The State of Medical Device Security in 2024: Challenges, Trends, and Ownership Shifts

The medical device industry has entered a new era of cybersecurity defined by expanded regulatory guidelines aimed at strengthening device security across the entire product lifecycle. Leading this movement is the FDA’s 2023 cybersecurity guidance, which establishes comprehensive requirements for managing product security from design through post-production. This year’s 2024 Medical Device Security Survey explores how these guidelines, alongside global standards from the EU and IMDRF, are reshaping the strategies and priorities of medical device manufacturers (MDMs) worldwide.

With this clearer regulatory environment, MDMs are adopting more holistic approaches to cybersecurity, yet they now face fresh challenges and shifting priorities. The survey’s findings offer a global perspective on how product security teams, compliance officers, and key decision-makers are adapting to this changing landscape. As the industry aligns with these evolving regulations, understanding these shifts is essential for ensuring resilient and compliant security practices across the board.

The drive for innovation has always been central to the medical device industry, but in 2024, the race to get products to market is prioritized more than ever—often even above cybersecurity.

The latest survey reveals a striking shift: 93% of companies now report prioritizing time-to-market over security, a dramatic increase from just 14% in 2023. This shift is no surprise in an industry where the rapid pace of technological advancement and competitive pressures push manufacturers to accelerate their product release timelines, but it raises questions about the long-term implications of such a trade-off.

Larger, mature organizations, particularly those operating outside the United States, are leading this shift. For these companies, quickly bringing new devices to market can make or break their competitive advantage. Regulatory landscapes vary globally, and in many regions, timing for market entry takes precedence as companies strive to meet both the growing demands for advanced medical technologies and local market expectations. 

The FDA’s 2023 cybersecurity guidance has set new standards in the US, but elsewhere these requirements are often more flexible, allowing companies to focus on speed and expansion. This environment has paved the way for manufacturers to prioritize rapid deployment and innovation, even if it means compromising on certain security measures.

While prioritizing time-to-market can deliver short-term gains, the long-term risks are significant. Reducing focus on security to expedite product launches could expose companies—and their devices—to future vulnerabilities. Medical devices are unique in that security breaches can have immediate, far-reaching impacts on patient safety, device functionality, and data privacy. When security is sidelined, MDMs face the risk of increased recalls, reputational damage, regulatory non-compliance, and ultimately, a loss of customer trust.

Moreover, sidelining security early on may lead to increased costs over time. Without robust, proactive security measures, companies may find themselves addressing vulnerabilities after devices are already on the market—a costly and challenging scenario. Rectifying security issues post-launch may require device updates, recalls, or even compliance penalties, each of which disrupts operations and impacts market standing.

In 2024, medical device manufacturers report three primary challenges in cybersecurity: asset management, integrating security within R&D, and operational efficiency. These challenges reflect the industry’s need to build secure products without sacrificing innovation and productivity.

Leading the list of challenges is asset management, with 36% of companies highlighting it as their primary security issue. Effective asset & SBOM management ensures the accurate tracking of devices and software throughout their lifecycle. As regulatory requirements continue to evolve, the need for precise asset tracking only grows. One of the main reasons for this challenge is the expanding amount of software in these devices, often combined with multiple versions and components for each product developed. Managing these many configurations requires robust systems that can provide clear visibility and control over every component, especially as regulatory demands evolve.

Second, 30% of respondents report that integrating security within R&D processes remains a significant hurdle. Establishing a strong collaboration between security and R&D teams is crucial to ensure security considerations are included in early-stage development. The importance of “shift-left” practices—embedding security in the R&D lifecycle—has been well recognized, especially in the US, where 41% of respondents prioritize continuous security throughout product development.

Rounding out the top challenges is operational efficiency, with 28% of MDMs highlighting this area. As security processes become increasingly complex, companies are seeking to maintain productivity while meeting security standards. 

Figure 12 shows that companies with advanced security practices, particularly those that incorporate automation into asset management and assurance activities, often report fewer efficiency issues, highlighting the role of automation in streamlining security workflows.

Security budgets continue to increase, with 70% of companies reporting growth in 2024, but this year’s increase is more restrained—10.8% on average compared to 17% in 2023. This measured growth suggests a shift toward optimizing existing security investments, especially among companies with higher security maturity, which are channeling resources into specific initiatives like automation and proactive risk management rather than broad increases.

In contrast, companies with lower security maturity are often scaling back or keeping budgets steady as they focus on building foundational capabilities. For these organizations, addressing core needs is a priority over expanding security functions, as they work toward stabilizing security before growing.

Regional variations reveal further nuances. In the United States and other regions outside Europe, security investments remain strong, with many companies prioritizing resources to support innovation and regulatory compliance. German companies, however, show more restrained budgets, with some even reducing their allocations as they balance compliance pressures against economic constraints. 

The survey reveals a notable shift in how security ownership is distributed within medical device companies, moving towards a more decentralized approach. While the Chief Product Security Officer (CPSO) or VP of Product Security has traditionally led security efforts, Chief Information Security Officers (CISOs) and Chief Information Officers (CIOs) now play increasingly central roles. This shift reflects how security is becoming a cross-functional responsibility, aligning with various aspects of compliance, risk management, R&D, and IT.

While decentralization allows organizations to draw on expertise from different areas, it also risks creating fragmented strategies. Without clear coordination, security efforts may lack cohesion, leading to inconsistent priorities across departments.

To address this, many companies are implementing centralized frameworks and cross-departmental communication structures to ensure alignment. Establishing these frameworks allows MDMs to benefit from the expertise of each role while maintaining a cohesive, consistent security strategy across the organization. 

While this overview captures some of the key trends shaping medical device security, the full report offers a closer look at the challenges and strategies shaping the industry today. From adapting to new regulations to managing decentralized security responsibilities, the report provides insights to help medical device manufacturers stay informed and prepared in a rapidly evolving landscape.

As the industry navigates these shifts, finding the right balance between innovation and security is more essential than ever. With an approach that addresses both regulatory demands and practical security needs, MDMs can help ensure the resilience and integrity of their devices, building a stronger foundation for the future. 

Register to download the complete 2024 Medical Device Security Report to gain a comprehensive understanding of the landscape and equip your organization with the knowledge to advance confidently toward a secure future.