NPD Sprint

Your prototype and your paperwork, together

design_services

Three concepts

We design your device three ways, so the best idea wins — not just the first.

precision_manufacturing

One prototype

The strongest concept built into a single ready-to-build prototype.

science

Evidence, not guesses

Proven on the bench and with FEA before you commit to launch.

folder_supervised

An audit-ready DHF

Complete the day the prototype is finished. Nothing to reconstruct.

01 · The problem we solve

Good devices don't stall because the engineering is weak.

You build for months — designing, changing, fixing, until the prototype finally works.

Then the FDA asks for proof: “show us the record of every design decision, risk and test.”

But nothing was written down — it lives in old emails and people's memories.

So the submission gets rejected, and your timeline slips while you rebuild a history you never recorded.

The NPD Sprint makes sure this never happens to you.

02 · What we set up — two things, your choice

Take the design, the documentation, or both.

Think of us as the architect who draws the blueprints and pulls the safety permits before the house goes up.

Design

Design · prototype · test

DesignWith the 3-Concept Method we design your device three ways, so the best idea wins — not just the first.

PrototypeWe build the strongest concept into one ready-to-build prototype.

TestWe prove it on the bench and with FEA, so you launch on evidence, not a guess.

Document

Recorded from day one

RequirementsYour idea becomes exact numbers — “all-day” becomes “≥ 12 hrs.”

TraceabilityEvery requirement linked to its design and its test.

Risk (ISO 14971)Every way the device could harm, logged with the fix tracked.

Testing (V&V)Exactly which safety tests prove readiness, planned and recorded.

★ The SolidPro tool

StartSmart DesignVault™ — your DHF, built as you go

Our software captures every design decision, risk and test the moment it happens — all linked in one place. So the day your prototype is finished, your Design History File is already complete and audit-ready inside the tool. Structured to 21 CFR 820.30 / ISO 13485 §7.3. Nothing to reconstruct. Nothing lost.

03 · Proof

Real projects, real numbers.

30–40%Fewer physical iterations

A surgical instrument, designed right the first time with the 3-Concept Method.

5%Cost out at design stage

Taken out before it was locked in — because decisions were made on evidence.

200+Engineers, 4 countries

Device teams across the US, India and Ireland on the same ISO 13485 framework.

Every figure above is a real, anonymised SolidPro project. Nothing here is aspirational.

✕ Not for

A device already selling in the market. For that, ask us about a Cost-Down Teardown instead.

04 · How to start — three easy steps

Proof first. Commitment later.

Step 1 · Try itNPD Lifecycle Checklist

Self-score your design-controls readiness in a few minutes, in your browser. You instantly see your gaps — and we can turn it into an honest snapshot of what a reviewer would flag today.

Step 2 · TalkBook a StartSmart call

60 minutes, no deck, no pitch. We tell you straight whether we can help and what the Sprint would cover for your device.

Step 3 · StartRun the NPD Sprint

A short, low-risk pilot on your real device. You finish with the design, the documentation, or both — plus a clear findings list and a recommended next step.

Book your StartSmart call

A straight answer about whether we can help. No deck, no pitch.

No meeting is booked automatically.

What the call covers

60 minutes. No deck. Free.

Where your design controls stand today — and what a reviewer would flag first.
Whether the Sprint fits your device, or whether something else would serve you better.
What the Sprint would actually cover: design, documentation, or both.
A clear findings list and a recommended next step.

Built for startups and first-device teams working to 21 CFR 820.30 and ISO 13485 §7.3.

NPD Sprint · A ProofX Pilot · Medical Device Design & Development

Design your device and build its Design History File — together, from day one.

A short pilot where our engineers design your device and build its regulatory paperwork at the same time — so nothing has to be reconstructed later.

Take the design, the documentation, or both.

StartupsFirst-device teamsActive development21 CFR 820.30 / ISO 13485 §7.3

60 minutes · No deck · Free

NPD Sprint

Your prototype and your paperwork, together

design_services

Three concepts

We design your device three ways, so the best idea wins — not just the first.

precision_manufacturing

One prototype

The strongest concept built into a single ready-to-build prototype.

science

Evidence, not guesses

Proven on the bench and with FEA before you commit to launch.

folder_supervised

An audit-ready DHF

Complete the day the prototype is finished. Nothing to reconstruct.

01 · The problem we solve

Good devices don't stall because the engineering is weak.

You build for months — designing, changing, fixing, until the prototype finally works.

