Cybersecurity in 2024 and Beyond; Benefits of a Systems Approach in Medical Device Development
Thursday, March 14, 2024 (12:00 PM - 1:00 PM) (EDT)
In the rapidly evolving landscape of cybersecurity, the emergence of new FDA guidance underscores the critical need for a comprehensive systems approach to safeguarding patient safety and sensitive data and ensuring the integrity of medical devices. Join us as we explore the benefits of adopting a holistic cybersecurity strategy in response to the evolving threat and regulatory landscape in the healthcare sector. By delving into the key elements of the new FDA guidance, this panel will explore the interconnectedness of cybersecurity components and the necessity of addressing vulnerabilities within a broader systems context.
Key takeaways include how to integrate cybersecurity into system risk management practices, and methods for continuous monitoring to help control risk post market launch in the face of evolving threats. Our goal is to push for a paradigm shift towards taking a systems perspective in cybersecurity, recognizing its pivotal role in enhancing resilience against cyber threats and fostering a secure environment for healthcare technologies.
- Understanding how interconnected components contribute to a more robust and resilient cybersecurity strategy
- Importance of incorporating cybersecurity considerations into the initial design phases of medical devices
- The role of interdisciplinary collaboration in achieving a comprehensive systems approach to cybersecurity
Senior Principal Software Engineer
Nick Daniell has over 15 years of experience in software development, predominantly in medical devices. Nick’s background covers embedded software development, GUI development, Linux application, kernel programming, fluid management, database, server infrastructure, mobile device development and medical device security. Nick has developed and utilized a consistent approach to evaluating medical device security risk profiles and developing security risk mitigations that don’t compromise patient safety.
He holds a Bachelor of Science in Computer Engineering from Vermont Technical College.
VP of Engineering
Dave has over 20 years of experience in leading medical device development for surgical, home use, and clinical products, in a mixture of an engineering services environment and a direct sales and support engineering environment. He has developed products for Stress Echocardiography, Image Guided Surgery, Intra-operative Imaging, Radiation Oncology, Dialysis, and Diabetes Care.
Dave’s background covers Project Management of electromechanical devices, embedded software, Linux applications, high volume disposables, and Android applications in products including volumetric delivery systems and highly accurate patient positioning systems.
He earned a Bachelor of Science in Biomedical Engineering from Boston University. He holds several patents for a home use peritoneal dialysis device.
Director of Software
Christine is a seasoned software leader with over 20 years of experience developing software and leading teams for medical devices, lab automation applications, and green technologies. Her project experience spans the entire product life cycle, from concept through product release. Areas of expertise include embedded systems, communication protocols, battery powered and wireless devices. In addition to her technical abilities, she has expertise in IEC-62304, planning, requirements generation, software architecture and design, cybersecurity, and Agile methodology.
She holds a Bachelor of Science in Computer Engineering from Tufts University.
Cytrellis Biosystems, Inc
As Chief Technology Officer, Shivkumar Sabesan leads Cytrellis' innovation and technology strategy as it continues to advance its proprietary ellacor® Micro-Coring® Technology and expand indications. Cytrellis is a medical technology company dedicated to the development and commercialization of first-in-class aesthetic devices. Cytrellis' first product, ellacor with Micro-Coring Technology, is a novel, proprietary system that removes sagging skin to address moderate and severe wrinkles.
Prior to Cytrellis, Sabesan held global roles in research and development and product management at multiple health technology companies including Philips Healthcare, Google, Medtronic, and LivaNova, as well as at innovative startups such as Alto Neuroscience and Movella. Sabesan holds his PhD in electrical engineering from Arizona State University and has successfully launched over ten FDA/CE-regulated medical devices and software, along with market-specific healthcare products for the APAC and Latin American regions.