Ramakrishnan Pillai, CISSP, CRISC

Ramakrishnan Pillai (Ramki) is a seasoned cybersecurity professional and product security executive. At Aktriva, he advises and supports executive leadership, engineering, quality, regulatory, and product teams on regulatory-ready cybersecurity programs, including threat modeling, risk management, security architecture, vulnerability management, and cybersecurity submission packages for FDA 510(k) and PMA, EU MDR, NMPA, and PMDA. His work is grounded in a secure-by-design and secure-by-default philosophy, with deep alignment to ISO 81001-5-1, AAMI SW-96, and MedTech Joint Security Plan v2. His experience with HIPAA and GDPR helps bring privacy-by-design principles into the products he helps develop.

Ramki brings more than 25 years of experience across technology, cybersecurity, and healthcare, with a career dedicated to advancing patient safety, data protection, and regulatory-compliant medical device security. He has built and scaled high-performance product security organizations in both global enterprises and growing companies, establishing governance models, security engineering practices, and post-market surveillance programs that withstand regulatory scrutiny while enabling business innovation.

Prior to Aktriva, Ramki served as Senior Director of Product Security at LivaNova, where he established and led the product security organization supporting neuromodulation and cardiopulmonary products during the post-FDA 524B regulatory era. His leadership enabled successful pre-market submissions and strengthened post-market cybersecurity operations for both new and legacy devices.

Earlier, Ramki was the Chief Product Security Officer and HIPAA Security Officer at Elekta, where he founded the company's global product security organization. In this role, he implemented cybersecurity governance, security risk management processes, security testing programs (SAST, SCA, DAST), vulnerability disclosure and incident response programs, and supported major compliance initiatives including SOC 2 Type II and FedRAMP audits. As HIPAA Security Officer, he also supported enterprise privacy and information security teams, advising on HIPAA audits, breach response, and security controls across both IT and product environments.

In addition to his industry leadership, Ramki is a recognized contributor to global healthcare cybersecurity policy and best practices. He has been an active member of the Health Sector Coordinating Council (HSCC) Cybersecurity Working Group since 2016 and previously co-chaired the HSCC Legacy Medical Devices Task Group in collaboration with the FDA. This group produced widely adopted guidance on securing legacy medical devices in the field and preventing devices from becoming legacy through secure design.

Ramki is a published author and contributor to several influential industry resources, including the Medical Device and Health IT Joint Security Plan (JSP2), a comprehensive total product lifecycle cybersecurity reference recognized by FDA and used by manufacturers, providers, and regulators worldwide. He has also been interviewed on industry podcasts and regularly publishes and shares practical guidance on medical device cybersecurity regulations, standards, and emerging risks.

A frequent speaker and presenter, Ramki has delivered presentations and chaired sessions at healthcare and cybersecurity conferences, including industry summits focused on medical device security, supply chain risk management, and regulatory compliance. His speaking engagements emphasize actionable guidance for aligning cybersecurity, usability, regulatory expectations, and business continuity.

Ramki holds a U.S. patent in device vulnerability management, which introduces a structured, risk-based approach to assessing and prioritizing remediation of security vulnerabilities across complex device environments. He maintains professional certifications including ISC² CISSP and ISACA CRISC.

Through Aktriva, Ramki continues to help organizations operationalize cybersecurity in a way that is regulatory-ready, engineering-practical, and aligned with the ultimate goal of protecting patients and clinical outcomes.