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Key Takeaways
- Medical device cybersecurity cost is driven by device complexity, attack surface, and submission pathway (510(k), De Novo, or PMA), plus whether you need premarket work, postmarket support, or both.
- The largest cost is usually a delay: an FDA request for more information stops the review, and you have 180 days to respond.
- A fixed fee removes scope-creep risk; hourly billing pushes that risk onto the buyer.
- Retests are included in Blue Goat Cyber's fixed fee, which keeps medical device penetration testing cost predictable.
- A scoped, fixed-fee quote is available within 24 hours of a short scoping call.
Medical device cybersecurity cost depends on the device's complexity, its attack surface and the submission pathway, not on a fixed price list. A single penetration test sits at the lower end; a full premarket package for a complex connected device sits higher. Blue Goat Cyber scopes each engagement to a fixed fee with retests included, so the cost of medical device cybersecurity is known before work begins.
For most manufacturers, the largest cybersecurity cost is not the engagement. It is the delay. When the FDA sends an Additional Information request over cybersecurity gaps, the review clock stops, and you have 180 calendar days to respond before the FDA treats the submission as withdrawn. Every week spent fixing documentation is a week the device is not on the market. That is why medical device cybersecurity cost should be weighed against launch timing, not only against the invoice.
This guide explains what moves the price, how fixed-fee and hourly models differ, how premarket and postmarket budgets differ, and how to compare the engagement fee with the cost of a delayed clearance. Dollar figures for delay are illustrations; run your own numbers in the calculator linked below.
Why This Matters
Under Section 524B of the FD&C Act and the FDA's final guidance "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions," issued February 3, 2026, covered cyber-device submissions require an SBOM, a postmarket vulnerability plan, and cybersecurity processes and procedures. The guidance recommends supporting evidence such as threat models, architecture views, and testing, including penetration testing. The FDA can refuse to accept a submission that is missing required cybersecurity information, so treating cybersecurity as an afterthought is effectively budgeting for a delay.
The applicable standards, including AAMI SW96, AAMI TIR57, IEC 81001-5-1, IEC 62304, and ISO 14971, all assume security is built in during design, not added after the fact. Pricing follows the same logic: scoped early, the work is predictable. Scoped late, every dollar buys less.
Official sources: FDA, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026); FDA eSTAR Program; FDA Cybersecurity in Medical Devices FAQs (Section 524B).
What Drives Medical Device Cybersecurity Cost?
Four factors move the cost of medical device cybersecurity more than any others. Once you can describe them, a competent firm can give you a real number.
Device complexity and connectivity
Firmware, wireless links, cloud services, and mobile apps each add scope. A standalone device with one interface costs a fraction of a connected system that pairs an implant, a clinician programmer, a patient app, and a cloud back end.
Attack surface and testing depth
Testing one interface is a very different job from testing the full stack. The number of interfaces, not the number of features, drives penetration testing effort, and manual testing depth matters more than tool count.
Review our fixed-fee medical device penetration testing for testing scope and deliverables.
Submission pathway
A 510(k), De Novo, and PMA all need the same core documents, but FDA guidance recommends more depth as risk rises, with PMA the most demanding. See the 510(k) vs De Novo vs PMA comparison.
Premarket versus postmarket
Premarket is a one-off package tied to your submission. Postmarket is an annual engagement for as long as the device is on the market. Treat them as separate budget lines.
A useful way to sense-check a quote: if a firm cannot tell you which of these factors drove the number, the number is a guess.
Cost drivers at a glance
| Cost driver | Lower cost → Higher cost |
|---|---|
| Submission pathway | 510(k) → De Novo → PMA |
| Device connectivity | Standalone → Wireless / cloud-connected |
| Attack surface | Single interface → Firmware + BLE/RF + mobile + cloud + APIs |
| Software origin | First-party only → Heavy third-party / open-source (SBOM depth) |
| Engagement scope | Premarket only → Premarket + ongoing postmarket |
| Starting point | Security designed in → Retrofitting after design lock |
Cost by engagement scope
| Scope | What it covers | Main cost drivers | When it is the right scope |
|---|---|---|---|
| Penetration test only | Manual testing of the device, its interfaces, and any app or cloud it talks to, plus a report the FDA can review | Number of interfaces, testing depth, travel to the device | You already have a threat model and SBOM and need independent test evidence |
| Threat model + SBOM | Architecture views, threat model, security risk assessment, SBOM with support status | Architecture complexity, amount of third-party software | Design is settling and you need the core documentation before testing |
| Full premarket package | Everything the FDA's February 2026 guidance describes: plan, threat model, risk assessment, SBOM, testing, labeling, postmarket plan | Pathway (510(k), De Novo, or PMA), connectivity, how much exists already | You are preparing a submission and want one team to own the cybersecurity section |
| Annual postmarket | SBOM monitoring, vulnerability triage, disclosure handling, periodic retesting, and reporting | Number of devices and versions in the field, release cadence | The device is cleared and on the market |
What we can tell you up front
A penetration test for a simple device with no travel starts at about $15,000. A full premarket cybersecurity package is quoted as a fixed fee after a scoping call, because the drivers above vary too much between devices for a list price to be accurate. New to the topic? Start with What Is Medical Device Cybersecurity?. Building your first device? See medical device cybersecurity for startups.
The full premarket package is the scope most manufacturers need, because the FDA reviews the cybersecurity documentation as a connected set: a pen test without a threat model, or an SBOM without a risk assessment, tends to draw questions.
Why a Delay Costs More Than the Engagement
For most manufacturers the largest cybersecurity cost is not the engagement, it is the delay a deficiency causes.
When the FDA asks for more information, the review stops until you respond, and you have 180 calendar days to do it. Fixing a missing SBOM, an unsigned update path, or an untested wireless interface can take weeks or months, and the launch waits.
