Deep Domain Expertise
R&D and Engineering experience in complex medical devices.
AI-Powered Insight
Intelligent analysis that connects the dots and reveals what was missed.
Better Decisions, Faster
Move forward with fewer hidden design risks and costly surprises.
The problem
The gaps are often invisible until they’re expensive.
Medical device teams move fast. Under schedule pressure and often without specialized expertise on every subsystem, an incomplete or poorly defined design, a wrong material, an off tolerance, a missing dimension or requirement, or an overlooked interface can pass review unnoticed.
Those gaps do not stay quiet. They surface later, in verification, in transfer to production, in clinical studies, in due diligence, or on the market where the cost of the fix is a multiple times of the cost of catching it early.
What Traceween finds
Engineering-level design intelligence, not checkbox traceability.
- 01
Materials & specifications
- 02
Dimensions & tolerances
- 03
Design requirements
- 04
Engineering decisions
- 05
Interfaces & system interactions
- 06
Manufacturing implications
How it helps
Close the loop earlier.
- 01Design
- 02Review
- 03Find the gap
- 04Fix
- 05Move forward
Where it matters most
Let’s talk.
We’re building Traceween with medical-device teams who can’t afford to miss any details.
Founders
- Boris Kadtsyn
- Co-Founder & CTO
- Roei Samuri
- Co-Founder & CEO
Medical-device R&D leader with 15+ years of experience developing complex Class II/III devices across vascular and structural-heart technologies, including leadership roles at Edwards Lifesciences, InspireMD, THeart and other MedTech companies. After seeing how small engineering gaps can become costly failures, he co-founded Traceween to help teams find those gaps earlier.
Operations executive with 20+ years of experience scaling medical device manufacturing and supply chain across companies like Omrix (J&J), InspireMD, and Scopiolabs. After seeing how engineering design gaps translate into costly operational problems, he co-founded Traceween to help teams catch them earlier.
More to come.
We’re building something exceptional. Stay tuned.