Consulting pentesting is an equation of time versus cost, and quality pays for both. Agentic testing deletes the equation: unbound discovery, expert reasoning, code-level fixes, and FDA traceability, on a fixed subscription.
Consultants bill by the hour. AI doesn't have one. So we test all year, every build, and the price never moves.
A consulting pentest is a calendar: a week of setup, four weeks of testing, then a manual report. About six weeks to the surprises. ELTON returns findings in days.
The report describes the release you already shipped past. ELTON tests the build you have now, and the next one, on the same subscription.
The median consulting pentest runs about $100,000 and returns fewer than 10 true positives. ELTON averages 10x the true-positive discovery at 75% less cost.
Volume is not noise when every finding is exploit-verified on the device. 10x the discovery, each one a true positive, ranked by reachability.
Basis of claim: median cost of approximately $100,000, a 4-week testing window, and fewer than 10 true-positive findings per consulting pentest, verified across 3 medical device cybersecurity consulting firms. ELTON delivers findings inside 2 days on covered devices.
Time competes with cost, and quality suffers from both. A consulting pentest is expert humans running tools and reasoning about what they see. The hours are expensive, so the hours are few.
The consultant has days, not months. So they test the subset of the target that, in their opinion, matters most. The scope is a judgement call made before the first packet is sent.
Customers will not pay infinite amounts of money to find all vulnerabilities. Time times rate equals cost, and coverage is whatever fits inside the number.
Look in the wrong place and the engagement still ends on schedule. Bad discovery and a clean-looking report are indistinguishable from the outside. Time is up either way.
In most consulting reports you cannot tell. There is no record of what was tested and why nothing was found there, because writing that record would spend hours the engagement does not have, and because documenting a wrong guess is embarrassing. The industry’s own shorthand for the method is a blackbox: smart pentester does things. How does that sound for compliance? Not good.
With agentic pentesting, the decision about where to look is gone. ELTON looks everywhere, then reasons about the results in expert fashion. The tradeoff of human time for money no longer exists, so coverage no longer gets rationed.
The ELTON agentic pentesting pipeline is not a wrapper around a general model. Bring your own model; the harness, the tools, and the tradecraft are ours, built from a decade of physical device testing.
Discovery runs tools designed to evaluate firmware, hardware (yes, physically), and software. Not web-app scanners pointed at an infusion pump.
Connected mobile and web applications are tested with the device as one system, seams included. The attack does not stop at the enclosure, so neither does the testing.
A consulting report ends with a few vulnerabilities and advice like “sanitize input” or “perform better encryption.” There is no time or context to write prescriptive remediation, so quality suffers at the most important part. Knowing everything that is wrong just leaves a manufacturer holding regulatory risk. What they need is remediation assistance, close the loop.
A high-level description is all the clock allows. The report names the problem and hands you a category of advice.
Which input, in which file, on which line? Not in the report. There was no time to write it, and no test to prove it.
ELTON ships prescriptive remediation down to the code fix, delivered as a ticket or over ELTON MCP.
Prescriptive fixes for the exact line, delivered where your developers already work. Open a ticket, or run it closed-loop over ELTON MCP.
Writing up a finding takes time, and time is the one thing the engagement ran out of. So consulting reports hand you a handful of highly curated issues and leave tens or hundreds unspoken. Not because they are not real: because reporting them did not fit the clock. Those unspoken issues are the vulnerabilities of the coming months and years, and you need to know about them today.
A few polished write-ups make the report. The rest of what the tester saw is cut for time and never leaves their notes.
The issues left out surface later as CVEs on your components. You learn about them with the rest of the world, in postmarket, on a deadline.
Agentic reasoning writes up every true positive at no marginal cost. Nothing is left in anyone’s notes.
Reporting everything does not mean calling everything a vulnerability. ELTON uses conditions to defensibly separate a directly exploitable vulnerability from a weakness, so you are not holding regulatory debt for findings that are not exploitable on your product.
ELTON rates each vulnerability in isolation, then lets the dependency graph decide what is actually exploitable. Entry vectors produce conditions. Findings require them. When a condition is met, the graph reclassifies on the fly, with the evidence attached.
FDA expects hundreds of test cases, each traced from documentation to result. A point-in-time pentest cannot produce that. ELTON generates coverage and traceability as it tests. Submission-proof, audit-proof.
Every one of these traces to point-in-time testing and a lack of exploitability management. Across 1,000+ cybersecurity submissions we have watched deficiencies add months to ship dates, and in postmarket, a few end in recalls. ELTON closes them all and ships the knowledge with it: SOPs, templates, and submission language included, no consultants. The AI stays on the hard part, finding and managing the vulnerabilities.
The FDA will not accept a justification for leaving pentest findings unfixed.
USB, Wi-Fi, and Bluetooth each need evidenced verification, not a summary.
Section 524B requires postmarket monitoring and a plan, not just documentation.
The FDA wants all in-scope components and historical testing, not a subset.
A postmarket plan without annual third-party pentesting draws a deficiency.
High-level vendor advice and unproven mitigations do not close a finding.
See the pipeline run on one of your devices: continuous discovery, on-device verification, and evidence a reviewer can replay.