The Importance of Cybersecurity in the MedTech Industry

A medical device vulnerability can disrupt treatment, affect the device's function, and could expose critical healthcare infrastructure. Medical device cybersecurity is essential in protecting patient safety, clinical operations, and healthcare data. In 2026, 24% of health institutions experience cyberattacks or vulnerability exploitation on medical devices, with 80% of these cases resulting in moderate or severe disruption to healthcare delivery.

As MedTech becomes increasingly connected through IoT, cloud platforms, APIs, and AI, security must remain a priority throughout the device lifecycle. Understanding key cybersecurity risks, their impact, supply chain security, regulatory requirements, and practical security measures can help maintain security in your organization. At Medysec, we are committed to helping you build security that lasts beyond product launch. We support safer devices, stronger resilience, and continuous protection as threats evolve.

The Growth of the MedTech Industry in the Field of Cybersecurity

The MedTech industry consists of companies that develop connected medical devices, SaMD, and IoMT technologies for diagnostics, therapy, and patient monitoring. With the increased connectivity of medical technologies, the importance of cybersecurity has increased for medical devices.

In 2026, the global medical device cybersecurity market is estimated at USD 8.99 billion and is projected to reach USD 18.28 billion by 2031. This growth reflects the increasing need to secure connected medical technologies.

What is the Role of Cybersecurity in the MedTech Industry?

Cybersecurity helps secure medical devices, medical information, and healthcare infrastructure from threats that can affect patient safety. With increasing integration of the IoTs, cloud computing, API’s, and AI in MedTech, security has become crucial for medical devices. Cybersecurity requirements for medical devices cover areas such as secure design, vulnerability management, software updates, access controls, and post-market monitoring. 

• Patient safety: Security controls help prevent device tampering and disruption that could affect treatment. Around 80% of medical-device-related cyber incidents cause moderate or significant disruption to patient care.
• Continuity of treatment: Ransomware attacks and device exploitation can lead to disrupted treatments and cancellations of operations or medical procedures.
• Data security: Cybersecurity ensures proper protection of data stored by devices, logs, and electronic health records.
• Market access: Strong cybersecurity helps manufacturers meet buyer security requirements, demonstrate product trustworthiness, and avoid rejection during procurement.
• Compliance with regulations: FDA Section 524B and other guidelines demand that manufacturers take actions regarding SBOM, coordinated vulnerability disclosure, and cybersecurity throughout the life cycle of the device.
• Innovation safety: Proper security practices allow for adoption of technologies such as AI and connectivity by manufacturers while mitigating introduced risks.

Common Cybersecurity Risks Across Medical Devices and MedTech Systems

Medical devices can be integrated into hospital systems, cloud solutions, mobile apps, and other clinical systems. This enhances medical care provision, but it also opens up various access points to malicious actors. The most frequent threats involve:

1. Ransomware and cyberattacks

Ransomware may cause interruptions in hospitals' network infrastructures and restrict access to their medical devices and clinical systems. The 2025 FBI IC3 Report on Health Care and Public Health Cyber Incidents has registered 642 incidents in this sphere. 460 of these were associated with ransomware, and 182 were breaches.

• Device connectivity can allow ransomware to spread across clinical networks.
• System outages can delay treatments and disrupt hospital operations.

2. Medical device vulnerabilities

Unpatched software, outdated firmware, and weak security controls can leave medical devices open to exploitation.

Some common flaws include:

• Insecure and out-of-date software components
• Weak or insufficient authentication
• Encryption is not strong enough
• Old firmware and operating systems
• Poorly protected device interfaces

3. Unauthorized access

Poor authentication and access management can enable unauthorized access to devices and allow attackers to move across the entire connected health network. 

These controls are crucial:

• Role-based access control (RBAC)
• Multi-factor authentication (MFA)
• Password policies
• Session timeouts
• Least privilege access

4. Data breaches

Medical devices can perform processing and transmission of such information from patients to other hospital networks or applications. Poor API security, inadequate authentication methods, and weak encryption are potential vulnerabilities that attackers can exploit.

5. Third-party and supply-chain risks

Medical device cybersecurity relies on third-party software, libraries, firmware, and cloud services. A single flaw may result in security vulnerabilities for the entire medical device system.

Manufacturers should:

• Keep an accurate Software Bill of Materials (SBOM)
• Identify vulnerabilities in third-party components
• Evaluate security practices of suppliers
• Monitor vulnerabilities in the device’s life cycle
• Specify requirements for updates and security support

6. Attacks on connected systems and APIs

Modern medical devices may communicate through USB, CAN, serial interfaces, Wi-Fi, Bluetooth Low Energy (BLE), radio frequency, cloud platforms, and APIs. Each connection can introduce another potential attack path.

Security testing should therefore assess:

• Device interfaces and communication protocols
• Mobile and web applications
• Cloud back-end infrastructure
• APIs and authentication mechanisms
• Wireless communication
• Data transmitted between devices and external systems

Real-Life Example of a Healthcare Cybersecurity Incident 

On 25 August 2026, McKesson detected unauthorized access to their third-party applications. The company informed the SEC about the incident, saying that data from their Oncology & Multispecialty and Medical-Surgical businesses was compromised.

The attack was reportedly linked to ShinyHunters, which claimed to have taken 1 Terabyte (TB) of data from McKesson’s systems. This reportedly included 284 million raw database records, while the attackers demanded a $55.2 million ransom.

This incident shows how a breach involving third-party software can expose large volumes of sensitive healthcare data and disrupt critical business operations.

Cybersecurity Regulations and Standards Medical Device Manufacturers Need to Follow

How Can MedTech Companies Manage Cybersecurity Throughout the Device Lifecycle?

