Center for Medical Device Validation

Medical Device

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.

Bookmark and Share

Donate Online

Give Today

We rely on your generosity to provide quality medical care to every child who needs us.
Donate Online

Contact Us


find a location
Find a location Type the first 3-5 letters of a specialty, service or location:
Or, view: a map, a list of all locations, locations by city or locations near me.
find a doctor
Find a doctor Type the first 3-5 letters of the name, location or specialty:
Or, view a list of all doctors by name, location and specialty.