Illustration only: a device expected to earn $40M in its first year brings in roughly $110K per day once it ships. A three-month delay would defer about $10M in revenue, before counting the engineering team's time spent on fixes. Your numbers will differ.
Plug your own figures into the cost-of-delay calculator before you finalize your cybersecurity budget.
Fixed Fee Versus Hourly: Why the Model Matters
See also: Does FDA 524B Apply to Legacy Medical Devices?, FDA Section 524B Subsections Explained, and Medical Device Cybersecurity Standards.
A fixed fee scoped upfront protects the budget in a way hourly billing cannot.
Hourly (time and materials) looks predictable per hour, but the total is not. Threat models grow as the architecture becomes clearer, each fix needs a retest, and deficiency responses become new work orders. The buyer carries every hour of scope creep.
Fixed fee with retests included flips that risk. The firm commits to a price for defined deliverables and absorbs the cost of extra test passes. You know the number on day one, which makes board reporting and launch budgeting straightforward.
Premarket vs Postmarket: Two Different Budget Lines
Premarket is a defined project tied to your submission: threat model, SBOM, security architecture views, pen test, labeling, and secure development documentation. The cost is finite and forecastable.
Postmarket is ongoing. Section 524B requires a plan to monitor, identify, and address vulnerabilities after clearance, which means SBOM monitoring, vulnerability disclosure, coordinated response to new CVEs, and software updates for the life of the device. Finance should plan for it like any recurring operating cost. Our FDA postmarket cybersecurity services page shows what an annual program includes.
How to Build a Realistic Cybersecurity Budget
- Scope the attack surface early, before design lock. Interfaces added later cost more to secure.
- Decide premarket vs postmarket scope explicitly. Most growth-stage MedTech companies need both.
- Get a starting range. The Scope Estimator uses the same drivers above and returns a range without a sales call.
- Refine with a scoping call. A short call turns the range into a fixed-fee quote.
Want a fixed-fee number for your device? Get a quote for our FDA premarket cybersecurity services within 24 hours of a short scoping call.
How Blue Goat Cyber Prices Engagements
Every Blue Goat Cyber engagement is a fixed fee with retests included: one number for the agreed scope, and as many test passes as it takes to close findings, with no hourly meter and no retest surcharge.
After a short scoping call about your device, interfaces, pathway, and timeline, you receive a written fixed-fee quote within 24 hours, listing the deliverables, schedule, and retesting commitment. Deliverables follow the evidence the FDA's February 2026 guidance describes: an AAMI SW96-aligned risk file, a traceable threat model, SBOM, architecture views, an independent penetration test, and a postmarket plan. Our US-based team of employees has supported more than 275 device submissions across 510(k), De Novo, and PMA.
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed to you. For the full scope and method, see FDA premarket cybersecurity services.
Frequently asked questions
How much does medical device cybersecurity cost?
Cost depends on device complexity, submission pathway, attack surface, and whether you need premarket work, postmarket support, or both. Specialist firms typically price fixed-fee with retesting, so the figure is known up front. Use a scope estimator for a device-specific range, and weigh it against the revenue lost to a single delayed launch - that is the comparison that determines whether the spend is justified.
Is medical device cybersecurity priced hourly or fixed-fee?
Both models exist. Hourly FDA cybersecurity consulting fees can drift as scope grows and re-tests add up - the buyer carries the risk of every extra pass. Fixed-fee engagements with retesting give a known total and remove the re-test surprise; the firm absorbs the cost of getting the device to acceptable risk, no matter how many passes it takes.
What's the difference between premarket and postmarket cybersecurity cost?
Premarket is a defined project tied to your submission - threat model, SBOM, pen test, submission package, cleared once. Postmarket is an ongoing annual obligation under Section 524B - SBOM monitoring, vulnerability disclosure, periodic reporting - so it is a recurring budget line, not a one-time fee. Budget for both if your device is heading to market and staying there.
How much does medical device penetration testing cost?
Medical device penetration testing cost depends on how many interfaces the device has (wireless, USB, network, mobile app, cloud), how deep the manual testing goes and whether testers need to travel to the device. A simple device with one interface costs far less than a connected system with an app and cloud back end. See what drives penetration testing cost for the detail.
Do you charge extra for retests?
No. Blue Goat Cyber's fixed fee includes retests included. When your engineers fix a finding, we retest it until it is closed, with no extra invoice. Under hourly billing, each retest is a new charge, which is how many testing budgets end up well over the original estimate.
What makes one device more expensive to secure than another?
It is not the physical size of the device. Cost follows connectivity and pathway. A small wearable with Bluetooth, a phone app, and a cloud platform has a larger attack surface than a large standalone instrument. A PMA also needs deeper evidence than a 510(k). More interfaces and a more demanding pathway mean more work.
Get a fixed-fee number for your device
Get a fixed-fee quote within 24 hours of a short scoping call. If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed to you. Book a scoping call or start with the Scope Estimator.
About the author. Christian Espinosa - Founder & CEO, Blue Goat Cyber. Christian has scoped and priced hundreds of FDA cybersecurity engagements across 510(k), De Novo, and PMA pathways, and built the fixed-fee + unlimited-retesting model the firm runs on today. More from Christian.
About the author
Christian Espinosa, MBA · Founder & CEO, Blue Goat Cyber
U.S. Air Force Academy graduate and veteran with 30+ years in cybersecurity. Founded Alpine Security in 2014 (acquired 2020), then Blue Goat Cyber in 2022. Blue Goat track record: 275+ FDA submissions supported, zero cybersecurity rejections. Author of three books including The Smartest Person in the Room. Ironman triathlete and mountaineer.
Sources & references
Primary sources cited in this article. Links open in a new tab.