Case StudyEndovascular Surgical Navigation System
About This Project
Our client, a spin-off from a leading US-based cardiovascular innovation center, was commercializing a 3D GPS-like surgical navigation technology that enables highly accurate minimally invasive vascular surgery with reduced radiation exposure. This is a Class III medical device.
- Challenges
- Approach & Solution
- Outcomes
• After 10 years of perfecting the approach and technology, the client was ready to commercialize but they did not have in-house FDA development experience
• System was developed in a research environment, so documentation was sparse
• Client did not have a quality management system in place
• Worked closely with client as software development partner for over three years
• From concept and rough prototype through pre-clinical trials and on to FDA submission
• Partnership encompassed both staff augmentation and project-based work
• Full Spectrum was engaged to design and develop the complete software solution, including software-assisted generation of the aorta model, and dual-volume patient registration with real-time corrective capabilities
• Worked with client to develop a realistic plan for evolving the software from research quality to commercial grade
• Produced and managed all of the software the DHF artifacts required for submission
• FDA 510(k) Clearance Achieved in June 2019
• Transferred support to the client at the end of the project