3 min read
Mar 1, 2024 10:45:00 AM

For medical device manufacturers, the stakes continue to rise in the ever-evolving connected device ecosystem of connected medical devices. Today's medical device manufacturers must deliver, in equal parts, innovation, quality, and security. That's never been easy, and it's no easier now. 

In securing medical devices, traditional Application Security (AppSec) tools have long proven their value, but they often fall short in meeting the rigorous demands of the Food and Drug Administration (FDA)'s cybersecurity guidelines.

Even if it sometimes gets overlooked or deprioritized for the benefit of speed or cost savings, the value of compliance can't be overstated. Failing to adhere to regulatory guidelines can lead to significant setbacks, including the FDA's "Refuse to Accept" notice, delayed product launches, and substantial financial implications.

The SBOM and the FDA's Cybersecurity Guidance

The Software Bill of Materials (SBOM) brings critical value to the compliance equation for medical device manufacturers. With many binary components integrated at the final stages of software development—often without accessible source code—traditional AppSec tools cannot achieve the visibility they need to see within them.

The firm stance that the FDA takes in its Final Guidance underscores the need for comprehensive SBOMs, and regulators' increasing demands for documentation that encompasses all software components, whether commercial, open-source, or off-the-shelf, within a connected product.

To meet the demands of the market, and of regulators in particular, today's solutions must transcend the traditional barriers of AppSec tools by generating thorough and easily accessible SBOMs. These solutions must facilitate compliance with FDA guidelines while also equipping manufacturers with in-depth analysis and visibility into every software component, enhancing security and streamlining the path to market.

Security Solutions for the Medical Device Industry

The Finite State Next Generation Platform is redefining security tooling for medical device manufacturers, with a suite of services designed to ensure seamless FDA premarket submissions:

  • Insights Dashboard: A centralized view of product submissions, offering unparalleled clarity.
  • Prioritized Vulnerability List: Guiding teams to focus on critical security issues.
  • Comprehensive Evidence Documentation: Easy access to SBOMs in JSON format, Vulnerability Disclosure Reports, and results from various security assessments.

A Comprehensive SBOM Solution

Finite State's end-to-end SBOM solution changes the connected-device security game. by offering capabilities that include the generation, import, enrichment, and distribution of SBOMs.

The Next Generation Platform also offers binary Software Composition Analysis (SCA), which dissects uploaded binaries to reveal both open-source and proprietary components, providing a granular view of the software ecosystem.

By importing SBOMs from various sources and enriching them with the latest vulnerability intelligence, Finite State ensures that your product's security posture is both current and robust.

Beyond SBOM: A Holistic Approach to Security

Finite State doesn't stop at SBOM generation. Its industry-leading binary analysis, capable of breaking down binary images into their components and examining decompiled source code, sets a new standard in identifying and mitigating security vulnerabilities.

By integrating over 150 AppSec scanning tools, Finite State offers a unified platform for visibility and risk management, complete with intuitive risk scoring and a suite of dashboards for tracking security objectives.

Meeting Diverse Needs with Flexible Deployment

Finite State understands the many and diverse needs of medical device manufacturers and provides a spectrum of deployment options. Whether you choose SaaS, hybrid cloud, or on-premise installations, you can get security solutions tailored to your specific requirements.

As the medical device industry continues to navigate the complexities of cybersecurity compliance, the Finite State Next Generation Platform emerges as a pivotal ally.

By offering a comprehensive suite of tools designed to generate detailed SBOMs and beyond, Finite State not only facilitates compliance with FDA guidelines but also empowers manufacturers to enhance product security, reduce time-to-market, and mitigate financial risks.

Want to learn more? Dive into this new data sheet to explore the depth of Finite State’s solutions and understand how, together, we can transform the security posture of medical device manufacturing.

Read our new datasheet!