Cyberattacks in the Biotech Sector: How firmware and hardware hacking puts medical devices at risk

The biotechnology and medical sector has undergone a significant transformation with the integration of advanced digital technologies. Laboratory equipment, diagnostic devices, and monitoring systems are now network-connected, equipped with sophisticated firmware, and managed through digital interfaces. While this digitalization enhances the efficiency and capabilities of these devices, it also introduces new attack surfaces for cybercriminals.

Firmware is a type of embedded software that resides in a device’s non-volatile memory. It controls the most basic hardware functions and acts as a bridge between high-level software (such as the operating system) and the physical components of the device. In the medical context, this can include anything from calibrating biomedical sensors to managing automated cycles in clinical analyzers.

Firmware is often overlooked in security audits and rarely updated, partly due to the complexity of maintaining it and its lack of visibility to end users. This makes it an ideal target for attackers. Some of the main vulnerabilities include:

• Lack of encryption in the firmware update channel: Many updates are transmitted in plain text, allowing interception and modification of the package during download or installation.

• Absence of digital signatures to verify firmware integrity: Without this mechanism, there’s no way to ensure the firmware comes from a legitimate source and hasn’t been tampered with.

• Uncontrolled physical access to devices: In labs or clinics where devices are left unattended, an attacker may gain direct access to the hardware.

• Lack of tamper detection mechanisms: Without alerts or logs of unusual activity, changes made by an attacker can go unnoticed for extended periods.

Hardware cyberattacks: What is hardware and why is it vulnerable?

Hardware hacking involves the physical modification of a device to alter its behavior for malicious purposes. These modifications can be made directly to the printed circuit board, connection ports, or even through the addition of external electronic components that act as backdoors or surveillance points. This technique is especially dangerous because, once implemented, it is extremely difficult to detect without a thorough physical inspection.

Examples of hardware attacks in Biotech

• Spy chip implants in laboratory devices: These microcomponents can be introduced during the manufacturing process (supply chain attack) or through physical access. They are designed to intercept, alter, or relay data without visibly affecting the device’s operation.

• Tampering with medical sensors: An attacker can manipulate the readings of biomedical sensors, such as those used in heart monitors, glucose meters, or blood pressure devices, to produce false results, potentially leading to serious diagnostic or therapeutic consequences.

• Side-channel attacks: Using advanced techniques such as monitoring electromagnetic emissions, vibrations, or power consumption, a malicious actor can infer sensitive data being processed by the device, without breaking any encryption systems.

Impact of these attacks on the biotech sector

Compromised or leaked data

The data generated and processed in the biotech field is highly sensitive. A single alteration in the readings of a molecular analyzer, for example, could lead to misinterpretation of a critical biomarker. The same applies in clinical settings, where subtle modifications to lab results can directly impact patient health or undermine the reliability of clinical trials.

Disruption of critical operations

Firmware or hardware hacking can completely halt automated processes such as DNA sequencing, chemical analysis, or cell culture growth in digitally controlled incubators. These disruptions not only delay operations but can also result in the loss of irreplaceable biological samples or the need to repeat long and costly experiments.

Leakage of intellectual property and sensitive data

Examples of documented real-world cases

Cybersecurity tips to mitigate firmware and hardware attack risks

Secure firmware updates

• Mandatory Digital Signatures: Every firmware update should be cryptographically signed by the manufacturer to ensure authenticity.

• Encrypted Distribution Channels: Use HTTPS with TLS 1.3 or similar protocols to prevent interception or tampering during transmission.

• Version Control and Change Logs: Maintain strict control over installed versions and their update history to support forensic audits in case of incidents.

Physical and access protection

• Role-Based Access Control (RBAC): Only authorized personnel should have physical access to devices or their configuration interfaces.

• Regular Hardware Inspections: Conduct physical checks to detect signs of tampering, such as added components or suspicious markings.

• Security Seals and Shielded Enclosures: Physical protections that trigger alerts or prevent unauthorized access.

Monitoring for anomalous behavior

• Embedded Intrusion Detection Systems (IDS): Internal sensors capable of identifying unusual firmware behavior or abnormal data bus traffic.

• Predictive Machine Learning Models: Algorithms trained to learn the device’s normal behavior and flag subtle deviations that may indicate an attack.

Collaboration with Manufacturers

• Secure Firmware Lifecycle: Vendors should document every stage of firmware development and updates, and incorporate security testing from the design phase.

• Independent External Audits: Regular assessments conducted by third parties to verify device security.

• Commitment to Regular Updates: Lack of timely patches or long-term support is a risk indicator. Partner with vendors who provide ongoing maintenance and security updates.

The biotech sector is facing an emerging and critical challenge: the security of device firmware and hardware. As these systems become increasingly interconnected and complex, so do the opportunities for malicious actors to exploit deeply embedded vulnerabilities.

Cyberattacks are no longer limited to traditional software. Protecting firmware and hardware must become a strategic priority for organizations in the biotechnology and healthcare industries. Through proactive measures, continuous auditing, and a security-first culture integrated from the design phase, it is possible to mitigate these risks and ensure the integrity and safety of data, processes, and, most importantly, patients.