Medical Device Innovation

For patients in the United States with serious medical conditions, access to new medical technologies can mean the difference between life or death. Those patients rely on new devices—such as cardiac stents or prosthetic joints—to treat, cure, or diagnose debilitating or life-threatening conditions.

But medical device development—from prototype to approval—can take years, leaving some patients without treatment options in the meantime. Healthcare experts need to find ways to shorten this development process without compromising safety, especially for those patients with unmet medical needs. In response, the U.S. Food and Drug Administration has issued policy proposals designed to accelerate patient access to novel medical devices and establish a new expedited process for innovative technologies.

Pew is working to advance policies designed to accelerate access to novel medical devices without putting patients in unnecessary harm.