Idea validation

Before any engineering money is spent, we test whether the need is real and which of the possible concepts is worth building.

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When idea validation is the right step

At the very start, before any money goes into engineering. You have a clinical problem or an idea for a device, and you need to know if it is worth building.

Test a clinical need
You see a problem in your own practice. A workshop tests who has it, how often, and what a good answer looks like.
Choose between ideas
You have several ways to solve the problem. Concepts are sketched and compared on the same criteria before one is chosen.
Decide before you spend
You need a go, change or stop decision for a board, a grant or yourself, with the evidence written down.

What you bring, and what you get back

You bring

The clinical problem, in your own words
Who has the problem, and where it happens
Any sketches, notes or papers you already have
Access to clinicians or users who can join a workshop
What a decision needs to show, for you or your funder

You get back

A written statement of the clinical need and the users
A first list of needs that can become design inputs
Concept sketches, compared on the same criteria
A feasibility view of the chosen concept
The main risks and unknowns, listed for the next stage
A go, change or stop recommendation, with the reasoning

Three questions, asked in order

Each early stage answers a different question. Idea validation asks if the problem is real and if a solution is feasible. It does not prove the mechanism works. That is the next stage. Skipping ahead to a prototype often means building a good answer to the wrong problem.

How idea validation works

Step 1
Run a clinical-need workshop
Clinicians, users and engineers describe the problem and where it happens.
Step 2
Write the need down
The problem, the users and what a good answer looks like, in plain words.
Step 3
Sketch concepts
Industrial designers and engineers draw several ways to solve it.
Step 4
Check feasibility
Each concept is checked against physics, parts, cost drivers and the likely regulatory route.
Step 5
Select a concept
Concepts are compared on the same criteria, and one is chosen for the next stage.
Step 6
Decide
Go, change or stop, with the evidence and the reasoning written down.

Questions clinicians and founders ask

Do I need a patent before I share my idea?

Not to start, but take care. Publishing or showing an invention in public before a patent application is filed can affect whether it can be patented. It is common to sign a non-disclosure agreement first. Prior art and landscape shows what is already out there.

What happens if the answer is stop?

Then you have spent the least on the idea. The reasons are written down, so you can see what would have to change for the answer to become go.

Will I know which regulatory class my device falls in?

You get a first view. In India, the Medical Devices Rules, 2017 place devices in classes A, B, C and D by risk. The class and route tool gives a quick first read.

Why write the need down so early?

Because it becomes a design input later. ISO 13485 expects design inputs to be recorded, and a need written down now saves reconstructing it at the end.

Designers sketching on a tablet in front of a board of notes

Clinicians and engineers in one room

We work with 100+ clinician partners. Industrial designers run the concept work with engineers from the same nine-discipline team that later designs and builds the device.

Our quality system · About us

Run under an ISO 13485:2016 quality system certified by TÜV SÜD, certificate 99 400 00046. What it covers.