Regulated health AI · SaMD · diagnostics · medtech · digital health

Your product works. That doesn't make it US-ready.

Not because it's bad. Because no one has de-risked the buyer, the claims, the evidence, or the contract. That gap has a name: trust debt.

A small, application-only cohort that closes it, before you spend a year in market.

Small cohort By application Next cohort forming

Built by Arvita Tripati. 30+ FDA-regulated, AI-enabled, and regulated health products shipped or scaled, including cardiac AI on the Apple Watch.

The meeting is not the milestone.

None of it means there's a buyer, a budget, or a deal that survives procurement. The lab tells you what the market needs to believe before you chase it.

Trust debt

Five places the US deal dies

Not product problems. Trust problems. Most companies hit them in this order.

Interest isn't demand. Polite meetings, encouraging advisors, no budget owner. Nothing moves.

The fan isn't the buyer. The person who loves it rarely controls the budget. Find who can sign.

Your proof doesn't travel. Home-market traction won't carry a US buyer, regulator, or investor. They want different evidence.

Claims aren't marketing. In regulated health they set your path, your evidence bar, and your risk. Broad claims cost you.

A pilot isn't a strategy. It only counts if the buyer, the metrics, and the next contract exist before it starts.

All five are fixable before you commit the year. That's the lab.

Six questions. Six artifacts.

Each ends in something you can hand a US buyer, investor, or regulator. A package, not a certificate.

The segment with real pain, a budget, and a path to purchase.

Artifact: US Beachhead Memo.

Intended use, positioning, and the proof each claim demands.

Artifact: Regulatory and Claims Map.

What buyers, payers, and investors need to believe, and where your proof falls short.

Artifact: Evidence and Adoption Plan.

The privacy, security, governance, and procurement questions a buyer will ask first.

Artifact: Buyer Trust Packet.

Ownership, metrics, pricing, and the conversion criteria set up front.

Artifact: Pilot-to-Contract Plan.

The expansion story, pressure-tested the way an investor or partner will.

Artifact: US Entry Diligence Pack and 90-Day Roadmap.

How it works

Four moves. In person, hybrid, or virtual. The work doesn't change.

1
Diagnose
Name the first real US beachhead, buyer, and claims posture.
2
Test the thesis
Run structured buyer, investor, and advisor calls with our scripts and office hours.
3
Build the package
Turn the answers into six artifacts you can use in market.
4
Make the ask
Present your plan and a specific ask in a readiness review. Not a pitch contest.

Apply if

  • You have a working product
  • You have home-market traction or real early customers
  • You build regulated health AI, SaMD, diagnostics, medtech, or digital health
  • You're eyeing US entry in the next 6 to 18 months
  • You need to know if the US is even the right next market
  • You'll narrow the beachhead and do real fieldwork

Not a fit if

  • You're still at the idea stage
  • You want guaranteed pilots or intros
  • You want a pitch contest
  • You won't narrow your US market
  • You want encouragement over market truth

Who runs it

Arvita Tripati, founder of Vahana Labs. Her whole career is the gap this lab closes: the distance between a product that works and a US contract that survives review.

30+ FDA-regulated, AI-enabled, and regulated health products shipped or scaled. Cardiac AI cleared on the Apple Watch. Clinical-trial tech run with Moderna, Gilead, the NHS, and Bristol-Myers Squibb. Three founding teams through Series A and B.

In the lab she's the operator connecting every thread, buyer to claims to evidence to investor story, and brings in named specialists where a cohort needs more depth.

Judge for MedTech Innovator and BioTools Innovator; mentor at Rutgers, Alchemist, Redesign Health, and Plug and Play. Background only; no endorsement implied.

30+
FDA-regulated, AI-enabled, and regulated health products shipped or scaled
3x
founding team through Series A and B
0→1
first product to enterprise deployment, repeatedly

Apply for the next cohort

Small, by application. It starts with a short fit call.