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Regulatory Focus™ > News Articles > 2019 > 8 > MDIC Kicks Off Framework on Patient Input in Device Trials

MDIC Kicks Off Framework on Patient Input in Device Trials

Posted 16 August 2019 | By Zachary Brennan 

MDIC Kicks Off Framework on Patient Input in Device Trials

The nonprofit Medical Device Innovation Consortium (MDIC) is seeking comments on the first of three resources to support its Framework for Patient Input in Medical Device Clinical Trials, which is set to be complete next year.

Overall, MDIC seeks to use this framework to better integrate patient input and preferences into the design of device trials and seek to reduce the burden on patients participating in such trials.

The white paper published Wednesday, which is open for comments through 13 September, deals with how to best communicate the benefits, risks and uncertainty of medical technology to patients and providers.

The 14-page paper deals with key factors in communicating benefits and risks, ways to help industry and providers effectively communicate risk and benefits, as well as challenges and other background information.

“Because patients rarely read technology labels themselves, providers are expected to incorporate the clinical data embodied in labeling information, as well as additional studies of the treatment options, into the information that they communicate to patients,” MDIC says. “Medical device manufacturers and healthcare organizations may develop decision aids to help patients better understand the risks and benefits of treatment options.”


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