Introduction

Abstract

The medical device industry is a booming area of technological development that is advancing with breakneck speed. Creative thought, in conjunction with ingenuity, can produce an innovative medical device that can have immense value for the medical device company that brings the product to market. An innovative medical device can enable healthcare providers to administer care more effectively and can provide patients with better quality care. Innovators are designing and developing new medical devices on a daily basis, but developing new, life-saving medical device technologies is not without it challenges. Medical device innovators in the United States must navigate hurdles in both the intellectual property space, as well as federal regulations by ensuring compliance with the regulations set out by the Food and Drug Administration (FDA). FDA compliance is often crucial to successfully bringing a medical device product to market, and securing intellectual property rights in the medical device technology is key to gaining and maintaining a competitive advantage.