Blue Goat Cyber

Medical device manufacturers face immense pressure to innovate while ensuring patient safety and meeting rigorous FDA cybersecurity requirements. The complexity of these challenges can be overwhelming, with the risk of vulnerabilities threatening not just compliance but patient lives.

You want to create life-saving devices that patients and healthcare providers can trust. But navigating cybersecurity requirements, building robust threat models, and preparing FDA submissions can pull focus away from your core mission. It’s easy to feel stuck, wondering if your device is truly secure and compliant.

At the heart of the issue is a need for clarity, confidence, and guidance through the cybersecurity landscape. That’s where Blue Goat Cyber comes in. We specialize in helping manufacturers create secure devices that meet FDA eSTAR guidelines while protecting patient safety. Our proven processes, fixed-fee pricing, and expert support ensure that your devices are secure and compliant without disrupting your innovation.

When you partner with Blue Goat Cyber, the path becomes clear. By addressing cybersecurity early, managing risks effectively, and implementing robust security measures, you can move forward with confidence. Your devices will not only meet regulatory expectations but also demonstrate your commitment to patient safety.

Imagine the peace of mind that comes with knowing your devices are secure, compliant, and ready to improve lives. With Blue Goat Cyber’s guidance, you can focus on advancing technology while leaving cybersecurity challenges behind. Your reputation as a trusted innovator grows, and your patients are safer because of it.

The stakes are high, but the solution is within reach. You’re building the future of healthcare—Blue Goat Cyber ensures nothing holds you back.

Founder

As the host of The Med Device Cyber Podcast, my mission is to help MedTech innovators, cybersecurity professionals, and regulatory experts navigate the complex and ever-evolving world of medical device cybersecurity. Cyber threats in healthcare are no longer hypothetical—they’re real, increasing, and directly impacting patient safety. Yet, many manufacturers don’t know what they don’t know when it comes to cybersecurity and compliance. That’s where this podcast comes in.

With decades of experience in cybersecurity, penetration testing, and regulatory compliance, I’ve seen firsthand how medical device manufacturers struggle to balance innovation, security, and the stringent requirements of the FDA, EU MDR, and global regulations. Security is often an afterthought, leading to costly rework, approval delays, and devices vulnerable to cyber threats. This podcast is designed to bridge the gap—bringing practical insights, expert interviews, and real-world strategies to help MedTech professionals integrate cybersecurity early and effectively.

Each episode breaks down complex cybersecurity concepts into actionable insights—whether it’s understanding SBOMs, securing AI-driven medical devices, or ensuring postmarket cybersecurity compliance. I engage with industry leaders, ethical hackers, and regulatory experts to uncover what’s working, what’s failing, and how to fix it. If you’re developing a medical device, leading a security team, or simply want to understand how cybersecurity impacts healthcare, this podcast gives you the knowledge you need to make informed, strategic decisions.

Cybersecurity isn’t just about checking a compliance box—it’s about protecting patients, building trust, and ensuring that life-saving devices work as intended, without interference. Subscribe to The Med Device Cyber Podcast and join me in securing the future of medical technology

Podcast Host

Shrinking Ego

Christian Espinosa’s personal brand under Shrinking Ego is built on his mission to help individuals and organizations overcome ego-driven limitations, develop emotional intelligence, and enhance leadership skills. As a bestselling author of The Smartest Person in the Room and The In-Between, Christian shares insights from his journey of transformation—shifting from ego-centric to compassionate leadership—while bridging the gap between technical expertise and human connection. Through his dynamic keynote speeches, workshops, and courses, Christian inspires audiences to embrace vulnerability, improve communication, and foster collaboration. His proprietary framework, the Secure Methodology, equips technical professionals with the soft skills necessary to break down barriers, enhance teamwork, and succeed in complex environments.

Christian’s work extends beyond writing and speaking. As a Certified High Performance Coach (CHPC), he guides leaders in aligning their values, improving decision-making, and cultivating continuous improvement, drawing from his own experiences as a cybersecurity expert, extreme sports enthusiast, and adventurer. His emphasis on authentic, purpose-driven leadership has resonated with diverse audiences, from technical teams to C-suite executives. Through relatable storytelling and actionable strategies, Christian challenges individuals to move past ego-driven mindsets, unlock their full potential, and create meaningful, lasting change in their lives and organizations. With a focus on transformative leadership, communication, and emotional intelligence, Christian’s personal brand serves as a catalyst for growth, helping others live and lead with clarity, compassion, and courage.

Founder, Author, Speaker

Cerberus Sentinel

Managing Director

Alpine Security

CEO | Founder

Maryville University of Saint Louis

Cybersecurity Instructor

TechGuard Security

Senior Consultant

Vice President, Security Products

Bear Grylls Survival Academy

Instructor

InfoSec Institute

Senior Instructor

Delta-Risk LLC

Christian Espinosa

Cyber Security Consultant | Trainer

Many MedTech professionals are tasked with delivering life-saving technologies, but they face a critical challenge: ensuring their devices are secure from cyber threats while meeting complex FDA regulations. Blue Goat Cyber exists to make this process seamless and successful.

Founded by Christian Espinosa, a trusted expert in medical device cybersecurity, Blue Goat Cyber specializes in premarket and postmarket FDA submissions. With a 100% clearance rate and expertise in threat modeling, SBOM documentation, and vulnerability testing, we take the guesswork out of securing your devices.

We understand the stakes are high—your devices protect lives, and a single vulnerability could have devastating consequences. That’s why we provide a proven roadmap to navigate regulatory hurdles and ensure your devices meet the latest cybersecurity standards.

Our team partners with you to simplify the process, delivering fixed-fee pricing, unlimited retests, and eSTAR-compliant documentation. You can focus on innovation while we handle the technical complexities of cybersecurity.

When your devices are secure and your submissions are successful, you gain confidence, protect patients, and drive trust in your brand. Blue Goat Cyber is here to ensure your success, so you can continue transforming healthcare with safe, cutting-edge solutions. Let’s secure your future together. Visit bluegoatcyber.com to get started.

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