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Originally Posted On: https://bluegoatcyber.com/blog/cybersecurity-for-medical-devices-4-ways-to-remain-compliant/

Cybersecurity for Medical Devices: 4 Ways to Remain Compliant

Medical device manufacturers have a long list of requirements to bring a product to market. The mandates from the Food and Drug Administration (FDA) include a variety of provisions. One of those is cybersecurity for medical devices. Since the FDA’s update in 2023, the landscape of approval has changed. These regulations also impact what happens after approval and market launch.

The FDA guidance is complex, as cybersecurity for medical devices involves many dependencies. Here’s a quick, curated list to keep handy when concerned about compliance.

1. Adopt a Secure Product Development Framework (SPDF)

The FDA urges manufacturers to implement SPDF. The agency called it a practical approach to cybersecurity for medical devices. These processes have benefits and help to mitigate vulnerabilities that arise during development.

You can use IEC 81001-5-1 as your guide for this, as it specifically relates to healthcare.

2. Optimize Your Software Bill of Materials (SBOM)

The FDA now requires an SBOM with your premarket submission. You may have already been practicing this, but it’s time to improve it. It must be thorough and accurate, or the FDA will kick it back.

Developing the best SBOM aligns with visibility and transparency. You must know every piece of code that integrates into your devices. Gaps here cause problems downstream. Some things to keep in mind with SBOMs:

• SBOMs should support supply chain security, which is an emerging issue that hackers have been exploiting. An SBOM offers a comprehensive view of all third-party software.
• A product’s lifecycle should begin with an SBOM. Don’t wait until development is well underway to start recording what’s in your device.
• SBOMs are living documents. Update them as needed.
• Medical device cybersecurity firms can help you develop an SBOM that meets FDA rules and delivers benefits for you. Consider working with one.

3. Conduct Premarket Testing That Exceeds the Basics

The FDA also wants you to test your devices before submitting them for approval. In terms of cybersecurity, you can perform pen tests, vulnerability assessments, and threat modeling. Each of these techniques plays a key role in determining the overall security rating of your device.

Medical device vulnerability assessments and pen testing are very unique. You don’t want to engage a general cyber firm to do these. You need a team that has rich experience in the field.

You’re looking for a partner that provides these solutions:

• Abuse and misuse scenario testing to evaluate resiliency
• Robustness and fuzz testing to find coding errors and security gaps
• Attack surface analysis to review all entry points and their risk level
• Vulnerability chaining to look at connections between individual weaknesses
• Software composition analysis (SCA) for generating your SBOM
• Evaluation of static and dynamic code
• Comprehensive pen tests that are customized to your business and needs

Once you have results from these assessments and pen tests, you’ll have an itemized and prioritized list of areas to remediate. As a result, your premarket submission should meet the FDA’s criteria.

Vulnerability and pen tests should be ongoing. You have to monitor devices once they are in use for patching and updates. Your vigilance must be ongoing.

4. Implement Agile Risk Management Strategies

Managing risk stands as a crucial component for FDA cybersecurity for medical devices. You have to identify, assess, and mitigate all risks. Since cyberattacks are always evolving, your risk management approaches need to be agile. If they aren’t, your risk grows.

A great way to achieve this is with hazard analysis techniques. You review all the potential hazards within devices. Then, you can link the best measures to eliminate or minimize them. You’re acting proactively rather than reactively.

You’ll have the most flexible risk management strategies when collaborating with cybersecurity experts. They have insights that will support your vision and keep you abreast of new threats and best practices.

Cybersecurity for Medical Devices: Work with Us to Be Compliant and Secure

We’re medical device cybersecurity experts dedicated to supporting manufacturers in premarket submissions and ongoing monitoring. Partnering with us ensures you stay compliant and more. Let’s talk about how we can help. Request a discovery meeting today.