Cyberattacks on medical devices are escalating — targeting patient data, clinical workflows, and even safety-critical functions. Security is no longer optional. Below are six areas every medical device manufacturer must master to stay secure, compliant, and resilient.
1. ISO 9001: Using Quality Systems to Strengthen Security
ISO 9001 isn’t a cybersecurity standard, but it enforces discipline that supports secure development and operations:
- Process control: Ensures cybersecurity tasks (patching, testing, access controls) are consistent and auditable.
- Risk-based thinking: Proactively addresses threats during development and post-market phases.
- Continuous improvement: CAPA and audits help close security gaps revealed in real-world use or internal review.
Action: Embed cybersecurity SOPs into your QMS. Examples: procedures for secure software updates, incident response, third-party code approval. Track security KPIs like “vulnerabilities per release” and “patch lead time.”
2. SOUP: Managing Software of Unknown Provenance
SOUP refers to third-party software components — open-source libraries, proprietary drivers — where you don’t control the code.
Risks include:
- Known CVEs (e.g., Log4j, OpenSSL) may be included unknowingly.
- Vendors may abandon support or updates.
- No guarantee of secure development or patch processes.
Actionable Practices:
- Maintain an inventory: name, version, origin, license, function.
- Use IEC 62304 Section 7.1 to assess SOUP risk and failure modes.
- Monitor CVEs for each component; demand disclosures from vendors.
- Use sandboxing or containerization to isolate risky modules.
- Create a patch policy: severity thresholds and update timelines.
Example: If using a third-party Bluetooth stack, check for vulnerabilities like Sweyntooth CVEs and implement runtime protection.
3. SBOM: Your Blueprint for Software Transparency
A Software Bill of Materials (SBOM) lists all software components in your device — including dependencies, licenses, and versions.
Why SBOMs Matter:
- Match CVEs to specific components for faster remediation.
- Accelerate response to zero-day exploits.
- Required by regulators like FDA and EU MDR.
How to Build and Use SBOMs:
- Use formats like:
- SPDX: Linux Foundation standard.
- CycloneDX: Includes dependency graphs and license metadata.
- Automate with tools like OWASP Dependency-Track or Anchore Grype.
- Generate SBOMs using CI/CD pipelines (e.g., GitHub Actions).
- Archive SBOMs with each software release for audit traceability.
Example: Submit a CycloneDX SBOM to the FDA showing cryptographic libraries and CVE exposure status.
4. Security Facades: Avoiding False Protections
Superficial security measures can create dangerous blind spots. Don’t rely on cosmetic defenses.
Common Facades:
- Obfuscation instead of encryption (easily reversed).
- Hardcoded admin credentials or debug ports.
- Claiming “air-gapped” security while allowing USB/Bluetooth.
How to Detect and Eliminate Them:
- Conduct penetration testing and red teaming.
- Apply threat models like:
- STRIDE: Spoofing, Tampering, Repudiation, Info Disclosure, DoS, Privilege Escalation.
- DREAD: Damage, Reproducibility, Exploitability, Affected Users, Discoverability.
- Design with defense-in-depth: Secure boot, encryption, logging, anomaly detection.
Example: A touchscreen lock doesn’t stop attackers from accessing debug ports and injecting firmware if internal ports are exposed.
5. Embedding Security Across the Lifecycle
Cybersecurity must be designed in from the beginning — not retrofitted after deployment.
| Lifecycle Phase | Cybersecurity Focus |
|---|---|
| Design | Threat modeling, SOUP vetting, SBOM planning |
| Development | Secure coding, automated scanning, CI-based SBOMs |
| Testing | Static/dynamic analysis, penetration testing, SOUP validation |
| Deployment | Secure updates, key management, integrity checks |
| Post-Market | Vulnerability monitoring, coordinated disclosure, patch rollout |
Example: Establish CVE response plans for software components — even years after launch.
6. Regulatory and Standards Alignment
Cybersecurity labeling and documentation is now a legal and regulatory requirement in many regions.
U.S. FDA
- Premarket Guidance (2023 Draft): Requires threat modeling, SBOMs, patchability, secure-by-design systems.
- Postmarket Guidance (2016): Focuses on vulnerability handling, coordinated disclosure, and field updates.
EU MDR / IVDR
- Cybersecurity is treated as a General Safety and Performance Requirement.
Key International Standards
- IEC 81001-5-1: Lifecycle processes for health software cybersecurity.
- IEC 62304: Medical software lifecycle with SOUP controls.
- AAMI TIR57 / TIR97: Risk-based threat modeling frameworks.
Food for Thought
Cybersecurity isn’t a feature — it’s a responsibility.
- Use ISO 9001 to embed secure practices.
- Treat SOUP as a critical supplier, not a black box.
- Automate SBOM creation and integrate into your CI/CD pipeline.
- Eliminate facades; adopt layered, verifiable controls.
Secure medical devices require discipline, foresight, and vigilance — from the first line of code to the last post-market patch.
