The landscape of medical device innovation thrives on the vigor of Early Feasibility Studies (EFS), a critical mission within the Medical Device Innovation Consortium. The collective pursuit revolves around advancing patient care through novel device accessibility, uniting stakeholders under a common goal. Early Feasibility Studies and pivotal trials rely on strong relationships among industry, research sites, and principle investigators, with MDIC playing a major role in fostering collaborative success. In November 2023, MDIC hosted a roundtable discussion on Early Feasibility Studies in the electrophysiology space. The roundtable was moderated by Dr. Vivek Reddy, Director of Electrophysiology for the Mount Sinai Health System, and Dr. Pete Weiss, Cardiac Electrophysiologist at Banner University. Panelists included Devi Nair, MD, Andrew Farb, MD, Hetal Odobasic, Olav Bergheim, and Eileen Mihas.
Watch the Full Roundtable on MDIC’s YouTube Channel:
Key Insights from the Medical Device Innovation Consortium/FDA Electrophysiology Roundtable
At the heart of EFS success lies the crucial role of Principle Investigators (PIs). An investigators influence in expediting negotiations, rallying legal support, and engaging industry teams ensures the seamless progression of EFS and pivotal studies. Collaborative efforts between PIs, legal teams, and industry counterparts foster timely decision-making and alignment.
Success in EFS and pivotal trials hinges on robust relationships among industry, sites, and PIs. Building and nurturing these alliances creates an environment for collaborative success.
EFS serves as a bridge to pivotal trial discussions. Roundtable participants made clear that consistent communication and alignment with the FDA enables a smoother transition towards pivotal trials. Discussions about pivotal trials commence during the EFS and the pre-submission phase, fostering alignment with the FDA throughout the process.
Complexities in the Ecosystem
The EFS Roundtable highlighted common issues in navigating CMS (Centers for Medicare & Medicaid Services), coding, and coverages—a persistent challenge that the Medical Device Innovation Consortium continues to address.
Securing Clinical Trial Insurance serves as a pivotal step, which can save valuable time and resources. When negotiating with clinical sites it is important to remain aware of the slip streams and be willing to migrate rapidly to other sites in parallel to ensure a timely process for study site initiation and first patient enrolled. When challenges arise with certain sites, continued perseverance in navigating the contracting process is of great importance for capturing diverse data.
The Right Testing at the Right Time
Initiating dialogue with the FDA early on remains a critical factor in the success of an EFS. Aligning strategies and utilizing parallel pathways (US and non-US) streamlines the crucial Investigational Device Exemption (IDE) process, expediting innovative device integration into the US market. Fostering early US site experience and aligning with FDA expectations ensure operational efficiency and helps mitigate learning curves.
Data is the currency that fuels progress! Investing upfront in data generation and establishing safety profiles while maintaining open lines of communication with the FDA paves the way for iterative product enhancements and robust IDE applications. Embracing feedback loops—be it positive, negative, or constructive—ensures an optimized trial process through collaborative engagement.
FDA is an equal partner in a very complex clinical trial ecosystem. FDA appreciates all feedback. By working together and providing a continuous feedback loop, the clinical trial process can be optimized.
Collaborative synergy among stakeholders, proactive engagement with regulatory bodies, and a commitment to agile adaptation stand as the pillars fostering groundbreaking advancements in the medical device industry.
Busting EFS Myths
Facts
- Studies can be expanded beyond 15 patients, as data becomes available
- New study phases can be under the same IDE
- Non-GLP studies may support EFS with appropriate rationale
Myths
- All non-clinical assessments must be completed prior to initiating an EFS
- First in Human studies must be EFS
- Protocol iterations are not possible
For more information about Early Feasibility Studies, visit mdic.org/program/early-feasibility-studies-efs or contact Eileen Mihas, EFS Program Director, at emihas@mdic.org.
