Prosthetic heart valve performance: Long-term follow-up

Abstract

The regulatory aspects of the heart valve business are profoundly polarizing. From the perspective of a medical device company, the regulatory requirements for bringing a product to market are almost always viewed as overly burdensome, time-consuming, costly, irritating and an impediment to bringing good products to market, saving lives, and making good money. If you are a medical device regulator, tasked with reviewing a design dossier that can be thousands of pages long, the regulatory requirements are principles that must be adhered to because they are the law. If you are a patient in need of a medical device, you really have no idea what studies were done on the device to demonstrate that it is safe, but at least there is some comfort in your mind that there is a process to “protect us” from “dangerous medical devices.” In the court of public opinion, medical device manufacturers are only second lowest on the rank of mistrust and loathing, right behind the drug manufacturers. Having spent 7 years bringing a heart valve product from concept to clinical testing and 2 years as a medical device and heart valve product reviewer at a regulatory agency, I have witnessed the regulatory process in all its elegance and ugliness from both sides. The purpose of this chapter, therefore, is not to review all the regulatory issues that a valve developer and manufacturer needs to consider, but rather to list a handful of aspects of the regulatory world that are interesting and instructive to the heart valve profession as a whole.