The MedTech Cybersecurity Funding Ask Guide

Free Guide · Blue Goat Cyber · Updated 2026

GUIDE · INVESTOR-READY CYBER BUDGETING

The MedTech Cybersecurity Funding Ask Guide How to size, justify, and defend a cybersecurity line item in your next investor raise.

60–80% 6–10 wk 90–180 d 0 Founders underbudget cyber by Class II eSTAR cyber pack Avg. delay from a single AI letter Submissions rejected INDUSTRY AVERAGE TYPICAL TIMELINE FDA DATA BLUE GOAT TRACK RECORD

WHAT YOU'LL GET FROM THIS RESOURCE

Investors fund de-risked roadmaps. Cybersecurity is no longer an optional line item - it is a Section 524B requirement. This guide gives you a self-sizing framework, the artifacts that have to be in the budget, and the language to defend the ask in the room.

Why cyber is now a fundraising line item

Section 524B of the FD&C Act, in force since March 29, 2023, gives the FDA explicit authority to refuse a 510(k), De Novo, or PMA that lacks the required cybersecurity content. The Feb 3, 2026 final guidance set the substantive bar: SBOM, threat model, risk assessment, security testing evidence, and a coordinated vulnerability disclosure plan. None of that is free.

Sophisticated MedTech investors know this. A submission that lists cybersecurity as a placeholder line - or omits it - reads as a roadmap that has not been costed. That is the signal to underwrite a smaller round, or to push the close.

How to size the cyber line item

Use the effort drivers below to size your own line item from the bottom up. Each driver is something a reviewer will look for in your eSTAR; together they define the scope of work that has to fit inside the round.

Effort driver What changes the size Typical timeline

Software footprint Lines of code, languages, third-party 1–2 weeks of analysis libs (SBOM size)

Architecture surface Number of trust boundaries (cloud, 1–2 weeks per boundary mobile, gateway, device)

Connectivity BLE / Wi-Fi / cellular / cloud - each 1–3 weeks per channel adds threats and tests

Hardware Firmware, JTAG/UART access, +2–3 weeks if in scope secure boot - adds physical pen test

Pathway 510(k) baseline; De Novo or PMA +1–4 weeks for De Novo / PMA add cyber documentation depth

HOW TO READ THIS

Most early-stage Class II teams come in expecting a single pen test as the entire cyber program. That is not the eSTAR cyber package. The realistic floor for a Class II software-enabled device is a 6–10 week engagement that produces SBOM, threat model, SPDF documentation, and one round of independent penetration testing - all traceable to your risk file.

What goes in your investor model

Premarket line items

• Threat modeling and architecture review
• Software Bill of Materials (SBOM) generation and curation
• Cybersecurity risk assessment aligned with AAMI TIR57
• Secure Product Development Framework documentation
• Independent penetration testing
• Cybersecurity labeling content for the eSTAR

Post-market line items

• Vulnerability monitoring and SBOM refresh
• Coordinated Vulnerability Disclosure (CVD) program
• Patch development and validation pipeline
• Annual or major-release re-test

Red flags investors look for

• No dedicated cybersecurity line item in the financial model.
• Cyber bundled into 'regulatory consulting' as a single number.
• A budget that funds only one pen test and nothing else.
• No post-market cyber spend after launch.
• A founder who cannot name the artifacts FDA expects.

When to use this guide

This guide is most useful in one of the following situations. If none of them describe your team, the resources index has a better fit.

• You are sizing a Series A or B round and cyber is currently a placeholder line.
• Your CFO has asked you to defend cyber spend in the next board meeting.
• An investor has flagged the cyber line in your model as 'thin'.
• You are building the budget for a 510(k), De Novo, or PMA submission.

The four-driver sizing framework

Cyber effort scales with four drivers. Score each driver, then translate the total into a realistic engagement window.

Driver Low Moderate High

Software footprint Single small codebase Mobile + cloud + firmware Multi-language, large OSS surface

Connectivity USB only BLE + cloud BLE + Wi-Fi + cellular + cloud

Driver Low Moderate High

Hardware access None Debug header behind Open JTAG/UART, enclosure removable storage

Pathway 510(k) predicate De Novo PMA

Step-by-step playbook

1. Score each driver low/moderate/high. Don't try to be clever. If you have BLE + cloud, you are moderate on connectivity even if BLE is 'just for pairing'. Reviewers don't grade on intent, they grade on attack surface.

2. Translate scores into engagement windows. All-low → 4–6 wk. Mostly moderate → 6–10 wk. Any high → 10–14 wk. These are the typical windows behind a Class II eSTAR cyber pack and are what a credible partner will scope to.

3. Build the line item bottom-up by artifact. List every Section 524B artifact (SBOM, threat model, risk assessment, SPDF, pen test, labelling, CVD plan). Assign effort per artifact. A single all-in number is a red flag to sophisticated investors.

4. Reserve post-market spend in the model. Vuln monitoring, SBOM refresh, CVD operations, and re-test cadence are all post-clearance commitments. Investors expect to see them as a line - not as 'we'll figure it out after launch'.

5. Defend the ask with FDA language, not vendor language. Quote Section 524B and the Feb 3 2026 final guidance directly. Show that the cyber line is the cost of doing business, not a vendor preference.

Worked example - a typical Class II MedTech

Setup Series A diagnostic device, BLE wearable + iOS app + AWS backend, going for 510(k) with predicate. Founder originally budgeted a single pen test as the entire cyber line and called it done.

Walk-through We score the four drivers: software (moderate, three codebases), connectivity (moderate, BLE + cloud), hardware (low, sealed enclosure), pathway (low, 510(k)). Net = moderate, 6–10 wk engagement window. Bottom-up artifact list: SBOM, threat model, cyber risk assessment, SPDF, independent pen test (firmware

• app + cloud), labelling content, CVD plan. Post-market line: vuln monitoring, SBOM refresh, annual re-test.

