Regulatory Pathway Overview
Regulatory Pathway Overview
Join Dr. Geetha Rao and Ester Carrasco, MEng, as they demystify the complex world of medical product regulation in this comprehensive regulatory pathway overview. Whether you’re developing medical devices, pharmaceuticals, or digital health solutions, this session provides the strategic foundation you need to navigate FDA approval and global market entry successfully.
Learn how medical products are regulated across their entire lifecycle—from pre-market development through post-market surveillance—and discover why regulatory approval is just the beginning of your commercialization journey. This session covers risk-based device classification, the critical differences between 510(k), De Novo, and PMA pathways, and how to build quality management systems that scale with your startup.
Understanding these regulatory frameworks is essential for securing investment, planning clinical trials, and achieving commercial success. You’ll gain practical insights on defining intended use, aligning your regulatory strategy with reimbursement and clinical adoption goals, and avoiding common pitfalls that delay approval. The session includes a hands-on worksheet to help you apply these concepts to your own innovation. By the end, you’ll be equipped to make informed decisions about your product’s regulatory journey and communicate effectively with investors about your pathway to market.
Learning Objective
• Mastered Product Lifecycle Compliance: Acquired comprehensive operational knowledge of the federal regulatory lifecycle for medical products, establishing execution milestones across pre-market development, market clearance, and post-market surveillance phases.
• Formulated FDA Regulatory Strategies: Evaluated and mapped device-specific submission pathways, including 510(k) premarket notification, De Novo classification, and Premarket Approval (PMA) protocols, to align product risk profiles with necessary clinical data thresholds.
• Defined Target Labeling Parameters: Authored formal “Intended Use” and “Indications for Use” declarations, structurally balancing target patient demographics, clinical environments, and contraindications against downstream regulatory burdens and reimbursement models.
• Applied Global Risk Classifications: Utilized international risk-based device classification matrices (Class I, II, and III systems) to accurately forecast, budget, and schedule multi-jurisdictional regulatory pipeline requirements.
• Engineered Quality Governance Frameworks: Designed foundational architecture for an FDA-compliant Quality Management System (QMS), establishing core operational controls for product development, design verification, and cross-lifecycle quality assurance.
Geetha Rao
Dr. Rao is an executive and strategic advisor on innovation and regulation of medical technology platforms, and connected health systems. Her particular focus is on digital transformation with specific application to agile compliance strategies for rapid commercialization.
She provides the vision for her company, as it enables clients to rapidly and cost-effectively meet compliance requirements and move their products to market. She also provides clients with regulatory and legal problem-solving related to submissions, contractual issues in quality and risk, audit findings, and adverse events.
She is an internationally recognized expert in interoperability and risk management for health software, supporting international regulation policy and standards development. She leads standardization efforts for assuring safe and secure interoperable medical systems.
She has addressed numerous industry forums on issues of emerging health technologies and innovation trends for connected medical technologies and mentored numerous startups on regulatory and market strategy.
Ester Carrasco
Ester Carrasco is the Head of Client Services at Springborne Life Sciences, a leading compliance service provider supporting early to mid-stage Digital Health and Medical Device companies. At Springborne, she specializes in supporting these companies navigate the complexities of their compliance journey to enable rapid commercialization of innovative healthcare products.
Her responsibilities include regulatory strategy, compliance planning, and leading regulatory filings including FDA submissions.
Ester completed her MEng in Biomedical Engineering from the University of Toronto.
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