Case Study: How a Fortune 100 Life Sciences Company Measures Product Security

Background

A Fortune 100 (F100) Life Sciences company measures product security by adopting a comprehensive approach. The company emphasizes the relationships between product quality, cybersecurity risk management, and process maturity. The leading Life Sciences company’s Chief Information Security Officer (CISO), understands that cybersecurity-focused reporting must align with the needs of various business objectives and stakeholder communities. Thus, the CISO’s team developed a multi-faceted measurement and reporting strategy tailored to different audiences, ensuring each group receives meaningful, relevant, and actionable information.

Business Challenge

The Fortune 100 Life Sciences business challenge is transforming how they measure and report medical device security. Previous metrics often centered on technical details like incident counts, response times, and patch rates, which, while essential, failed to connect with the larger business context and lacked the necessary confidence from third-party stakeholders and regulators. Previously, there was a lack of focus on how these security measures impacted the products. The company saw an opportunity to shift this paradigm, emphasizing the critical relationship between quality, cybersecurity risk, and process maturity. The goal is to transform traditional methods of understanding cybersecurity, into a holistic framework, addressing technical security issues that integrate metrics into a comprehensive view meaningful to all stakeholders. This new approach has the goal of ensuring product stakeholders view cybersecurity as a vital component of product excellence representing business resilience.

Cybersecurity as a Function of Quality

With significant experience in quality management, the product security team brought a unique perspective to managing and measuring medical device security. The team recognized that product quality was directly tied to the effectiveness of cybersecurity controls in support of the production of medical devices. They organized their product security program around the principle that cybersecurity is a function of quality. Thus, the communications strategy focused on using metrics that support and enhance quality objectives and goals while still focusing on cybersecurity. To accomplish this goal, the product team combined product quality, cybersecurity risk, and process maturity measurement into an overall cybersecurity performance score. The team aimed to “connect the dots” between these three pillars while addressing each one individually, ensuring that improvements in one area bolster the others. This approach allowed the Life Sciences business to provide a comprehensive view of cybersecurity posture across its line of products. By doing so, this demonstrates how effective quality processes and mature operational practices lead to reduced cybersecurity risks and improved product resilience.

Definitions for Key Cybersecurity Performance Metrics

The product security team pre-defined their desired metrics, focusing on their relevance in the context of medical device manufacturing and cybersecurity.

Product Quality

In the context of medical devices, product quality refers to the degree to which a medical device meets regulatory and customer expectations. In the context of regulatory obligations, this covers compliance with standards defined under US Food and Drug Administration (FDA) regulation 21 CFR Part 820, which includes requirements for design, production, quality assurance, and post-market surveillance. To gain approval from the FDA and to bring a medical device to market (and keep it on the market), manufacturers must consistently produce and control their products according to strict quality standards to ensure safety and efficacy.

Higher product quality correlates with lower cybersecurity risk and higher process maturity, and vice versa.

Cybersecurity Risk

Cybersecurity risk in medical devices refers to the potential for unauthorized access, use, disclosure, disruption, modification, or destruction of the medical device’s electronic information and operations. Managing cybersecurity risk involves identifying vulnerabilities in device software and hardware, assessing the potential likelihood and impact of threats exploiting these vulnerabilities, and implementing appropriate security measures to protect patient health and device functionality. The FDA emphasizes the importance of cybersecurity risk management in the design and development of medical devices to prevent patient harm. Privacy and security regulations in support of HIPAA also figure prominently in the F100 Life Science’s cybersecurity risk identification, prioritization, and remediation activities.

Higher cybersecurity risk tends to correlate with lower product quality and less mature cybersecurity processes, and vice versa.

Process Maturity

Process maturity relates to how an organization defines, manages, measures, and controls its internal processes. In the context of cybersecurity, process maturity indicates how well an organization’s cybersecurity processes are developed, implemented, and continuously improved. These processes also influence control effectiveness. Higher process maturity involves systematic, proactive, and advanced cybersecurity practices that are integrated into all stages of the medical device lifecycle. The F100 Life Science company uses maturity models like the Capability Maturity Model Integration (CMMI)® and the NIST Cybersecurity Framework (CSF) 2.0, to evaluate and enhance F100 Life Science company’s cybersecurity process maturity.

Highly mature cybersecurity processes correlate with lower cybersecurity risk and high product quality, and vice versa.

