In this episode I speak with Suzanne Levy Friedman who is a Senior Associate in the Medical Devices and Technology Regulatory Group at Hogan Lovells in Washington, D.C.. In that role, Suzanne assists device companies in a wide range of activities across the life cycle of their products, including preparing regulatory submissions for clearance or approval of new devices, advising manufacturers on the lawful promotion and advertising of their devices, and addressing post-market enforcement issues.

She has a particular specialty in dealing with the FDA's evolving paradigm for software and digital health products, and she has helped clients determine the appropriate regulatory pathway for various products in this space and bring them to market. In law school, Suzanne interned at the FDA's Office of Chief Counsel, where she learned firsthand about the range of legal and regulatory issues addressed by the agency's Food, Drug, Device, Veterinary, and Tobacco centers and spent two years before law school working for a health policy consulting firm advising clients on the business impact of FDA actions and related legislation.

We live in a world where consumer health products and even software can serve an important role in keeping us healthy. As a result we discuss the fast-moving and ever-growing practice area of medical device law where Suzanne regularly practices before the FDA. We also discuss Suzanne's path, the mindsets and skills necessary to succeed in a scientific practice area (even if you are not a trained scientist), the varied toolbox of experience necessary to work in a heavily regulated area, how to communicate with in-house partners to succeed as outside counsel, and the importance of project management skills to young lawyers.

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Bonus episode: Why Australia is better than Britain