Passwords remain one of the most common forms of authentication—and one of the most exploited. In the healthcare ecosystem, where medical devices increasingly connect to hospital networks, cloud platforms, and other devices, weak or predictable passwords can create serious risks.
The FDA’s 2025 Cybersecurity in Medical Devices Guidance emphasizes authentication and access control as required security controls. Manufacturers must be able to demonstrate that their devices can resist brute-force and dictionary-based attacks as part of their premarket submissions.
One of the most effective ways to validate password security is through the use of password wordlists. At Blue Goat Cyber, we apply this method responsibly, helping medical device manufacturers strengthen authentication, reduce risk, and align with FDA expectations.
What is a Password Wordlist?
A password wordlist is a curated file containing thousands—or millions—of potential passwords. Hackers use wordlists in brute-force or dictionary attacks, where automated tools attempt password after password until one succeeds.
However, wordlists are used defensively in cybersecurity testing. Security experts employ them during penetration testing to evaluate how well an authentication system can withstand real-world attack scenarios.
This type of testing is critical for medical device manufacturers. The FDA’s guidance requires authentication to be robust, tested, and documented within a Secure Product Development Framework (SPDF). Demonstrating that devices can withstand password-based attacks strengthens both device safety and regulatory compliance.
Why Password Security Matters for Medical Devices
Password security in medical devices is not just about protecting data—it’s about protecting patients. Weak authentication can lead to:
- Patient safety risks if devices are disabled, delayed, or manipulated.
- Regulatory noncompliance if authentication controls fail to meet FDA requirements.
- Operational disruption across hospitals or networks if attackers gain access.
Weak or hardcoded default passwords have been repeatedly linked to medical device recalls and FDA safety communications. Proactive testing with wordlists allows manufacturers to identify and correct these issues before devices reach patients.
FDA-Cited Authentication Failures
The FDA has documented multiple cases where authentication weaknesses created security vulnerabilities in medical devices. These included:
- Hardcoded default passwords that users could not change, leaving devices permanently exposed once discovered.
- Easily guessable credentials such as “admin/admin,” which attackers could exploit through brute-force attempts.
- Unsecured remote access accounts protected only by static passwords, granting attackers elevated privileges if compromised.
In each case, the root problem was inadequate authentication. The FDA’s 2025 Cybersecurity Guidance now directly addresses these issues by requiring manufacturers to demonstrate that devices:
- Do not rely on weak or unchangeable default credentials.
- Can resist brute-force and dictionary-based attacks.
- Have secure processes for updating and patching if authentication vulnerabilities are discovered postmarket.
By addressing these risks upfront, manufacturers can reduce the likelihood of recalls, regulatory scrutiny, and patient harm.
FDA Cybersecurity Requirements for Authentication
Under Section 524B of the FD&C Act, cyber devices must meet clear cybersecurity requirements. For authentication, manufacturers are expected to:
- Ensure only authorized users can access critical device functions.
- Avoid default or easily guessed passwords in both development and deployment.
- Demonstrate resilience to common attack methods, including brute-force attempts that rely on password wordlists.
These expectations mean that strong authentication is not simply a best practice—it is now a regulatory obligation.
Creating Effective Password Wordlists for Testing
When used responsibly, password wordlists are powerful tools for improving device security. An effective wordlist should:
- Contain common weak passwords (e.g., “123456,” “password,” or vendor defaults).
- Reflect healthcare-specific terms an attacker might guess, such as device names, drug names, or manufacturer abbreviations.
- Include variations and complexity (capitalization, numbers, symbols) that mimic real-world user behavior.
- Be targeted in scope, since a well-curated list is often more effective than an excessively large one.
Many practitioners also test with freely available, community-curated lists to simulate real-world attacks. A commonly referenced example is rockyou.txt, a widely used historical password list that is useful for simulating password-guessing attacks in defensive testing. If you use public lists like rockyou, do so only in an authorized test environment and under a controlled scope (see caution below). weakpass.com
Important caution: Public wordlists (including rockyou.txt) are dual-use — they are used by both defenders and attackers. Never use them against systems you do not own or do not have explicit, written permission to test. Misuse can be illegal and unethical.
At Blue Goat Cyber, we create and use customized wordlists during penetration testing that reflect the realistic threats medical devices face in hospitals, clinics, and remote monitoring environments.
Integrating Password Security into the Secure Product Development Framework (SPDF)
The FDA encourages manufacturers to adopt a Secure Product Development Framework (SPDF) to embed security throughout the device lifecycle. Password security fits into this framework at multiple stages:
- Design Phase – Define authentication requirements and eliminate weak defaults.
- Development Phase – Test authentication strength using wordlists as part of validation.
- Premarket Submission – Provide evidence to the FDA that devices resist brute-force attempts.
- Postmarket Phase – Monitor emerging password vulnerabilities and ensure devices can be patched securely.
By incorporating password security into SPDF processes, manufacturers can create devices that are secure by design and easier to defend over their full lifecycle.
