How Medical Device Manufacturers Can Create a Cyber

Medical device manufacturers must navigate a host of threats and regulations to ensure approval and continuous compliance. The latest Food & Drug Administration (FDA) cybersecurity guidance offers a variety of strategies and best practices focused on the logistics of keeping devices secure.

What the publication may not touch on enough is creating a cyber-first culture. Doing so can improve the depth of your premarket submission and your ability to detect and address vulnerabilities.

So what does a cyber-first culture mean, and how can you implement it?

Key Takeaways

• Prioritize cybersecurity in all operational aspects.
• Go beyond technical compliance for better security.
• Integrate security practices into all workflows.
• Foster collaboration for stronger cybersecurity.
• Maintain cyber resilience to ensure continuous operation.
• Perform regular penetration testing and vulnerability assessments.

Table of Contents

• Key Takeaways
• What Is a Cyber-First Culture?
• How Does a Medical Device Manufacturer Establish a Security-First Culture?
• Is Cybersecurity a Strategic Business Priority for Your Organization?

Why this matters

The FDA's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Feb 3, 2026 final guidance) made cybersecurity documentation a gating criterion for clearance under Section 524B of the FD&C Act. Reviewers now apply this guidance to how medical device manufacturers can create a cyber-first culture the same way they apply software lifecycle expectations from IEC 62304 and security risk-management expectations from AAMI TIR57 and ANSI/AAMI SW96:2023.

Gaps in this area are the single most common driver of first-cycle cybersecurity Additional Information (AI) requests. The FDA's FY2024 CDRH performance reports show cybersecurity is among the top deficiency categories cited in 510(k) and PMA AI letters, behind only software documentation and clinical evidence. Treating it as a checklist exercise rather than a design-controlled engineering artifact is what creates the gap.

What Is a Cyber-First Culture?

A cyber-first culture exceeds the technical solutions that drive compliance and security. This approach prioritizes cybersecurity in all aspects of operations. It involves all the best practices to prevent cyber-attacks and the continuous improvement of those tactics.

A cyber-first culture contains specific attributes, including:

• Protecting sensitive information
• Mitigating risks
• Integrating security practices into workflows
• Fostering collaboration with other stakeholders to strengthen cybersecurity within the entire industry

How Does a Medical Device Manufacturer Establish a Security-First Culture?

It starts by following the FDA guidance on medical device cybersecurity, including:

• Developing and maintaining a software bill of materials (SBOM)
• Creating a plan to locate threats, resolve them, and push updates to the software
• Embracing secure by design with frameworks like ANSI/AAMI SW96
• Instituting security across the entire lifecycle of a device

These principles are the anchor of a security-first culture. There’s more to it than controls, checks, and balances.

Cyber Resilience Is the Heart of a Security-First Culture

Cyber resilience is an umbrella term. In short, it’s a company’s ability to keep operating should a cyber incident occur. It involves robust backup and data recovery processes. True redundancy is one of the best tools against ransomware.

Technical measures provide the foundation, but strong governance and a culture of cybersecurity awareness are also essential. Key to this is shared responsibility, both internally and externally.

In medical device development, lots of people work across platforms, share data, and connect often. Building your cyber barriers early translates to less overall risk in testing and deployment.

For awareness, your organization probably has standard cybersecurity training. That’s a start, but making it part of a culture requires more. What’s necessary includes crafting internal policies that promote secure behavior and clear communication of these expectations.

Proactive Cybersecurity Supports a Cyber-First Culture

Two other ways to achieve a cyber-first culture are through proactive measures. The two most important are penetration testing and vulnerability assessments.

Pen testing should be ongoing and cover the lifecycle of the technology. You’ll need a partner that specializes in medical device penetration testing. It’s a niche part of the cyber devices realm, so you need experts.

See also: Cybersecurity Before MVP vs After Market Fit: What It Actually Costs to Wait, Why Your Medical Device Go-to, and Managing Connected Medical Devices: A Strategic Approach.

Vulnerability assessments take stock of all your technology assets. The objective is to identify missing patches and misconfigurations that hackers could exploit. Performing these regularly and remediating vulnerabilities is critical once devices are in use.

Is Cybersecurity a Strategic Business Priority for Your Organization?

The mission of building secure devices and deploying them to the field with layers of protection can be a strategic priority. Elevating it means it goes beyond developers, architects, and other cyber experts. It’s the responsibility of every person in your company.

With this level of importance, security policies can combine with innovation from the start. With this position, you’re also not spending additional time, money, and resources on addressing security flaws late.

No matter your status in achieving a cyber-first culture, our team can help. We’ll work with you to build a strategy, improve security awareness, reduce threats, and remain compliant.

Get started with a no-cost consultation.

Related Articles in This Series

• Where Did 2600 Come From? What It Teaches About Medical Device Cyber Risk
• What Is the Electronic Frontier Foundation (EFF)? Why It Matters for Medical Device Cybersecurity
• Debunking Device Cloning Myths: What Medical Device Manufacturers Need to Know
• WAFs vs. Reverse Proxies: What Medical Device Manufacturers Need to Know
• Cybersecurity Concerns with HL7
• 7 Software Testing Principles for Medical Devices

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How Blue Goat approaches this

Blue Goat Cyber's medical device practice is led by engineers with CISSP, OSCP, and prior military red-team backgrounds. We treat cybersecurity documentation as design-controlled engineering output, not a submission template, every artifact (threat model, SBOM, security risk assessment, penetration test, labeling) traces back to a controlled requirement and a verified result.

Our engagements deliver the full Feb 3, 2026 guidance documentation set scoped to the device's risk profile, integrated with the existing IEC 62304 software lifecycle and ISO 14971 risk file. See our medical device cybersecurity services for the full scope. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost.

FAQ

What does a cyber-first culture mean for medical device manufacturers?

A cyber-first culture means prioritizing cybersecurity across all aspects of medical device operations, from initial design to post-market surveillance. It involves integrating security practices, fostering collaboration, and continuously improving threat detection and vulnerability management.

How does a cyber-first culture relate to the FDA's cybersecurity guidance?

A cyber-first culture supports and extends the FDA's cybersecurity guidance (February 3, 2026 final guidance) by Ensure cybersecurity principles are embedded proactively throughout the total product lifecycle, rather than being treated as an afterthought or mere compliance task.

Why is cyber resilience important in a cyber-first culture?

Cyber resilience is vital because it ensures medical device manufacturers can continue operations even during a cyber incident. This includes strong backup, data recovery processes, and strong governance to minimize disruption and protect patient safety.

Does the FDA require a cyber-first culture for medical devices?

While the FDA's February 3, 2026 final guidance does not explicitly use the term "cyber-first culture," its emphasis on secure by design, SBOMs, and post-market vulnerability management implicitly encourages such an approach for medical device security.

How can medical device manufacturers assess their cybersecurity posture?

Medical device manufacturers can assess their cybersecurity posture through regular penetration testing by specialized experts and complete vulnerability assessments to identify missing patches, misconfigurations, and potential exploit points.

What role does employee training play in a cyber-first culture?

Employee training is crucial because cybersecurity is a shared responsibility. Crafting internal policies that promote secure behavior and clearly communicating these expectations ensure all personnel contribute to maintaining a secure environment.

About the author

Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance. Read more about Christian.