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Readiness check

Eight questions on the need, the build and the market. You get a plain verdict on whether to build now, and the three steps that would move it most.

  1. 1Readiness check
  2. 2Intended use
  3. 3Class and route
Who, apart from you, says this problem needs solving?

Count the people who said it without being led to it.

What happens to the patient today if nothing changes?

Pick the usual outcome, not the rare worst case.

How many patients face this where you plan to sell?

A number with a source beats a large number without one.

What exists of the device today?

This also tells the other two tools where you are.

Do you know what it would cost to make one?

The cost of one unit at volume, not the cost of the prototype.

Do you know which approval it needs?

In India, the class decides who licenses it and what evidence you file.

Who will pay for it, and have they said so?

The buyer is often not the user: a hospital buys what a nurse uses.

How does it compare with what is sold today?

Something is always used today, even if it is a workaround.

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How this works

Eight questions, three areas

The need, the build and the market. Each answer is scored from what it shows, and each area is read on its own, so one strong area cannot hide a thin one.

A verdict, then three steps

If the need is not shown, that comes first, whatever else is strong. Otherwise the thinnest area sets the next three steps.

Private

It runs in your browser. Your answers live only in the address of this page, and move to the next tool only when you follow its link. Nothing is sent to us unless you choose to send it.

Other tools

Each one answers a different question in the same scoping conversation, and each runs in your browser.

Intended useAnswer ten short questions and get an intended use statement you can edit and copy, with the points where your wording commits you to evidence.
Class and routeFind the likely risk class of your device under the Medical Devices Rules, 2017, the licence and the form you apply on, the standards that apply and the route step by step.

Questions about the readiness check

Are my answers sent to you?

No. The tool runs in your browser and does not send your answers to us. The site's analytics counts page visits, and whether a tool was started or finished, without cookies. It does not see what you enter.

How is the verdict worked out?

Each answer scores from 0 to 3 for what it shows. The need comes first: if nobody but you has shown it, the verdict is to validate it, whatever else is strong. Otherwise the thinnest of the build and the market sets the next steps.

Is it a prediction of success?

No. It is a structured self-check. It says where the evidence is thin, not whether the device will succeed.

Can I retake it?

Yes, as often as you like. Retake it when new evidence arrives.