The FDA's January 2025 guidance on AI-enabled medical devices sets clear expectations for ensuring safety, effectiveness, and security throughout a device's lifecycle. It emphasizes transparency, requiring manufacturers to explain how AI models function, make decisions, and adapt. The guidance also stresses real-world monitoring, risk management, and cybersecurity to prevent vulnerabilities. Given AI’s ability to evolve, manufacturers must implement strict change control processes to ensure updates don’t introduce new risks. This shift reinforces that AI in medical devices isn’t just about innovation—it’s about patient safety, reliability, and regulatory compliance. Early alignment with these expectations will be key to securing approval and building trust in AI-driven healthcare.
About Us
A Mission Born from Expertise & Personal Resolve
Blue Goat Cyber’s story is one of professional expertise and personal transformation. In 2014, Christian Espinosa founded Alpine Security, leveraging his extensive industry experience to help manufacturers secure their products, navigate FDA regulations, and protect patient lives. After selling Alpine in 2020, Christian faced a life-changing health scare that gave him a profound appreciation for the life-saving role of medical devices—and the critical importance of their cybersecurity.
This experience reignited Christian’s passion for safeguarding lives through secure medical technologies. In 2022, he founded Blue Goat Cyber, channeling his expertise and personal resolve into a renewed mission: to protect lives by ensuring the security and trustworthiness of medical devices in an ever-evolving digital landscape.
Since its founding, Blue Goat Cyber has helped clients ranging from innovative startups to large manufacturers, including Intuitive Surgical, bioMérieux, Nova Biomedical, Inogen, and Natera, secure FDA approvals for life-changing devices such as robotic surgery systems, diagnostic tools, and blood analyzers. With a 100% success rate and a commitment to excellence, Blue Goat Cyber has become a trusted partner for medical device manufacturers seeking to navigate regulatory complexities and implement robust cybersecurity measures.
Comprehensive Solutions for Every Phase
Blue Goat Cyber provides full-service medical device cybersecurity support, addressing challenges throughout the premarket and postmarket phases. From managing Software Bill of Materials (SBOM) to conducting threat modeling, penetration testing, and Static Application Security Testing (SAST), we integrate cybersecurity into every stage of your product lifecycle. Our solutions ensure compliance with FDA guidelines, IEC 62304, ISO 14971, and EU MDR/IVDR regulations while safeguarding patient safety and device reliability.
Transparency and Results You Can Trust
We offer a fixed-fee pricing model with unlimited retests until acceptable risk levels are achieved. We guarantee FDA clearance for cybersecurity-related submissions and resolve deficiencies at no additional cost, ensuring a smooth approval process.
A Veteran-Owned Business with a Commitment to Excellence
As a service-disabled veteran-owned business, Blue Goat Cyber brings a unique perspective, discipline, and dedication to protecting lives. Fully aligned with the FDA’s latest eSTAR guidance, our team ensures compliance, patient safety, and a seamless regulatory experience for every client.
Securing the Future of Healthcare
Blue Goat Cyber’s mission is deeply personal. Driven by Christian Espinosa’s experience and unwavering commitment to patient safety, we combine professional expertise with a passion for making a meaningful impact. Let us be your trusted partner in securing the future of healthcare. Schedule a complimentary Discovery Session today to see how we can tailor our solutions to your needs.
Latest Episode of The Med Device Cyber Podcast
Team Core Values
- Think flexibly to solve problems
- Find the opportunity in every situation
- Listen carefully, respond clearly
- Own the problem, find the solution
- Grow beyond your comfort zone
- Obsess over critical details
- Learn fast, learn often
Recent Clients
Why Blue Goat Cyber?
Transparent, Fixed-Fee Pricing with No Surprises
Transparency is at the core of our pricing model. With fixed fees, you’ll never face unexpected charges—giving you clarity and confidence from start to finish.
Proven Expertise and a Decade of Experience
Since 2014, we’ve specialized in medical device cybersecurity. Our founder, Christian Espinosa, brings unmatched expertise from leading Alpine Security and launching Blue Goat to focus exclusively on medical devices.
Hundreds of FDA-Cleared Devices Across All Categories
From startups to major manufacturers like Intuitive Surgical, Inogen, and Natera, we’ve guided hundreds of devices—ranging from diagnostic tools to robotic surgery systems—through successful FDA submissions.
Guaranteed FDA Cybersecurity Clearance
If your submission is rejected for cybersecurity reasons, we’ll fix it at no additional cost. Our 100% success rate means your device gets cleared the first time.
Unlimited Retests Included
Cybersecurity is a process, not a one-time event. We include unlimited retests within our fixed-fee model to ensure your device’s risks are fully mitigated.
A Personal Commitment to Medical Device Security
After a portable Doppler ultrasound saved Christian’s life in 2022, Blue Goat Cyber’s mission became deeply personal: to protect lives by ensuring the safety of life-saving medical devices.
Lifecycle Approach to Device Security
We go beyond premarket submission by offering postmarket surveillance and compliance support to keep your devices secure throughout their lifecycle.