Then the FDA asks for proof: “show us the record of every design decision, risk and test.”

But nothing was written down — it lives in old emails and people's memories.

So the submission gets rejected, and your timeline slips while you rebuild a history you never recorded.

The NPD Sprint makes sure this never happens to you.

02 · What we set up — two things, your choice

Take the design, the documentation, or both.

Think of us as the architect who draws the blueprints and pulls the safety permits before the house goes up.

Design

Design · prototype · test

DesignWith the 3-Concept Method we design your device three ways, so the best idea wins — not just the first.

PrototypeWe build the strongest concept into one ready-to-build prototype.

TestWe prove it on the bench and with FEA, so you launch on evidence, not a guess.

Document

Recorded from day one

RequirementsYour idea becomes exact numbers — “all-day” becomes “≥ 12 hrs.”

TraceabilityEvery requirement linked to its design and its test.

Risk (ISO 14971)Every way the device could harm, logged with the fix tracked.

Testing (V&V)Exactly which safety tests prove readiness, planned and recorded.

★ The SolidPro tool

StartSmart DesignVault™ — your DHF, built as you go

03 · Proof

Real projects, real numbers.

30–40%Fewer physical iterations

A surgical instrument, designed right the first time with the 3-Concept Method.

5%Cost out at design stage

Taken out before it was locked in — because decisions were made on evidence.

200+Engineers, 4 countries

Device teams across the US, India and Ireland on the same ISO 13485 framework.

Every figure above is a real, anonymised SolidPro project. Nothing here is aspirational.

✕ Not for

A device already selling in the market. For that, ask us about a Cost-Down Teardown instead.

04 · How to start — three easy steps

Proof first. Commitment later.

Step 1 · Try itNPD Lifecycle Checklist

Self-score your design-controls readiness in a few minutes, in your browser. You instantly see your gaps — and we can turn it into an honest snapshot of what a reviewer would flag today.

Step 2 · TalkBook a StartSmart call

60 minutes, no deck, no pitch. We tell you straight whether we can help and what the Sprint would cover for your device.

Step 3 · StartRun the NPD Sprint

A short, low-risk pilot on your real device. You finish with the design, the documentation, or both — plus a clear findings list and a recommended next step.

Book your StartSmart call

A straight answer about whether we can help. No deck, no pitch.

No meeting is booked automatically.

What the call covers

60 minutes. No deck. Free.

Where your design controls stand today — and what a reviewer would flag first.
Whether the Sprint fits your device, or whether something else would serve you better.
What the Sprint would actually cover: design, documentation, or both.
A clear findings list and a recommended next step.

Built for startups and first-device teams working to 21 CFR 820.30 and ISO 13485 §7.3.

Design your device and build its Design History File — together, from day one.

Your prototype and your paperwork, together

Good devices don't stall because the engineering is weak.

Take the design, the documentation, or both.

Design

Document

StartSmart DesignVault™ — your DHF, built as you go

Real projects, real numbers.

Proof first. Commitment later.

Book your StartSmart call

60 minutes. No deck. Free.

Your prototype and your paperwork,
ready together.

Design your device and build its Design History File — together, from day one.

Your prototype and your paperwork, together

Good devices don't stall because the engineering is weak.

Take the design, the documentation, or both.

Design

Document

StartSmart DesignVault™ — your DHF, built as you go

Real projects, real numbers.

Proof first. Commitment later.

Book your StartSmart call

60 minutes. No deck. Free.

Your prototype and your paperwork,
ready together.

Design your device and build its Design History File — together, from day one.

Your prototype and your paperwork, together

Good devices don't stall because the engineering is weak.

Take the design, the documentation, or both.

Design

Document

StartSmart DesignVault™ — your DHF, built as you go

Real projects, real numbers.

Proof first. Commitment later.

Book your StartSmart call

60 minutes. No deck. Free.

Your prototype and your paperwork, ready together.

Book a StartSmart call

Design your device and build its Design History File — together, from day one.

Your prototype and your paperwork, together

Good devices don't stall because the engineering is weak.

Take the design, the documentation, or both.

Design

Document

StartSmart DesignVault™ — your DHF, built as you go

Real projects, real numbers.

Proof first. Commitment later.

Book your StartSmart call

60 minutes. No deck. Free.

Your prototype and your paperwork, ready together.

Book a StartSmart call

Your prototype and your paperwork,
ready together.

Your prototype and your paperwork,
ready together.