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Life Sciences ERP Software Medical Device Manufacturing—Challenges and Opportunities


Applying Technology: Turning Challenges into Opportunities

Identifying the challenges is a necessary part of understanding how to successfully navigate the future. Determining the opportunities that lie ahead requires taking a closer look into each medical device manufacturers operations and the specific strategies they intend to achieve. There is no doubt that software technology specifically designed for medical device and life sciences manufacturers is needed for a strategic approach to take on these mounting expectations.

As many manufacturers attest, you can never have too much information and data when it comes to the medical device industry. Companies across all industries leverage Enterprise Resource Planning (ERP) systems to integrate, streamline and centralize their data, information, and processes. Of all the industries where this is of utmost importance, medtech manufacturers are at the top when it comes to the depth and breadth of precise documentation needed for regulatory requirements.

In addition to complex compliance requirements, being competitive and innovative in the global marketplace while maintaining profitable margins requires a 360 degree view of your business. Complete visibility and control throughout the manufacturing process is needed in order to understand what process improvements can be made, where waste can be cut, and how each step in the manufacturing process is progressing.

Here are four common areas of ERP functionality that medical device manufacturers routinely rely on to effectively meet the challenges presented by regulation, globalization and rising costs.

1) Regulatory Compliance and Reporting Functionality

There's no question the ability to retrieve data is crucial. Accumulating this data and archiving it in a complete, accurate and continuous manner for the purposes of recording a product’s history becomes extremely important for reporting. In addition to archiving, the ability to leverage a comprehensive document-handling-tool enables manufacturers to link appropriate documentation to specific products, product groups and transactions.

A significant challenge presents itself for global manufacturers who have operations in multiple locations and need the confidence that geographic specifications are managed and documented accurately and effectively. Every country will have a different set of requirements, and as such, having functionality that allows manufacturers to manage product compliance, regulation conformance, and the necessary documentation for a product based on geography is crucial. For example, a medical device may be regulated in the UK, totally restricted in the US and unregulated in Sweden. Simultaneous compliance in these different regions can be managed effectively within this type of software functionality.

2) Batch Management / Serialized Product Control

One of the most important elements of integrating ERP software into a medical device manufacturer is achieving complete visibility throughout the entire manufacturing process. Industry experts frequently list lot/batch management, serial tracking and traceability among some of the most important features offered by an ERP system.

Whether a company takes a batch approach, a unique identifier approach, or a combination of the two – life sciences manufacturers need the confidence that their products can be effectively tracked. Full serialized product tracking as well as full batch traceability tools are needed to provide immediate visibility both up and down the supply chain. This visibility and control becomes critical in the case of identifying, locating, containing and reporting on suspect products or product recalls.

Batch disposition functionality is another capability that manufacturers leverage to help manage the product life cycle as well as material usage control of their devices. Manufacturers look to ERP systems to organize materials throughout the process for partial or full blocking of inventory use and master planning. For example, automatic batch dispositions allow manufacturers to restrict certain batches for certain transactions. Batch disposition can also be assigned based on quality order results, creating another check point of quality assurance, as the product will not move on to the next step in the process without meeting the requirements set for it.

As a part of this batch management, medical device manufacturers who make parts that could be used for various end products or uses find that leveraging tools with customer-specific attributes that link to specific requirements simplifies the manufacturing process and decreases the possibility of error. For example, quality testing results may have a tighter tolerance in certain instances, or for certain customers. Attributes like test result tolerance requirements can be linked to specific customers, and to products both manually, or automatically through quality order results. These batches can then be reserved for specific applications or specific customers based on the attributes.

Inventory control is another significant area of concern associated with batch and serial management. That’s why master planning and scheduling of materials based on "First Expiring, First Out" batch management is so important. For the purposes of regulation, as well as profitability of the manufacturer, this kind of software technology provides master planning and consumption management based on first expiring inventory, which is defined at the product batch level. This reduces waste and disposal of expired products, and increases overall efficiency in the companies planning cycle by systematizing this aspect of inventory control.

Next: ERP Software for Medical Device Manufacturers >>



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One of the most important elements of integrating ERP software into a medical device manufacturer is achieving complete visibility throughout the entire manufacturing process.



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