Medcrypt, a leader in medical device cybersecurity, has officially announced the launch of enhanced capabilities for its SBOM Vulnerability Management Tool called Helm, which is built specifically for medical device manufacturers (MDMs).
According to certain reports, the stated new capabilities are expected to help Helm in providing industry-specific features that reduce compliance burdens, lower risk, and improve efficiency, as well as cut down significantly on costs and accelerate time to market.
More on that would reveal how Helm arrives on the scene bearing an ability to tackle compliance, security and lifecycle management challenges in a rather straightforward fashion. This it markedly does through features like FDA ready SBOM reports, auto-rescoring of vulnerabilities, and audit ready documentation, empowering manufacturers meet regulatory measures efficiently.
Such a comprehensive mechanism, like you can guess, allows for manufacturers to more seamlessly navigate FDA submissions, streamline audits, reduce security risks, and maintain product innovation timelines.
Talk about the whole value proposition on a slightly deeper level, we begin from the technology’s promise to accelerate time to compliance. Here, Helm automates manual tasks, and therefore, reduces the time required for SBOM management, vulnerability dispositioning, and regulatory preparation.
Next up, there is the potential for reduced security risk, something which is achieved by improving component matching accuracy and reducing false positives. The given setup eventually guides the user towards an enhanced vulnerability management mechanism.
Another detail worth a mention is rooted in the solution’s prospects when it comes to ensuring efficient lifecycle management. Helm effectively conceives automated EOS/EOL lifecycle rules to track components across portfolios. Beyond that, we have intuitive status indicators capable of highlighting components approaching or past EOS/EOL.
The overarching idea here is to help teams prioritize upgrades and manage risks proactively.
Joining that would be the availability of superior quality and accuracy. This stems from the solution’s bid to automate risk and compliance management, reducing human error and providing more precise, consistent security documentation.
In fact, during initial deployment, Helm also outperformed competitors in component matching accuracy and associated vulnerability identification so to eliminate false positives and redirect attention to more high-impact threats.
Anyway, the technology is now also well-equipped to cut down on operational costs. Again banking upon the automation aspect, it shrinks down hours spent on compliance and security tasks. Furthermore, its lower false positive rate also minimizes need for unnecessary fixes.
Hold on, we still have a few bits left to unpack, considering we haven’t yet expanded upon the solution’s industry-standard SBOM & FDA-ready reports. You see, Helm can generate on-demand, exportable SBOMs, in CycloneDX and SPDX formats to meet industry standards.
In case that wasn’t enough, the solutions also brings forth FDA-ready vulnerability disclosure reports (VDR), VEX, and other critical reports to streamline audits and regulatory submissions. These reports, on their part, are backed by insights from former FDA reviewers who have shaped important medtech cybersecurity policies.
We also haven’t dug deeper into the integrations that are available to facilitate a seamless workflow. The stated integration pave the way for you to package Helm into your CI/CD pipeline and get SBOMs to align with the latest builds. You can even leverage its API, GitHub action, upcoming Azure DevOps extension, or even manually create or upload SBOMs.
Alongside that, there is a facility in play to automatically pull vulnerabilities, like those on the CISA KEV, before integrating them into your ticketing system using a custom script or external workflow.
Among other things, it must be acknowledged that Medcrypt’s latest innovation comes on the back of multiple collaborations with regulatory bodies, meaning it is poised to accommodate the evolving nature of policies.
“Over my many years in the cybersecurity space, and working on global industry best practices and specifications, I have witnessed the immense pressure MDMs are under to meet evolving cybersecurity regulations while keeping costs and operational burdens in check,” said Bob Lyle, Chief Revenue Officer at Medcrypt. “Helm is designed specifically to accelerate compliance, improve security, and reduce the cost of meeting FDA expectations. By automating processes and enhancing accuracy, Helm allows manufacturers to spend less time on compliance and more time driving innovation and patient safety.”
