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.
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
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.
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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