Our Operating Model
One partner from the whiteboard stage through regulatory strategy, manufacturing, and launch.
Explore Our ModelIntegrated OEM Solutions
Full-service device development from concept through regulatory clearance, manufacturing, and market launch. One partner owns the entire program.
Learn MoreManufacturing Solutions
Precision machining, forging, and finishing for implants, instruments, and enabling technologies. Scalable capacity across global facilities.
Learn MoreWhy This Model
Define the concept, operating assumptions, and path to feasibility.
Tie design, regulatory, and manufacturing decisions together earlier.
Transition faster into validated production and launch readiness.
How It Works
Every stage is staffed with dedicated resources — not shared capacity borrowed from other programs.
What OEMs Need
Integrated OEM Solutions
DFM from first design iteration
EXALTA holds the DHF through lifecycle
510(k) and EU MDR pathway embedded
Single operating model across 3 continents
CAST team activated at launch
Manufacturing Solutions
Production-grade from first article
Clean design transfer, no requalification
FDA registered, ISO 13485 all sites
Nearshoring and supply chain resilience
Scalable from prototype to high-volume