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The FDA Group’s Nick Capman recently sat down with Marwan Fathallah, President and CEO of DIA Global, for an in-depth discussion on what it takes to lead effectively across the life science product development cycle—from early innovation through commercialization.
With nearly 30 years of experience spanning pharmaceuticals, medical devices, and diagnostics, and leadership roles across R&D, regulatory, clinical, scientific affairs, and operations, Marwan brings a rare, holistic view of how leadership, culture, and systems thinking unite to drive successful outcomes in complex, regulated environments.
Marwan shares how to build a culture that allows innovation and compliance to coexist, how to structure cross-functional teams for consistent execution, and why emotional intelligence, integrity, and systems thinking matter just as much as technical expertise.
Nick and Marwan also explore practical ways to align R&D, regulatory, and commercial priorities without compromising rigor, and how to keep the patient, not internal silos, at the center of every decision.
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Marwan’s key takeaways and recommendations
If you’re short on time, here are standout insights from this episode.
Balance innovation with rigor. Innovation and compliance don’t have to be in conflict. The key is culture. Teams need an environment where it’s safe to test, fail fast, and learn quickly—but within boundaries of scientific and regulatory discipline. Embedding regulatory and quality early in R&D ensures compliance is built in, not bolted on at the end. “You want to embed compliance into innovation—not bolt it on at the end. Bring regulatory, R&D, and marketing together early. They’ll rub off on each other and drive a more balanced, informed process.”"
Build structured collaboration. Cross-functional excellence doesn’t happen by chance. Marwan emphasizes forming product development committees where R&D, regulatory, clinical, operations, and marketing leaders share ownership. Each function has defined deliverables, clear communication channels, and a common understanding of the problem being solved. Using Lean and Six Sigma practices keeps the collaboration efficient and transparent:
Daily stand-ups led by a project manager “maestro.”
Visual KPIs and milestone tracking visible to all stakeholders.
Regular “lessons learned” reviews that drive continuous improvement.
Use the right KPIs. Lagging indicators tell you what already happened. Leading indicators—like early feasibility data, interim study results, or regulatory feedback cycles—help teams predict and prevent issues. Tracking progress through shorter, iterative milestones creates agility and keeps teams focused on learning and course correction, not just end-stage validation.
Lead with transparency, empathy, and systems thinking. Cross-functional success depends on leadership, not just process. Marwan highlights four essential traits:
Communication: Translate technical detail into business language.
Integrity: Share the full picture—good or bad—early.
Empathy: Understand how each discipline measures success.
Manage conflict directly and respectfully. Conflict is inevitable in development teams. What matters is how it’s handled. Address issues quickly, separate emotion from fact, and focus on action. Regular “retrospectives” help teams depersonalize setbacks and embed continuous learning.
Keep the patient at the center. Every successful cross-functional team shares one anchor: patient impact. Framing decisions through the patient lens helps align departments and maintain moral clarity under pressure.
One thing to bring back to your team
Establish or revisit your product development committee:
Embed regulatory and commercial leaders early.
Define ownership and accountability by function.
Hold short, structured stand-ups with visual KPIs.
Encourage transparency and psychological safety.
Then ask: Are we truly one team focused on patient outcomes—or separate groups optimizing for our own priorities?
Marwan Fathallah is President and CEO of DIA Global. He is a veteran life science executive with nearly three decades of experience spanning R&D, regulatory affairs, operations, and commercialization. Before joining DIA, he served as Chief Operating Officer at a global diagnostics company and has led cross-functional teams responsible for taking products from concept to market launch.
Connect with him on LinkedIn here.
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