Event Recap – Saison-al Session Panel Discussion

At Gardner Law’s May 22nd Saison-al Session: A Legal Update for FDA-Regulated Industry, four seasoned leaders in medical device compliance and legal affairs took the stage to share their front-line perspectives on navigating risk, regulation, and culture in a shifting enforcement environment.

Panelists included:

• Mark Gardner, Managing Attorney, Gardner Law (Moderator)
• Jonelle Burnham, General Counsel, CVRx
• Bryan Phillips, General Counsel & Chief Compliance Officer, Inspire Medical Systems
• Wendy Cusick, Regulatory & Compliance Advisor, CoNextions Medical

Navigating the Shifting Enforcement Landscape

Panelists opened by reflecting on heightened scrutiny from the DOJ and HHS OIG, particularly in areas like speaker programs, third-party relationships, and fair market value justification. Burnham emphasized the significance of available data under the Sunshine Act and the increasing likelihood of regulators using AI to detect problematic activity.

“It does seem clear that enforcement efforts are continuing in this area, and we need to be careful and vigilant,” she said.

Bryan Phillips stressed that even amid uncertainty in Washington, healthcare compliance remains a consistent federal priority. He encouraged legal teams to avoid siloed decisions and to consider risk holistically across the organization.

“If you haven't thought about risk in the aggregate,” he cautioned, “your overall risk profile may exceed the appetite your organization has for it.”

Making Training Matter—and Stick

When asked about effective compliance education, all three panelists shared creative strategies. Burnham described her passion for turning compliance training into something employees actively enjoy, including simulated legal cases and game-like incentives. Cusick highlighted the benefits of “real-time training”—quick interventions following mistakes that double as teachable moments.

Phillips advocated for clear, accessible policies and continuous reinforcement, not just once-a-year checkboxes. The consensus was clear: engaging, relevant training is not a luxury but a cornerstone of effective compliance.

AI, Privacy, and Regulatory Strategy

From privacy compliance to product submissions, regulatory change is influencing internal strategies in profound ways. Cusick described a cautious approach to FDA engagement, explaining that her team is holding off on certain tendon repair product submissions until they better understand how recent guidance may affect clinical requirements.

“Going slow is what we’re doing,” she said. “There’s just so much unknown.”

The panel agreed that AI is reshaping both regulatory oversight and internal compliance expectations. From document review in investigations to postmarket monitoring, legal teams are under pressure to stay ahead of technology while ensuring data privacy and responsible governance.

Building a Culture of Compliance

Perhaps the most resonant theme was corporate culture—how it’s built, measured, and maintained. Panelists emphasized the need for leadership buy-in, peer accountability, and a visible commitment to patient-first values. Cusick emphasized the importance of frontline relationships and paying attention to overlooked staff. She emphasized making sure that staff is comfortable talking to compliance personnel, because very often it’s those folks who pick up the phone.

Mark Gardner closed the conversation by underscoring the stakes.

“Sometimes people need to be reminded they are personally liable,” he noted. “It’s not just about protecting the company—it’s about protecting everyone involved.”

Looking Ahead

The panel discussion highlighted that compliance and legal professionals must balance speed and innovation with oversight and accountability—especially as government tools become more sophisticated, expectations rise, and reputational risks loom larger.

Need help implementing real-world compliance strategies? Gardner Law provides practical, business-savvy counsel to companies operating in FDA-regulated industries. Contact us to learn how we can support your legal, compliance, and regulatory goals.