The increasing reliance on software in medical devices has made transparency in software components a critical factor for regulators and manufacturers alike. In recent years, the US Food and Drug Administration (FDA) has emphasised the importance of Software Bills of Materials (SBOMs)—detailed inventories of software components—highlighting their role not only in managing risk but also in supporting compliance and forward-thinking development strategies.
Medical devices frequently integrate proprietary code, third-party software, and open source components. This mix can complicate the management of various compliance and operational issues. Consider, for example, how SBOMs can now serve a broader role: beyond identifying vulnerabilities, they can list cryptographic libraries and modules used within the software. This level of detail is especially important as manufacturers prepare for the quantum era, ensuring that the cryptographic practices in place will stand up to future advances in computing power.
Moreover, SBOMs offer significant advantages for export compliance. When medical devices are destined for international markets, regulations often require a detailed account of the software components to verify that export controls are met. By providing a clear and comprehensive list of software dependencies—including any cryptographic tools—SBOMs assist manufacturers in navigating complex export regulations with greater confidence and precision.
In addition to supporting export compliance, SBOMs also play a vital role in clarifying software licences and establishing clear lines of code ownership. With manufacturers increasingly relying on a combination of open source and proprietary components, maintaining an accurate SBOM ensures that all software licences are correctly tracked and that intellectual property rights are respected. This transparency is invaluable for avoiding potential legal disputes and ensuring that every element of the software supply chain is accounted for.
While SBOMs remain an essential tool for identifying and mitigating risks—as highlighted by past incidents like the 2023 Log4j vulnerability—they are evolving into a critical element of a broader compliance and governance strategy. The FDA’s guidance, which mandates the inclusion of SBOMs in premarket submissions, reflects this wider perspective. By requiring manufacturers to list all software components—including direct and transitive dependencies—in standardised formats such as SPDX or CycloneDX, the FDA is ensuring that these documents remain dynamic and relevant throughout the extended lifecycles of medical devices.
To meet these evolving demands, manufacturers can leverage solutions like SCANOSS—a comprehensive open source risk management tool known for its accurate SBOM generation. SCANOSS not only automates the creation and maintenance of SBOMs but also integrates seamlessly into DevSecOps pipelines. This integration guarantees that every change in the software ecosystem, from cryptographic updates to license modifications, is immediately reflected in the SBOM, thereby reducing the administrative burden and enhancing overall compliance.