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Blue Goat Cyber’s origin story combines professional expertise and personal resolve. Christian Espinosa founded Alpine Security in 2014 as an industry veteran, helping manufacturers secure their products to meet FDA regulations and protect patients. In 2020, Christian sold Alpine, but two years later, a severe health scare gave him a newfound appreciation of the life-saving role of medical devices and the critical importance of their cybersecurity. This experience reignited his passion for the field and drove him to spin off the medical device security focus from Alpine, founding Blue Goat Cyber in 2022. With a renewed mission, Blue Goat Cyber specializes in helping manufacturers navigate regulatory complexities and implement robust cybersecurity measures to protect both their devices and the patients who rely on them, blending Christian’s deep expertise with a personal commitment to safeguarding lives.
Since then, Blue Goat Cyber, along with Christian’s previous work through Alpine, has helped hundreds of clients, including Intuitive Surgical, bioMérieux, and Nova Biomedical, receive FDA approval for hundreds of medical devices, from diagnostic tools to robotic surgery systems and blood analyzers. Blue Goat Cyber specializes in navigating regulatory complexities and implementing robust cybersecurity measures, ensuring device security and patient safety. With Christian’s deep expertise and personal commitment, Blue Goat Cyber is dedicated to elevating medical device security to the highest standards.
We provide full-service medical device cybersecurity services to address the unique cybersecurity challenges medical device manufacturers face throughout the pre-market and post-market phases. Our comprehensive offerings include Software Bill of Materials (SBOM) management, where we help create and maintain detailed documentation of all software components, including third-party and open-source elements, to identify vulnerabilities and ensure compliance. We also specialize in threat modeling, systematically identifying potential threats during the design phase and updating models post-market to address new risks. Our Static Application Security Testing (SAST) services ensure secure coding practices by identifying vulnerabilities early in development and continuously testing updates and patches post-market to prevent new issues. Additionally, our penetration testing rigorously simulates real-world attack scenarios to uncover pre-market development weaknesses and verify deployed devices’ resilience post-market. By integrating these services into your device lifecycle, we ensure compliance with FDA guidelines, IEC 62304, ISO 14971, and EU MDR/IVDR regulations while safeguarding patient safety and device reliability. Let Blue Goat Cyber be your trusted partner in securing the future of healthcare. Schedule a complimentary Discovery Session today to explore how we can tailor our solutions to your needs.
Our fixed-fee pricing model ensures transparency, with unlimited retests included until acceptable risk levels are achieved. Additionally, we guarantee FDA clearance for submissions related to cybersecurity—if any deficiencies arise, we resolve them at no additional cost.
As a service-disabled veteran-owned business, we bring a unique perspective and dedication to medical device security. Blue Goat Cyber has a 100% success rate, with all submissions cleared on the first attempt. Our processes are fully aligned with the FDA’s latest eSTAR guidance, ensuring regulatory compliance and patient safety.
Blue Goat Cyber is committed to making a meaningful impact in medical device cybersecurity. We combine professional expertise with a personal commitment to safeguarding lives.
1. Fixed-Fee Pricing with No Surprises
Transparency is at the core of our pricing model. We offer fixed-fee pricing, ensuring you’ll never encounter unexpected charges. You know exactly what you’re paying for from the beginning to the end of the process.
2. A Decade of Experience in Medical Device Cybersecurity
Since 2014, we’ve been dedicated to the cybersecurity of medical devices. Christian Espinosa, Blue Goat Cyber’s founder, led Alpine Security before selling it in 2020 and launching Blue Goat to focus exclusively on medical device cybersecurity. This strategic shift allowed us to build a highly specialized team with unmatched expertise in this niche.
3. Hundreds of FDA-Cleared Devices Across All Categories
Our experience spans nearly every type of medical device, from simple tools to complex software-driven systems. We’ve successfully guided hundreds of devices through the FDA’s premarket submission process, ensuring that every submission meets the stringent cybersecurity requirements outlined in FDA guidelines.
4. Expertise in Resolving FDA Deficiency Reports
Manufacturers often come to us after receiving deficiency reports from the FDA, struggling with cybersecurity issues in their submissions. We’ve worked with countless clients to resolve these issues, giving us insider knowledge of FDA expectations.
5. A Personal Commitment to Medical Device Security
Our commitment to this field is more than professional—it’s personal. In 2022, Christian Espinosa’s life was saved by a portable Doppler ultrasound device that quickly diagnosed life-threatening blood clots. This experience was a powerful reminder of the importance of medical device technology, inspiring Christian to dedicate his expertise to making these devices safer for everyone. Our mission is to protect lives by securing the devices that matter most.
6. Unlimited Retests Included
We believe that cybersecurity is a process, not a one-time event. That’s why we offer unlimited retests within our fixed-fee structure. We work until your device’s cybersecurity risks are mitigated to an acceptable level, ensuring your product is fully prepared for the market.
7. Guaranteed FDA Submission Clearance
We are so confident in our expertise that we offer a guaranteed FDA submission clearance. If your submission is rejected due to a cybersecurity issue, we’ll address the deficiency at no extra cost—until your device gets the green light from the FDA.
