Blue Goat CyberSMMedical Device Cybersecurity
    K
    Side-by-side comparison

    Blue Goat Cyber vs MedSec

    Two MedTech-focused security consultancies - different delivery models and pricing.

    250+
    Submissions supported
    100%
    FDA clearance rate
    5.0
    Average Google review
    2014
    MedTech-focused since
    Trusted by MedTech teams worldwide
    Intuitive Surgical bioMérieux Inogen Natera Velico Medical Medivis Spiro Robotics Nova Biomedical VitalConnect
    The details

    Side-by-side breakdown

    Comparison rows about other firms are based on their publicly available website, press releases, and product materials as of May 2026. Claims about Blue Goat Cyber are our own. If a competitor's positioning has changed and we have it wrong, email us and we'll correct it.

    Dimension ★ Blue Goat Cyber MedSec
    Company type MedTech cybersecurity services firm, US-based. MedTech cybersecurity consultancy, US-based.
    Core offering Penetration testing, threat modeling, SBOM, full FDA premarket package, postmarket. Security assessments, advisory, and research.
    Pricing model Fixed-fee per engagement, scoped before kickoff. Typically time-and-materials consulting.
    Submission deliverables Cybersecurity package guaranteed to clear FDA review. Advisory inputs; deliverable ownership varies by SOW.
    Team model US-based employees, not outsourced. Award-winning support. Senior consulting team.
    Lifecycle coverage Design to disposal. Premarket and postmarket assessments.
    Track record MedTech-focused since 2014. 100% success rate on submitted cybersecurity packages. Founder-led by Christian Espinosa, whose blood clots were diagnosed by a Doppler ultrasound - he's alive because of a medical device. Long-standing MedTech security research reputation.
    Be honest with yourself

    Who should pick Blue Goat Cyber, and who should pick MedSec

    We'd rather lose a deal we're not the right fit for than win it and disappoint you. Here's the straight read.

    Pick Blue Goat Cyber

    Pick Blue Goat when you need a defined cybersecurity submission package on a fixed fee and timeline, with one vendor owning every artifact.

    Pick MedSec

    Pick MedSec when you need ongoing senior advisory hours or specialized research input and have internal capacity to integrate it into your submission.

    Pricing transparency

    How we price - so you can budget before the call

    Fixed fee, not hourly
    Every engagement is scoped before contract. No hourly meter, no scope-creep invoices, no change orders.
    Written quote in 24 hours
    After a 30-minute scoping call we send a written quote with deliverables, timeline, and the fee - typically within one business day.
    Unlimited retests included
    Our full-service premarket package covers unlimited pen-test retests until you're ready to submit. No per-retest invoices.
    No platform license
    We don't sell software you have to license year over year. You pay once per engagement and own the deliverables.

    Typical premarket cybersecurity packages run high-five to mid-six figures depending on device class (II vs III), interface count, and whether hardware-level testing is in scope. We share the exact number on a 30-minute call - no NDA required to get a quote. Postmarket management (continuous monitoring, vulnerability triage, regulatory reporting) is available as an add-on after clearance if you want us to stay on.

    Why teams pick Blue Goat

    We're not the cheapest. We're the certain choice.

    If you want a commodity vendor, we're not it. We're specialists - medical device cybersecurity is the only thing we do - and we back our work with a written clearance guarantee. Teams pick us when a rejected submission would cost them a quarter of revenue, an investor round, or a launch window. The bullets below are why.

    100% FDA clearance
    on cybersecurity packages
    Start this week
    no 6-week onboarding
    Fixed-fee pricing
    no scope-creep invoices
    Unlimited retests included
    in our full-service premarket package
    Postmarket coverage available
    100% managed after clearance, if you want it
    US-based team
    never outsourced
    Founder-led
    alive thanks to a medical device
    5.0 on Google
    award-winning support
    Global clients
    since 2014
    Design → disposal
    full lifecycle coverage
    Specialists, not generalists
    medical device cybersecurity is all we do
    Certainty over guesswork
    we remove the unknowns before submission
    Family-run, clinically informed
    Melissa Espinosa (RN) shapes our partnerships
    Veteran-owned
    USAF veteran, speaker & best-selling author
    Hundreds of FDA deficiency letters reviewed
    via our deficiency response service - we know exactly what works
    Proprietary pen test library
    extensive medical-device-specific test cases
    Optimized, defined process
    no improvisation, no missed steps
    Dedicated project manager
    assigned to every engagement
    The Blue Goat Cybersecurity Guarantee

    100% FDA cybersecurity clearance - in writing.

    If the FDA issues a cybersecurity deficiency on a package we delivered, we respond at no additional cost until the device is cleared. No hourly meters. No change orders. No finger-pointing.

    Lock in the guarantee
    Submission rescue

    Already got a deficiency letter from the FDA? We've read hundreds.

    Deficiency response is included free with our premarket package, and we almost never need to use it on our own submissions. Where we earn our deficiency-response reputation is rescuing teams whose previous firm prepared the cybersecurity package and it bounced. We've reviewed hundreds of cybersecurity deficiency letters across Class II and Class III devices, so we know exactly what reviewers flag, what language clears it, and what gets you stuck in a second round.

    • Threat model gaps reviewers cite most
    • SBOM format and VEX language that passes review
    • Pen test scope errors that trigger a second round
    • 524B-era expectations vs. legacy guidance
    Our process

    A defined, optimized path - not improvisation.

    Every engagement runs the same proven five-step process, with a dedicated project manager keeping it on rails.

    1. 01
      Kickoff & scope
      Device classification, predicate review, risk framing.
    2. 02
      Threat model
      STRIDE, asset/data flow, 524B-aligned.
    3. 03
      Testing
      Pen test from our proprietary medical-device library.
    4. 04
      Submission package
      SBOM, VEX, controls, full cybersecurity documentation.
    5. 05
      Deficiency response
      Included. We respond until cleared - but we rarely need to.
    500+ proprietary pen test cases across 12+ device classes - wireless implants, infusion pumps, imaging, SaMD, wearables, and more.
    What you can buy

    Buy the full lifecycle, or just the piece you need.

    We're best known for the full design-to-disposal engagement, but every service is also available standalone if that's all you need today.

    Your dedicated PM

    A real human runs your project - not a ticket queue.

    Every engagement is assigned a senior project manager who owns the timeline, the deliverables, and the FDA interaction end-to-end.

    FAQ

    Frequently asked questions

    “Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience.”

    AN
    Anna Norman
    VP of Product, InfoBionic.Ai
    Switching from MedSec?

    Send us your current scope, quote, or in-flight cybersecurity package. We'll do a free 30-minute review on the call below and tell you - honestly - whether switching is worth it for your submission window. If it's not, we'll say so.

    Skip the form

    Book a 30-minute strategy session

    Pick a time that works. No sales pitch - just a working session on your submission scope, timeline, and how we'd price it.

    Awards

    Recognition

    • Medical Device Cybersecurity Partner of the Year - 2026
      MedTech World North America 2026 Awards (in collaboration with CS Lifesciences).
      Read the announcement
    • Medical Device Cybersecurity Solution of the Year - 2026
      Medical Tech Outlook cover story (2026).
      Download the cover story (PDF)
    • MedTech Service Provider Excellence Award of the Year - 2025
      MedTech World Malta 2025 Awards Gala (sponsored by the Malta Medicines Authority).
      Watch the announcement
    • Medical Device Cybersecurity Services Company of the Year - 2025
      Healthcare Business Review (February 2025).
      Read the feature
    Related

    Keep exploring

    Ready to compare for real?

    Get a fixed-fee quote in 24 hours.

    30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.