Strengthening Medical Device Cybersecurity: Key Takeaways from Our Latest Webinar

The cybersecurity landscape for medical devices is evolving at a pace that most organizations struggle to keep up with. New FDA expectations, rapidly shifting threat vectors, and increasingly connected ecosystems mean manufacturers must rethink how they manage cybersecurity across the full product lifecycle.

During our recent PulseForward webinar, “Building a Cyber-Ready Development Lifecycle,” we explored the most pressing cybersecurity challenges facing device manufacturers today – and the practical steps teams can take to build resilient, compliant, and scalable programs.

Below are the biggest insights, themes, and actions our audience took away.

1. Cybersecurity Is Now a Core Design Requirement

One of the strongest messages during the discussion: cybersecurity can no longer be bolted on at the end of development.

Manufacturers must treat security as a fundamental design constraint, beginning at concept development and continuing through release and post-market monitoring. Attendees learned how threat modeling, secure architecture reviews, and requirements mapping reduce downstream failures and prevent costly rework.

2. FDA Expectations Are Becoming More Prescriptive

The FDA’s recent cybersecurity updates are reshaping how organizations document, validate, and maintain security controls.In the webinar, we broke down:

• Software Bill of Materials (SBOM) expectations

• Cybersecurity risk management alignment with ISO 14971

• Evidence requirements for premarket submissions

• Post-market monitoring and PSUR integration

For many teams, the challenge isn't understanding the regulations—it’s building repeatable workflows to meet them every time.

3. Threat Modeling Is the Most Undervalued Tool

Participants were especially interested in our step-by-step review of medical device threat modeling.

We emphasized that a good threat model:

• Identifies misuse scenarios early

• Guides secure design decisions

• Links directly to risk controls and testing

• Simplifies evidence packages for regulators

Teams that invest in this early step see measurable improvements in testing efficiency and documentation clarity.

4. Verification & Test Automation Reduce Security Gaps

As device software grows more complex, manual testing alone cannot ensure proper coverage.Our speakers demonstrated how automated test frameworks:

• Validate controls consistently

• Catch regressions early

• Accelerate release cycles

• Strengthen cybersecurity evidence

Several attendees noted plans to incorporate automated security testing into their 2025–2026 roadmaps.

5. Cybersecurity Must Continue After the Product Ships

Cyber threats evolve long after a device enters the field.We reviewed the operational components of a closed-loop cybersecurity program:

• Vulnerability monitoring

• SBOM change management

• Patch planning and communication

• CAPA integration

• Incident response readiness

Companies that succeed in post-market security treat it as a structured operational function—not an ad-hoc reaction.

6. How PulseForward Helps Teams Build Cyber-Ready Systems

As we wrapped the session, we highlighted how PulseForward supports clients across regulatory, engineering, and operational cybersecurity:

• Cybersecurity Threat Modeling

• Secure Architecture & System Requirements

• Risk Assessment & Preliminary Hazard Analysis

• IEC 62304 & 60601 Compliance Support

• Verification Planning & Test Automation

• SBOM Management

• Post-Market Surveillance & CAPA Integration

Our goal is simple: help teams accelerate innovation while building devices that are secure, safe, and compliant from day one.

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Let’s Build Your Cybersecurity Roadmap

If your team needs support developing or improving your cybersecurity processes, our experts are here to help.PulseForward offers structured assessments, hands-on engineering support, and implementation consulting tailored to the medical device lifecycle.

Reach out anytime to schedule a conversation.

PulseForward — building safer, stronger, more resilient devices.