Aligned with FDA Guidance and eSTAR
Our documentation is fully aligned with the latest FDA cybersecurity guidance and eSTAR template, streamlining your submission and reducing delays.
Holistic Cybersecurity Services
We cover every aspect of medical device cybersecurity, from threat modeling and penetration testing to incident response and vulnerability management, ensuring compliance with FDA and EU MDR/IVDR requirements.
Veteran-Owned and Built on Excellence
As a service-disabled veteran-owned business, we bring a sense of discipline, duty, and precision to every project—approaching medical device cybersecurity with the same excellence required in the military.
Team Background
Unparalleled Expertise Tailored to Medical Device Security
At Blue Goat Cyber, we take pride in the exceptional qualifications of our team, which include industry-leading certifications such as:
- CISSP (Certified Information Systems Security Professional)
- CSSLP (Certified Secure Software Life Cycle Professional)
- OSWE (Offensive Security Web Expert)
- OSCP (Offensive Security Certified Professional)
- CRTE (Certified Red Team Expert)
- CBBH (Certified Bug Bounty Hunter)
- CRTL (Certified Red Team Lead)
- CARTP (Certified Azure Red Team Professional)
Our team doesn’t just hold certifications—we bring extensive real-world experience to the table. This includes participation in U.S. government red team operations and military cyber operations, where precision and resilience are paramount. Beyond government work, we’ve conducted extensive commercial cybersecurity assessments across industries, including healthcare, aerospace & defense, education, and finance.
Specialized Expertise in Medical Device Manufacturing
We understand the unique challenges medical device manufacturers face, from ensuring regulatory compliance to addressing the complex security risks associated with connected healthcare systems. Our team has conducted advanced penetration tests and cybersecurity assessments for a wide range of systems, with a focus on medical devices that require:
- Embedded system security testing
- Cloud-based and IoT device evaluations
- Vendor-supplied system audits
Our in-depth knowledge of FDA guidelines and IEC 62304/ISO 14971 standards ensures that our assessments go beyond technical evaluations to provide actionable insights that align with regulatory expectations.
Hands-On, Customized Security Services
Unlike many firms that rely heavily on automated tools, our approach emphasizes manual business logic testing to uncover vulnerabilities that automated scanners often miss. This process allows us to:
- Fully understand the unique workflows and logic of your systems.
- Identify vulnerabilities in application functionality that could compromise security or patient safety.
- Provide tailored recommendations to address risks specific to your device’s lifecycle.
Where Did Blue Goat Come From?
Christian Espinosa chose the name Blue Goat Cyber as a deeply personal reflection of his experiences and values. As an avid mountain climber, Christian has often encountered goats navigating steep, rugged trails with remarkable tenacity and resilience. Their relentless drive to reach the next peak inspired him to create a company that embodies these same qualities—perseverance, determination, and the pursuit of excellence.
The “Blue” represents both Christian’s favorite color and the vivid blue skies he’s seen against snow-covered mountains during his climbs. It symbolizes clarity, trust, and limitless potential—core values that align with Blue Goat Cyber’s mission.
Just as mountain goats overcome obstacles to reach the summit, Blue Goat Cyber is committed to helping medical device manufacturers navigate the challenges of cybersecurity and regulatory compliance. The company reflects Christian’s passion for always striving to reach higher levels of security, trust, and reliability in an ever-evolving digital landscape.
With every step, Blue Goat Cyber brings the focus and determination needed to protect the devices that safeguard lives, guiding its clients to success, no matter how steep the climb.
Founder Background
Christian Espinosa knows the high stakes of medical device manufacturing: the pressure to innovate, meet stringent regulatory standards, and protect patients from evolving cyber threats. As the founder and CEO of Blue Goat Cyber, Christian has made it his mission to empower manufacturers to secure their devices and build trust in an ever-changing digital world.
Christian’s journey to becoming a leader in medical device cybersecurity is both personal and professional. He built and sold Alpine Security, a successful cybersecurity company, and then founded Blue Goat Cyber to focus exclusively on the unique challenges of securing life-saving medical devices. After a health scare in 2022, when a portable Doppler ultrasound helped save his life, Christian’s commitment to protecting patients through secure medical technologies became deeply personal.
With decades of experience in cybersecurity, Christian has helped medical device manufacturers—from innovative startups to industry leaders—successfully navigate regulatory complexities, address emerging cyber threats, and ensure patient safety. Under his leadership, Blue Goat Cyber has achieved a 100% success rate in FDA cybersecurity submissions, securing hundreds of devices, from diagnostic tools to robotic surgery systems.
Christian’s extensive background includes serving as a Veteran and white hat hacker, participating in U.S. government red team operations, and developing expertise in offensive and defensive cybersecurity strategies. These experiences enable him to guide manufacturers with precision and clarity, ensuring their devices are secure, compliant, and ready to meet market demands.
Beyond his professional achievements, Christian is an adventurer and problem-solver at heart. Whether scaling two of the Seven Summits, completing 24 Ironman triathlons, or skydiving as a C-License holder, he exemplifies discipline, resilience, and a drive to overcome challenges—qualities he brings to solving the toughest cybersecurity problems for his clients.
