Why Time-to-Market is Overtaking Device Security as a Top Priority

Innovation and speed-to-market have become key competitive factors in today’s medical device industry. As demand for new healthcare technologies accelerates, manufacturers are under pressure to deliver devices rapidly. Yet, with this push for faster market entry, the importance of robust security practices can often take a backseat, leaving potential gaps in product protection and compliance.

This increasing prioritization of time-to-market over security presents a complex challenge for manufacturers. Rushed timelines can mean fewer resources for thorough security assessments, leading to devices that may not meet stringent security standards. According to the 2024 Medical Device Security Survey, this trend is taking hold across the industry, with 93% of companies now ranking speed over security—a significant leap from the 14% recorded in 2023. 

This blog dives into the regional and organizational factors behind this shift, its potential risks, and the strategies leading manufacturers are adopting to maintain security while keeping up with the pace of innovation.

The survey reveals that the push to prioritize time-to-market over security is especially pronounced among larger, mature organizations, particularly those outside the United States. These companies are feeling intensified pressure to deliver products quickly, even if it means compromising on security protocols.

For larger organizations, the stakes in competitive markets are high. These companies often have more substantial product portfolios and established brands that consumers and clients expect to deliver new technologies swiftly. Larger firms may feel compelled to push out innovations faster to maintain market relevance, satisfy stakeholder expectations, and outpace competitors. In some cases, releasing a product quickly can help these companies capture market share and build consumer trust before newer, smaller entrants can establish a foothold.

Moreover, larger organizations tend to have complex operational structures that can create friction when implementing extensive security measures across multiple departments and product lines. For these companies, the cost of delaying product launches to implement thorough security checks can be higher than the perceived risk of launching with reduced security measures. They may instead choose to rely on post-launch security patches or incremental updates to manage vulnerabilities, viewing these as more feasible than time-consuming pre-launch security protocols.

Additionally, regulatory oversight on medical device security, though increasing, is still relatively new. Few companies have faced outright product denials from the FDA due to cybersecurity concerns, although some have received the ‘refuse to accept’ notice for identified cybersecurity gaps. This limited precedent for stringent cybersecurity enforcement may lead some manufacturers to deprioritize comprehensive security measures in the early stages, opting to address them after release.

Outside the US, particularly in regions with flexible or evolving regulatory requirements, companies have more leeway to prioritize time-to-market. For example, European and Asian markets, while stringent in some areas, often have varying compliance timelines that allow larger organizations to balance regulatory demands with speed. These differences enable companies in these regions to adopt accelerated release schedules without facing the immediate compliance penalties that might be seen in the US.

Prioritizing speed at the expense of security exposes device manufacturers to heightened risks, from increased vulnerabilities to potential regulatory penalties. In an environment where medical devices are becoming increasingly interconnected, mitigating these risks while maintaining speed-to-market requires careful strategy and robust tools.

When security measures are minimized in favor of speed, manufacturers face multiple risks, including:

• Vulnerabilities in deployed devices: When products are rushed to market without thorough security checks, unaddressed vulnerabilities are more likely to be present, posing a risk to patient safety. These vulnerabilities could allow malicious actors to tamper with devices, potentially causing malfunctions or unauthorized access to essential medical functions.
• Regulatory non-compliance: While speed can help companies respond to market demands, neglecting compliance with standards like FDA guidelines or EU MDR/IVDR can lead to costly penalties, recalls, and “Refuse to Accept” notices.
• Brand reputation: Security breaches in medical devices can severely damage a company’s reputation, particularly in healthcare, where patient safety and data privacy are critical.

Cutting back on security measures to accelerate product launches introduces risks, including increased vulnerabilities, regulatory non-compliance, and potential damage to brand reputation. To mitigate these risks without compromising on speed, many companies are adopting innovative strategies to integrate security into agile development cycles.

Examples of industry-wide mitigation strategies include:

1. Shift-Left Security: Many manufacturers have embedded security protocols earlier in the development process, an approach known as “shift-left” security, which includes methods such as threat modeling and Adaptive Risk Management. By involving security teams from the outset, companies can identify and address vulnerabilities in the design phase, reducing the likelihood of issues later on. 
2. Automated Testing and Vulnerability Management: To save time while maintaining security, companies are increasingly using automated testing tools to conduct continuous vulnerability scans throughout the development lifecycle. These tools help detect potential security flaws in real-time, allowing development teams to respond swiftly. 
3. Modular Product Design: By designing devices with modular, easily upgradable components, some manufacturers are able to reduce development time and address security vulnerabilities through targeted updates rather than overhauling entire products. Philips has adopted this approach, enabling more agile responses to security risks without requiring full-scale redevelopments or extensive delays.
4. Use of Software Bill of Materials (SBOMs): SBOMs allow manufacturers to catalog all software components used in a device, making it easier to track and update them when security vulnerabilities are discovered. Many companies, including BD and Abbott, use SBOMs to manage software assets and ensure they remain secure throughout a product’s lifecycle. This proactive approach reduces the time needed to identify and remediate potential issues.

Cybellum’s Product Security Platform offers an integrated solution for managing these security challenges across the entire product lifecycle. By automating SBOM creation, vulnerability management, compliance validation, and incident response, Cybellum enables manufacturers to ensure devices are secure and compliant without sacrificing speed. Through centralized workflows, companies can streamline their security operations and manage risks efficiently, helping them maintain rapid development cycles while safeguarding their products.

The growing emphasis on time-to-market underscores a core tension within the medical device industry. As companies strive to capture market share and meet consumer demands, they face difficult choices about how best to prioritize security without hindering development speed. This year’s survey reveals the need for a balanced approach, where organizations can leverage automation and centralized security platforms to ensure that robust security protocols remain in place even as they accelerate product launches.

For a more in-depth analysis of these industry trends and more, download our 2024 Medical Device Security Report and equip your organization with insights to manage today’s security landscape.