The FDA's 2022 legislation and updated 2023 cybersecurity guidance have transformed medical device development, making security-by-design mandatory rather than optional. Organizations must now integrate robust threat modeling, secure development life cycles and vulnerability disclosure programs within quality management systems while balancing transparency requirements with intellectual property protection. The challenge lies in implementing consistent security practices across diverse business units while maintaining innovation velocity and regulatory compliance.

In this insightful discussion, the panelists will discuss:

• What are the biggest challenges in harmonizing security strategies across IT, product security and compliance teams, and how can we overcome these gaps?
• With evolving threats in the medical device landscape, what proactive measures should organizations take to ensure compliance while maintaining innovation and efficiency?
• What best practices can organizations adopt to foster collaboration between security teams, regulatory affairs and executive leadership to build a cohesive security strategy?