8. 100% Success Rate with FDA Cybersecurity Submissions
Our track record speaks for itself: we have a 100% success rate in FDA submissions. Not a single submission prepared by our team has been kicked back for cybersecurity reasons, reflecting our attention to detail and in-depth understanding of FDA requirements.
9. Service-Disabled Veteran-Owned Business
We are proud to be a service-disabled veteran-owned business. Christian Espinosa’s military background instills a sense of duty, discipline, and precision in everything we do. We approach medical device cybersecurity with the same commitment and excellence required in the military.
10. Full Alignment with eSTAR and FDA Guidance
Our documentation and processes are fully aligned with the latest FDA cybersecurity guidance and eSTAR, the FDA’s electronic submission template. This alignment ensures compliance and helps streamline the submission process, saving you time and reducing the likelihood of delays.
11. Lifecycle Approach to Medical Device Security
Our approach doesn’t end with premarket submission. We ensure your device remains secure throughout its lifecycle by providing post-market surveillance support and ongoing compliance with FDA postmarket cybersecurity guidelines.
12. Holistic Cybersecurity Services
Our comprehensive services cover every aspect of medical device cybersecurity—from initial risk assessments and threat modeling to penetration testing, vulnerability management, and incident response. We provide all the necessary documentation, such as security risk management and postmarket surveillance plans, which align perfectly with FDA and EU MDR requirements.
We are proud to highlight our team’s qualifications, which include but are not limited to:
Our personnel are not only trained and certified, but also bring a wealth of real-world experience. This includes participation in United States government red teams and military cyber operations, both offensive and defensive. Additionally, our team is adept in conducting commercial cybersecurity assessments, audits, penetration testing, risk assessments, and incident response.
Our expertise is particularly notable in the realm of medical device manufacturing. We understand the critical importance of security in this sector and have conducted thorough penetration tests and assessments for various industries, including healthcare, aerospace & defense, education, and finance.
At Blue Goat, we offer a comprehensive suite of security services, adeptly handling web applications, embedded systems, cloud-based systems, and client-developed systems, with a special focus on medical devices and vendor-provided systems on client premises.
Our unique strength lies in our approach to business logic testing. We employ manual analysis to understand the application thoroughly, as automated tools often fall short in this area. This depth of understanding and our hands-on approach ensure that we deliver security and peace of mind to our clients in critical sectors
We are a trusted partner with only one purpose – to help you succeed. We realize cybersecurity is probably not the main focus of your business and is often viewed as a “necessary evil.” We are not a “one-and-done” company. We value long-term relationships where we help you protect your data. We know if we add enough value for you, we will both succeed. Give us a chance.
We value progress. We value relationships. We value attention to detail. We value aptitude. We value attitude. We value clear communication. We value a growth mindset. We value taking ownership. We value adaptability. We value stepping outside of our comfort zones. We value thinking outside the box. We value creativity and innovation. We value persistence. We value wellness. We value learning. We value success. We value the journey.
Christian Espinosa named Blue Goat Cyber as a personal reflection of his experiences and values. Christian is an avid mountain climber who often encounters goats on steep, rugged trails, witnessing their relentless drive to reach the next peak. He admired their tenacity and resilience—qualities he wanted his company to embody. The “Blue” comes from both his favorite color and the vivid blue skies he’s seen against snow-covered mountains during his climbs, symbolizing clarity, trust, and limitless potential. Blue Goat Cyber represents Christian’s passion for always striving to reach higher levels of security, much like the goats he encounters on his climbs while bringing the trust and reliability needed to safeguard medical devices in an ever-evolving digital landscape.
Christian Espinosa, a renowned thought leader, is most known as the bestselling author of “The Smartest Person in the Room,” which explores the limitations of seeking validation through achievement and the desire to be the brightest intellect in any room.
With a deep desire to inspire others to harness their innate wisdom, overcome perceived barriers, and summon the courage to tread new paths, Christian authored his latest book, “The In-Between: Life in the Micro.” This book chronicles his remarkable transformation—from a “me against the world” mindset cultivated during his tumultuous upbringing to his evolution as a compassionate global citizen committed to uplifting humanity.
A dynamic entrepreneur, Christian built and successfully sold Alpine Security, a cybersecurity business. He founded and currently leads Blue Goat Cyber. He also has an array of professional and personal development certifications.
His expertise extends beyond the confines of the corporate world: he’s a white hat hacker, a Veteran, a captivating keynote speaker, a perceptive real estate investor, and a connoisseur of heavy metal music and fiery cuisines. He’s also spent time in the Mexican jungle with Mayan Shamans, is a C-License skydiver, and is a PADI divemaster. Whatever Christian tries, he tends to master.
Beyond his impactful professional pursuits, Christian’s zest for life knows no bounds. An adventurer at heart, he fearlessly leaps from planes and balloons, conquers towering peaks, explores the globe, imparts wisdom in outdoor wilderness survival, and even takes on the rigorous challenges of Ironman triathlons. Having completed an impressive 24 Ironman triathlons and scaled two of the renowned Seven Summits, Christian Espinosa epitomizes the spirit of transformative leadership and unyielding exploration.
The number of cybersecurity incidents continues to climb. The variety of attacks continues to grow. It is no longer a question of if you will have a cyber event.
