Medical Devices
and Implants:
Certifiable Security for Life-Critical Systems
Secure cryptography and OTA updates for ultra-constrained, mission-critical medical electronics
Medical devices and implants must protect sensitive patient data, device integrity, and real-time operational safety, often without the benefit of hardware security features. From insulin pumps and pacemakers to neural interfaces and surgical tools, these systems face strict safety, regulatory, and cybersecurity requirements. FortifyIQ enables advanced cryptographic protection for these devices, delivering certifiable resistance to physical attacks (SCA/FIA), even in the absence of hardware crypto.
Why Cryptographic Security in Implants Is Hard
Minimal Resources
Medical implants typically have extremely limited RAM, ROM/flash, and processing power.
OTA Update Requirements
Secure updates must protect against malicious firmware, even years after deployment.
Physical Exposure
Devices may be subject to proximity-based EM fault injection or power analysis attacks.
No Crypto Accelerators
These devices often lack AES engines, hardware RNGs, or secure enclaves.
Lifespan & Safety
Devices must remain secure for over a decade without compromising medical performance.
Why FortifyIQ ?
FortifyIQ delivers cryptographic protection that meets the unique constraints of medical implants and ultra-constrained healthcare devices:
- Security Without Hardware Crypto – Our hardened AES and HMAC software libraries provide strong SCA/FIA resistance even in devices without hardware accelerators, RNGs, or secure enclaves.
- Compact and Efficient – Designed for minimal RAM/ROM usage and optimized CPU performance, FortifyIQ software fits within the strictest implant constraints while maintaining uncompromising security.
- OTA Update Protection – Ensures firmware integrity and secure boot, safeguarding devices against malicious updates throughout their operational lifespan.
- Proven Physical Attack Resistance – Validated against side-channel and fault injection attacks, including EM and power analysis, to defend devices exposed to real-world proximity threats.
- Flexible Options – For systems requiring hardware-based security, FortifyIQ also provides compact, configurable IP cores and Roots of Trust that integrate seamlessly into low-power medical SoCs.
FortifyIQ Solutions: SCA/FIA-Hardened Software Crypto Libraries
Symmetric Cryptography
- AES-256, HMAC-SHA2
- Comply with the strictest security regulations on cryptographic modules, including SESIP, FIPS 140-3 Levels 3/4 and Common Criteria AVA_VAN.5
- Minimal RAM requirements for AES encryption (from 2 KB)
- Suitable for 16-/32-bit MCUs and custom microarchitectures
- Supports secure boot, firmware authentication, telemetry integrity
- No Secure Hardware Required
- Runs on legacy and resource-constrained platforms
- No crypto engines or secure elements needed
- Fully OTA-upgradable in the field
Asymmetric Cryptography
FortifyIQ’s software cryptographic libraries also include physically hardened public-key cryptography (PKA) for operations such as secure boot, key exchange, and digital signature verification. These functions are critical when protecting device authenticity, update integrity, and secure communication. However, not all implants are built equally:
- Update-Capable Implants (e.g., pacemakers with telemetry, cochlear implants, insulin pumps): These devices support firmware updates or secure reboots via RF or inductive interfaces.
FortifyIQ’s PKA libraries (ECC/RSA, etc.) can be integrated to protect firmware authenticity, enable device authentication, and support secure communications.
- Ultra-Constrained or Passive Implants (e.g., orthopedic implants, passive glucose sensors): These devices typically lack update capability and cannot support the overhead of public-key cryptography.
FortifyIQ’s AES and HMAC libraries are suitable here, enabling secure communications and integrity checks, with minimal RAM requirements. Software Post-Quantum Cryptography (PQC) is also under active development at FortifyIQ and will be available for platforms that require future-proof asymmetric protection. As with PKA, PQC is suited for update-capable implants where asymmetric functions are viable.
When Hardware is an Option
While FortifyIQ’s software cryptography is engineered for devices that lack hardware protection, our hardware cryptographic IPs offer extraordinary energy efficiency, minimal gate count, and protection. For medical devices that support ASIC or secure SoCs, FortifyIQ’s hardened AES, HMAC, and PKA IP cores, as well as our modular Cryptobox solutions, deliver maximum protection with minimal power, area, and latency.
Use Cases:
Pacemakers & Defibrillators:
Secure firmware updates, fault-tolerant integrity checks
Implantable Sensors:
Secure wireless telemetry and ensure firmware authenticity
Insulin Pumps & Drug Infusion Systems:
Prevent unauthorized control and protect dosing logs
Neurostimulators & Brain Interfaces:
Protect patient signals and device state
Certifiable and Standards-Aligned
FortifyIQ enables compliance with:
IEC 62304
Supports traceable, version-controlled software lifecycle practices with hardened cryptographic modules suitable for certified development flows.
FDA Cybersecurity Guidance
Provides layered cryptographic defenses, secure boot, firmware authentication, and OTA updates to prevent unauthorized access and manipulation.
EU MDR and ISO 14971
Assists in risk mitigation by addressing physical-layer threats (e.g., SCA/FIA), helping reduce residual risk in threat models.
NIST SP 800-213 and 800-82
Implements secure cryptographic modules for embedded and networked medical systems, aligned with NIST recommendations for IoT and ICS security.
Trusted Protection for Embedded Health Systems
FortifyIQ empowers medical OEMs to retrofit and deploy certifiable cryptographic protection using pure software. By eliminating the need for hardware acceleration or redesign, we offer a practical path to compliance, security, and patient safety across the implant lifecycle.
