OUR MISSION
We build tools to empower the next generations of surgeons.
Our Process
We follow a six-step process to get our tools into the hands of surgeons
01.
Innovation
Gather ideas from based on surgeon feedback on areas that could be improved
File for intellectual property protection when appropriate
02.
Prototyping
Rapid prototyping using FDM/SLA 3D printing models and injection molding
03.
Refinement
Consult surgeons for design improvements, and optimize for manufacturing and to meet FDA & ISO requirements
04.
Manufacturing
Create a supplier and manufacturer pipeline that can guarantee the reliability and functionality of every product
05.
Post-Processing
Industry-standard ethylene oxide sterilization and sterile packaging
Create labels and indications for use. Submit regulatory filings.
06.
Marketing
Getting FDA-cleared product marketed to surgeons, hospitals, and investors
Our Products
Committed to Quality
We are working to achieve reliable devices that surgeon can count on in the operating room.
Clinical Development
Comprehensive animal, electrical, and clinical testing
Regulatory & Access
Working towards ISO 13485 compliance and FDA clearance
Biocompatibility & Safety
Meeting biocompatibility standards set under ISO 10993 and testing to ensure product quality
Intellectual Property
Patent pending products and a legal team to help patent prosecution
