Press Releases

PITTSBURGH, PA, USA, January 5, 2023/EINPresswire.com/
On December 29, 2022, United States President Joe Biden signed into law the $1.7 trillion federal government spending package, officially avoiding a government shutdown. “What this means for the Medical Device Manufacturer community is that FDA now has legal authority to require specific cybersecurity related documentation starting 90 days from the signing of the bill.  By (or before) the end of March 2023, they must be prepared to submit specific documentation.” said Ken Zalevsky, CEO at Vigilant Ops. Specific documents include:

• Software Bill of Materials including commercial, open-source, and off-the-shelf software components
• Vulnerability monitoring plans addressing postmarket cybersecurity vulnerabilities and exploits
• Postmarket cybersecurity updates and patches periodically and on-demand

A particularly burdensome requirement for medical device manufacturers is the secure maintenance and monitoring of devices at customer sites. The continuous monitoring of vulnerabilities and the need to respond with security patches on a “…reasonably justified regular cycle…” and “…as soon as possible out of cycle…” means that informal, manual solutions will not be sufficient to meet the letter of the law.

Vigilant Ops has been at the forefront of these looming requirements, offering a cost-effective solution immediately available to medical device manufacturers of all sizes. “We founded Vigilant Ops with the healthcare industry in mind and have leveraged our collective global medtech experience to develop the InSight Platform, the leading SBOM generation, management, and vulnerability monitoring tool on the market today,” said Zalevsky. “Our InSight Platform is already being utilized at some of the world’s largest medical device manufacturers, and we are continuing our intense focus on solution development and innovation as the SBOM ecosystem continually evolves.”

Vigilant Ops has closely monitored the US Food and Drug Administration lobbying efforts focused on similar requirements since their initial draft of “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” issued on October 18, 2018.  We have followed the progression of FDA requirements to ensure that Vigilant Ops cybersecurity solutions meet or exceed the expected standards. As far back as September 2021, we reviewed FDA’s request for legislative authority to enforce the requirement of a Software Bill of Materials and vulnerability monitoring plan.

Securing the Software Supply Chain

In addition to SBOM generation, continuous vulnerability monitoring, and sophisticated SBOM management, the InSight Platform leverages natural language processing techniques and patent-pending machine learning algorithms to efficiently and effectively find vulnerabilities associated with device components, eliminating false positives, and making an impossible task reliable, scalable, and automatic.

In Summary

The US government has long been concerned with the improvement of the nation’s cybersecurity posture, and this recently passed legislation is the culmination of years of effort and various legislative and guidance documents including the Presidential Executive Order 14028, released in May 2021.  In response to the continuing threats and attacks in healthcare, the bill details the new legal requirements that must be met by all medical device manufacturers to ensure the cybersecurity of their products.  Medical device manufacturers still trying to manage the effort in-house will end up having to divert an enormous quantity of resources to the issue, possibly slowing innovation and product development. The passage of this bill into law, however, will precipitate a sea change in the cybersecurity posture of medical device manufacturers. Complying with the law might be the immediate concern but lacking the ability to deliver on required cybersecurity mandates will quickly lead to further speculation from customers and lost opportunities and revenue.

Press release on EINPressWire can be found here.

Founded in 2019, Vigilant Ops is an innovator in the medical device cybersecurity industry. Led by seasoned medical device cybersecurity experts with more than forty years of combined experience, Vigilant Ops provides medical device manufacturers and hospitals with unprecedented insight into device risk profiles, enabling proactive management of threats before they impact the quality of patient care.

For more information about Vigilant Ops or the InSight Platform, please visit our website at www.vigilant-ops.com
Or drop us an email at: inquiries@vigilant-ops.com

Alicia Bond
Chief Revenue Officer

alicia.bond@vigilant-ops.com
412-704-4585

Vigilant Ops, an innovator in medical device cybersecurity and developer of the Software Bill of Materials (SBOM) automation platform InSight, announced a partnership with BeanStock Ventures of San Diego, California.

BeanStock Ventures is a medical device software product development organization with regulatory expertise. It is one of only nine FDA-Recognized 510(k) Third Party Review Organizations (3P510K), enabling the fast-track of medical devices for 510(k) clearance, which is a premarket submission made to FDA to demonstrate medical device safety and effectiveness. BeanStock’s designation provides medical device manufacturers with an alternative review process which can significantly reduce the average FDA wait time.

“Partnering with BeanStock Ventures enables one-stop shopping for medical device manufacturers looking for both pre and post market regulatory compliance support,” said Ken Zalevsky, CEO at Vigilant Ops. “Our InSight Platform automates the generation of the device Software Bill of Materials (SBOM) and the documentation to submit with the 510(k) application to FDA. Our InSight Platform also provides continuous monitoring and maintenance of the SBOM, enabling medical device manufacturers to adhere to FDA postmarket surveillance requirements.”

