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FDA

Published On May 20, 2021

POLICY

What Is a Collaborative Community?

An unconventional new model makes industry meetups a key part of medical device regulation.

Biopsies are still mostly read under a microscope by a human pathologist. The diagnostic process can be a painstaking endeavor and often renders an up-or-down opinion: cancer or no cancer, for example. Digitizing this work would not only speed up processing but, coupled with artificial intelligence, might give more accurate information—a 90% chance a tissue specimen is malignant and the patient will respond to a therapy, for example—that could affect treatment considerations. 

But this frontier of digital pathology calls for new tools—scanners, viewers and software. And a lack of regulatory standards for these components has slowed their development and wider adoption. The same story is echoed across many new areas where device innovation moves quickly but expertise is limited to a small circle of specialists. 

Enter the collaborative community (CC). The Center for Devices and Radiological Health (CDRH), which oversees regulation of medical devices for the U.S. Food and Drug Administration, launched the program, but the Medical Device Innovation Consortium is now acting as the formal convener. It encourages stakeholders—including those who make, sell, use and regulate medical devices—“to solve shared challenges in an environment of trust, respect, empathy and openness,” says Michelle Tarver, deputy director of CDRH’s Office of Strategic Partnerships and Technology Innovation.

These communities can help lay the groundwork for potential policy related to the devices, although the work that comes out of them is often much broader. While the CDRH has created a Collaborative Communities Toolkit, the FDA isn’t in charge of any CC; rather, the agency is only one of many equal members. (The CDRH currently participates in 10 communities.) Collaborative communities work to find solutions to problems that affect a broad sector of the device industry. The experience of one group—the Pathology Innovation Collaborative Community (PIcc)—is shown below.