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Bill of Materials (BOM) for Medical Devices: Everything You Need To Know

January 21, 2022

Bill of Materials (BOM) for Medical Devices - Everything You Need To Know

When it comes to complexity, medical devices run the gamut.

On one end of the spectrum you’ll find devices like tongue depressors—just a six-inch piece of wood. On the other end, you’ll find medical devices made up of many highly-engineered parts, like pacemakers or cochlear implants.

But regardless of how complex your medical device is, it can always be broken down into a bill of materials (BOM). Your BOM—the list of everything you need to build your device and how to do it—is a critical component for manufacturing your medical device.

Here’s what you need to know about a bill of materials and its role in bringing your device to market:

Want to build and manage your multi-level BOMs while you continue to design your medical devices? See how Greenlight Guru Products makes it easy by getting your free demo today →

What is a bill of materials for medical devices?

You can think of your bill of materials as the recipe for your medical device. It includes a comprehensive list of all the materials and parts needed to manufacture a device as well as directions for how to use them. Your BOM should also explain how and where materials should be acquired in the first place. 

It’s likely that your medical device company won’t just have a single BOM. Each department within the company may have a bill of materials that corresponds to their particular needs, such as:

  • Manufacturing Bill of Materials (MBOM): An MBOM includes all the items and assemblies that are necessary for the manufacture of your final product. Any parts that require processing before assembly should also be included in your MBOM.

  • Engineering Bill of Materials (EBOM): Your EBOM defines the parts or assemblies that have been designed by the engineering department, including mechanical or technical drawings of your product. As the EBOM is created during the design process, you’ll likely update and revise it several times before you have a finished product.

  • Sales Bill of Materials (SBOM): The SBOM is used for a product in the sales stage, and it consists of the finished product and a list of the components needed to assemble it. 

  • Cybersecurity Bill of Materials (CBOM): As the market for software in a medical device (SiMD) and software as a medical device (SaMD) has grown, so has the importance of CBOMs. A CBOM lists the software and hardware components in your medical device, and keeping this list up-to-date is crucial to maintaining the safety of any device that relies on software to any extent.

Though the elements in each bill of materials differ to some extent, taken together, they provide a detailed account of everything you need to produce your medical device.

 

Why do medical devices need a bill of materials?

Your BOM is the basis for your entire production planning. Everything involved in manufacturing your device is built off that foundational information. 

Your medical device company will rely on the information stored within its BOM to make informed decisions about issues in your supply chain like:

  • Resource planning

  • Cost planning

  • Inventory control

  • Facility maintenance

For instance, having a detailed and accurate bill of materials is critical to your ability to source the resources you’ll need to build your device. Both suppliers and contract manufacturers need to know how much of a given material, item, or part is required in order to properly quote you for their services, manage their inventory, and deliver on time.

Furthermore, your bill of materials provides the instructions for the production of your medical device; it’s your roadmap for assembly. A detailed bill of materials both helps ensure your product is free from deviations and allows you to spot any quickly if they occur. That’s important because nonconforming products may result in corrective and preventive actions (CAPAs) or, in some cases, even a recall. 

The work that goes into creating a BOM is substantial, but it pays dividends when you avoid problems with manufacturing down the road that can result in costly delays.

 

How does a BOM function within a QMS?

Your bill of materials should be a part of your device master record (DMR), which contains all the information and specifications required to manufacture your medical device, starting with design and ending with distribution.

As such, your bill of materials is subject to the same regulatory requirements as any other documentation within your QMS, including your documented change management process. Your BOM may need to be updated several times, and changes can be triggered during the design, development, manufacturing, or postmarket surveillance phases of your medical device’s lifecycle.

Changing a product is the most obvious trigger for changing your BOM, as the bill of materials will have to be updated if the physical product requires a change in the type or amount of its constituent materials and parts. But even a change to one of your processes could require an update to the bill of materials, as this may affect the instructions for procuring materials, for instance.

Regardless of the reason for the change, your BOM must be kept up-to-date in your QMS to reflect the latest version of your product. Outdated and incorrect information can lead to problems with your suppliers and manufacturing partners, not to mention a significant impact on your bottom line.

Want to build and manage your multi-level BOMs while you continue to design your medical devices? See how Greenlight Guru Products makes it easy by getting your free demo today →

Keep your BOM organized and always up-to-date with intelligent document management powered by AI/ML

Because your BOM is so sensitive to changes in your product, it’s imperative you have a tool at your disposal that lets you achieve closed-loop traceability and understand what elements of your QMS are affected by a change.

Greenlight Guru’s Medical Device Success Platform (MDSP) uses intelligent document management powered by artificial intelligence and machine learning to give you data-driven insights into key connections that exist within your QMS—and provide the regulatory guardrails to help you stay compliant in a rapidly changing environment.

Don’t let managing your medical device’s bill of materials slow you down. Get your free demo of Greenlight Guru’s MDSP today.


Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software

 

Laura Court is a Medical Device Guru and Mechanical Engineer who loves learning about new technology and sharing her experiences with others. She has experience in New Product Development and Manufacturing with both small and large companies. Having managed products through their full product lifecycle into post...

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