Build, Launch, Grow: Legal-Regulatory Strategy Across the Medical Product Lifecycle

Description

NOVEMBER 12, 2026
1:00 - 4:15 PM PT
NETWORKING RECEPTION TO FOLLOW

COMPLIMENTARY IN-PERSON / LIVE-STREAMED EVENT

LIDO HOUSE
3300 NEWPORT BLVD.
NEWPORT BEACH, CA

3 CLE & RAPS RAC CREDITS 

Join Gardner Law for practical insights into the legal and operational challenges facing medical products companies, including how to align FDA regulatory strategy with clinical evidence and product claims, manage AI and patient data, establish guardrails for commercial activities, and strengthen compliance controls as businesses evolve. 

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Agenda

1:00–1:30 PM PT

Hot Topics in Regulatory, Privacy, and Compliance

Nathan Downing, Amanda Johnston, & Paul Rothermel

1:30–2:10 PM PT

Build: Establishing the Foundation for Commercialization

Moderator: Nathan Downing
Panelists: Dr. Cord Willhöft (Fieldfisher), Alex Vayser (Concur Biophotonics), Jeff Lau (Glaukos)

2:10–2:50 PM PT

Launch: Entering the Market Without Creating Unnecessary Risk

Moderator: Paul Rothermel

2:50–3:05 PM PT

Refreshment Break

3:05 – 3:45 PM PT

Grow: Scaling the Business and Its Compliance Infrastructure

Moderator: Amanda Johnston
Panelists: Shannon Treviño (Spyglass Pharma), Brian Kelly (Advanced Bionics)

3:45–4:15 PM PT

Ask the Experts: Regulatory, Privacy, and Compliance Q&A

Moderator: Mark Gardner
Panelists: Melissa Hoffman (Edwards Lifesciences), Chase Leavitt (Mobia Medical), Sarah Karranne (Glaukos), Christopher Shurland (Asahi Intecc)

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