Blue Goat Cyber vs Cybermed.ai
Two MedTech-focused FDA cybersecurity services firms. Both claim 100% submission success. The differences are scope of testing, pricing model, and how the submission package is delivered.
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 | Cybermed.ai |
|---|---|---|
| Company type | MedTech-only cybersecurity services firm, US-based, founder-led since 2014. | MedTech-focused FDA cybersecurity services firm; smaller team, documentation-led. |
| Core offering | Penetration testing (software and hardware), threat modeling, SBOM authoring, full FDA premarket cybersecurity package, postmarket monitoring. | Security architecture and design, FDA cybersecurity artifacts (threat model, SBOM, security controls), pen and fuzz testing, postmarket surveillance. |
| Hardware pen testing | Yes - JTAG/UART, firmware extraction, RF, side-channel, SiMD device testing in-house. | Not advertised; offering is centered on software, architecture, and documentation. |
| Signature engagement | Fixed-fee, retest-included engagements scoped before kickoff. | CyberSprint - a packaged 30-day plan to align teams and artifacts. |
| Pricing model | Fixed-fee per engagement, retest included, no subscription. | Productized sprint plus services engagements; pricing not published. |
| FDA submission outcome | We author and own the cybersecurity section with a guaranteed-clearance commitment - we respond to any cybersecurity deficiency at no extra cost until it clears. | Prepares the FDA-ready artifacts and reviewer narrative for the customer's submission. Claims 100% submission success. |
| Track record signals | MedTech-focused since 2014. no client has failed to clear due to cybersecurity on cybersecurity packages submitted. Public Google reviews. Founder Christian Espinosa is alive because of a medical device that diagnosed his blood clots - origin of the firm's MedTech-only focus. | 100% submissions success claim. Testimonials from Hexoskin, Etiometry, Axena Health, MEDIcept. Smaller organic footprint and shorter public track record. |
Who should pick Blue Goat Cyber, and who should pick Cybermed.ai
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 when the device has hardware, wireless, or firmware in scope, or when you want a fixed-fee engagement backed by a written guaranteed-clearance commitment - especially if a deficiency letter is already on the table.
Pick Cybermed.ai when your scope is mostly software and documentation, you want a packaged 30-day sprint to organize artifacts, and you do not need hardware pen testing.
How we price - so you can budget before the call
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.
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.
Guaranteed 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.
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
A defined, optimized path - not improvisation.
Every engagement runs the same proven five-step process, with a dedicated project manager keeping it on rails.
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01Kickoff & scopeDevice classification, predicate review, risk framing.
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02Threat modelSTRIDE, asset/data flow, 524B-aligned.
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03TestingPen test from our proprietary medical-device library.
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04Submission packageSBOM, VEX, controls, full cybersecurity documentation.
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05Deficiency responseIncluded. We respond until cleared - but we rarely need to.
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.
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.
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.”
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.
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.
Recognition
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Medical Device Cybersecurity Partner of the Year - 2026MedTech World North America 2026 Awards (in collaboration with CS Lifesciences).Read the announcement
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Medical Device Cybersecurity Solution of the Year - 2026Medical Tech Outlook cover story (2026).Download the cover story (PDF)
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MedTech Service Provider Excellence Award of the Year - 2025MedTech World Malta 2025 Awards Gala (sponsored by the Malta Medicines Authority).Watch the announcement
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Medical Device Cybersecurity Services Company of the Year - 2025Healthcare Business Review (February 2025).Read the feature
Where we give back
Free public resources we built and causes we sponsor.
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