A successful initial meeting was held at the FDA on July 18, 2019.
Over 50 attendees from various entities were in attendance. Attendees shared an interest to encourage innovation and commercialization by developing evaluation tools, methods and standards, and clarifying regulatory pathways in digital pathology and specifically in the AI space were present. A temporary alliance has been established between the different participating entities with the intent to grow the alliance to incorporate additional stakeholders.
Below are four of the key presentations by FDA, MDIC, DPA, and The Alliance for Digital Pathology Proposal.
MICHELLE TARVER, FDA, COLLABORATVIE COMMUNICATIONS
The presentation outlines best practices for establishing and maintaining collaborative communities.
Specifically, a collaborative community may be appropriate when challenges are ill-defined and there is interrelatedness of the partners.
The presentation outlines also some potential deliverables.
PAMELA GOLDBERG, MDIC, OVERVIEW
The Medical Device Innovation Consortium (MDIC) is a public-private partnership with a sole objective: advancing regulatory science of medical devices for patient benefit.
MDIC is the leading resource on issues important to the Medtech Innovation ecosystem and has successfully organized several projects and programs. The presentation outlines the MDIC’s organizational structure and focus area projects.
More information on the MDIC here
ESTHER ABELS, DPA, WHAT TO EXPECT
The Digital Pathology Association (DPA) is a not-for-profit organization comprised of pathologists, scientists, technologists and representatives from industry that focus on advancing digital pathology.
The DPA has a strong interest in regulatory sciences and established a regulatory and standards task force. The presentation outlines the DPA’s history, general principles, and concrete questions.
More information on the DPA here
JOE LENNERZ, MGH/CID, ALLIANCE PROPOSAL
This is the original proposal to establish The Alliance for Digital Pathology held on July 18th, 2019 at the FDA. The proposal gives the reason for establishing a voluntary and temporary collaboration to accomplish concrete practical deliverables and relevant strategic aims that are of shared interest to the whole field. The key element in the presentation is the proposed framework to have domain experts collaboratively develop ideas that are presented to a steering committee. Until more resources are available, the organization of The Alliance is led by CID/MGH (Boston, MA).