Improving Regulatory Frameworks for High-Risk Medical Devices: A Case Study Approach Using Abiomed Products

This capstone project evaluates the effectiveness and consistency of the FDA’s 510(k) premarket notification process, particularly in the context of high-risk medical devices such as the Impella heart pump family. The objective is to analyze regulatory review timelines, identify sources of delay, and assess how these factors impact innovation and patient access to life-saving technologies. By combining FDA regulatory data with case study analysis, the project aims to recommend evidence-based improvements to streamline the 510(k) process for future high-risk device submissions.