Team and Specialty
Our team completed clinical rotations in the Cardiovascular Surgery department at the University of Rochester Medical Center (URMC).
Medical Condition
Coronary Artery Disease (CAD) is a narrowing of coronary arteries in the heart due to a build up plaque. The main symptom is angina (chest pain). CAD is diagnosed through a series of diagnostic testing. The disease affects roughly 16.5 million U.S. citizens over the age of 20.
Surgical Difficulty/Problem
- Most vein harvester have no hands-on experience before operating on their first patient.
- Training new vein harvesters is expensive and time-consuming for hospitals.
Market Opportunity
BioDesign Statement
An improved training method for harvesting the saphenous vein endoscopically to decrease the number of errors made by novice harvesters on patients early in the training process.
Our Solution
Prototype
Regulatory Strategy
After completing an FDA Pre-Submission, it was determined that our product does not classify as a medical device or medical device accessory. Due to this determination, our product is not regulated by the FDA.
Conclusions
It has been determined that there is a need for an improved training model for endoscopic vein harvesting. Feedback from potential customers and end users has been overwhelmingly positive. There is a large market opportunity for this product and we would not be infringing on any other patents or intellectual property.
Acknowledgments
Many thanks to our advisory team for their guidance and contributions to our project!
- Dr. Gregory Gdowski – Project Advisor
- Martin Gira – Engineering Advisor
- Dr. Jonathan Stone – Medical Advisor
- Dr. David Kleinman – Entrepreneur Business Coach
- Deanna Kaprow – User Experience and Human Factors Advisor
- Ashish Mishra – New Venture Business Team Member