Navigating the FDA Maze: Insights from FDA Reviewers and Innovators

Regulatory success isn’t just about good data—it’s about presenting the right evidence, at the right time, in the way reviewers expect.

Even the most innovative device can stall when evidence, claims, or communication misalign with FDA expectations. Understanding how reviewers interpret data, risk, and usability can transform how early studies, submissions, and documentation are designed. Anticipating reviewer expectations—and aligning strategy, evidence, and presentation—can save months of rework and significantly improve the likelihood of clearance.

In this one-hour webinar, former FDA reviewers and MedTech leaders share practical insights into how regulatory decisions are made and what distinguishes a clear, credible submission from one that stalls. You’ll gain a reviewer’s perspective on evidence planning, risk communication, and regulatory strategy—helping you chart a more confident path from concept to approval.

Key Takeaways

• Insider view of FDA decision-making
• Avoidable mistakes that delay approval
• Strategies to align evidence and communication for faster clearance

Speakers

Francesca D. Joseph, MD, MBA is a physician, educator, and business leader specializing in pediatric medical technology innovation and regulatory strategy. She has advanced more than 150 pediatric innovations, including over 20 that achieved FDA clearance or approval, and pioneered clinical trial infrastructure tailored to children’s needs. With experience spanning the FDA, clinical practice, and advisory roles with health tech start-ups, she bridges clinical, regulatory, and business expertise to accelerate innovation and improve outcomes for children.

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Mo Choudhury is a strategist and mission-driven leader with more than 15 years of experience advancing medical device innovations from concept through commercialization. Her career spans the FDA, NIH, and industry, where she has shaped regulatory strategy for technologies ranging from AI-enabled diagnostics to digital and pediatric devices. At Philips Ultrasound, she led global regulatory strategy for AI-driven imaging platforms and partnered with the Gates Foundation to expand access to maternal health technologies in low- and middle-income countries. As a Program Director at the NIH, she advised on translational research, small-business funding, and technology transfer to accelerate innovation from lab to market. At the FDA, Ms. Choudhury directed technical reviews and regulatory science initiatives for emerging technologies across cardiac, neuro, and optical diagnostics, as well as AI, digital health, and pediatric device programs.

Martha Wang, Ph.D., is the Assistant Director of the Robert E. Fischell Institute for Biomedical Devices at the University of Maryland, College Park, where she mentors student entrepreneurs developing and commercializing medical devices. She also teaches in the Fischell Department of Bioengineering, focusing on biomaterials, device design, and commercialization. With a proven track record in FDA-compliant manufacturing, Dr. Wang brings extensive experience in medical device development, regulatory compliance, and technology translation. Her expertise spans cGMP, GLP, ICH, and process scale-up, bridging academic innovation with industry-ready execution. In addition to her work at the Fischell Institute, she leads initiatives such as Maryland MedTech Week to strengthen regional collaboration among researchers, industry partners, and government agencies.

Moderator:

Dr. Fehmida Kapadia CEO, Amplify MedTech. Dr. Kapadia helps MedTech innovators accelerate their journey from concept to market. She brings expertise in commercialization, regulatory strategy, and market pathways, empowering startups and established companies to navigate the challenges of product development.

What is Amplify MedTech?

Amplify MedTech is building a collaborative MedTech ecosystem. We aim to drive innovation, foster collaboration, and support the development of groundbreaking healthcare solutions. By connecting entrepreneurs, startups, investors, service providers, economic development agencies, and researchers, Amplify MedTech seeks to revolutionize patient care locally and globally.

Sponsorship Opportunities

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