Medical device cybersecurity needs to be addressed at all stages of the Total Product Lifecycle (TPLC). Each stage requires specific controls to identify vulnerabilities early and reduce security risks over time.

• Design and development: Apply secure-by-design principles, perform threat modelling, reduce unnecessary attack surfaces, and use secure default configurations.
• Testing and validation: Combine SAST, DAST, SCA, fuzz testing, and penetration testing to identify software, authentication, API, and device-level vulnerabilities before release.
• Pre-market preparation: Maintain an accurate Software Bill of Materials (SBOM) and establish a coordinated vulnerability disclosure (CVD) process. Prepare cybersecurity documentation required for regulatory submissions.
• Deployment: Secure the initial device configuration, protect device provisioning, and use network segmentation to separate medical devices from broader enterprise systems.
• Post-market monitoring: Monitor emerging vulnerabilities and threat intelligence, assess newly disclosed CVEs, release security patches, and maintain an incident response and recovery plan.
• End-of-life management: Define clear end-of-support dates and provide migration or replacement guidance.

The Importance of Medical Device Supply Chain Security

Medical devices depend on third-party software, open-source libraries, hardware components, and cloud services. A vulnerability in any of these components can introduce security risks into the final device. 

To reduce supply chain risks, MedTech manufacturers should:

• Conduct cybersecurity due diligence on suppliers.
• Include clear security requirements in vendor RFPs.
• Maintain and regularly update an accurate SBOM.
• Scan third-party and open-source components for vulnerabilities.
• Monitor components throughout the device lifecycle.

A vulnerability in software, firmware, libraries, or cloud services may provide attackers with a pathway into connected clinical environments. Medical IoMT device security therefore requires manufacturers to monitor third-party components, assess newly discovered vulnerabilities, and maintain security throughout the device lifecycle. 

How Medysec Helped Strengthen Healthcare Platform Security: A Case Study 

An AI healthcare platform assists clinics and hospitals with patient communication, scheduling, and follow-ups. This platform analyzes patient information, scheduling information, and communication information using its web application and GCP environment. Since the platform contains patient information of healthcare, there was an increased need for improved security for HIPAA compliance.

Medysec addressed these security requirements through:

• Application and cloud assessment: Assessed the web application, GCP environment, and vulnerability exposure across the platform.
• Vulnerability identification: Uncovered IDOR, broken authentication, sensitive data exposure, cloud misconfigurations, and missing rate limiting.
• HIPAA-focused reporting: Structured findings against HIPAA Security Rule requirements to support compliance documentation.
• Remediation and retesting: Provided practical remediation guidance and independently validated implemented fixes through structured retesting.
• Security assurance: Helped strengthen the platform’s security posture and advance its HIPAA compliance journey with documented security evidence.

Why Prefer Medysec While Maintaining Cybersecurity of a Medical Device

Medysec is a specialized MedTech cybersecurity company. We help medical device manufacturers manage cybersecurity risks beyond initial testing or regulatory clearance, covering vulnerability monitoring, security testing, remediation, and ongoing evidence throughout the device lifecycle.

As one of the medical device cybersecurity companies, we help you with:

• Identify new vulnerabilities: We monitor CVEs, CISA KEV, vendor advisories, security research, and applicable threat intelligence for problems that could impact your device or its parts.
• Prioritize and assess vulnerabilities: We assess affected versions, exploitability, attack vectors, impact on the device, and patient safety impact to prioritize action accordingly.
• Test the entire attack surface: We assess hardware interfaces, firmware, wireless communication, APIs, applications, cloud services, identity management, and connectivity of the device to the cloud.
• Maintain visibility into software: We review and manage your SBOM to assist in identifying vulnerabilities from third-party and open-source software, and their use in the product.
• Validating the mitigation: After fixing a vulnerability, we test your update or compensating control, and re-test the initial vulnerability to prove the fix.
• Keep cybersecurity evidence current: We help maintain risk assessments, threat models, vulnerability records, testing evidence, and other cybersecurity documentation as your device evolves.
• Support postmarket security: For devices already in the field, we can support vulnerability intake, remediation, security updates, disclosure activities, and ongoing cybersecurity management.

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Conclusion

Modern medical devices are becoming interconnected, so cybersecurity is an important factor to consider for ensuring secure and efficient delivery of healthcare. Medical device cybersecurity must be considered during the design, testing, implementation, monitoring, and disposal of devices. This can be achieved through secure design, security testing, management of SBOMs, vulnerability monitoring, and access control.

Meeting applicable regulatory and industry requirements also helps strengthen security across the device lifecycle. A proactive approach protects patient data, supports clinical continuity, and helps ensure medical devices remain safe and resilient as threats evolve.

If you want to secure your medical devices or meet certain regulations, then contact us regarding your cybersecurity needs, or explore our medical device security services.

FAQs

1. Can a medical device be hacked even if it is not connected to the internet?

Yes, attackers can exploit USB ports, wireless interfaces, local networks, removable media, outdated firmware, or other exposed device interfaces to gain unauthorised access.

2. What makes connected medical devices vulnerable to cyberattacks?

Connected devices interact with each other using networks, APIs, clouds, and wireless protocols, making several attack surfaces available to hackers, who exploit their vulnerabilities.

3. Can a cybersecurity attack on a medical device affect patient safety?

Yes. An attack may disrupt availability, cause changes in settings or data, cause delays in treatment, and potentially even impact the clinical decision-making process.

4. How often should medical devices undergo security testing?

Testing should be conducted before release and throughout the life cycle of the device, along with follow-up tests after major modifications have been made to the software or firmware.

5. What should an SBOM contain for a medical device?

SBOM should list the software parts, versions, dependencies, and suppliers to enable the manufacturer to monitor vulnerabilities and security threats.