Q&A: Malvina Eydelman, MD, on leading CCOI and catalyzing global ophthalmic innovation

Malvina Eydelman, MD, discusses her vision for CCOI, focusing on global collaboration, modernizing innovation pathways, and advancing patient-centered ophthalmic solutions. (Photo courtesy of Malvina Eydelman, MD)

As newly appointed chief executive officer of the Collaborative Community on Ophthalmic Innovation (CCOI), Malvina Eydelman, MD, is leading efforts to accelerate innovation, unite global stakeholders, and transform the future of eye care. Her appointment marks a pivotal moment for CCOI as it expands its mission to improve patient outcomes and advance groundbreaking ophthalmic solutions.

Before stepping into this new role, Eydelman spent more than three decades at the FDA, where she played a central role in shaping regulatory pathways for medical devices across multiple specialties.¹ Most recently, she served as Director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, guiding multidisciplinary teams in the development and oversight of cutting-edge technologies.

Eydelman recently sat down with Sheryl Stevenson, executive editor with the Eye Care Network, to discuss her vision for the future of ophthalmic innovation, the regulatory landscape, and the collaborative initiatives shaping the field.

Transcript edited for clarity.

After decades of leadership at the FDA, you’re now stepping into a very different kind of role. What excites you most about leading CCOI at this moment in your career?

Malvina Eydelman, MD: What excites me most about leading CCOI at this point in my career is the shift from enabling innovation within the government to directly catalyzing it on a global scale. At the FDA, I spent decades creating pathways for safe, effective technologies to reach patients faster. Now, I have the opportunity to go further, to build the plane and not just clear the runway. CCOI isn’t just another initiative. It’s a global launch pad for change. We’re uniting patients, regulators, clinicians, and industry leaders to dismantle the silos and rewrite how ophthalmic innovation is developed, assessed, and delivered worldwide. This is more than regulatory reform. It’s about re-engineering the entire ecosystem. The innovation pipeline, unfortunately, is clogged not for lack of ideas but because we’ve been working within an outdated framework, legacy endpoints, misaligned incentives, fragmented data, and slow uptake of real-world evidence. CCOI is tackling these head on. We are aligning global regulators, testing bold new models, and making data work across borders. After years of evaluating innovation from a regulatory vantage point, I now get to shape the global infrastructure that determines how fast and how far innovation can go. We are designing the future of eye care faster, smarter, and together.

You’ve spoken about the importance of uniting diverse stakeholders—industry, regulators, clinicians, and patients. How do you plan to expand and deepen that collaboration through CCOI?

Eydelman: Real collaboration isn’t just about gathering people in the room. It’s about aligning incentives, building trust, and co-creating clear, actionable road maps. By leveraging the collective strengths of all stakeholders, we can break down the systemic barriers that are holding the innovation back. That starts with bringing patients, innovators, clinicians, regulators, and industry leaders to the table early, aligning on trial design, end points, evaluation metrics from the ground up. Our goal is to set a new standard for collaboration: proactive, strategic, and outcome driven. This is how we’re going to make real-world progress.

CCOI is known for identifying and addressing barriers to innovation. From your perspective, what are the most pressing challenges in ophthalmic product development today—and how can CCOI help overcome them?

Eydelman: I believe that today’s biggest barriers to progress include a fragmented innovation ecosystem, outdated clinical trial end points, limited global harmonization, and insufficient patient input early in the development. These challenges are significantly slowing down the path from discovery to patient impact.

First, we face a lack of standardized outcome measures. Without a shared understanding of what success looks like, particularly for emerging therapies, sponsors are navigating unpredictable approval pathways. To address this, we are codeveloping and validating patient-centered end points in close collaboration with global stakeholders.

Watch the video: CCOI's new CEO Malvina Eydelman, MD, outlines her mission and vision for the organization

Second, the high cost and complexity of clinical trials remain major obstacles. Patient recruitment and data collection continue to be resource intensive, and there is a global shortage of sites that are properly trained to conduct trials to the highest standards. CCOI’s vision is to establish a global consensus on the criteria for ophthalmic clinical centers of excellence. From there, we will implement a robust training and certification process to formally designate sites as global centers of excellence in clinical trials. This will significantly improve the speed, reliability, and scalability of clinical research worldwide, ultimately accelerating access to innovative treatment for patients.

With your extensive experience advancing technologies like AI, premium IOLs, and bioelectronic implants, how do you see CCOI shaping the next wave of ophthalmic innovation?