How Blue Goat Cyber Helps Manufacturers
At Blue Goat Cyber, we specialize in aligning practical cybersecurity measures with FDA regulatory requirements. Our support includes:
- Penetration testing with tailored password wordlists.
- Regulatory mapping of test results to FDA submission requirements.
- Risk management guidance for postmarket monitoring and updates.
- SPDF consulting to ensure authentication and other security measures are embedded in device design.
This approach not only helps manufacturers secure their products but also provides the documentation and evidence needed for FDA approval.
Key Takeaways
Password wordlists are an essential tool for testing authentication strength in medical devices. The FDA has made it clear that:
- Authentication must be robust and validated against real-world attacks.
- Past recalls have shown the dangers of weak and default passwords.
- Testing against brute-force and dictionary attacks supports both safety and compliance.
By partnering with Blue Goat Cyber, manufacturers gain both technical resilience and regulatory readiness—ensuring devices are secure for patients and ready for FDA review.
Call to Action
Is your medical device ready for FDA cybersecurity scrutiny? Don’t leave authentication to chance.
Contact Blue Goat Cyber today to strengthen your device security and ensure FDA compliance.
Wordlists and Password Cracking FAQs
Wordlists are collections of words, phrases, common passwords, and other strings of characters that are used in penetration testing and cybersecurity assessments to simulate attacks on systems. These lists are crucial for conducting brute-force attacks or dictionary attacks against passwords, usernames, and other security parameters to identify weak points in a system's security. By using wordlists, penetration testers can effectively mimic the techniques employed by hackers to test the resilience of systems against real-world attacks, helping to enhance the security posture of organizations by identifying and mitigating vulnerabilities.
Wordlists are created by compiling commonly used passwords, technical terms, names, and other relevant strings that might be used as credentials or keys. This compilation can be derived from various sources, including public data breaches, password dumps, social engineering, and linguistic research. Maintenance involves regular updates to incorporate new findings from recent data breaches, cybersecurity research, and changes in user behavior patterns. This ensures that the wordlists remain effective tools for penetration testing and security assessments, reflecting the evolving landscape of cybersecurity threats.
Yes, custom wordlists can be significantly more effective than generic ones, especially when they are tailored to the target environment or organization. Custom wordlists take into consideration the specific language, terminologies, and patterns used within an organization or industry. This might include technical jargon, acronyms, and conventions in password creation specific to the target's culture or operational context. By focusing on likely word combinations and terms, custom wordlists can reduce the time required to identify vulnerabilities and increase the success rate of penetration testing efforts.
The use of wordlists in penetration testing involves several ethical considerations, primarily centered around permission and intent. It is crucial that penetration tests, including those utilizing wordlists for brute-force or dictionary attacks, are conducted only with explicit authorization from the entity owning the systems being tested. This ensures that testing activities are legal and ethically sound. Moreover, the intent behind using wordlists should be to improve security, not to exploit vulnerabilities for malicious gain. Ethical testers must also ensure that any sensitive information uncovered during testing is handled responsibly, with measures in place to protect the privacy and security of the affected parties.
Password cracking is the process of attempting to gain unauthorized access to restricted systems by guessing or decrypting a user's password. This process can be performed through various methods, including brute force attacks, dictionary attacks, and exploiting system vulnerabilities.
Cybersecurity professionals study password cracking techniques to understand potential vulnerabilities within their systems and to develop stronger defense mechanisms against unauthorized access. It helps in conducting security assessments and penetration testing to ensure the robustness of password policies and authentication methods.
Several tools are utilized in password cracking, each designed for specific types of attacks. Popular ones include John the Ripper, Hashcat, Hydra, Aircrack-ng, and RainbowCrack. These tools vary in their approach, efficiency, and the types of encryption they can target.
Password cracking is considered illegal when performed without explicit permission as part of a malicious act to gain unauthorized access to data or systems. However, it's a legitimate practice in ethical hacking, cybersecurity assessments, and penetration testing, with the aim of improving security.
To protect against password cracking, it's essential to use strong, complex passwords that are difficult to guess or brute-force. Implementing multi-factor authentication, using password managers, and regularly updating passwords also significantly reduce the risk.
A brute force attack is a method where an attacker tries every possible combination of characters until the correct password is found. It's a straightforward approach that can be time-consuming and is less effective against strong passwords.
A dictionary attack uses a list of common passwords and phrases (the dictionary) to guess a user's password. It's faster than brute force but less effective against passwords not included in the dictionary.
Password complexity significantly impacts cracking efforts. Complex passwords that include a mix of uppercase and lowercase letters, numbers, and special characters take much longer to crack due to the increased number of possible combinations.
While 2FA doesn't prevent password cracking itself, it adds an additional layer of security, making unauthorized access much more difficult even if a password is compromised. It's a highly recommended security measure.
The future of password cracking and security involves advancing encryption technologies, biometric authentication methods, and AI-driven security protocols. However, as security measures evolve, so do cracking techniques, making ongoing research and adaptation crucial in cybersecurity.