Medical Device Cybersecurity Survey Report Released
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Cybellum released a medical device survey report on April 20, 2022 entitled “Medical Device Cybersecurity: Trends and Predictions.” The company’s website states that their “mission is to enable manufacturers and their suppliers to develop and maintain products that aren’t just safe, but are also secure.”
According to the company website, in preparing the new report, Cybellum “asked top security experts from hundreds of medical device manufacturers, about their main challenges and how they plan to solve them in 2022, and beyond.”
Cybellum lists the following key findings from the report:
Almost 90% admitted they need to improve on key areas, such as SBOM [software bill of materials] analysis and compliance readiness
Over 55% do not have a dedicated response team (PSIRT) in place
Almost 55% increased their cybersecurity budget by more than 25% in 2022
Other media outlets described the report as finding “widespread cybersecurity noncompliance despite rising investment,” and “[m]ore than half of medical device companies think they are noncompliant with cybersecurity regulations, standards and guidelines.” Further, “compliance with requirements ranged from 54% for Food and Drug Administration premarket submissions to 37% for International Medical Device Regulators Forum (IMDRF) cybersecurity principles and practices.”
According to MedTechDive, the report states that “[m]ore than 80% of respondents see device security as a competitive advantage and almost every polled company increased its security budget this year. However, 78% of those surveyed indicated they are doing the minimum to achieve compliance and 80% view device security as a ‘necessary evil’ imposed by regulators.”
According to a press release by Cybellum, “[m]edical device cybersecurity has become an extremely complex challenge. With medical devices becoming software-driven machines, and the rapid pace at which cybersecurity risk evolves due to new vulnerabilities, complex supply chains, new suppliers, and new product lines, it has become seemingly impossible to keep the entire product portfolio secure and compliant at all times. It is now more important than ever to learn from peers and try to find the best way forward.”
The full text of the survey report can be found here.
Tom is a Partner in the San Diego office and serves clients worldwide in aerospace, mechanical, and medical technologies. He counsels clients on overall IP strategy, performs IP audits, prosecutes patents and trademarks, conducts pre-litigation enforcement of IP rights, negotiates licenses, and conducts offensive and defensive diligence such as patentability and infringement studies.
As a former aerospace engineer with experience at NASA and Northrop Grumman, and holding a master’s degree in biomedical engineering, Tom’s legal services are supplemented with his advanced technical abilities in a wide range of inventive domains.
Tom has particular experience with assisting startups from the conceptual design phase through acquisition. One recent example is Millipede, Inc., developer of a heart valve annuloplasty device. Tom prosecuted their patent portfolio and provided defensive patent diligence, resulting in investments and an acquisition by Boston Scientific totaling $540,000,000.
Other example particular technologies in Tom’s patent experience include cardiac devices, intracranial sensors, prosthetics, aircraft and rockets, robotics, unmanned aerial vehicles (drones), semiconductors, imaging and biosensors, high altitude balloons, control systems, thermal management systems, software, and more.
Additional highlights include:
Keynote Speaker, “Patent Basics for the Aerospace Industry,” at the 2019 Space Foundation Space Commerce Workshop
Former Mechanical engineer at Northrop Grumman, where he designed and tested complex structures and mechanisms for various spacecraft programs
Interned at NASA Armstrong Space Center, Aerodynamics Branch, where he analyzed data for the Quiet Supersonic Platform
Inventor of the “Inflate-A-Brake,” a system for de-orbiting small satellites to reduce space debris
Publications Coordinator for the firm’s medical device practice group, which leads the nation in medical device patent prosecution having obtained over 4,800 medical device patents since 1976 and 2,700 medical device patents since 2010
Member of the firm’s pro bono committee and coordinates with the U.S. Patent & Trademark Office’s regional patent pro bono program to assist indigent individuals and non-profit organizations
Co-Chair of the Licensing Executives Society (LES) for the San Diego Chapter
Holds a minor in Chinese and studied Chinese language and history at Shaanxi Normal University in Xian, China
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