Eydelman: Great question! CCOI will shape the next wave of ophthalmic innovation by derisking the development path for emerging technologies, whether it’s AI-driven diagnostics, smart implants, or regenerative therapies. These innovations don’t fail because the science isn’t there. They fail because the ecosystem, regulatory, clinical, financial isn’t ready, and that’s where CCOI comes in. We are focused on building the infrastructure, clear guidelines, validated frameworks, and aligned incentives that industry and investors need to move fast without compromising safety or efficacy. For instance, AI tools for early diagnosis can transform care, but only if clinicians and regulators trust the outputs. CCOI is working to establish that trust by building consensus, eliminating friction, and accelerating adoption. My goal for CCOI is very simple, to ensure that the next generation of ophthalmic medical products isn’t just invented but implemented.

You’ve led initiatives that center the patient voice, including developing patient-reported outcomes. How will patient perspectives inform CCOI’s strategy under your leadership?

Eydelman: Well, the patient voice isn’t just a check box. It’s the foundation of meaningful innovation. Under my leadership, it will be a cornerstone of CCOI strategy. We can’t claim progress if it doesn’t resonate with the people it’s meant to help. That means integrating patient perspectives from day one through design, development, clinical validation, and even post market use. At CCOI, we’re not just listening to patients, we are giving them a seat at the table. I’m building on the work that I led at the FDA to embed patient-reported outcomes and functional assessments into the heart of product development. Our work group on vision assessment and outcome measures is focused on defining and validating tools that reflect what patients actually care about, not just what’s easy to measure. If we want innovation that truly matters, we have to measure what matters to patients. That’s how we ensure that the next wave of technology improves, not just the clinical metrics, but the real lives.

As someone who bridges both regulatory insight and academic mentorship, how do you envision CCOI engaging the next generation of innovators?

Eydelman: To truly engage the next generation of medical product innovators, we must radically rethink how we mentor, educate, and empower them. It’s no longer enough to focus solely on clinical and technical expertise. Today’s innovators need a comprehensive understanding of regulatory science, strategic decision making, IP protection, reimbursement, and organizational dynamics. These are critical but often overlooked skills that drive real-world innovation, yet they’re rarely taught in traditional medical training. At CCOI, we’ve laid a strong foundation through our global, no cost, annual conference, which we have attracted over 1200 participants from nearly 50 countries. These events have been instrumental in fostering cross-border collaboration and highlighting cutting-edge developments. But this year, we’re not stopping there.

In the coming year, we’re scaling up significantly with the launch of the CCOI Innovation Academy. This will include virtual conference, in-person symposia, and a suite of online courses designed to fill the gaps left by conventional medical education. We’re also very proud to announce a strategic partnership with the Byers Eye Institute Innovation Fellowship at Stanford. Together, we are taking this program global under the CCOI banner and creating a very unique training pipeline that equips the next generation of ophthalmic innovators with the tools to bring ideas from concept to clinic, globally and sustainably. This is how we shape a future ready, innovation driven generation by giving them not just knowledge but the system for navigating the complexity of real-world impact.

You’ve called this a ‘critical time’ for the ophthalmic community. What does success look like for CCOI in the next 2–3 years under your leadership?

Eydelman: Well, unfortunately, right now, the ophthalmic innovation ecosystem is facing a defining moment. There’s real anxiety across the field, uncertainty around regulatory pathways, market access, and the long-term viability of innovation. If decisive action isn’t taken, the pipeline could slow dramatically, but with pressure comes opportunity, and CCOI is uniquely positioned to lead. Success to me over the next 2–3 years won’t mean incremental progress; it will mean transformation. CCOI will evolve into the global nerve center for ophthalmic innovation, the place where the future of eye care isn’t just imagined but engineered and delivered. That means we’re moving from reactive to proactive, anticipating challenges before they arise, cutting time to market, accelerating regulatory pathways and expanding global access to care. We’ll drive smarter trial designs, faster approvals, and deeper cross-sector alignments that lifts the entire field. CCOI’s role will shift from being a form to a force multiplier, launching frameworks that others adapt, influencing policy at the highest levels, and ensuring innovations reach patients faster. The goal isn’t just progress; it’s building an ecosystem that preempts barriers and redefines what’s possible. In 2–3 years, the question won’t be ‘Why CCOI?’—it’ll be ‘What would we do without it?’

Reference

1. Malvina Eydelman, MD, appointed CEO of Collaborative Community on Ophthalmic Innovation (CCOI). News release. Collaborative Community on Ophthalmic Innovation. April 3, 2025. Accessed April 24, 2025. https://www.prnewswire.com/news-releases/malvina-eydelman-md-appointed-ceo-of-collaborative-community-on-ophthalmic-innovation-ccoi-302420294.html