ELTON’s Leadership and Credibility in Medical Device Cybersecurity

For more than a decade, ELTON has been at the center of advancing medical device cybersecurity, combining technical depth, regulatory experience, and long-term partnerships to redefine how manufacturers achieve and sustain compliance. Our foundation was built through years of direct collaboration with industry leaders, standards bodies, and regulators, ensuring that every service and feature of the ELTON platform aligns with the expectations of both the FDA and global authorities.

Deep Experience Across Every Product Type

ELTON’s team has supported the cybersecurity programs of some of the most complex and widely deployed medical devices in the world, ranging from implantables and diagnostic imaging systems to in-vitro diagnostics and remote monitoring platforms. With over 10 years of experience, our experts have conducted more than 2,000 targeted vulnerability tests, delivered over 600 FDA-ready vulnerability reports, and managed more than 100,000 validated vulnerabilities. Each engagement has contributed to the evolution of our defensible methodologies that help manufacturers meet FDA, UL, IEC, and global standards with confidence.

ELTON’s work is trusted and recommended by members of the Health Information Sharing and Analysis Center (H-ISAC) for its accuracy, consistency, and ability to streamline regulatory approvals. We have built long-term programs with leading innovators and small manufacturers alike, providing sustainable, subscription-based cybersecurity that eliminates the inefficiencies of traditional consulting models.

FDA Approved and Scientifically Grounded

ELTON is the first cybersecurity solution advancing through the FDA’s Medical Device Development Tool (MDDT) program, a validation pathway reserved for tools that generate scientifically sound, regulator-accepted results. Through this qualification, ELTON’s vulnerability scoring, triage, and reporting methods will be formally recognized by the FDA as appropriate for use in premarket submissions, enabling manufacturers to demonstrate security readiness using an already validated methodology.

This unique status positions ELTON as not just a technology vendor, but as a recognized contributor to the scientific and regulatory foundation for medical device cybersecurity. Our processes mirror FDA and IMDRF expectations for vulnerability risk assessment, ensuring manufacturers can submit standardized, defensible data that aligns with the latest guidance.

Industry Contributions and Thought Leadership

ELTON’s leadership team has played an influential role in shaping the direction of cybersecurity policy and practice across the medical device ecosystem. We have authored, spoken, and advised at some of the industry’s most respected forums:

• Black Hat 2025 Innovation Track: Rethinking Vulnerability Management for Medical Devices presenting a modern approach to scalable, architecture-aware vulnerability management for regulated products.

• Health Sector Coordinating Council (HSCC) Joint Security Plan 2 (JSP2): ELTON authored the Verification and Validation Testing section, establishing standardized expectations for how medical device manufacturers conduct and document security testing for regulatory readiness.

• MedTech Cybersecurity Risk Mitigation Conference: Smart Patching Strategies for Efficient Updates defining approaches for minimizing downtime and cost while maintaining compliance with postmarket obligations.

• HIMS and Regulatory Law Conferences: Navigating the 2023 and 2025 FDA Medical Device Cybersecurity Laws equipping manufacturers to understand how vulnerability management metrics, SBOM surveillance, and annual testing requirements align with Quality System Regulation (QSR) updates.

• CISA Medical Device Flaws Report: Contributed to national awareness campaigns around vulnerability disclosure and coordinated response for connected healthcare technology.

• Publication: The Alarming Reverse Backdoor Hidden in Two Patient Monitors pioneering research that exposed a critical backdoor affecting multiple patient monitoring systems, leading to stronger validation controls and new guidance on embedded software testing.

• White Paper: The Most Concerning Security Vulnerabilities in Medical Devices one of the industry’s most widely cited analyses on systemic risks and design-level security gaps in healthcare technology.

Proven Methodology and Expert Team

Every assessment conducted under ELTON follows a disciplined, standards-based approach derived from the Penetration Testing Execution Standard (PTES) and the Information System Security Assessment Framework (ISSAF). Each engagement begins with threat modeling to identify potential attack vectors, followed by deep analysis of system controls, interfaces, and design assumptions.

ELTON combines manual expert testing with automated discovery to uncover vulnerabilities that often go undetected by traditional scans. Our analysts chain low-risk vulnerabilities together, exploit logical flaws, and model real-world attacker behavior to determine realistic exploitability and patient impact. This approach enables accurate prioritization of vulnerabilities, ensuring manufacturers focus only on issues that truly affect device safety and performance.

Our practitioner team brings over 50 years of combined experience across product security and regulatory testing. Each assessment is led by professionals holding advanced certifications, including CEH, GPEN, GWAPT, OSCP, CPT, and PenTest+, and all members maintain deep specialization in medical device environments encompassing embedded hardware, wireless communication, mobile applications, cloud ecosystems, and regulated data systems.

Building Confidence Through Measurable Outcomes

ELTON’s impact can be seen not only in the number of devices we’ve secured, but in the measurable outcomes achieved by our customers: shorter review times, reduced remediation costs, and stronger postmarket compliance posture. Our platform transforms cybersecurity from a reactive cost center into a predictable, defensible part of product quality.

Through continuous monitoring, automated CVSS contextualization, and traceable digital twin modeling, ELTON allows manufacturers to maintain FDA-compliant vulnerability management without expanding internal security staff. Every vulnerability is automatically correlated to its architecture, every score justified, and every change tracked to its impact, creating a complete, auditable record that meets FDA expectations for Total Product Lifecycle Management (TPLM).

A Global Standard for Trust

ELTON’s mission extends beyond compliance, it is to set the standard for how medical technology remains secure and safe throughout its lifecycle. Our experience, regulatory partnerships, and scientific approach make us a trusted authority and a practical partner for every manufacturer seeking to build cybersecurity assurance into their products from design to decommissioning.

With proven results, an FDA-approved foundation, and leadership recognized across the world’s top security and regulatory forums, ELTON continues to define what modern medical device cybersecurity looks like: credible, efficient, and defensible.