A Complimentary In-Person and Live-Streamed Program from Gardner Law

Join Gardner Law in Newport Beach, California, on November 12, 2026, for Build, Launch, Grow: Legal-Regulatory Strategy Across the Medical Product Lifecycle. This complimentary, in-person and live-streamed program will bring together regulatory, privacy, and compliance attorneys and industry leaders for practical discussions about the challenges companies encounter as they develop products, enter the market, and expand their operations.

Program Details

1:00–1:30 p.m. PT

Hot Topics in Regulatory, Privacy, and Compliance

The program will begin with three focused updates addressing current regulatory, privacy, and compliance developments affecting medical products companies from Nathan Downing, Paul Rothermel, and Amanda Johnston.

Each presenter will provide a 10-minute briefing on a timely issue that companies should be watching as they evaluate their legal, compliance, and business priorities.

1:30–2:10 p.m. PT

Build: Establishing the Foundation for Commercialization

Moderator: Nathan Downing

Panelists: Dr. Cord Willhöft (Partner, Co-Head of Life Sciences & Healthcare, Fieldfisher), Alex Vayser (Founder, CEO, Concur Biophotonics & Founder, Videra Surgical), and Jeff Lau (Associate General Counsel, Glaukos)

This panel will examine how companies can design and develop products in a manner that supports regulatory strategy, privacy compliance, commercialization, and future diligence. The discussion will address product development, clinical evidence, data practices, and the internal controls companies should consider establishing before risks become embedded in their operations.

Panelists will discuss how early decisions can affect:

• FDA submissions and regulatory strategy
• Clinical evidence development
• Product claims and intended use
• Data collection, use, and governance
• Privacy and cybersecurity considerations
• Compliance program development
• Investment, partnership, and acquisition diligence

2:10–2:50 p.m. PT

Launch: Entering the Market Without Creating Unnecessary Risk

Moderator: Paul Rothermel

Panelists: Sameena Habib (Global R&D AI & Data Counsel, Medtronic), Chase Leavitt (General Counsel, Mobia Medical), and Brian Kelly (VP, Chief Compliance Officer, Advanced Bionics)

Moving a product from development or approval into the market requires coordination across regulatory, legal, privacy, compliance, reimbursement, sales, and marketing functions. This panel will explore how companies can commercialize products while managing the risks that arise when products, data, patients, providers, and field teams begin interacting in the marketplace. Topics will include:

• Promotional claims and communications
• Reimbursement and patient support activities
• Sales and field team guardrails
• Patient engagement and data collection
• Privacy notices, consent, and digital tracking
• Vendor and commercial partner oversight
• Cross-functional review and escalation processes

2:50–3:05 p.m. PT

Refreshment Break

3:05–3:45 p.m. PT

Grow: Scaling the Business and Its Compliance Infrastructure

Moderator: Amanda Johnston

Panelists: Shannon Treviño (General Counsel, SpyGlass Pharma), Karyl Haskell (VP Regulatory Affairs and Quality Assurance, Orthalign), and Liana Edgar (Corporate Counsel, Heartflow)

As companies grow, their regulatory, privacy, and compliance obligations become more complex. New products, markets, data uses, commercial models, vendors, and enforcement exposure can strain systems that were designed for an earlier stage of the business.

This panel will discuss how companies can mature their infrastructure as the organization expands, including:

• Scaling policies, procedures, and internal controls
• Evaluating new products and commercial models
• Managing expanding data uses and technology deployments
• Strengthening monitoring, auditing, and investigations
• Overseeing vendors, distributors, and other third parties
• Preparing for inspections, enforcement, and diligence
• Maintaining coordination across legal and business functions

3:45–4:15 p.m. PT

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

Moderator: Mark Gardner

Panelists: Melissa Hoffman (Vice President, Lead Counsel: TMTT, Edwards Lifesciences), Christopher Shurland (Managing Counsel, Asahi Intecc USA), and Sara Kerrane (Vice President, Intellectual Property, Regulatory and Litigation Counsel, Glaukos Corporation)

The program will conclude with a structured question-and-answer session featuring Gardner Law’s managing partner and industry experts. Attendees participating in person or by livestream may submit questions about the issues discussed during the program or other legal and operational challenges affecting their organizations.

Who Should Attend?

This program is designed for professionals at medical device, pharmaceutical, biotechnology, digital health, and other medical products companies, including:

• In-house attorneys
• Regulatory affairs professionals
• Privacy and cybersecurity leaders
• Compliance officers
• Quality professionals
• Commercial and reimbursement leaders
• Senior executives and business decision-makers

Registration

Advance registration is required for both in-person and livestream attendance. Space for the in-person program is limited.

Cost

Complimentary

Certifications

The program has been submitted for approval for 3 CLE credits with the Minnesota and California State Bars and 3 RAC certification credits with the Regulatory Affairs Professional Society.

Contact

For questions about registration, livestream access, or continuing education credit, please email office@gardner.law.