In the rapidly evolving world of healthcare technology, medical devices have become increasingly interconnected and sophisticated. While these advancements have revolutionized patient care, they have also introduced new cybersecurity risks that cannot be ignored.
This blog post will examine the top 10 most common and dangerous vulnerabilities discovered during real-world medical device penetration testing, providing practical insights and actionable advice for manufacturers, healthcare providers, and cybersecurity professionals.
The Importance of Penetration Testing in MedTech
Penetration testing, or “pen testing,” is a critical process in medical device cybersecurity. It involves simulating the tactics and techniques of malicious actors to identify vulnerabilities before they can be exploited. As Trevor Slattery, the Chief Technology Officer and Director of MedTech Cybersecurity at Blue Goat Cyber, explains:
“Penetration testing is in its essence trying to simulate what a bad hacker is doing before they can do it. If a good guy hacks into a device, they responsibly and ethically tell the manufacturer of the device how they did it so that they can go and fix these problems before it’s in the market. It’s going to lead to a safer product as opposed to waiting for someone with maybe more malicious intentions to find these vulnerabilities first.”
Unlike traditional cybersecurity, which often focuses on data breaches and information disclosure, the stakes are much higher in the medical device industry. As Myles Kellerman, the Director of MedTech Cybersecurity at Blue Goat Cyber, explains:
“If somebody hacks into a defibrillator and shocks you to death, it’s a little bit more severe than your credit card information being stolen. You can recover from your credit card information being stolen, but you can’t recover if you die from being shocked to death, obviously. So, the risk is much greater.”
This unique risk profile requires a specialized approach to cybersecurity, one that blends traditional information security principles with a deep understanding of patient safety and the regulatory landscape of the medical device industry.
The Top 10 Medical Device Vulnerabilities
Based on their extensive experience conducting penetration tests on real-world medical devices, the team at Blue Goat Cyber has identified the top 10 most common and dangerous vulnerabilities. Let’s dive into each one and explore practical examples, industry standards, and mitigation strategies.
1. Hardcoded or Default Credentials
One of the most prevalent vulnerabilities discovered during pen testing is the presence of hardcoded or default credentials in medical devices. As Myles Kellerman explains, this issue is all too common:
“We’ve seen many examples of this. A lot of times where I see it is in static code analysis, we will see these passwords hardcoded in, and then with device access as well when we’re physically testing medical devices, we’ll find that certain menus are using default passwords that can clearly be looked up on the internet or just best guess passwords either using the company name or just as simple as admin admin or password one two three.”
Beyond just default passwords, the team has also encountered issues with BIOS passwords that are either hardcoded or not enabled at all, which can lead to devastating consequences if exploited.
To address this vulnerability, manufacturers should follow industry standards such as IEC 62304 for secure software development and IEC 81001-5-1 for the total product life cycle. These standards emphasize the importance of proper password management, secure coding practices, and continuous monitoring to identify and mitigate emerging threats.
2. Unsecured Communication Channels
Another common vulnerability found in medical devices is the lack of secure communication channels, particularly regarding data encryption. As Myles Kellerman explains:
“We’re looking at data flows that are encrypted. So encryption in transit to protect the patient data if there is any part of that data flow. And so some of the things we see are no encryption at all for the data in transit, and that includes PHI or PII being part of those data flows, or maybe they’re using encryption but it’s maybe a standard that’s no longer supported or has been sunsetted.”
Beyond just the type of encryption used, the team has also encountered issues with poor key management, where the encryption keys are easily discoverable, rendering the encryption useless.
To mitigate this vulnerability, manufacturers should follow the guidance provided by the FDA’s Cybersecurity for Medical Devices initiative, which recommends the use of the latest encryption standards, such as those outlined in FIPS 140-3. Additionally, they should implement robust key management practices to ensure the confidentiality and integrity of sensitive data.
