What should the public know about implantable material and device innovation in the us?

Abstract

Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks. At the macro level, designers and manufacturers of implantable devices and regulators must balance the need for assurance of devices' safety and effectiveness with industry and clinical investigational enthusiasm about innovation. At the micro level, clinician-investigators need to inform patient-subjects about a particular device's influence, for better or worse, on short- and long-term health goals.