Addressing the FDA’s Cybersecurity KPIs As Outlined in the PMA’s Cybersecurity Guidelines

The Total Product Lifecycle (TPLC) approach to risk management has emerged as a crucial framework in the medical device industry. It’s not just about meeting regulatory requirements; it’s about ensuring the safety and effectiveness of medical devices throughout their entire lifecycle—from initial conception through design, manufacturing, market entry, and end-of-life. Given the increasing integration of software components in medical devices, this comprehensive approach is especially critical in managing cybersecurity risks.

TPLC risk management involves continuously evaluating and mitigating risks associated with a medical device. It spans all stages of a product’s life, incorporating feedback from post-market surveillance to refine pre-market risk assessments and vice versa. This dynamic method is vital in cybersecurity because threats evolve rapidly, and static risk management practices quickly become outdated.

Despite the FDA’s best efforts to create a clear, concise, and universal guideline for incorporating a TPLC approach, questions always arise regarding implementation. For some, those questions may surround SBOM submissions, vulnerability triaging, or information sharing, but ultimately, all these questions boil down to “What will enforcement look like?”

That’s where the FDA’s TPLC KPIs come in.

To evaluate the effectiveness of TPLC risk management in cybersecurity, the FDA focused on three key performance indicators (KPIs) critical for maintaining medical devices‘ security integrity.

They are:

1. Percentage of identified vulnerabilities that are updated or patched (defect density);
2. Duration from vulnerability identification to when it is updated or patched; and
3. Duration from when an update or patch is available to complete implementation in devices deployed in the field, to the extent known.

To execute all of these correctly, teams must mature their processes by ensuring that SBOMs and various reports flow freely from relevant internal and external teams into a single automated workflow. 

TPLC risk management enhances the capability to identify vulnerabilities early and throughout the device’s lifecycle. By integrating continuous monitoring and threat analysis, medical device manufacturers can reduce defect density while ensuring a more reliable product. 

The way some companies are addressing this today is by identifying which assets across their product line may be affected and comparing that with how long it took to triage the vulnerability. The benefits of implementing an automated vulnerability management system over manual activities mean groups of vulnerabilities can be triaged in minutes– compared to the labor-intensive process of manually skimming databases to understand a vulnerability risk level. 

The Product Security Platform’s VM Co-Pilot helps meet this KPI by scanning firmware and SBOMs to identify vulnerabilities, gauge their risk and potential impact, and then automatically triage them as high, medium, and low. Product Security teams can then determine if those vulnerabilities apply to older versions and how they stand against industry standards or internal markers.

The speed at which vulnerabilities are patched is crucial for maintaining device integrity and patient safety. 

TPLC risk management streamlines the process from vulnerability identification to patch deployment. With a lifecycle-integrated cybersecurity strategy, manufacturers can deploy automated systems for vulnerability detection and patch management, reducing the time needed to develop and implement fixes. This rapid response is facilitated by the continuous feedback loop inherent in TPLC, allowing for quicker assessment of threats and faster initiating remedial actions.

Some companies measure patch velocity today by the number of days it takes between detecting a vulnerability and officially handing over the field-ready patch to the customer. To improve on this critical KPI, product security teams must analyze their processes against the latest technologies to understand which activities can be further automated, reducing patch velocity.

The Product Security Platform employs a centralized approach, allowing for a vulnerability’s information to be shared with various internal teams and tracked as it moves from discovery to patching. This shortens response time while ensuring no false information enters the system due to normalization across various disconnected tools or human error. 

Implementing updates and patches in deployed devices poses significant challenges, especially regarding coordination and compliance across different healthcare settings. TPLC risk management supports a structured rollout of patches by using predictive analytics to assess the impact of updates and manage deployment schedules effectively. By understanding the device environment and usage patterns throughout its lifecycle, manufacturers can predict optimal windows for updates and prepare for potential complications, thus minimizing downtime and disruption in clinical settings.

Teams are improving this KPI by speeding up the patch development process, as mentioned above, and measuring the time since deployment against the number of updated devices in the field.

With The Product Security Platform, teams can identify precisely when a patch was sent to a customer, stamping a precise handoff time.

To further empower manufacturers in their TPLC risk management efforts, dashboards are critical to KPI values, tracking these critical metrics and their progression over time. Real-time monitoring tools allow manufacturers to log in at any moment to gain an updated overview of their product security health.

In practice, manufacturers can log in anytime for an updated overview in what matters most for them. Moreover, the dashboard features customizable notification settings, allowing manufacturers to set alerts for KPIs that exceed or fall below predetermined thresholds. This proactive alert system helps product security team leaders quickly address and mitigate security issues, enhancing control over device security throughout the product lifecycle and safeguarding their products and end-users.

Moreover, it reduces the strain on customer success and product security teams who need to update customers on headline-making threats, allowing them to provide details on the status of a patch and its deployment date.

TPLC risk management is not just a regulatory requirement; it’s a strategic approach that enhances the cybersecurity posture of medical devices throughout their lifecycle. By focusing on the critical KPIs of defect density, patch turnaround time, and patch implementation efficiency, manufacturers can comply with stringent FDA KPIs to protect patients and secure their devices against evolving cyber threats.

By measuring these three KPIs, managers can ensure that their medical devices remain safe, effective, and secure from conception to decommissioning. As the landscape of medical technology evolves, so must the strategies we employ to protect these essential tools. TPLC risk management offers an adaptable, thorough framework, and, most importantly, proactive in addressing the cybersecurity challenges of today and tomorrow.