Vigilant Ops Insight provides a cloud-based platform for creating, maintaining, and securely sharing Software Bill of Materials (SBOM) to improve organizational awareness of cyber threats and to enable a proactive approach to medical device security.
3rd Party Software vulnerabilities as root cause of breaches
Percentage of medical devices targeted by cyberattacks
Number of medical devices connected to healthcare networks
Percentage of medical device manufacturers responsible for the security of third-party software components utilized in their devices
Cost to a medical device manufacturer to compile and maintain a list of software components in a single version of a single device
Average cost of a healthcare breach – highest cost of any industry
Cost of a breach in healthcare compared to other industries
Time to identify and contain a breach in healthcare compared to other industries
Average number of days to identify and contain a breach in healthcare
Percentage of healthcare organizations with deployed automated security
Ken Zalevsky, CEO at Vigilant Ops, has over seventeen years of experience in the medical device industry, most recently as Head of Medical Device CyberSecurity at Bayer.
Ken is an active participant and member of the software cybersecurity teams of several industry trade associations including MITA (Medical Imaging Technology Alliance) and AdvaMed (Advanced Medical Technology Association). Ken has been a featured speaker on medical device cybersecurity and related topics at various industry events including the Medical Device R&D Summit and the FDA Premarket Guidance Public Workshop. Ken has been the contributing author to multiple medical device cybersecurity whitepapers including CSP-1-2015 CyberSecurity in Medical Imaging and CSP 2-2018 Cyber Hygiene Best Practices and is also the author of Effective Strategies Must Protect Medical Devices, featured in DotMed Healthcare Business News.
Ken earned a certification in CyberSecurity Leadership from Carnegie Mellon University, an undergraduate degree in Applied Math from Carnegie Mellon University and a graduate degree in Business Management from Carnegie Mellon University. Ken also attended the Executive Education program at Harvard Business School.
FDA has published premarket and postmarket guidances that offer recommendations for comprehensive management of medical device cybersecurity risks, continuous improvement throughout the total product life-cycle, and incentivize changing marketed and distributed medical devices to reduce risk.
Dispelling myths and understanding facts about medical device software regulations, responsibilities, and testing.
Guidance intended to provide recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk.