GLOSSARY

Bill of Materials (BOM)

A bill of materials (BOM) is a comprehensive list of everything needed to manufacture a medical device. It includes the raw materials, components required, assemblies, subassemblies, and the quantities of each required for the production of a device.

A medical device company’s bill of materials can be considered the shopping list for manufacturing a particular product. With a bill of materials in hand, it is clear what is needed, how it should be acquired, and where it should come from. It will also explain how to assemble the product from the gathered materials.

A well-executed bill of materials helps organize the purchase of materials. It is also used for related material management tasks, such as estimating costs, monitoring inventory, maintaining records, and reducing waste.

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What is the purpose of a bill of materials (BOM)?

The bill of materials acts as the basis for production planning. From this foundation, various processes throughout the supply chain, such as resource planning, cost planning, inventory control, and facility maintenance can pull necessary information.

For a medical device company, a well-managed bill of materials can save revenue and prevent investigations, purchasing issues, and other breakdowns in the production process. 

Beyond manufacturing, a wide variety of departments rely on the bill of materials, including design, sales, engineering, and inventory management. 

 

What are the types of bill of materials (BOM)?

In terms of function, there are four main types of bill of materials commonly used in the medical device industry:

  • Manufacturing bill of materials (MBOM): includes a list of all items required for the production of the final product. It is structured to provide information about processing of subassemblies as well as the final product.

  • Engineering bill of materials (EBOM): explains the product’s parts and assemblies from a functional perspective, and may include technical drawings. This may be revised multiple times as the product design is refined.

  • Sales bill of materials (SBOM): lists the finished product and its components. 

  • Cybersecurity bill of materials (CBOM): lists hardware and software components used in devices. It is used to develop processes that keep devices functioning, even when faced with the vulnerabilities that result from unsafe internet connections. A cBOM is different from a software bill of materials, which refers strictly to software.

 

What is a single level bill of materials vs. a multi-level bill of materials?

A single-level bill of materials is a list of all the components required to build a product, but it does not include any sub-assemblies or raw materials needed to produce those components. This means that all the components are listed at the same level and are not nested under any other components. Single-level BOMs are useful for simple products with few components and limited levels of complexity.

On the other hand, a multi-level bill of materials is a more complex list that includes all the components, sub-assemblies, and raw materials needed to manufacture a product. This type of BOM lists the components and raw materials required for each sub-assembly and then lists the sub-assemblies needed to produce the final product. A multi-level bill of materials is particularly useful for complex products with many components and multiple levels of assembly.

Using a multi-level bill of materials can help streamline the manufacturing process and ensure that all the necessary components and raw materials are available when needed. It also allows for easier tracking and management of inventory levels, as well as more accurate costing of the final product.

 

Why is a detailed bill of materials important for medical device manufacturing?

In medical device manufacturing, a well-constructed bill of materials can reduce revenue loss and delays from conception to marketing of the device. 

The detailed bill of materials allows suppliers and contract manufacturing organizations to provide accurate pricing quotes. It ensures that inventory is properly managed and available as needed during the manufacturing process.

It provides a roadmap for product assembly so that production is free of deviations that can result in corrective and preventive actions (CAPA) and even recalls. This means every department involved in development, manufacturing, or sales must pay attention to the way the bill of materials impacts product structure, as well as the bill of materials structure.

 

Make the most of your bill of materials with Greenlight Guru Products

Your bill of materials should be a living document that everyone on your team can turn to for the most up-to-date documentation. More than that, your BOM should bring your product development documentation together under one single source of truth. 

That’s where Greenlight Guru comes in. Our end-to-end solution means you can easily create your BOM, then link them to your documentation and design controls. With our Medical Device Product Development Software you can build your multi-level bill of materials while you design your medical devices, as well as manage your Items by documenting units of measure, supplier detail, quantity, and more.

Greenlight Guru Products

If you’re ready to accelerate your product development, drive collaboration, unlock traceability, and gain critical visibility, contact us today for your free demo of Greenlight Guru!

 

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