Outcome

The board approves the round with a defensible cyber line that maps directly to the Feb 3 2026 guidance. The lead investor specifically calls out that the cyber model 'reads like the team has actually read 524B.' Submission ships on schedule.

Standards crosswalk

The work this guide describes does not live inside any single standard. The crosswalk below shows how each artifact ties to the regulatory text and the consensus standards a reviewer expects you to cite. Use it when you are asked, mid-review, 'where does this come from?'

Artifact	Primary regulatory anchor	Consensus standard
SBOM	Section 524B(b)(3)	NTIA / CycloneDX / SPDX
Threat model	Feb 3 2026 final guidance §V	AAMI TIR57, STRIDE
Cyber risk assessment	Feb 3 2026 final guidance §V	AAMI TIR57 + ISO 14971
Security testing	Feb 3 2026 final guidance §VI	AAMI SW96, IEC 62443-4-1
SPDF documentation	Feb 3 2026 final guidance §IV	IEC 62443-4-1, AAMI SW96
Cybersecurity labelling	Section 524B(b)(2)(A)	Feb 3 2026 final guidance §VII
CVD plan	Section 524B(b)(1)	ISO/IEC 29147 + 30111

HOW TO USE THIS IN A REVIEW MEETING

When a reviewer or an internal stakeholder challenges an artifact, do not defend it on its own merits - point to the row in this crosswalk. Every artifact in your eSTAR cyber package should sit on top of both a statutory anchor and a consensus standard.

Reviewer lens - what FDA actually looks for

Reviewers do not score artifacts on weight or polish. They score them on traceability, independence, and whether the cyber story matches the safety story. The bullets below are what an experienced reviewer scans for first.

• Traceability - every cyber control must trace back to a specific hazard in the ISO 14971 risk file.

• Independence - the engineer who built the system did not also test it.

• Currency - the SBOM and threat model reflect the build that is actually being submitted, not last sprint's.

• Coverage - the threat model addresses every trust boundary shown on the architecture diagram.

• Disclosure - a coordinated vulnerability disclosure (CVD) plan exists, with a published intake path.

• Labelling - end-user cybersecurity content (intended use, controls, residual risks) is in the IFU.

What 'evidence-grade' looks like

Reviewers are not impressed by length. They are impressed by traceability. The four characteristics below are what separates an evidence-grade cyber package from one that draws an Additional Information letter.

1. Versioned Every artifact carries a version, a date, and a commit/build identifier. The SBOM in your eSTAR matches the build under review, not last sprint's.

2. Linked Threat-model entries link to risk-file hazards. Pen-test findings link to threat-model entries. Mitigations link to design controls. The reviewer can walk any chain end-to-end without leaving the package.

3. Independent Testing was performed by an engineer who did not write the code. The org chart in the SPDF documentation makes that visible.

4. Operational Post-market processes (vuln monitoring, CVD intake, patch validation) exist as live processes with named owners - not as procedures that will be 'stood up at launch'.

Pitfalls we see in the wild

• Single all-in number for cyber with no artifact breakdown.
• Pen-test-only line, no SPDF, no threat model, no SBOM work.
• Zero post-market cyber spend in the operating plan.
• Cyber bundled into 'regulatory consulting' - invisible to the diligence team.
• Scope justified by vendor proposal language instead of FDA guidance language.

Frequently asked questions

How much detail belongs in the investor deck vs. the data room?

Deck: one slide showing the artifact list and the engagement window. Data room: artifact-level effort and timing, plus a one-pager on TPLC alignment. That combination satisfies both fast-pattern and deep-diligence investors.

Should we name a partner in the model? Name a category and an engagement window, not a vendor. Diligence teams will ask why you chose a specific partner; deferring that conversation until contract stage is fine.

What if we already raised and didn't budget cyber?

Re-baseline. The most common path is a cyber-only mini-engagement that stabilises the artifact set, plus a board memo that explains the new line. It is far cheaper than the alternative - discovering the gap during eSTAR review.

How does this fit Section 524B? Section 524B of the FD&C Act, in force since March 29, 2023, makes cybersecurity content a refusal-to-accept item for any 'cyber device'. The Feb 3, 2026 final guidance, Cybersecurity in Medical Devices, defines what that content looks like in practice: SBOM, threat model, risk assessment, security testing evidence, SPDF documentation, labelling, and a coordinated vulnerability disclosure plan. Everything in this guide is written to land cleanly inside that package.

What if our device isn't a 'cyber device'? The Section 524B test is broad: software + connectivity (even transient, even via a phone) + any exploitable technological characteristic. Most software-enabled Class II devices meet it. Even when they don't, the FDA can still ask for cyber content under its general safety-and-effectiveness authority, and a right-sized threat model is the cheapest insurance you can buy against an Additional Information letter.

Action checklist

Use this checklist to confirm the artifacts and decisions covered in this guide are in place before any premarket conversation.

Cyber line broken out from regulatory consulting. Each Section 524B artifact has its own effort estimate. Engagement window justified using the four-driver framework. Post-market cyber spend reserved in the operating plan. Board memo references Section 524B and the Feb 3 2026 final guidance. Data room contains a one-pager on TPLC-phased cyber activity.

What to do this week

Before any partner conversation, do three things this week: (1) pull the current architecture diagram and confirm every trust boundary is labelled, (2) export the latest SBOM (CycloneDX or SPDX) for the build you intend to submit, and (3) note the TPLC phase you are in. With those three inputs, a good cyber partner can scope a right-sized engagement in 20 minutes - without them, every conversation re-starts from zero.

NEXT STEP

Book a 20-minute discovery call

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