3. Outdated or Vulnerable Third-Party Components
Medical devices often rely on a complex ecosystem of third-party software components, and the failure to properly manage and maintain these components can lead to significant vulnerabilities. As Trevor Slattery explains:
“We’ve already talked about the fact that medical systems have higher risk than other systems just because we’re dealing with patient safety. But moving through regulated industries is much harder than say, you know, I know in the past we’ve talked about the Silicon Valley mindset, move fast and break things. […] But in a regulated industry such as healthcare, there are processes that need to be followed, standards you need to adhere to, documentation requirements and traceability that is just far too commonly missing.”
To address this vulnerability, manufacturers should implement a robust Software Bill of Materials (SBOM) process, which involves continuously monitoring and updating their devices’ third-party components to identify and mitigate emerging threats.
4. Improper Access Control
Weak or improper access control is another common vulnerability found in medical devices, both at the logical and physical levels. As Trevor Slattery explains:
“When we’re looking at access control, that’s the FDA terminology would be authentication. So, how are we determining who is authenticated into different levels of permission, different amounts of information, different levels of access? […] We see this all too often where one user is able to read another user’s information. This can be very dangerous especially if they have PHI involved or one user can say like a general user can access an admin role.”
Myles Kellerman has also encountered issues with web applications, where low-privilege users can access admin functions or bypass authentication mechanisms altogether:
“A lot of times I’ll find that the low-privilege user can use an admin function that it’s not intended to be able to use or even see and then that goes into like information disclosure of patient data even. So it can really get nasty with not having a proper pen test that checks the access controls.”
To address this vulnerability, manufacturers should implement robust authentication and authorization mechanisms, following industry standards such as IEC 80001-1 for risk management in IT networks incorporating medical devices.
5. Debug Interfaces Left Enabled
Medical devices often include debug interfaces, such as UART and JTAG ports, which can be exploited if enabled in production devices. As Trevor Slattery explains:
“JTAG and UART will be a little bit different from say a USB port which is intended to be exposed on the outside. But if we have a JTAG port, UART port, usually that’s going to be on a printed circuit board itself. So that’s deeper in the system. If you need to shred apart the plastic on a device, tear it open to access that port, that’s going to be evidence enough of compromise.”
While these debug interfaces can be useful for maintenance and updates, they must be properly secured or disabled in production devices to prevent unauthorized access and potential exploitation.
Manufacturers should implement controls such as JTAG and UART authentication, as well as tamper-evident seals, to mitigate this vulnerability and ensure the integrity of their medical devices.
6. Missing or Weak Firmware Integrity Checks
Ensuring the integrity of a medical device’s firmware is crucial, as any unauthorized modifications can have severe consequences. As Trevor Slattery explains:
“If someone can flash on their own firmware or modify the existing firmware, it can be extremely dangerous because they can change it to do pretty much anything they want. And this is why we do white box penetration testing to cover these things which would reveal even the type of microcontroller and chipset that a manufacturers’s chosen because certain microcontrollers don’t support secure boot.”
To address this vulnerability, manufacturers should implement secure boot processes and code signing mechanisms, as recommended by the FDA’s Cybersecurity for Medical Devices guidance.
7. Poor Session Management
Weak session management can leave medical devices vulnerable to session hijacking and other attacks. As Myles Kellerman explains:
“Poor session management, the top form that I see a lot would be if the session does not have a timeout period. So for example, if I can I log in, a session’s created for me while I’m logged in and then what happens next is I hit the log off button and then better security would be to have that session invalidated as soon as I hit the logoff button.”
To mitigate this vulnerability, manufacturers should implement robust session management controls, such as session timeouts, session invalidation upon logout, and session activity logging to detect potential session hijacking attempts.
8. Fuzzing Vulnerabilities (Buffer Overflows)
Fuzzing, the process of sending unexpected or malformed inputs to a system, can often reveal vulnerabilities such as buffer overflows. As Trevor Slattery explains:
“Fuzzing is pretty much just taking tons of different bits of input and putting it at a certain field or connection that is meant to receive input. […] And often times there will be a problem where the system does not handle it properly on the back end and this can lead to most commonly a denial of service which is when the system can no longer operate due to receiving unexpected input that causes it to crash and this is often through a buffer overflow.”
