Electrophysiology (EP) Collaboratory
Overview
Convened and co-hosted by MDIC with the Stanford Center for Arrhythmia Research, the Electrophysiology Collaboratory (EP Collaboratory) is dedicated to advancing the science, evidence, and clinical infrastructure needed to bring electrophysiology innovation to patients — faster and in the United States.
Bringing together device manufacturers, clinical investigators, FDA, CMS, academic medical centers, professional societies, and patient advocates, the EP Collaboratory operates in the pre-competitive space where shared challenges benefit from a shared solution. Our work spans the full spectrum of EP innovation: from the earliest human experience with novel devices to the generation of clinical evidence that informs regulatory approval and patient access.
Vision
Our central vision is to serve as the authoritative, inclusive home for pre-competitive regulatory science in electrophysiology — one where stakeholders at every stage of the innovation cycle can find tools, partners, and a clear path forward.
Impact
The EP Collaboratory envisions an ecosystem within which electrophysiology innovations are imagined, developed, tested, and delivered to patients in the United States with optimized quality and efficiency.
We see a future in which clinical sites across academic medical centers, integrated health systems, and high-volume community practices are equally equipped to participate in early-stage device research with industry partners that are motivated and confident to pursue early stage device studies in the US, and where the evidence generated in those studies is accepted by regulators and payers alike.
Mission
The EP Collaboratory brings together a broad and diverse coalition of stakeholders to:
• Reduce barriers to conducting early feasibility studies (EFS) in the United States by developing practical tools, playbooks, and site infrastructure
• Generate consensus on clinical trial design, safety endpoints, and efficacy measures for atrial fibrillation therapies through the AF Ablation Academic Research Consortium
• Facilitate direct, productive engagement between industry sponsors and FDA — early and often — to align on evidence strategies before IDE submission
• Build a self-sustaining clinical site network of EP Pioneer Institutions ready to enroll first-in-human and EFS patients within 90 days of protocol finalization
• Develop key performance indicators to monitor and communicate progress on reducing barriers to U.S.-based EP clinical research
EP Collaboratory Projects
The Collaboratory advances its mission through two flagship initiatives, each targeting a distinct stage of the EP innovation lifecycle.
Early Feasibility Studies (EFS) Initiative
The FDA’s 2013 EFS IDE Guidance created a pathway for conducting small-scale, first-in-human device studies in the United States. Despite strong regulatory support, the majority of EP early feasibility studies continue to be conducted overseas — not due to FDA barriers, but because of site-level operational challenges including contract complexity, budget unpredictability, and long startup timelines.
The EFS Initiative addresses these root causes directly through a comprehensive, freely available toolkit and a growing network of EP Pioneer Institutions committed to 90-day protocol-to-enrollment performance.
Atrial Fibrillation Ablation Academic Research Consortium (AF-ARC)
Establishing consensus on safety endpoints, efficacy measures, and clinical trial design for atrial fibrillation ablation therapies.
The landscape of AF ablation therapy has expanded dramatically — from catheter-based pulmonary vein isolation to pulsed field ablation, surgical approaches, and emerging hybrid therapies. Yet clinical trial design in this space remains inconsistent, with heterogeneous endpoint definitions, variable follow-up durations, and disparate patient selection criteria that limit cross-study comparability and complicate regulatory and payer review.
The EFS Initiative addresses these root causes directly through a comprehensive, freely available toolkit and a growing network of EP Pioneer Institutions committed to 90-day protocol-to-enrollment performance.
What is a Collaborative Community?
Collaborative Communities are an FDA initiative to address common challenges, collaborate with stakeholders to achieve common outcomes, and advance the medical device ecosystem. The FDA Collaborative Community model enables multi-stakeholder groups to work in the pre-competitive space on regulatory science questions that benefit the entire field — without the constraints of bilateral sponsor-agency interactions.
The EP Collaboratory is among the first FDA-recognized Collaborative Communities in electrophysiology. To learn more about the FDA Collaborative Community program, visit the FDA Collaborative Communities webpage.
FAQ
The EP Collaboratory is open to any organization or individual with a stake in electrophysiology innovation. This includes device manufacturers, clinical investigators and academic medical centers, community and integrated health system EP programs, FDA and CMS, professional societies (including HRS), patient advocacy organizations, and CROs. MDIC membership is not required.
No. MDIC serves as the convener of the EP Collaboratory, and non-MDIC members are welcome to participate fully. Certain MDIC member benefits — including priority access to working groups and toolkit development — are available to MDIC members.
EP Pioneer Institutions are clinical sites that have committed to the operational infrastructure needed to achieve 90-day protocol-to-first-patient enrollment timelines for EFS studies. Qualifying sites have identified dedicated study management personnel, secured institutional buy-in from key stakeholders (IRB, contracts, budget, technology), and adopted the MDIC EFS toolkit. Reach out to the EP Collaboratory team to begin the qualification process.
Sponsors can engage through the EFS Explorer to identify site partners, participate in working groups, or request facilitated informal conversations with FDA through the Collaboratory network. Sponsors at any stage of EP device development — from early design through IDE — are encouraged to connect early.
The EP Collaboratory charter is available on the Collaboratory resource page. [Link to charter — insert URL]
All EP Collaboratory resources — including the EFS Playbook, CTA template, budgeting template, site selection tools, FDA engagement checklist, and EFS Explorer — are freely available here. The toolkit is currently in preview mode, with a full public launch planned for June 2026.
The EP Collaboratory is a distinct, independently operating Collaborative Community focused on electrophysiology. It shares the MDIC Collaborative Community infrastructure and draws on learnings from the Heart Valve Collaboratory — particularly in the areas of EFS site readiness and clinical trial agreement standardization — while addressing the unique regulatory and clinical landscape of EP device development.
Join Us!
Whether you are a clinical site looking to build EFS infrastructure, a sponsor navigating the IDE pathway, or a researcher shaping the next generation of AF ablation trial design — there is a place for you at the table.
To join the EP Collaboratory or learn more, contact the MDIC EP Collaboratory team below
EP Collaboratory Leadership
Paul Wang, MD, Stanford Center for Arrhythmia Research
Co-Chair, EP Collaboratory; Director, Stanford Center for Arrhythmia Research
Hetal Odobasic, FDA
Division Director, Office of Cardiovascular Devices
Eileen Mihas, MDIC
Center Head, Center for Evidence and Patient Engagemenet
Jonah Golder, MDIC
Senior Project Manager
Learn more about Early Feasibility Studies at MDIC
To learn more about MDIC’s Early Feasibility Studies (EFS) initiative reach out to efs@mdic.org.