“BeanStock Venture’s Software Product Development expertise allows us to approach execution strategically with our regulatory and product development expertise infused. Our team holds expertise in working with legacy software and creating new software to ensure a product platform can be built for cybersecurity.” said Shawnnah Monterrey, CEO at BeanStock Ventures.

The Vigilant Ops InSight Platform uses various techniques to interrogate medical devices and automatically generate SBOMs, which are then continuously monitored and updated. By leveraging natural language processing techniques and patented machine learning algorithms, vulnerabilities associated with device components are found and communicated in near real-time.

Press release on EINPressWire can be found here.

Founded in 2019, Vigilant Ops is an innovator in the medical device cybersecurity industry. Led by seasoned medical device cybersecurity experts with more than forty years of combined experience, Vigilant Ops provides medical device manufacturers and hospitals with unprecedented insight into device risk profiles, enabling proactive management of threats before they impact the quality of patient care.

For more information about Vigilant Ops or the InSight Platform, please visit our website at www.vigilant-ops.com
Or drop us an email at: inquiries@vigilant-ops.com

Matt Lentine
matt.lentine@vigilant-ops.com
412-704-4602

Healthcare Delivery Organizations Gain Visibility into Risk Profile of Deployed Medical Devices. Today, Vigilant Ops, an innovator in medical device cybersecurity, announced the immediate availability of InSight Platform V1 for Healthcare Delivery Organizations, providing HDOs with an automated solution for monitoring the health of their deployed medical devices.  The InSight Platform V1 for Medical Device Manufacturers (MDMs) was released on May 11 and provided MDMs an automated solution for generating and maintaining device software bills of materials (SBoMs).  With the release of the HDO functionality, these generated SBoMs can be shared with authorized HDOs directly and securely through the platform.

“The Vigilant Ops InSight Platform V1 is the only solution of its kind that brings together both the producer and the consumer of the SBoM on the same platform,” said Ken Zalevsky, CEO at Vigilant Ops and former Head of Medical Device Cybersecurity at Bayer. “Medical device manufacturers generate device SBOMs, and via secure connection, share them with authorized HDOs through the InSight Platform.”

The InSight Platform uses advanced techniques to interrogate medical devices and automatically generate bills of materials. Using artificial intelligence and machine learning, the InSight Platform continuously monitors for vulnerabilities in discovered device components. Thus enabling HDOs and MDMs to gain visibility into risk profile of medical devices and respond proactively to the latest discovered threats.

Founded in 2019, Vigilant Ops is an innovator in the medical device cybersecurity industry. Led by seasoned medical device cybersecurity experts with more than forty years of combined experience, Vigilant Ops provides medical device manufacturers and hospitals with unprecedented insight into device risk profiles, enabling proactive management of threats before they impact the quality of patient care.

For more information about Vigilant Ops or the InSight Platform, please visit our website at www.vigilant-ops.com
Or drop us an email at: inquiries@vigilant-ops.com

On May 11 2020, Vigilant Ops, an innovator in medical device cybersecurity, announced the immediate availability of InSight Platform V1, enabling medical device manufacturers to begin automatically generating, updating, and monitoring device software bills of materials (SBOMs). FDA’s draft version of their premarket guidance refers to these as CBOMs (Cybersecurity Bill of Materials)^​1​, given the original desire to include hardware components in device bills of materials. Since the original draft guidance, FDA and others have begun referring to the documents as SBOMs (Software Bill of Materials) and eliminating the hardware component inclusion. Vigilant Ops will also refer to these device software bills of materials as SBOMs.

“The Vigilant Ops InSight Platform V1 is a game-changer in medical device cybersecurity,” said Ken Zalevsky, CEO at Vigilant Ops and former Head of Medical Device Cybersecurity at Bayer. “Medical device manufacturers are under extreme pressure from customers, prospects, and regulatory bodies to prove the safety and security of their devices. SBOMs are an industry-accepted solution but are very labor-intensive to generate and require continuous monitoring and maintenance. The InSight Platform eliminates this manual generation effort, while providing real-time monitoring of various public vulnerability sources and continuous maintenance of device bills of materials.”

The InSight Platform uses advanced techniques to interrogate medical device and automatically generate SBOMs. Using artificial intelligence and machine learning, the InSight Platform continuously monitors for vulnerabilities in discovered device components, enabling device manufacturers to respond proactively to the latest discovered threats.

Founded in 2019, Vigilant Ops is an innovator in the medical device cybersecurity industry. Led by seasoned medical device cybersecurity experts with more than forty years of combined experience, Vigilant Ops provides medical device manufacturers and hospitals with unprecedented insight into device risk profiles, enabling proactive management of threats before they impact the quality of patient care.

For more information about Vigilant Ops or the InSight Platform, please visit our website at www.vigilant-ops.com
Or drop us an email at: inquiries@vigilant-ops.com