Sage X3 – an ERP system for medical device manufacturers

The medical device manufacturing sector is unique among many industries in that there is little room for error. In some cases, getting a product to market on time can be a matter of life and death.

To deliver a quality product that complies with stringent and ever-changing industry regulations, medical device manufacturers need to embrace technologies such as Enterprise Resource Planning (ERP) solutions.

In this article, we’re sharing how an ERP system, like Sage X3, can help to overcome key challenges for today’s medical device manufacturers.

1. Supply chain disruptions

The medical device sector can struggle to identify quick solutions to supply chain disruptions, whether it be a new supplier or a minor adjustment to a manufacturing line.

Because the production of a medical device depends on each component, every material order must be delivered on time. Visibility across the supply chain is therefore imperative.

How Sage X3 helps

Features such as supplier management, sub-contract processes, purchasing, inventory management and production scheduling planning help to ensure the availability of critical components and materials, reducing the risk of production delays and compliance issues.

2. Quality and recalls

Poor quality in a medical device is a serious issue, as it could result in end-user injuries or worse. Quality management helps to create and enforce quality standards across the organisation. It helps ensure that all products meet regulatory and industry standards and can track defects and recalls in case of any issues.

How Sage X3 helps

Sage X3 has fully integrated quality control processes that can trigger the enforcement of inspections, ensuring that items conform to required characteristics, operational tolerances and expected results.

3. Increasing calls for sustainability

The industry association MedTech Europe has summarised what constitutes sustainability in medical technology as follows:

‘Good health and well-being, responsible consumption and production, climate action and partnerships are the goals that we see as particularly relevant for our trade association.’

Medical equipment can have a significant environmental impact, and manufacturers must work to develop more sustainable products and manufacturing processes, but it’s not straightforward.

How Sage X3 helps

Sage X3 provides real-time data on energy use, waste creation, and other environmental parameters, which can help organisations to reduce their environmental impact. This data can then be utilised to pinpoint areas that need improvement and to optimise procedures.

4. Regulatory compliance

The risks to patient safety associated with medical devices have led this industry to be one of the most tightly regulated. A medical device firm may need to adhere to several different standards depending on where it markets its products.

The medical device sector is under increasing pressure to address market uncertainties in the face of growing product complexity and ever-changing regulatory requirements. There are shared concerns that the processes as dictated by broad and evolving regulatory and governing bodies (such as FDA, GMP, EU MDR, IVDR, etc.) negatively impact time to market and development time.

In the medical device industry, maintaining traceability and ensuring regulatory compliance of processes is crucial.

How Sage X3 helps

The system can help medical device manufacturers maintain quality data and track all product information across the entire supply chain to assist in showing their processes, especially those where the ERP system is a key part of the process, as well as comply with government and industry regulations.

5. Cost of innovation

Speed and time-to-market are more important for medical device producers than in any other sector. This responsiveness, though, needs to be maintained by a persistent drive for innovation.

One proven efficiency strategy is better reuse of technology, such as standardising parts and systems, and reusing components, leading to simplified (and less time-consuming) regulatory and validation processes.

How Sage X3 helps

Sage X3 helps manage the cost of innovation to meet increasing market demands by providing visibility across the company and ensuring that products and components are not losing money by sitting on the shelf through better control over inventory management.

Thrive and be agile

A medical device manufacturer can become a more agile organisation by ensuring that its processes are well thought through, operate at peak efficiency and perfectly align with the strategic goals of the company. Using Sage X3 to manage all business processes can greatly reduce the burden of compliance whilst enhancing the effectiveness of standard business processes.

Download our ‘Sage X3 – an ERP system for medical device manufacturers’ guide to find out more about how Sage X3 can help medical device manufacturers stay agile even when faced with multiple challenges.

If you’re looking at Sage X3 ERP software for manufacturing industries, then these guides may help you.

  1. Eight essential value propositions in manufacturing ERP
  2. Intelligent inventory guide
  3. A guide to Sage X3 Manufacturing
  4. Sage X3 – an ERP system for medical device manufacturers

Also please take a look at a couple of our client success stories

  1. Belzona Polymerics Supporting growth and managing chemical formulas with Sage Manufacturing Solution X3
  2. A UK pharmaceutical company Improved profitability and streamlined stock management

If you would like to discuss your project with us, please contact our team or book a tailored Sage X3 demo

FAQs

Can Sage X3 integrate with other business systems and technologies, and how does this integration enhance manufacturing operations?2024-04-16T10:14:25+00:00

Sage X3 is designed with integration in mind, allowing businesses to create a seamless ecosystem of applications and technologies:

Flexible Integration Options: It offers various integration capabilities through APIs and specialised connectors, enabling communication between Sage X3 and CRM, HRM, specialised production equipment, and other software solutions.

Streamlined Operations: Integration allows for the automatic transfer of data between systems, reducing manual data entry, minimising errors, and ensuring that all parts of the business have access to up-to-date information. This can significantly enhance efficiency in manufacturing operations, inventory management, customer service, and beyond.

Customisation and Scalability: Sage X3 can be customised to meet the specific needs of a business, ensuring that integration supports unique processes and workflows. It’s also scalable, able to grow with the business and accommodate new technologies and systems as they are adopted.

How does Sage X3 ensure compliance with industry-specific regulations, especially in process manufacturing sectors like pharmaceuticals and food and beverages?2024-04-16T10:13:28+00:00

Sage X3 provides comprehensive tools designed to help businesses in regulated industries, like pharmaceuticals and food and beverages, comply with strict standards and regulations. Here’s how:

Traceability: Sage X3 offers end-to-end traceability for materials and products, allowing businesses to track every item from receipt through production to final delivery. This capability is crucial for recall management and responding to compliance inquiries.

Quality Control: It integrates quality management processes throughout the supply chain, ensuring that products meet the necessary standards and specifications. Quality tests can be defined at various stages of the manufacturing process, and the results are recorded within the system, providing a detailed quality history.

Regulatory Reporting: Sage X3 can generate comprehensive reports necessary for regulatory compliance, including detailed documentation of manufacturing processes, quality control results, and traceability records. These reports can be customised to meet the specific requirements of different regulatory bodies.

Can Sage X3 assist in forecasting and planning to optimise production schedules and resource allocation?2024-01-23T09:23:21+00:00

Sage X3 includes forecasting and planning capabilities tools that leverage historical data and market trends to predict demand. These insights aid decision-makers in optimising production schedules, resource allocation, and inventory management for efficient operations.

What kind of analytics and reporting capabilities does Sage X3 offer to support informed decision-making?2024-01-23T09:22:41+00:00

Sage X3 provides comprehensive analytics and reporting that enable users to generate detailed reports, visualise data, and gain actionable insights. Customisable dashboards and reports help in identifying trends, performance metrics, and areas needing attention for better decision-making.

How does Sage X3 address compliance and regulatory requirements within the manufacturing sector?2024-01-23T09:21:54+00:00

Sage X3 incorporates compliance and regulatory requirements into its functionalities. It helps manufacturers stay updated and compliant with industry standards and regulations, ensuring that decisions align with legal requirements, minimising risks, and avoiding penalties.

What specific features of Sage X3 assist in inventory management and optimisation for manufacturing businesses?2024-01-23T09:21:22+00:00

Sage X3 offers robust inventory management features like real-time visibility into stock levels, demand forecasting, automated replenishment, and multi-location inventory tracking. These features enable manufacturers to optimise inventory levels, reduce carrying costs, and meet customer demands efficiently.

2024-05-03T10:55:35+00:00October 10, 2023|Blog|
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