Engaging with Medical Product Regulatory Expert, Steve Silverman


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Apr 01 2025 43 mins  

Our guest Steve Silverman is the President of Silverman Group, a consultancy that serves medical product companies on regulatory strategy and policy issues, and an expert consultant for NDA. Additionally, he has over two decades of experience in federal service, including senior roles at the FDA. Mr. Silverman holds a JD from the University of Pennsylvania.

In this episode…

Learning from your mistakes is crucial, according to Mr. Silverman. As a new expert witness, it is easy to jump into your first engagement relying solely on expertise, but doing your homework is just as important. He recommends a proactive approach—question your attorney before accepting an engagement to make sure expectations are clear.

Check out the entire episode for our discussion on remote etiquette, billable research, and expertise as a trainable skill.