From concept to certified product.
Engineering, prototyping, and manufacturing under one roof. We take medical devices from early concept through production-ready design.
14+
Projects Delivered
6+
Industries Served
ISO
Certified Partners
EU/TR
Based Operations
3D models shown represent project categories Leonith® has provided engineering and consultation services for. They are not products for sale.
Felix Engine®Teach. Validate. Deploy.
The desktop platform for robot validation and teaching. Instruct any robot in plain language, prove the motion is safe in a digital twin, and deploy it. Private. Local. Hardware-agnostic.
See Felix EngineMove to station B
J1: +37.9° J2: +57.1° J3: +1°
Collision: CLEAR
5 robots supported + bring your own
The Problem
Your technology works.
The system around it does not.
0%
of medical device startups never reach commercial success
3-0 yrs
average time from concept to regulatory clearance
0%
of FDA submissions receive requests for additional information
Most medical devices fail not because of bad ideas, but because of preventable engineering and regulatory mistakes. Design flaws found after tooling are thousands of times more expensive to fix than during development. 77% of total development costs for a 510(k) product are regulatory-related. The companies that survive are the ones that get the engineering right before production begins.
That is what Leonith is built for.
Three steps. One point of contact.
Our structured process removes the guesswork. You describe your device, we handle the engineering and manufacturing.
Understand
We analyze your device concept, clinical requirements, and regulatory pathway. No generic questionnaires. A structured engineering intake that identifies risks before they become costs.
Develop
Design, prototyping, and DFM optimization. Every decision is made with manufacturing and certification in mind. No redesign cycles caused by production afterthoughts.
Deliver
From approved design to manufactured product. Tooling specification, production coordination, quality inspection, and delivery. One point of contact throughout.
Portfolio
Medical device projects. Real results.
Full Product Development
MRI-Safe CSF Shunt with Micro Planetary Gear Control
Next-generation cerebrospinal fluid shunt featuring a micro-scale planetary gear mechanism for magnetic-free pressure adjustment and integrated patient monitoring software.
Full Product Development
Tibial Intramedullary Nail Kit
Complete intramedullary nailing system for tibial shaft fracture fixation, including the nail, proximal and distal locking screws, targeting instrumentation, and surgical technique documentation.
Ready to develop your medical device?
Start with a structured project intake. Our AI-powered system will assess your project scope and connect you with the right engineering path.