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 | Innolitics |
|---|---|---|
| Company type | MedTech cybersecurity services firm. | Medical device software development and regulatory consultancy. |
| Core offering | Penetration testing, threat modeling, SBOM, full FDA premarket cybersecurity package, postmarket. | SaMD and AI/ML software development, regulatory consulting, quality systems - cybersecurity as an adjacent service. |
| Cybersecurity depth | Offensive-security DNA: pen testers and threat modelers, not application developers. | Cybersecurity advisory layered on a software development practice. |
| Pricing model | Fixed-fee per engagement. | Consulting time-and-materials and project-based development. |
| FDA submission support | Cybersecurity package backed by 275+ devices supported, no cybersecurity-related rejections to date. | Strong regulatory writing across many sections of the submission. |
| Best fit | Companies that need an independent cybersecurity package delivered on a deadline. | Companies that need outsourced software engineering plus regulatory support. |
Who should pick Blue Goat Cyber, and who should pick Innolitics
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 your software is already built (or being built elsewhere) and you need the cybersecurity submission section, pen test report, and threat model done as a standalone deliverable.
Pick Innolitics when you need to outsource software development itself, especially for SaMD or AI/ML devices, with cybersecurity advice attached.
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 deficiency commitment. 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.
FDA cybersecurity deficiency commitment - 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.
- 01Kickoff & scopeDevice classification, predicate review, risk framing.
- 02Threat modelSTRIDE, asset/data flow, 524B-aligned.
- 03TestingPen test from our proprietary medical-device library.
- 04Submission packageSBOM, VEX, controls, full cybersecurity documentation.
- 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
- Medical Device Cybersecurity Partner of the Year - 2026MedTech World North America 2026 Awards (in collaboration with CS Lifesciences).Read the announcement
- Medical Device Cybersecurity Solution of the Year - 2026Medical Tech Outlook cover story (2026).Download the cover story (PDF)
- MedTech Service Provider Excellence Award of the Year - 2025MedTech World Malta 2025 Awards Gala (sponsored by the Malta Medicines Authority).Watch the announcement
- Medical Device Cybersecurity Partner of the Year - 2026MedTech World North America 2026 Awards (in collaboration with CS Lifesciences).Read the announcement
Where we give back
Free public resources we built and causes we sponsor.