The majority of medical devices introduced to the market do not undergo the same rigorous FDA approval process as pharmaceuticals. Introducing a medical device often requires only “Premarket Notification.” The manufacturer simply demonstrates their product is “substantially equivalent” in safety and effectiveness to another lawfully marketed device or recognized FDA standard when used for the same purpose (similar to generic drug approval).
Sometimes, however, manufacturers tout unsubstantiated clinical benefits. The FDA does not verify such claims—only that the device is safe for clinical use. Therefore, to motivate providers to adopt new technologies, medical device companies often face the challenge of proving the value of their devices at the bedside.
Akron Children’s collaborates with medical device manufacturers to design and conduct investigations intended to generate credible evidence of diagnostic and treatment value compared to current standards of care.
Occasionally, by contrast, such trials may result in findings that a newer, more expensive device, offers little or no clinical, safety, or efficiency advantages over existing technologies. This arms clinicians and administrators with valuable data when considering new equipment purchases.
At Akron Children's Rebecca D. Considine Research Institute, we view devoting resources to acquire medical device evaluation expertise as especially fertile territory.
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