Navigating Top Challenges in Medical Device Security for 2025

As medical devices become increasingly sophisticated, so do the cybersecurity risks they face. With interconnected technologies and software-rich components, modern medical devices are more vulnerable to cyber threats than ever before. Manufacturers now grapple with complex security demands across the device lifecycle, from design to deployment.

Against this backdrop, the 2024 Medical Device Security Survey highlights the top challenges manufacturers face in safeguarding their products. From managing complex assets to embedding security in R&D, and maintaining operational efficiency, the survey offers a clear picture of the obstacles that MDMs must overcome. This blog delves into these pressing challenges and explores strategies to help MDMs navigate the evolving landscape of medical device security.

Asset management emerged as the leading challenge in the 2024 survey, with 36% of respondents citing it as their primary security concern. As the software complexity in medical devices increases, so does the difficulty of maintaining visibility and control over every component within these products. Asset management ensures that each software element is tracked, updated, and safeguarded throughout its lifecycle, but for many organizations, this is easier said than done.

One key reason asset management is becoming more difficult is the expanding software footprint in medical devices. Modern devices often include a complex combination of firmware, applications, and networked components, each requiring careful oversight. Each update, patch, or version change introduces new variables that need to be tracked and documented. Without a robust asset management system, even a small oversight could lead to unaddressed vulnerabilities or missed compliance requirements.

Furthermore, the growing reliance on third-party software components makes asset management more complex. Many MDMs integrate third-party software libraries and modules, which are often necessary for enhancing functionality but bring additional security risks if not meticulously managed. These components require diligent tracking and updating, as vulnerabilities in external code can quickly become exploitable weaknesses in medical devices if left unchecked. 

Compounding the challenge, asset data is often spread across various teams and tools—from R&D to requirements management to threat modeling. This dispersion makes it difficult to consolidate the data and create a comprehensive picture of all assets and their security status. Without a unified view, potential gaps can go unnoticed, increasing the risk of vulnerabilities slipping through the cracks.

The survey reveals that the difficulty of asset management varies significantly by region and role within the supply chain. For instance, asset management is particularly challenging in Germany, where 48% of respondents identified it as their top issue, compared to only 31.8% in the United States. These differences may stem from the regulatory environment and varying expectations for component tracking in each region. German companies often face rigorous documentation requirements, which increase the complexity of asset management.

Furthermore, asset management is a more pronounced challenge for suppliers than it is for device manufacturers. According to the survey, 44.1% of suppliers ranked it as a top concern, compared to 30.9% of OEMs. This disparity may reflect the complex role suppliers play in providing components that integrate seamlessly with OEM products. Suppliers must maintain visibility and control over every component they deliver, as any gaps in asset management could introduce vulnerabilities for the entire device ecosystem.

In addition to asset management, integrating security into R&D processes and maintaining operational efficiency are critical concerns for MDMs in 2024. According to the survey, 30% of respondents reported friction between security and R&D teams, highlighting the difficulty of embedding security measures without disrupting product development timelines.

The “shift-left” approach, which involves integrating security early in the development cycle, is a known best practice. However, achieving this level of collaboration can be challenging, particularly in large organizations where R&D and security teams often operate independently. This disconnect can result in security requirements being overlooked or addressed late in development, leading to costly, time-consuming revisions.

For MDMs in the United States, where continuous product security ranks highly, integrating security into R&D is especially important, ranking as the number two challenge. Establishing strong communication channels and cross-functional workflows, as well as standardizing data across different teams, can help companies bridge the gap between security and R&D, ensuring that security considerations are addressed from the beginning. Some organizations are implementing regular checkpoints between departments to keep security at the forefront without slowing down development.

Operational efficiency remains another significant challenge, with 28% of respondents identifying it as a top concern. As security processes become increasingly complex, many companies are finding it difficult to maintain productivity while still adhering to security protocols. As seen in Figure 12, organizations with advanced security measures, such as fully automated asset management and data sharing, often report fewer efficiency issues, underscoring the importance of mature, streamlined workflows.

Automation has become a key strategy for addressing efficiency concerns. By automating routine security tasks, such as vulnerability scanning and compliance checks, companies can reduce manual workload and ensure consistent security practices across product lines. This approach allows MDMs to achieve a balance between robust security and efficient operations, ultimately enabling them to innovate faster without compromising product safety.

The top challenges in medical device security—asset management, R&D integration, and operational efficiency—highlight the need for MDMs to adopt advanced strategies that support both innovation and compliance. Companies can benefit from automating asset tracking, fostering closer collaboration between R&D and security teams, and streamlining workflows to maintain productivity.

By addressing these challenges directly, MDMs can enhance their security posture, protect their devices, and build consumer trust. For more detailed insights about managing medical device security, download the full 2024 Medical Device Security Report.