ABSTRACT
The translation of a sensor technology into clinical medicine is a complex and multifaceted undertaking [1-4]. In addition to challenges in the discovery phase, there are regulatory, reimbursement, and physician acceptance hurdles to clear. The latter challenges are often not considered in research-oriented journal articles and authors of such articles run the risk of reporting on developments that may ultimately be sterile in a translational sense. As research funding sources become increasingly challenging to obtain, work that purports to support new capabilities in human medicine must be complete in the sense of being able to clear all hurdles that will be arrayed against it. This is not to say that there is not a vital role for pure research projects, but work that is “justified” by an implied payback in advancing human health must evolve with a full recognition and acceptance of what that entails. Some questions that should be asked, even at the earliest stages of development are:
8.1 Introduction .................................................................................................. 147 8.2 The FDA Process for Medical Devices ........................................................ 148
8.2.1 Safety and Efficacy ........................................................................... 149 8.2.2 Establishing a Predicate .................................................................... 149 8.2.3 Regulatory Pathway .......................................................................... 150 8.2.4 Independent Device Testing ............................................................. 151 8.2.5 Some Specific Examples of Sensor Characteristics That Evoke
Regulatory Decision Points .............................................................. 151 8.3 Current Trends in FDA Regulations ............................................................. 157 8.4 Summary ...................................................................................................... 158 References .............................................................................................................. 159
• Will the product fit into existing reimbursement codes? • Will the product be approved by the FDA when a tractable clinical trial is
completed? • If the device is an implantable sensor, how is it implanted and can it be
included with an existing procedure? • Does the device fit with existing medical training and practices and if not
what is the learning curve for acceptance? • If the device involves sensor data, specifically, how will that data be used
to influence patient care? • Can the device be manufactured in a cost-effective way? • Does the implanted device meet the “burden of inconvenience” test, mean-
ing that the information provided is unique and valuable and cannot be obtained by less invasive means (e.g., a blood test)?
