Investor Cybersecurity Questions for MedTech Founders

Reviewed October 14, 2026

Cybersecurity used to be a footnote in medical device diligence. Since Section 524B took effect in 2023, the FDA can refuse to accept a cyber device submission that is missing required cybersecurity content, and hospitals run their own security reviews before they buy. That puts security on the critical path for both clearance and revenue, so investors now ask about it directly. Founders who answer with a plan and a few documents look prepared. Founders who say "we'll handle it before submission" raise a flag, because late security work is one of the most common causes of delay and rework. This post lists the questions you are likely to hear, what a strong answer looks like, and what to have ready before the meeting.

Why This Matters

Investors fund milestones, and for most device companies the biggest milestone is FDA clearance or approval. Cybersecurity deficiencies can add review cycles, and the FDA can refuse to accept a cyber device submission that lacks the content Section 524B requires. Fixing security after the design is frozen often means changing hardware, firmware, or architecture, which costs far more than building it in. Hospitals also review device security before purchase, so weak security can slow revenue after clearance. A founder who can show that these risks are understood and budgeted makes the investor's job easier and the round faster.

Official sources: FDA, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (February 2026); FDA Cybersecurity resources for medical devices; FDA Cybersecurity in Medical Devices FAQs (Section 524B).

Which Cybersecurity Questions Do Investors Ask?

These come up most often, grouped by what the investor is really trying to learn.

Regulatory risk

1. Is the device a cyber device under Section 524B? Why or why not?
2. Which FDA pathway are you using, and when do you plan to submit?
3. Have you had any FDA feedback on cybersecurity, such as a Pre-Submission meeting?

Readiness

4. Do you have a threat model and a security risk assessment tied to your ISO 14971 file?
5. Do you have an SBOM generated from your build?
6. When is penetration testing planned, and who will do it?
7. Do you have a plan for monitoring and patching vulnerabilities after launch?

Cost and team

8. How much of this raise is set aside for cybersecurity, and what does it buy?
9. Who owns cybersecurity today?
10. What would it cost and how long would it take to close your current gaps?

Market

11. Have hospital customers asked for security questionnaires or an MDS2?
12. Does your cloud or data setup create any hospital or privacy concerns?

What Does a Good Answer Look Like?

A good answer is specific, short, and points to a document. Compare two answers to "Is security handled?"

The strong answer shows that you know the rules, have started the work, have a date, and have a budget. It also invites the investor to look at the plan instead of guessing.

What Should Founders Have Ready?

See also: AI Model Integrity for Medical Devices: Signing and Updates, AI Training Data Security for Medical Devices: FDA Evidence, and Threat Modeling AI-Enabled Medical Devices: Worked Example.

Put together a short security folder before diligence starts:

• One-page security plan: cyber device status, pathway, key dates, and who owns security.
• Threat model status: a draft or completed model, or a date for one. The free Threat Model Starter gives you a first draft.
• SBOM: generated from your build, with a plan to keep it current. See our SBOM guide.
• Testing plan: when penetration testing happens and how findings are fixed and retested.
• Budget by stage: what security work each round pays for. Our funding and cybersecurity budgets by stage page breaks this down from Pre-Seed to Series C and beyond.
• Known gaps: a short list with the plan and cost to close each one.

You don't need a finished submission package at seed stage. You need to show that you know what's coming and have planned for it.

How Does This Change by Funding Stage?

Expectations grow with the round:

• Pre-Seed and Seed: investors want awareness and a plan. Know your cyber device status and have security in the budget.
• Series A: expect questions about the threat model, architecture, and SBOM. Security decisions should be showing up in the design.
• Series B and later: investors may hire an outside reviewer to check the cybersecurity package against FDA expectations before the deal closes. See what that review covers on our cybersecurity due diligence page.

How Blue Goat Cyber Approaches This

We help founders get diligence-ready without building a full submission early. A threat model gap assessment gives you a ranked list of gaps and what it takes to close them, which is exactly what investors want to see. If you need ongoing help, our MedTech Cybersecurity Advisory retainer gives you a senior advisor who can answer investor and hospital questions and keep your files current. On the other side of the table, we run fixed-fee cybersecurity due diligence for investors and buyers.

FAQ

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If you're preparing for a raise and want your cybersecurity answers ready before diligence, book a free 30-minute discovery call. You get a fixed-fee proposal afterward, and nothing is billed until you approve it.

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