How to Choose an FDA Medical Device Cybersecurity Provider
A neutral buyer's guide to medical device cybersecurity providers - services-led firms vs platform vendors - and how to choose the right one for an FDA submission.
Side-by-side breakdown
| Dimension | Services-led firms | Platform vendors |
|---|---|---|
| Representative vendors | Blue Goat Cyber, MedSec, Velentium, Innolitics, Sekurno. | Medcrypt, Cybellum, Finite State, Censinet, CyberMed.ai. |
| Primary deliverable | Pen test report, threat model, SBOM, and the full FDA premarket cybersecurity submission section. | Continuous SBOM, vulnerability monitoring, binary analysis, or vendor risk assessments via a SaaS platform. |
| Owns the FDA submission? | Yes - the firm authors and owns the cybersecurity section through clearance. | No - platform output is consumed by the manufacturer's own submission writers. |
| Pricing | Fixed-fee or time-and-materials per engagement. | Annual platform subscription, often tiered by device count or user seats. |
| Hardware pen testing | Most do (JTAG/UART, firmware extraction, RF, side-channel). | Most do not - tools focus on binary, firmware, or SBOM analysis. |
| MedTech specialization | Varies - Blue Goat is 100% MedTech; Sekurno and many AppSec firms are multi-industry. | Varies - Medcrypt and CyberMed.ai are MedTech-only; Finite State and Censinet serve multiple industries or healthcare broadly. |
| Team size and capacity | Ranges from solo consultants to 50+ person firms. Capacity is the constraint: ask how many engagements a firm runs concurrently and who is assigned to yours. | Headcount is mostly engineering and customer success. Capacity is rarely the constraint; your own team's bandwidth to operate the tool is. |
| Typical start time | Days to weeks for boutique firms with open capacity; 4 to 12 weeks at larger consultancies with a queue. | Weeks to months - procurement, security review, and platform onboarding usually precede any usable output. |
| Best fit | Manufacturers preparing a 510(k), De Novo, or PMA submission and needing the cybersecurity package delivered on a deadline. | Manufacturers with internal product-security teams who need continuous tooling across a device portfolio, or HDOs assessing vendors. |
When to use which
If you have an FDA submission deadline and no internal cybersecurity team, hire a services-led firm. Tools do not author submissions - people do, and platform output still needs interpretation, mapping to ISO 14971, and integration into the cybersecurity section before a reviewer will accept it.
If you have a mature product-security team and a portfolio of fielded devices, buy a platform for continuous SBOM and vulnerability monitoring. Manual quarterly SBOM updates do not scale past a handful of devices.
If you are a hospital or IDN, your cybersecurity vendor question is different - you need third-party risk management (Censinet) to assess the devices and vendors you are buying, not a manufacturer-side firm.
Cross-check claims. Ask any provider for: number of FDA submissions cleared with their cybersecurity package, deficiency-letter rate, hardware testing capability (JTAG/UART, side-channel), and whether their report has survived an FDA reviewer line-by-line.
Seven questions that separate shortlisted firms
Every firm in the services column will tell you they do FDA cybersecurity work. These are the questions where the answers actually diverge - ask all seven, and ask for evidence rather than assurance.
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1
Do you author the cybersecurity section itself, or hand me a pen test report?
A pen test report is one exhibit. The submission section has to assemble the threat model, security risk assessment, SBOM, architecture views, testing evidence, and labeling into the structure a reviewer reads. Firms that stop at the report leave the assembly with you.
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2
How many submissions have gone out with your package, and what happened on review?
Ask for the count and the deficiency history, not a logo wall. A firm that tracks its own deficiency letters is a firm that learns from them.
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3
Do you test hardware, or only software?
JTAG/UART access, firmware extraction, RF, and side-channel work need lab equipment and specialists. If the device has a physical attack surface and the firm only does network and application testing, the gap lands in your submission.
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4
Is MedTech all you do, or one vertical among several?
AAMI SW96, ISO 14971 hazard linkage, IEC 81001-5-1, and eSTAR formatting are not transferable from enterprise AppSec. Generalists learn them on your timeline.
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5
Fixed fee or hourly, and what happens when the FDA responds?
Cybersecurity is the line item that most often blows past estimate, usually after the first round of agency feedback. Find out before signing whether the response work is included or re-billed.
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6
Who does the work - the people on the call, or a delivery team I have not met?
Common in larger consultancies: senior practitioners sell, juniors deliver. Ask to meet the person who will run your engagement.
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7
When can you actually start, and how much capacity is reserved for me?
Start date is where firm size shows up in practice. Ask for the kickoff date in writing, how many engagements your assigned team is running during your window, whether hardware lab time is reserved or shared, and the turnaround commitment for an FDA Additional Information response. A capable firm that starts in ten weeks is the wrong firm for a submission that files in eight.
Where Blue Goat Cyber fits
We publish this guide, so here is our own position stated plainly rather than buried in a neutral-sounding table. Blue Goat Cyber is a services-led firm in the first column. We are not the right answer for every reader on this page: if you have a mature internal product-security team and a portfolio of fielded devices, a platform is probably the better buy, and if you are a hospital or IDN assessing the devices you purchase, you need third-party risk management rather than a manufacturer-side firm.
- Medical device cybersecurity is all we do - no enterprise IT, no hospital network practice, MedTech-focused since 2014.
- We author and own the full FDA cybersecurity submission section through clearance, not just the pen test report.
- Hardware testing in house: JTAG/UART, firmware extraction, RF, and side-channel.
- Fixed-fee scoping with a quote inside 24 hours, unlimited retests in the full premarket package, and a dedicated project manager on every engagement.
- Small, senior, US-based team with no offshore delivery - the people who scope your engagement are the people who run it, and most engagements start within a week or two of a signed scope rather than after a multi-week queue.
- We work alongside platforms rather than against them - pairing our premarket package with a monitoring platform for postmarket is a common and sensible setup.
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