The digital transformation in the medical device industry has reshaped healthcare. We’ve streamlined our interaction with help professionals, optimized systems and lowered costs. Thanks to digital communication and data-driven medical devices, we can now provide higher-quality healthcare. However, these medical devices are also very vulnerable to cyber attacks. This blog post will provide six tips for managing your medical device cybersecurity risk, from development to regulatory submission.

 #1: Introduce cybersecurity analysis from the start

Cybersecurity risk analysis is an essential process for securing medical devices, and a mandatory step before submitting the device to the regulatory authorities. However, many medical devices only begin to touch upon cybersecurity after completing the software development process.

Cybersecurity risk analysis is interlinked with software development. Conducting the analysis in the end often leads to additional development tasks, which in turn postpones the regulatory submission and review, and the market release. 

Don’t wait. Mitigate risks by design by incorporating cybersecurity analysis in all steps of your software development cycles, from start to finish.

#2: Incorporate an end-to-end cybersecurity approach

The majority of your software development life-cycle processes and documents will be affected from the cyber analysis. Cybersecurity threats should be taken into consideration from software requirements specification (SRS) to software design description (SDD) and to software testing description (STD). Therefore, it’s important to incorporate all of your processes and assets into your cybersecurity plan and analysis, and incorporate cybersecurity into your entire development design and execution.

#3: Add IFU Labeling

User manual and IFU (Instructions For Use) are a regulatory requirement: agencies demand making cybersecurity information accessible to the end user, i.e patients or physicians. Therefore, it’s important to include the types of system controls you incorporated, how the end user is expected to protect the device, what happens if an attack occurs and what the patient should do in such a case.

#4: Run a Cyber Risk Analysis

The goal of the cyber risk analysis is to protect the safety, integrity and availability of your medical device, and to prevent data breaches. First, gather the software requirements and check the required regulations and guidelines. Then, run the following security tests:

  • Penetration tests –  Run penetration tests to get a clear picture of the attack surface, the vulnerabilities, and the threat level of each vulnerability. 
  • Vulnerability scans – You can run these by yourself with online tools. The scanner scans your source code and checks vulnerabilities against third party databases and libraries.

It’s also required to have a post-marketing surveillance plan to make sure that cybersecurity is kept along the entire product life-time and specifically post-development

#5: Prepare for Regulatory Submissions to the CE and FDA

Become familiar with the CE and FDA guidelines and expectations. Some of your attention should also be focused on making your information accessible. Often, agencies send questions or concerns because the information they were looking for was not accessible to them. This postpones the approval – for no reason.

#6: Consult with Cyber and Medical Experts

Cybersecurity compliance for medical devices is not an easy turf. Get help and consultation from experts that are knowledgeable about cyber and medical device technology. These experts are familiar with the regulatory requirements and controls and they will be able to assist in providing the right solution. Technology experts can also help with the best security-focused technological solution.

We’re here to accompany you throughout the entire inception, planning, design, development, testing, integration, deployment, submission, and support of your medical software application. Contact us for more information.