While buffer overflow vulnerabilities are becoming less common in modern software, they are still a concern, especially in legacy medical devices that may be using older, memory-unsafe programming languages. Manufacturers should ensure that their devices are designed and implemented with modern, memory-safe coding practices to mitigate this risk.
9. Lack of Tamper Detection
Ensuring the physical and logical integrity of a medical device is crucial, as any unauthorized modifications can have severe consequences. As Trevor Slattery explains:
“If we look at a device where you’re able to just pop it apart, it has, you know, maybe one or two screws and the whole thing falls apart and you can put it back together without anyone noticing. That wouldn’t be great control. But we often recommend that you can put like tamper evidence stickers that need to be signed by a service technician over these panels. So if there the panel is open that sticker would need to be torn or cut and then you have a labeling control saying hey you know before using the device check these stickers make sure they’re intact and if you see that one is broken you assume the device has been compromised and tampered with and you shouldn’t use it.”
In addition to physical tamper detection, manufacturers should also implement robust audit trails and logging mechanisms to detect any unauthorized logical modifications to the device.
10. No Rate Limiting or Automation Controls
The lack of rate limiting or automation controls can leave medical devices vulnerable to brute-force attacks and other automated exploitation attempts. As Trevor Slattery explains:
“Brute forcing attacks are a low-hanging fruit for a lot of hackers. And brute forcing is trying to just use a ton of different passwords against a single login or a single password against a whole bunch of login and trying to see if they can get a match. […] If we see that we can try our phone password 10,000 times and nothing happens, then we can set up an automation, which is what we’re doing in these cases, which does these 10,000 attempts in a matter of seconds.”
To mitigate this vulnerability, manufacturers should implement robust rate limiting and automation controls to prevent brute-force attacks and other automated exploitation attempts.
Secure Product Development Frameworks and DevSecOps
While penetration testing is a valuable tool for identifying vulnerabilities, it is a reactive approach. To truly address the cybersecurity challenges facing the medical device industry, manufacturers should adopt a proactive, holistic approach to secure product development. This includes implementing secure product development frameworks, such as those outlined in IEC 62304 and IEC 81001-5-1, and embracing DevSecOps practices to integrate security throughout the entire product life cycle.
As Christian Espinosa, the CEO and founder of Blue Goat Cyber, emphasizes:
“Penetration testing is more reactive. And unfortunately when we’re called into to do penetration testing, we find a lot of vulnerabilities that often result in a lot of extra effort on the manufacturer to fix them versus if they would have enabled a secure product development framework early on.”
Regulatory Perspective and the Importance of Patient Safety
The medical device industry is heavily regulated, and for good reason. As Trevor Slattery explains:
“The FDA and other regulatory authorities, they don’t want your device to be safe most of the time. They want it to be safe all of the time because the risk is super high. […] There’s very little room for error in a lot of these medical devices and we need to make sure that that’s considered when we’re handling security there.”
Manufacturers must prioritize patient safety above all else, and this requires a comprehensive approach to cybersecurity that goes far beyond checkbox compliance. Every vulnerability uncovered during penetration testing is a reminder that patient lives depend on secure devices, not just functional ones.
At Blue Goat Cyber, we’ve seen firsthand how even small oversights—default passwords, outdated components, weak encryption—can lead to significant risks if left unaddressed. But we’ve also seen the power of proactive security: organizations that embrace penetration testing, implement Secure Product Development Frameworks (SPDFs), and align with global regulatory expectations consistently bring safer, more trusted devices to market.
The path forward is clear: cybersecurity must be woven into the DNA of medical device development, from design through postmarket management. By doing so, manufacturers reduce risk and avoid regulatory delays and strengthen their competitive position in a rapidly evolving MedTech landscape.
The bottom line? Cybersecurity isn’t just about protecting systems—it’s about protecting patients. And when patients can trust the devices that support their care, the entire healthcare ecosystem becomes stronger.
Ready to strengthen your medical device cybersecurity? Contact Blue Goat Cyber today to schedule a penetration test or learn how our experts can help you achieve FDA and global regulatory compliance with confidence.