Need Statement and Need Criteria

Need Statement To prevent the reoccurrence of stenosis in coronary arteries. More specifically, to create a solution that lowers the possibility of blood vessels renarrowing after they have been treated from atherosclerosis. This problem has been seen following angioplasty treatments that use either bare metal or drug-eluting stents for widening arteries.

 Verify Accuracy of Need Statement The incidence rate is high in patients who have undergone balloon angioplasty (25-50%)  Need is solution independent No specified technology nor method that must be addressed in the final solution  Scope of the need is appropriate Coronary arteries are chosen as the target area of research

Need Criteria 1. Medical procedure should effectively solve the problem defined in the problem statement, namely restenosis. 2. Duration in which the procedure is effective against restenosis should last a patient’s lifetime. 3. The potential benefits of the new procedure should be significant enough to warrant further development pass the design phase, such as medical trials and eventually real world application. 4. Medical procedure should not present a higher risk in health then any existing artery widening procedures 5. Medical procedure should not introduce any post surgery complications that may jeopardize the health of patients 6. Medical procedure should be relatively easy and straight forward to apply for medical personnel trained in coronary artery surgery. 7. Time of preparation and surgical procedure should be kept to a minimum to reduce both operation cost and patient health risk. 8. Medical procedure should not require a larger incision size required for current angioplasty procedures, thus minimizing complications of surgical wounds like infection and blood loss. 9. Medical procedure should not require a longer recovery time than current angioplasty procedures. 10. Manufacturing cost should be sufficiently low, thus contributing less towards the total cost of the operation.