Measuring the Physiologic Use Conditions of Medical Devices: An Introduction

It is hard to overstate the positive impact that safe and effective medical devices have had on our world, saving lives and improving health for millions of patients a year. From stents placed in numerous different locations to stimulators aimed at activating specific tissues to pumps that act as physiologic surrogates, each of them must be designed to withstand the challenge of interacting with the human body. While other industries also require products designed in a way that enables successful interaction with and performance in unique environments, our physiology presents unique challenges for biomedical applications. Human physiology has been studied for many years, but mainly in the context of diagnosis and treatment. The understanding of how devices impact and are impacted by human physiology has only been studied in recent decades. We call the environment and stresses uniquely impacting any medical device the physiologic use conditions of that device. It is our goal with this book to introduce and shed light on a critical discipline in the process of conceptualizing, studying, developing, and maintaining reliability in medical devices.