Medical devices have changed significantly since 1976, when the FDA first began regulating them. The related sciences have progressed, leading the medical device industry away from purely mechanical products and toward technologically advanced, cloud-connected devices. A doctor who wanted to adjust a pacemaker before 2009 had to perform surgery to access the mechanical device within their patient. Today, wireless enabled pacemakers permit healthcare professionals to monitor their patients’ heart rhythms over the internet and make adjustments with external computers.

Cybersecurity has become a critical element of ensuring the overall safety of medical devices, and now the industry is one of the most heavily regulated in the world. In March 2023 Congress granted the FDA authority to enforce cybersecurity regulations in the United States. The strategies organizations adopt for their premarket submissions and postmarket monitoring will now directly affect the likelihood of their medical devices receiving market release approval from the FDA. While various cybersecurity approaches and implementations exist, selecting a holistic offensive security strategy that covers the full lifecycle will be the most effective way manufacturers can ensure their device not only makes it to market, but remains secure into the future.

Applying an offensive security strategy to medical device cybersecurity is about embracing the holistic nature of the technology and the industry. Complying with requirements only takes a manufacturer part of the way to genuine security, because doing the bare minimum will merely check the FDA’s boxes. Read on to learn why manufacturers that instead focus on developing a robust cybersecurity strategy will produce more secure devices and have a more profound impact on patients’ lives while inherently satisfying the FDA’s requirements.

For details on our Internet of Things (IoT) practice’s offensive approach to medical device security, check out the datasheet. Or, if you want to discuss tailoring an offensive security strategy to your organization’s specific needs, reach out to our experts!

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