The Congruence Audit · Diagnosis

Find where your story breaks, before an investor does.

You send four things: your deck, your website, your regulatory narrative and your founder profile. I read them the way an investor, a surgeon-KOL and a Notified Body will read them. Ten working days later you know exactly where they contradict each other, what that costs you, and what to repair first.

EUR 1,950 excl. VAT 10 working days 4 surfaces, scored 60-min debrief included

Incongruence rarely announces itself.

No investor emails you to say your deck contradicts your regulatory file. No surgeon tells you your website describes a different company than your pitch did. The gap stays invisible to you, and expensive. It shows up as three symptoms.

The rejected term sheetAn investor in MedTech reads for contradictions the way a reviewer reads a manuscript. The one you skipped is the one they find, and they rarely tell you that was the reason.
The KOL who goes quietA surgeon who hears one story at the podium and reads another on your website does not argue with you. They quietly deprioritize you.
The stalled regulatory conversationPublic claims that outrun your evidence stage raise questions under Medical Device Regulation (MDR) Article 7. Walking claims back costs more trust than never overclaiming.

A pre-market round that slips one quarter costs a quarter of runway. Re-answering the same doubt across ten investor meetings costs a season. Against that, a diagnosis is the cheap part.

Four surfaces, read by three rooms.

The audit reads everything a stranger can use to form a judgment about your company, the way each decisive reader actually reads it.

Your investor deckRead for risk and return. Does the business story match the evidence you hold today, or the evidence you hope to have.
Your websiteRead by everyone before every meeting. Does it describe the same company, at the same stage, as the deck.
Your regulatory narrativeRead for claim discipline. Does your public story survive the reading a Notified Body would give it.
Your founder profileRead first, in practice. Does the person behind the device tell the same story the company does.

What you receive, and the question each part answers.

Where exactly does my story contradict itself?

The Congruence Report

Every gap named and scored across the four surfaces, quoted from your own materials. You see the investor version and the regulatory version of the same claim side by side. Nothing generic, nothing hypothetical. Your sentences, your contradictions.

Which of my claims survive a skeptical reader?

The Claim-Ceiling Review

Each claim in your materials tested against the evidence you actually hold and against MDR Article 7 boundaries. You learn which claims stand, which need one qualifier to become defensible, and which to remove before they cost you a diligence round.

How do I tell one story to three different rooms?

Your Evidence Chain, drafted

One chain from idea to intended use to evidence logic to regulatory position to commercial value, written out for your device. Then translated three ways: what the investor hears, what the surgeon hears, what the regulator hears. Same spine, three doors in.

What do I fix first?

The Ninety-Day Repair Roadmap

Every gap ranked by what it moves. The two repairs that change your next investor meeting come first, the cosmetic ones come last or never. You leave with an order of operations, sized to a founder's week.

What if I read it differently?

The Debrief, sixty minutes

We walk the findings together. You push back where you disagree, I show you the reading that produced the finding, and we agree on the first three repairs. You keep the full report and the roadmap, whether or not we ever work together again.

How it runs.

Day 0You send the four surfaces: deck, website URL, regulatory narrative or summary, and your LinkedIn profile. A short intake call if anything needs context. Confidential by default, a non-disclosure agreement on request.
Day 1 to 8I read, score and write. No committee, no junior analyst. The same reading I applied at EIT, Cresco Spine and Atraxon Biotech.
Day 10You receive the report, the claim-ceiling review, your evidence chain and the roadmap. We schedule the debrief within the week.

Fixed price, EUR 1,950 excl. VAT, paid at the start. The invoice arrives automatically by email. Fixed scope, no upsell inside the audit. And if you continue into the Founder Signal Sprint, the full EUR 1,950 is credited toward it. If your materials are early or embarrassing, good. Early is when a diagnosis is worth the most.

Built for a specific founder.

The audit fits if

  • You build surgical implants or instruments in orthopedics, spine or neurosurgery
  • You are pre-market: Technology Readiness Level (TRL) 3 to 6, pre-CE, pre-Notified Body sign-off, or pre-incorporation with materials
  • Investors, surgeons and regulators each hear a version of your story and you have never checked the versions against each other
  • You are raising, or will be within two quarters

It does not fit if

  • Your product is on the market and the question is campaigns, not congruence
  • You want marketing execution first, diagnosis later
  • You are in diagnostics, digital health or pharma, adjacent fields the method reads less precisely

See the gap before an investor points it out.

Pay directly and you land on the intake page that tells you exactly what to send. The audit starts the day your four surfaces are in.

Start the Congruence Audit

Questions first? Send the intake by email and pay after we speak. Prefer to start smaller? The free Congruence Gap Scan covers the same four pillars in twelve self-checks.

The reading is not theoretical. Nancy Lamerigts, MD PhD, designed and positioned the EIT spinal implants sold today by DePuy Synthes as Conduit, built the branding and positioning behind Cresco Spine, FDA cleared and launching globally in 2026, and applies the same method at Atraxon Biotech. She has also read pitches from the receiving side, as co-founder of InSpine, the Dutch distribution company and MedTech incubator out of which those three companies emerged. Nine out of ten decks that crossed that desk never reached the management meeting. The audit is that reading, applied to your materials.