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.

 

 

 

 

 

 

 

 

 

 

2024-01-31T14:11:30+00:00October 10, 2023|Blog|
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