry, you know how critical process evidence and operation tracking are for your business. Transparency and traceability are paramount in medical devices manufacturing. We can help you harmonize and standardize all your key processes, from planning and scheduling, through supply chain and shop floor management, to enforcing compliance across the entire value chain.
Use our data-driven product and document management tools to:
Streamline predictive quality management to minimize compliance risks, reduce waste, and achieve flawless product quality.
Control electronic signatures and manage documents to ensure the safety and security of approvals required for FDA and other regulatory standards, such as FDA 21 CFR Part 11 and ISO 13485.
Leverage end-to-end traceability and available insights to eliminate non-value-added activities and track the manufacturing process for safety evidence.
Medical device manufacturers are expected to set standards for patient-focused and personalized customer experiences that improve patient condition, well-being, and health. The shift in innovation across the whole healthcare sector is driven by several critical factors, including medical discoveries, technology advancements, dedicated therapies, and specific processes developed to help patients function in their ecosystem.
This increasing complexity and changing industry standards require highly configurable systems that leverage data and models to strengthen good manufacturing practices and future-proof your production processes. Using DELMIA solutions, we help MedTech manufacturers digitalize every process across their entire value chain.
Systems like APS and MES for the medical device industry enable you to:
Better plan and accommodate resources for ad-hoc orders to improve delivery performance and on-time delivery of goods.
Connect patient insights to your design process for faster innovation cycles.
Collect and leverage critical data to run simulations for optimized medical device comfort, usage, and outcomes.
Leading manufacturers in the medical devices industry are gaining a competitive advantage because they understand it takes more than development to become a top market performer. Industry forerunners realize they need to also focus on the complete production process and services of their medical devices to achieve operational excellence.
With DELMIA Ortems APS and DELMIA Apriso MES for medical device manufacturing, you can improve agility and productivity across all of your operations. We can effectively integrate with your internal systems, including ERP software, to provide:
Enhanced responsiveness, traceability, and control of production cycles.
Harmonized production flows that lead to increased production rates, shortened lead times, improved management of raw materials inventory, and increased plant capacity.
Real-time visibility and access to critical data on inventory levels, work centers, and quality metrics to boost operational efficiency.
Seamless and synchronized collaboration across your global network of production sites for agile planning and medical device manufacturing.
Optimized services that drive business growth by enhancing client satisfaction through streamlined processes and consistent product quality.
With a proven track record of implementing DELMIA solutions for more than 80 global enterprises across over 260 manufacturing sites, we can guide you as you enter a new era of medical device manufacturing. We can empower you to stay competitive with next-generation solutions that connect digital innovation with regulatory compliance, quality management, and advanced manufacturing execution.
Through successful deployments of medical device manufacturing software, we have digitalized operations for industry leaders like Straumann and CoorsTek. We can do the same for you. Join the leading medical device manufacturers and capitalize on cutting-edge DELMIA technology to streamline operations, cut costs, and ensure quality in every product. Together, we can ensure you deliver high-quality medical devices while advancing patient safety and well-being.