At Blue Goat Cyber, Christian and his team are committed to simplifying cybersecurity for medical device manufacturers. They provide expert guidance to help you protect patients, achieve compliance, and build devices that inspire trust. Christian’s vision is to create a future where every medical device is secure, trusted, and enhances lives without compromise.
If you’re ready to secure your devices and protect what matters most, Christian Espinosa and Blue Goat Cyber are here to guide you. Schedule a complimentary Discovery Session today to see how we can help you navigate the complexities of medical device cybersecurity with confidence.
Blue Goat Cyber's History
Over 10 Years Experience in MedTech Cybersecurity
Today, Blue Goat Cyber is the trusted cybersecurity partner for MedTech manufacturers, providing comprehensive cybersecurity solutions that ensure devices are secure, compliant, and resilient against cyber threats. With a deep focus on FDA, EU MDR, and global security requirements, the company helps manufacturers integrate security early in development, avoid costly delays, and maintain postmarket protection for their devices.
Following the success of the podcast, Blue Goat Cyber introduced The Medical Device Cybersecurity Webinar Series to provide deeper, more technical insights into penetration testing, SBOM management, threat modeling, and postmarket security. Featuring industry experts, regulatory specialists, and real-world case studies, the series equips MedTech companies with the knowledge they need to proactively address cybersecurity challenges and maintain compliance.
https://www.youtube.com/watch?v=Q2cjmH0BrGo&list=PLWQj_E9ypCcQjgB33rXMQ33mUQ0BMPdh6&pp=gAQBiAQB
To further educate MedTech innovators, security professionals, and regulatory experts, Blue Goat Cyber launched The Med Device Cyber Podcast. The podcast covers real-world cybersecurity threats, FDA regulations, and best practices for securing medical devices. Whether listeners are MedTech professionals, cybersecurity experts, or simply individuals concerned about device security, the podcast provides practical insights to help navigate the evolving threat landscape.
https://www.youtube.com/watch?v=e1qwvYMg25U&list=PLWQj_E9ypCcTB1m-s4920VYxm1xNHraBW&pp=gAQBiAQBmAUB
Christian officially launched Blue Goat Cyber in July 2022 while living in Pocatello, Idaho, with the mission of helping MedTech manufacturers secure their devices from development through postmarket management. His experience as a cybersecurity expert, entrepreneur, and blood clot survivor shaped the company’s focus: cybersecurity in MedTech isn’t just about compliance—it’s about protecting patient safety and ensuring that life-saving devices can function without cyber threats. Blue Goat Cyber was built to provide end-to-end cybersecurity solutions, including premarket security testing, FDA submission support, SBOM management, penetration testing, and postmarket cybersecurity monitoring.
While leading cybersecurity initiatives at CISO Global, Christian saw that MedTech companies were not getting the dedicated expertise they needed to meet FDA, EU MDR, and global security requirements. Larger cybersecurity firms weren’t structured to provide the specialized, regulatory-driven security guidance that medical device manufacturers required. Rather than trying to fit MedTech security into a general cybersecurity framework, he decided to spin off a focused division to fully dedicate himself to securing life-saving medical technology.
Christian’s decision to focus exclusively on medical device cybersecurity became personal when a portable Doppler ultrasound helped diagnose his life-threatening blood clots. This experience underscored the critical role of medical technology in saving lives—and the risk that cyber vulnerabilities could compromise these very devices. At the same time, he saw firsthand how MedTech manufacturers struggled with evolving regulatory requirements and security challenges. This realization reinforced the need for a cybersecurity firm solely dedicated to protecting medical devices.
Christian published The Smartest Person in the Room to address a common issue he observed in cybersecurity: highly intelligent professionals struggling with communication, leadership, and collaboration. His experience leading Alpine Security reinforced that cybersecurity wasn’t just about technical skills—it required emotional intelligence and teamwork to drive real change. The book became a blueprint for technical professionals looking to enhance their leadership abilities and maximize their impact.
Christian sold Alpine Security to Cerberus Sentinel after successfully building it into a trusted cybersecurity firm known for its technical excellence. The acquisition allowed Alpine’s team and services to integrate into a larger cybersecurity platform while enabling Christian to focus on leadership development and industry transformation. He remained with Cerberus Sentinel for a period before realizing that MedTech cybersecurity required a dedicated and specialized approach.
Recognizing the unique cybersecurity challenges in the medical device industry, Alpine Security launched a dedicated MedTech cybersecurity division to help manufacturers meet FDA and global regulatory requirements while securing their devices against cyber threats. This division provided specialized services such as penetration testing, threat modeling, and compliance support. It was one of the earliest dedicated efforts to address cybersecurity risks in medical technology and laid the groundwork for what would eventually become Blue Goat Cyber.
Christian Espinosa founded Alpine Security to expand his impact beyond freelance cybersecurity work and build a company that could provide scalable, high-quality security solutions. He recognized that true cybersecurity resilience required more than technical expertise—it needed a structured, team-driven approach to penetration testing, incident response, and cybersecurity training. Alpine Security quickly gained recognition for its hands-on methodology and focus on educating both organizations and security professionals, leading to its acquisition in 2020.