Cybersecurity Performance

Cybersecurity performance represents the combined measurements defined above. In its most basic sense, cybersecurity performance reflects areas of efficiency and effectiveness across the medical device lifecycle. At the operational level, cybersecurity performance speaks to the needs of stakeholders across several organizational functions. At a strategic level, cybersecurity performance is easy to understand and can translate into an actionable data point for organizational executives and board members. As a unified metric, F100 Life Sciences company can demonstrate how incremental improvements in these areas collectively enhance the organization’s cybersecurity performance. By presenting cybersecurity performance as an integrated metric, the product security team ensures all stakeholders, from executive leadership to technical teams, can see the impact of cybersecurity efforts on the company’s products and operations.

Results

The introduction of the company’s integrated measurement process had a positive impact on stakeholders. By shifting the focus from traditional, siloed cybersecurity metrics to a holistic approach combining product quality, cybersecurity risk, and control maturity, the company successfully aligns continuous cybersecurity efforts with the broader business objectives of the company.

Improved Stakeholder Understanding and Engagement

The product security team’s strategy ensures all stakeholders, from executive leadership to technical teams, can easily understand and appreciate the significance of cybersecurity performance. The unified cybersecurity performance metrics provide a clear and actionable data point, making it easier for executives and other stakeholders to make informed decisions about resource allocation and strategic priorities. Technical teams, on the other hand, see how their work directly contributes to overall product quality and organizational security, fostering a sense of ownership and accountability.

Enhanced Product Reliability and Security

The emphasis on integrating cybersecurity with quality management and process maturity led to noticeable product reliability and security improvements. By addressing vulnerabilities and security risks during the product development phase, F100 Life Sciences can reduce the likelihood of security incidents that may compromise patient safety and product functionality. Taking a proactive approach enhances the resilience of the company’s products while ensuring compliance with stringent regulatory standards, thereby reducing the risk of costly recalls and regulatory exposure.

Streamlined Compliance and Audit Processes

F100 Life Sciences company’s holistic approach to measuring cybersecurity performance also streamlines the business’s compliance and audit processes. Integration of cybersecurity metrics with quality, risk, and maturity assessments provided a comprehensive view of the organization’s adherence to regulatory requirements such as FDA regulations and HIPAA privacy and security standards. This approach makes it easier to prepare for audits and demonstrate compliance, reducing the administrative burden.

Continuous Improvement and Innovation

The focus on process and control risk fostered a culture of continuous improvement across the company. By leveraging maturity models like CMMI and the NIST Cybersecurity Framework, the product security team ensures the company’s cybersecurity practices are not only robust but also evolving to meet new challenges. This commitment to continuous improvement and innovation builds market confidence that F100 Life Sciences company is staying ahead of emerging threats to maintain a competitive edge in the market.

Positive Business Outcomes

Ultimately, the company’s comprehensive approach to measuring and reporting cybersecurity performance translated into positive business outcomes for F100 Life Science. The improved reliability and security of its products enhanced customer trust and satisfaction, leading to increased market share and revenue growth. The alignment of cybersecurity efforts with business objectives also helped F100 Life Science company to optimize resource allocation, ensuring that investments in cybersecurity delivered maximum value to the organization.

Conclusion

The product security team’s innovative measurement methodology transformed F100 Life Science company’s approach to cybersecurity, delivering significant benefits across the organization. By integrating product quality, cybersecurity risk, and process maturity into a unified cybersecurity performance metric, product security ensured that the company leadership and related stakeholders viewed cybersecurity as a vital component of product excellence and business resilience.

This approach not only highlights the importance of robust cybersecurity measures but also shows how these measures contribute to the reliability and quality of medical devices. By shifting the focus from isolated technical details to a comprehensive performance metric, the product security team successfully aligns cybersecurity initiatives with broader business objectives. This approach fosters a culture of continuous improvement and resilience across the organization.

Next Steps

For companies looking to emulate F100 Life Science company’s successes, the TrustMAPP® Cybersecurity Performance Management platform offers an ideal solution. Designed for the needs of information security leaders, TrustMAPP facilitates the measurement and management of cybersecurity risk and maturity. TrustMAPP is an essential tool for any organization aiming to integrate cybersecurity into its strategic business framework.

We invite you to explore how TrustMAPP can enhance your company’s cybersecurity posture. Contact us today to learn more and begin your journey toward comprehensive cybersecurity maturity.