Prototype / MVP

The first build you can put in someone's hands. It works, it looks like the device, and it is still early enough to change cheaply.

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When a prototype or MVP is the right step

After the core mechanism is proven. The parts come together into a first working device that people can see, hold and try.

Show it to investors
A working unit makes a funding conversation about the device, not about slides.
Put it in front of users
Clinicians and users handle it and say what works, so the design changes before it is fixed.
Integrate the parts
Electronics, firmware and housing meet for the first time, and the problems between them show up early.

What you bring, and what you get back

You bring

The proof of principle results, or your own bench data
The clinical need and the main users
Target size, weight and key performance values
Who the prototype is for: investors, a board or clinicians
Any existing sketches, CAD or circuit work

You get back

A first working prototype
Breadboard or first-pass electronics, with schematics
First firmware to run the device
Mock-up housings, printed or machined
A list of what worked, what did not, and what to change
Inputs for the design and development stage

Looks-like, works-like, then both

Many first builds are two separate things: a model that looks right and a rig that works. An MVP puts both in one unit. It is still not the design you will verify. Design verification happens later, under design controls, on the released design.

How a prototype build works

Step 1
Agree what it must show
The demo, the user test or the question the prototype answers.
Step 2
Lay out the architecture
The main blocks of mechanics, electronics and firmware, and how they connect.
Step 3
Build the electronics
Breadboard or first-pass boards, brought up and checked.
Step 4
Write first firmware
Enough embedded code to run the device and log what it does.
Step 5
Make the housing
Mock-up housings, printed or machined, to fit the parts.
Step 6
Test and learn
The unit is run, tried by users, and the changes are listed for the next stage.

Questions founders ask

Can I use the prototype on patients?

Not without the right permissions. In India, a clinical investigation of a device needs permission under the Medical Devices Rules, 2017. A prototype usually goes to users for handling and feedback, not to patients.

Is the prototype the final design?

No. It shows the device can work as a whole. The design is then developed, verified and documented. Design and development takes it from here.

Does the prototype firmware count as medical device software?

Code written to learn is often rewritten. Software that ships in a medical device is developed under IEC 62304, so if you keep prototype code, bring it under that process.

How many prototypes should I build?

Enough for the people who must see it, plus spares for damage. For 10 or more units to a released design, look at a pilot batch.