The client, a prominent medical device manufacturer, faced increasing regulatory pressures and cybersecurity risks. They needed an efficient, standards-compliant method to generate SBOMs (Software Bill of Materials), evaluate vulnerabilities, and reduce risks. Manual processes were time-consuming, inefficient, and prone to errors, leading to delays in compliance and potential security risks.
Bosch SDS vulnerability management framework
Custom-built SBOM generation tool
The medical device industry is increasingly facing pressures not just from stringent regulatory standards but from rising cybersecurity threats as well. In the wake of more connected devices, manufacturers must be aware of the expanding attack surfaces – ranging from ransomware to system vulnerabilities that could be exploited to compromise patient safety and device functionality. Security gaps, such as weak operating system vulnerabilities or software supply chain risks, expose manufacturers to potential data breaches, device tampering, and compliance violations. Creating and maintaining SBOMs in the conventional way is time and manually intensive, leading to error-prone processes and ultimately the above-mentioned gaps. Adding to staff woes are issues with tracking the source of vulnerability across assets. With the FDA’s heightened focus on software security, manufacturers are now required to generate Software Bill of Materials (SBOMs) in SPDX format, a critical step toward ensuring transparency and traceability of software components used in medical devices.
For a leading medical device manufacturer, meeting these requirements presented a significant challenge. Their existing processes for SBOM generation and vulnerability management were predominantly manual and time-consuming — delaying regulatory approvals and increasing the risk of non-compliance. This led to missed deadlines, delayed product releases, and an increased risk of vulnerabilities that could compromise patient safety and data security. The client required a holistic solution to minimize residual risks and strengthen their cybersecurity posture, ensuring the safety and compliance of their products while accelerating time-to-market.
With our deep expertise in cybersecurity and regulatory compliance, Bosch SDS identified the key area for improvement, including gaps in vulnerability scanning and risk evaluation workflows. Recognizing the need for both automation and risk evaluation, we designed a tailored solution architecture to address these challenges and meet industry requirements.
We implemented the following measures to streamline the SBOM generation and vulnerability management process:
We introduced a transformative, compliance-driven cybersecurity framework to revolutionize the client’s vulnerability management and SBOM generation processes. Bosch SDS tailored a cutting-edge solution that seamlessly integrated automation, vulnerability management, and risk evaluation into the client’s existing processes. Additionally, this enabled the client to achieve regulatory excellence while strengthening its overall cybersecurity posture.
20% reduction in SBOM generation and scanning efforts
Accelerated time-to-market for new device updates and patches
Improved risk management with quicker identification of vulnerabilities
Strengthened compliance with FDA requirements, reducing the risk of non-compliance
Streamlined regulatory submissions, accelerating the approval process
Increased operational efficiency through consolidated vulnerability scan results
Enhanced security posture through comprehensive risk mitigation workshops
Bosch SDS recognized the client’s urgent need for a cybersecurity-first, compliance-ready enterprise architecture. We helped them adhere to stringent FDA regulations by automating SBOM generation in SPDX format, thus reducing the risk of non-compliance and ensuring quicker, more accurate regulatory submissions and approvals. They also witnessed expedited time-to-market with faster release of medical devices and software patches by streamlining SBOM generation and vulnerability assessment. Besides lowered costs associated with delayed compliance and vulnerability-related incidents, they were also able to bring down the potential financial impact of regulatory fines or security breaches. They also enhanced trust and credibility with regulatory bodies, partners, and end-users by showcasing robust compliance and security measures. Finally, they strengthened their competitive edge through quicker, more secure product launches.
