Market
Neurosurgery
Client Type
Market leading medical device OEM (Medtronic)
Unmet Need
Single-use, pyrogen-free operating disposable spine endoscope for percutaneous discectomy (removal of nerve-impinging disc material through a tiny incision in the back)
Approach
Replace the conventional lens relay system used in rigid endoscopes with fused fiberoptic image guides and a 3-element, molded plastic objective lens. Incorporate channels for instrument access and flushing of surgical debris.
Product Features
High resolution 30,000 pixel image guide, wide field-of-view, fiberoptic illumination, inflow and outflow lines, 6 fr operating channel, custom quick-release camera attachment, injection molded housing.
Services Provided by OTI
- Optical design & engineering
- Mechanical engineering, including injection molded part design & vendor sourcing
- Development of assembly methods, including bonding, ultrasonic welding, and optical alignment
- Design & fabrication of assembly & test fixtures
- Complete FDA-compliant documentation set, including all drawings & procedures
- Prototyping
- Verification & validation testing
- Transfer to manufacturing, including training of Production & QA staff