You have a concept. You have a timeline. But NPD without regulatory roadmap is how devices get delayed or cleared with gaps. NPD Sprint structures your development process - from requirements to verification to FDA submission - with compliance built in from day one.
From design control to risk management to V&V planning, we guide the sprint. You own the device.
Do not learn about design control gaps during FDA review. Plan from the start - systematically.
Self-score your design-controls readiness in a few minutes, in your browser. Instantly see your gaps and understand what a reviewer would flag today.
Design controls and DHF documentation are possible on your own. But:
NPD Sprint collapses the timeline, brings regulatory expertise from day one, and reduces costly re-work.
The real cost of going alone? Months of delay and 30-40% more iterations before submission.
Next: Talk through your timeline. Then decide what fits.
| BUILD INTERNALLY | NPD SPRINT | |
|---|---|---|
| Timeline | 8-24 months | 12-16 weeks |
| Regulatory Expertise Required | You need it on staff | We bring it |
| Risk of Design Control Gaps | High (discovered in FDA review) | Low (planned in sprint) |
| Process Documentation | You develop it as you go | Built into the sprint |
| Team Alignment | Depends on internal communication | Structured at each phase gate |
DO NOT START BY ASKING:
"Can our team do this ourselves?"
START BY ASKING:
"What does our regulatory pathway actually look like?"
Choose your path: Design only, documentation only, or both.
Test 3 approaches, pick the strongest
Build the strongest concept into a ready-to-build prototype
Prove it on the bench and with FEA, launch on evidence
Exact specifications from day one
Every requirement linked to design and test
Identify harms, track fixes
Safety tests planned and recorded
Every design decision, risk, and test is logged as it happens - structured to FDA (21 CFR 820.30) and ISO 13485 requirements. Nothing reconstructed later. Nothing lost.
Most device companies focus on speed. Then FDA review reveals design control gaps. We do both - speed AND compliance.
WE START WITH: THE QUESTION WE ASK:
"What does your regulatory pathway actually look like?"
NOT THIS:
"How quickly can we build this device?"
NPD Sprint is designed for device companies where development speed matters, but regulatory compliance cannot be compromised.
You have a concept. You do not know if it is Class II, 510(k), PMA, or something else. You need clarity on the regulatory path before you design.
You are improving an existing device. Timeline is compressed. You need to know which changes require re-validation.
Design decisions exist but are not documented. Risk management is informal. You need structure before FDA talks to you.
Funded and ready to build. Need to get from concept to cleared device in 12-16 months with regulatory compliance baked in.
You ship devices now. New product is different class or regulatory pathway. Need streamlined process without building from scratch.
Working on next generation or line extension. Want to embed regulatory expertise into development this time.
NPD Sprint takes you from concept to submission-ready in 12-16 weeks. See what that looks like for your device.
60 minutes | No deck | No pitch | Straight answer on your regulatory pathway