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?
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.
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.