Implantable Medical Devices: A closer look at issues related to regulatory oversight and cost

Implantable devices, like cardiac pacemakers and artificial hips, are a central part of medical treatment today. As the population has aged and technology has advanced, the range of implantable devices and the number that are being inserted in people have increased dramatically. As a result, AARP’s Public Policy Institute is taking a closer look at issues related to the regulatory oversight and cost of these devices.

While implantable devices provide potentially life-saving benefits, they also carry substantial risks to patients, including serious injury and even death if they fail. A number of serious implantable device failures have caught the public’s attention and raised questions about the need to improve their safety and effectiveness.

In an Insight on the Issues (and accompanying blog), Keith Lind examines regulatory reform options that could both strengthen and streamline FDA’s approval and oversight of implantable devices while improving protections for public health and safety.

And while millions of people have received expensive implantable devices, the marketplace for these devices remains surprisingly opaque. Market characteristics suggest that prices for many of these devices may be higher than they would be in a competitive market but studies have been unable to gather substantial direct evidence of high prices due largely to a lack of price transparency.

A second Insight on the Issues (and accompanying blog) delves into the market for implantable devices; financial incentives faced by manufacturers, hospitals, physicians, and payers; the impact of the current market structure on competition; and the lack of price transparency. This Insight suggests a number of policy options that could strengthen competition in the marketplace and benefit buyers, payers, and consumers.