When you think about cybersecurity, what comes to mind? Passwords, data breaches, maybe even the latest phishing scam? For most people, cybersecurity feels like a digital issue—protecting data and preventing hackers from infiltrating our laptops or smartphones. But in the world of MedTech, cybersecurity takes on a whole new meaning. It’s not just about protecting information; it’s about safeguarding devices that hold life or death in their circuitry.
This week on Inside MedTech Innovation, I had the privilege of speaking with Christopher Gates, a true pioneer in the field of medical device cybersecurity. With over 50 years of experience in engineering, Chris brought an extraordinary depth of knowledge to our discussion about the intersection of operational technology (OT) and cybersecurity.
What Is OT and Why Does It Matter?
If you’re unfamiliar with the term, OT refers to the hardware and software systems that control and monitor physical devices—think insulin pumps, ventilators, and even surgical robots. Unlike IT systems, which manage data, OT systems directly interact with the physical world.
Here’s the catch: when OT systems are vulnerable, it’s not just a data breach we’re worried about. It’s a breach that could shut down a device delivering life-saving medication or performing a critical procedure.
Chris explained this distinction in simple but sobering terms. “In IT, a cyberattack could result in lost data,” he said. “In OT, it can mean lost lives.”
The High Stakes of Healthcare Hacking
During our conversation, Chris shared stories that were both fascinating and terrifying—real-world examples of vulnerabilities in medical devices and the human toll they can take. He talked about a patient whose insulin pump malfunctioned due to unintended interference at DEFCON, a conference where hacking medical devices is part of a controlled learning environment.
It was a wake-up call for everyone involved, demonstrating how easily a device’s security could be compromised and the potentially catastrophic consequences.
But Chris also offered hope. By designing devices with security in mind and embedding cybersecurity into every layer of development, manufacturers can dramatically reduce these risks.
The Role of Regulation and the FDA
One of the most compelling parts of our discussion was about the evolving role of regulation in MedTech cybersecurity. Chris highlighted the FDA’s new guidelines, which require manufacturers to submit comprehensive cybersecurity documentation during the pre-market approval process.
It’s a shift that’s already forcing companies to take cybersecurity more seriously. Chris pointed out that some manufacturers, like Acutis, have faced devastating consequences for ignoring these standards—layoffs, delistings, and ultimately, the inability to bring life-saving devices to market.
As Chris said, “Cybersecurity isn’t just a technical issue; it’s a business issue, a regulatory issue, and, most importantly, an ethical issue.”
Lessons for MedTech Innovators
What struck me most during our conversation was Chris’s unwavering commitment to ethics. He sees cybersecurity as a moral responsibility—a commitment to the patients who trust these devices with their lives.
His advice to manufacturers? Start thinking about cybersecurity from day one. Build it into the DNA of your device. Don’t wait until the FDA forces your hand or until an incident brings your vulnerabilities into the spotlight.
Final Thoughts
Our discussion with Chris Gates reminded me why I started Inside MedTech Innovation in the first place: to shine a light on the people, technologies, and ideas that are shaping the future of healthcare.
Cybersecurity might seem like a daunting challenge, but as Chris showed us, it’s also an incredible opportunity to innovate, protect, and save lives.
If you’re ready to dive deeper into the world of OT, MedTech, and the high-stakes battle for cybersecurity, I invite you to listen to the full episode. Chris’s stories and insights will leave you inspired—and maybe a little more cautious about the devices we rely on every day.
Let me know your thoughts or share your favorite takeaway in the comments.
- Shannon & The Inside MedTech Innovation Team