🎙 Episode #042: Suzanne Levy Friedman (Medical Devices Lawyer)

👋🏻 Greetings (and an early Happy Thanksgiving) from freezing Washington, D.C.

You might not think of lawyers as playing a role in innovation, but they do! In a world where medical devices are not just used in hospitals but are also worn on our bodies and in apps on our phones there are lawyers behind the scenes working on regulatory approval, marketing accuracy, and so much more.

In this week’s episode I spoke with a lawyer who does just that. Suzanne Levy Friedman 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.

In the episode, 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.  

As always, if you have any questions or suggestions for the podcast you can just respond to this e-mail. And if you liked the episode and can share the podcast with a family/friend/colleague and/or leave a review on iTunes I’d appreciate it.

See you next week,

Jonah