Event Recap: FDA Leadership Perspectives for the Next Decade

The final session of Gardner Law’s 10-year anniversary program, Marking 10 Years: Past, Present, and Future Perspectives in FDA Law, focused on how in-house legal leaders are preparing for the next decade of FDA-related risk.

Mark Gardner moderated a panel discussion with Anne Miller of Medtronic, Scott Smith of Solventum, Bryan Phillips of Inspire Medical, and Neil Ayotte of Nuwellis. Across the conversation, the panel returned to a common point: in-house legal leaders add the most value when they help the business make decisions early. That early involvement matters before agency expectations change, technology risk compounds, reimbursement concerns limit adoption, or government scrutiny forces a response.

         

 

 

Be Ready to Pivot with FDA

The panel began with the changing FDA environment. Companies may build strategy around existing guidance, prior agency practice, or a particular reviewer interaction, but leadership changes and policy shifts can affect the path forward before formal rules are issued.

“Be ready to pivot. You may go down one path, and then leadership change may come.”
Anne Miller, Senior Strategic Legal Counsel, Medtronic

As products become more technical, FDA communications often require more than a procedural response. The agency may ask detailed questions about the science behind a product and the company’s development record. It may also probe how the company documented quality decisions or assessed risk. Internal teams and counsel need to understand those details well enough to respond accurately and recognize the practical implications of the agency’s position.

AI, Privacy, and Cybersecurity Require Governance Before Adoption

The panel then turned to privacy, cybersecurity, and AI. Bryan Phillips described a familiar challenge for legal and compliance teams. Business teams often want to adopt new tools quickly, while the governance framework is still catching up.

“Be very thoughtful and have an overarching strategy for how organizationally we want to adopt AI and where and how we want to deploy it.”
Bryan Phillips, Senior Vice President, General Counsel, and Chief Compliance Officer, Inspire Medical

The key point was that legal should be involved before adoption creates a problem to unwind. In-house counsel can help the business determine whether a new technology touches regulated records or sensitive data. It may also involve product claims, quality system obligations, or cybersecurity controls. That review becomes more important when AI-enabled tools and connected product features move faster than internal governance.

“If you are in AI, software, digital health, QMSR, or direct-to-consumer work, these areas are changing rapidly right now.”
Mark Gardner, Founder and Managing Partner

AI-Generated Records Need Careful Oversight

The panel’s discussion of AI returned to a practical concern for FDA-regulated companies. AI-generated content can appear polished while still being incomplete, inaccurate, or unsupported by the company’s actual record. That risk becomes more serious when AI output is used in documents that regulators, auditors, customers, or opposing counsel may later review. Quality system records and regulatory responses raise obvious concerns. Investigation files, reimbursement analyses, and other business records can raise the same issue when they support legal, regulatory, or commercial decisions.

The point is especially important for records that require human judgment. A quality system record should show what the company evaluated and why it made a particular decision. It should also reflect any approval, correction, or investigation in a way that matches the underlying evidence. If AI is used to draft or summarize that record, someone with appropriate responsibility still needs to verify the facts and confirm the rationale.

“Never, ever, ever, ever use AI to generate a quality system record without reading it.”
Anne Miller, Senior Strategic Legal Counsel, Medtronic

That warning applies beyond quality records. Companies should be careful when AI tools draft legal analyses, agency responses, customer-facing statements, or internal records. AI may help organize information or create a starting point, but the company remains responsible for the final record and any decisions it supports.

For legal, regulatory, compliance, and quality teams, the practical step is to define the boundaries of AI use. The policy should identify where AI is permitted, where heightened review is required, and where use should be restricted. The goal is to keep AI from becoming an unexamined source of regulated records, legal positions, or company commitments.

Preserve the Record When Scrutiny Begins

When government scrutiny arises, the first response can shape the entire matter. Companies need to preserve the relevant record and protect privilege before internal narratives harden. That means issuing appropriate document holds, identifying key witnesses, and being careful with speculative internal communications. Broad emails, “take it offline” language, or comments suggesting that records should be hidden or destroyed can create unnecessary risk.

“My first thought is document hold notices, preserving the evidence, preserving the record, identifying witnesses, and protecting privilege and work product.”
Neil Ayotte, Senior Vice President, General Counsel, and Chief Compliance Officer, Nuwellis

A disciplined first response helps the company understand the facts before positions harden. Internal teams should identify who may have knowledge of the issue and involve appropriate counsel early. They should also avoid broad speculation while the matter is still developing. The goal is to protect the record without slowing the company’s ability to assess the issue, respond to the agency, and make informed decisions about remediation, disclosure, or defense.

Reimbursement Strategy Belongs at the Beginning

The panel also emphasized that reimbursement strategy should inform product planning from the start. For many medtech companies, payment pathways shape customer adoption, investor confidence, commercialization planning, and legal advice. Companies should evaluate reimbursement assumptions early enough to influence how the product is developed, supported, and brought to market. 

“Do not work for or start a medical device company where you do not have a really clear reimbursement strategy from the beginning.”
Scott Smith, Senior Director, Assistant Chief IP Counsel, Solventum

Legal can also add value as companies prepare for inspections, address quality system issues, and respond to significant regulatory correspondence. In those settings, counsel can help the team clarify the facts, identify gaps in the record, strengthen written responses, and ensure that communications with regulators are accurate, complete, and tied to the company’s evidence.

Practical Takeaways

• Monitor FDA developments and adjust strategy as leadership and policy signals change.
• Treat AI adoption as a controlled business strategy with governance and accountability.
• Build cybersecurity plans around resilience, detection, response, and recovery.
• Preserve privilege, records, and credibility at the first sign of government scrutiny.
• Address reimbursement strategy early enough to shape product development and commercialization.
• Use legal as a strategic partner in inspection readiness and regulatory correspondence.

Watch the Discussion and Contact Gardner Law

Watch the session recording above and download the slides for more detail. If your organization is working through FDA strategy, AI governance, reimbursement questions, or inspection readiness, Gardner Law can help. The same is true when privacy concerns, cybersecurity risk, or government scrutiny require a disciplined response grounded in the regulatory record.