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How to validate a Regulated / health startup, stage by stage

10 stages, from the first conversation to a business that repeats. 5 are key milestones: if you do not beat them, nothing else counts. Each stage says how to know it is done and what to do this week.

  1. 01

    Clinical or operational problem

    Goal: Having the problem measured in a real setting: who suffers it and what it costs today.

    Where to start: Spend a day at the centre or company where the problem happens and write down how often it comes up and what it costs each time.

  2. 02

    Who uses it and who pays

    Goal: Knowing who uses it, who pays for it and who benefits, bearing in mind they are rarely the same person.

    Where to start: Interview one person of each kind and check whether all three agree on what the problem is.

  3. 03

    What the rules require

    Goal: Knowing, in writing, what kind of product you are under the regulations and what they require.

    Where to start: Ask a regulatory expert or the relevant agency, with a one-page description of your product.

  4. 04

    Evidence plan

    Goal: Having a plan for what you need to prove, with which study and to whom.

    Where to start: Write down what result the buyer would need to see to say yes, and what small study could measure it.

  5. 05

    Safe prototype

    Key milestone🎖️ Counts in the FounderSeal

    Goal: Having something that can be tested without risk to anyone.

    Where to start: Test it first with simulated data or with professionals, before it reaches patients or end customers.

  6. 06

    Authorised pilot

    Key milestone🎖️ Counts in the FounderSeal

    Goal: Getting a centre or company to use it under a signed agreement, with whatever permissions it needs.

    Where to start: Propose a pilot in a single centre, with a measurable result agreed before you start.

  7. 07

    Proven outcome

    Key milestone🎖️ Counts in the FounderSeal

    Goal: Having a result measured by someone outside your team.

    Where to start: Ask the pilot centre to measure the agreed result with its own staff and to sign it off.

  8. 08

    First payment

    Key milestone🎖️ Counts in the FounderSeal

    Goal: Getting someone to pay for it: a centre, an insurer or a public body.

    Where to start: Find out how the pilot centre buys today (tender, small contract or reimbursement) and prepare your offer in that format.

  9. 09

    Authorisation

    Goal: Having the marking or authorisation that lets you sell granted.

    Where to start: Ask the notified body or the agency for the timeline of the process and list every document you are missing.

  10. 10

    More customers

    Key milestone🎖️ Counts in the FounderSeal

    Goal: Winning a second and a third customer who did not come from the pilot.

    Where to start: Ask the pilot centre to introduce you to two similar centres and show them the measured result.

What gets measured

  • Centres in pilot
  • Clinical or operational outcome
  • Approval time
  • Cost per patient or case
  • Contracts

What kills it

  • Finding out late what the regulations require
  • Selling to the user when the buyer decides
  • Running out of cash before authorisation

Usual mistakes

  • A pilot with no agreed measurable result
  • Avoiding the regulator instead of talking to them early
  • Promising results without proof

Other kinds of company

B2B SaaSSelf-serve SaaS / B2CMarketplaceHardwareAI-enabled servicesDeep-tech / R&DGeneral path

Walk your path with your team and with data

Inside Madrid Ventures the path becomes your day: your AI CEO turns the stage you are at into missions for each person, and every proof you get raises your FounderSeal.

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