The Medical Device Innovation Consortium (MDIC) announced today that the organization will serve as the convener of the new Pathology Innovation Collaborative Community (PIcc), and that the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will be a participant. MDIC is convening the collaborative community as a regulatory science initiative that aims to facilitate innovations in pathology that may advance safety and effectiveness evaluation, and to harmonize approaches to speed delivery to patients using collaborative, pre-competitive approaches.
“As the Convener of the PIcc, MDIC can create a neutral environment for the diverse group of stakeholders within the healthcare ecosystem so that they can collaborate openly with other manufacturers, providers, patient groups, payors, and regulators” said Pamela Goldberg, CEO & President of MDIC.
The purpose of a collaborative community is to bring together stakeholders in a continuing forum of private- and public-sector members to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Ultimately, collaborative communities seek to contribute to the improvement of areas affecting U.S. patients and healthcare.
“FDA has accepted the invitation to join the Plcc in the hopes that it will help advance a common understanding of the technical and operational requirements of emerging digital pathology technologies. This baseline understanding can contribute to FDA’s development of a consistent and transparent regulatory approach that will help to speed innovation in the area and assure patient safety,” said Ed Margerrison, director of the Office of Science and Engineering Laboratories (OSEL), CDRH.
PIcc strives to accomplish the following preliminary goals: to unlock the potential of digital pa-thology using regulatory science approaches to help as many patients as possible; to train and educate each other in an interdisciplinary fashion with a focus on pre-competitive regulatory science; to create an environment that motivates and encourages all stakeholders to move the field of pathology forward. The collaborative community would ultimately like to identify and develop regulatory science tools that provide input into regulatory pathways that streamline innovation in pathology. “Pathology is on a brink; and the problem is not technology”, says Joe Lennerz, MD, PhD, Medical Director, Center for Integrated Diagnostics at Massachusetts General Hospital as well as Associate Professor, Harvard Medical School, who is the chief archi-tect of the PIcc/Alliance. “To improve patient care, we need to apply the best possible science as an input into regulatory activities. Not actively contributing and providing scientific input into regulatory decision-making is a missed opportunity. Many experts have recognized this tremendous opportunity and contributed to create this community.”
PIcc is the third collaborative community for MDIC. In 2019 MDIC’s National Evaluation System for health Technologies Coordinating Center (NESTcc) Collaborative Community was named one of the first collaborative communities with FDA participation. In October, MDIC announced the convening of the Case for Quality Collaborative Community, also with FDA participation.
Those who are interested in learning more and joining the PIcc are encouraged to visit initiative page here.