Are you copying someone else's life?

Or designing your own category?

The end of the consulting firm

3 days into the cease-fire with Iran, it’s Friday and I’m back to dancing Gaga at the Suzanne Dalal Center.

It is a time to rebuild and I’m building what I think will become a new category:

Expert-led, agent-operated services.

The present

I spoke with an Israeli digital health VC recently.

I pointed out that none of their portfolio companies had cleared FDA.

He said:

“We don’t have to. It’s easier to skip the regulatory pathways.”

A few years ago, I would have argued.

About moats.
About clinical evidence.
About randomized trials.
About defensibility.

That was Danny 2.005.

The past

I left the rat race 21 years ago.

My secret sauce is less ambition.

I don't:

• Want to change the world.

• Raise VC

• Build the next unicorn.

• Be featured on any lists.

• Get the highest valuation.

Instead:

• I want to spend my time working on things I love with people I love

• I want to be able to travel wherever I want to, whenever I want to.

• I want to spend way more time with my friends and family.

• I want to spend more time playing music

• I want to stop doing things I don't like doing.

Thinking about what you actually want in life can force different behavior.
Take you down a different path.
A path towards living more intentionally.
Are you copying someone else's life?
Or designing your own?

Six months ago, I designed Danny 2.026.

The future

I’m building a new category:

Expert-led, agent-operated services.

The rule with new categories is simple:

If you can’t explain it to your grandmother, it’s not real.

So here goes.

The Bubbie Version

I studied physics.
I became a good programmer.

Then after working at big companies like Intel, I became an entrepreneur. 5 startups, 4 wins, 1 glorious loss.

Over 20 years, I helped 42 companies get through FDA.

Today, cybersecurity is part of treating patients.

So I built a business that helps companies pass FDA cybersecurity:

Fixed price.
Fixed time.
Fixed outcome.

Not hours.

Results - what people have always wanted.

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Why Outcomes?

Why not talk about AI agents?

Because outcomes matter more than buzz.

AI agents are hot today.

FDA cybersecurity is:

• the gate to commercialization

• the difference between getting approved or not

• the difference between surviving post-deployment or not

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What’s Changing

The executives I speak with aren’t looking for more cyber consultants.

They’re looking for cost-effectiveness and prioritization for their product and their company - not for a JnJ.

Ransomware and supply-chain attacks now shape procurement of medical devices.

FDA expectations are higher:

• more explicit guidance

• deeper technical review

• stricter documentation

The old model—teams billing hours—is breaking.

---

What I’m Building

OpenCRO is built on one idea:

One accountable expert where agents handle the execution.

I distilled 20 years into a system:

• Human workflow for judgment

• Agentic engine (“Pattern Factory”) for execution

Agents:

• write reports

• extract patterns and anti-patterns

• reason over causal flows

• generate threat models from user stories

---

The Shift

Consulting firms sell hours.

Software sells tools.

This model sells outcomes.

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If You’re In This World

If you’re a MedTech leader navigating:

• FDA

• reimbursement

• commercialization

you already know how high the stakes are.

Drop me a note
or book time.

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