Introduction: Why a Case Study of Vaginal Mesh Kits?
Through the course of understanding why vaginal mesh kits failed in the market, I came to realize that the cycle of medical device innovation, introduction, failure, litigation, and withdrawal was prevalent in the medical device industry. With this book, I hope to compile an impartial account of the innovation of the medical device cycle and use the vaginal mesh kit example for specifics. As such, the book is divided in two sections. The first section is useful for the corporate leaders, medical device industry representatives, Master of Business or Health Administration (MBA/MHA) students, and medical device utilizers. It details the innovation of medical devices, business development aspects of new devices, medicolegal aspects of medical devices and a review of the FDA process, the ethics of the medical device industry, and finally a unique patient perspective on medical device innovations. The second half of this book is written by both the pro-mesh and anti-mesh authorities in the field of urogynecology to dissect the vaginal mesh kit complications as a case study of what could be done better and how the medical profession responded. It comprises the pertinent anatomy on why a medical device solution may have made sense, the basic science of mesh, the epidemiology of vaginal mesh complications, the evolution of ultrasound for mesh imaging, operative responses for vaginal mesh and sling complications, and the outcomes of vaginal mesh surgeries.
KeywordsInnovation Credentialing Swiss cheese
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