Ski-LE 2026 Recap: Key Takeaways for Medical Products Companies

On April 10, 2026, Gardner Law hosted Ski-LE 2026: The Mountain Summit for FDA Regulatory & Compliance Leaders at the Cliff Lodge at Snowbird, Utah.

The in-person program brought together legal, regulatory, compliance, quality, and business leaders from across the medical products industry for a focused morning of CLE and RAPS-recognized programming on the issues shaping medtech, biotech, pharmaceutical, and digital health companies.

The program featured Mark Gardner, Founder and Managing Partner, Gardner Law, Nathan Downing, Managing Attorney, Gardner Law, Mike Pisetsky, Chief Business & Legal Affairs Officer, SI-BONE, and Kelvyn Cullimore, President and CEO, BioUtah.

Across the morning, the discussion focused on FDA uncertainty, fast-moving medical technologies, commercialization pressures, advertising and promotion scrutiny, AKS and FCA risk, privacy and cybersecurity issues, AI, and practical compliance challenges facing medical products companies.

FDA, AI/ML, and Digital Health

Nathan Downing led a session on current FDA priorities and how industry can adjust. His presentation began with the legal foundations of medical device regulation, including the statutory definition of a device, FDA’s premarket pathways, and the historical framework that continues to shape medical product development.

The session then turned to one of the most important issues facing FDA and industry: the growth of artificial intelligence and machine learning in healthcare.

AI/ML is being used to assist diagnosis, predict outcomes, support remote care, manage large volumes of clinical data, and improve patient care. At the same time, FDA is applying a regulatory framework that was not originally designed for adaptive, data-driven software tools.

For companies developing or commercializing digital health products, the key questions remain practical: What is the product intended to do? What claims are being made? How will users interpret the output? Is the product presenting information, or is it driving diagnosis, treatment, clinical action, or medical management?

Clinical Decision Support and General Wellness Technologies

The program also addressed clinical decision support software and general wellness technologies.

For clinical decision support, the discussion focused on the 21st Century Cures Act framework and the importance of whether a healthcare professional can independently review the basis for a software recommendation.

For general wellness products, the discussion highlighted the importance of claims, interpretation, and user context. A product may measure physiological information, such as heart rate or blood pressure, without necessarily becoming a regulated medical device. But the analysis changes when the product interprets that information in a way that suggests diagnosis, abnormality, treatment, clinical action, or medical management.

In a Wall Street Journal article discussing FDA’s general wellness guidance and wearable technologies, Mark Gardner noted:

“I do think the guidance brings meaningful clarity to the wearable space and makes clear that WHOOP can provide blood pressure readings without violating the law, provided it is done appropriately.”
Mark Gardner, Founder and Managing Partner, Gardner Law, quoted in The Wall Street Journal

The practical takeaway is that claims, user interface, alerts, thresholds, and clinical context all matter.

FDA Engagement and Regulatory Strategy

The program also covered tools companies may use to engage FDA and reduce uncertainty, including pre-submissions, informational pre-submissions, requests for designation, 513(g) requests, and other communications during submission review.

The discussion emphasized that FDA engagement can be valuable, but companies should be thoughtful about when to seek input, how to frame questions, and when escalation or appeal strategies may be appropriate.

As Nathan Downing explained:

“FDA communication is most effective when companies are clear about what they know and what they need from FDA. Companies need to understand how to properly ask questions to avoid FDA going down a rabbit hole and know when to partner with FDA and when to challenge.”
Nathan Downing, Managing Attorney, Gardner Law

That theme applies across product development, digital health, medical device classification, FDA communications, and regulatory strategy more broadly.

Fraud, Abuse, Advertising, and Enterprise-Wide Compliance Risk

Mark Gardner led an interactive discussion on recent fraud and abuse cases and FDA hot topics. The session focused on the enforcement environment surrounding the Anti-Kickback Statute, False Claims Act, advertising and promotion, pricing, rebates, discounts, privacy, AI, and healthcare competition.

The discussion addressed enforcement trends involving copay assistance, speaker programs, consulting arrangements, pricing practices, rebate structures, medtech enforcement, whistleblowers, and data-driven government investigations.

A major theme was that FCA risk is no longer limited to traditional billing issues. It increasingly reaches pricing, contracting, patient support, physician relationships, data reporting, cybersecurity, promotional practices, and real-world compliance operations.

As Mark Gardner noted:

“FCA risk is no longer limited to billing. For medical products companies, enforcement risk increasingly touches pricing, contracting, patient support, physician relationships, data reporting, cybersecurity, promotional practices, and how the business operates in the real world.”
Mark Gardner, Founder and Managing Partner, Gardner Law

The program also addressed OIG Advisory Opinion 25-11 and the continued importance of structure, transparency, and reporting in discount and rebate arrangements. Flexible commercial arrangements may be possible, but they require careful analysis and clear documentation.

Advertising and Promotion Scrutiny

The program also covered FDA’s renewed focus on advertising and promotion, including direct-to-consumer advertising, OPDP activity, compounded GLP-1 marketing, and net impression concerns.

The discussion emphasized that companies should evaluate promotional materials as a whole. Literal accuracy is not enough if the overall presentation overstates efficacy, minimizes risk, lacks support, or creates a misleading impression.

As Nathan Downing explained:

“Promotional review cannot stop at whether individual words are technically accurate. Companies also need to evaluate visuals, context, risk presentation, substantiation, and the overall net impression created by the communication.”
Nathan Downing, Managing Attorney, Gardner Law

The program also addressed compounded GLP-1 marketing and the risks associated with claims suggesting that compounded products are FDA-approved, the same as branded products, or proven safe and effective in ways that are not adequately supported.

For medical products companies, the practical point is straightforward: advertising and promotion review should focus not only on individual claims, but also on how the overall message will be understood.

Privacy, Website Tracking, and AI

The program also addressed privacy and AI-related risks affecting medical products companies.

State privacy laws continue to expand, creating a growing patchwork of requirements related to disclosures, opt-outs, consent, contracts, risk assessments, and data practices. Website tracking litigation and demand letters also continue to create risk for companies using cookies, pixels, and other tracking technologies.

The discussion also touched on privilege risks involving public AI tools. Companies should not assume that AI-generated work is privileged, particularly when public tools are used outside the direction of counsel.

As Gardner noted:

“Privacy, website tracking, and AI use are no longer isolated legal issues. They are increasingly part of product strategy, commercial strategy, and the broader risk profile for medical products companies.”
Mark Gardner, Founder and Managing Partner, Gardner Law

For companies operating in the medical products industry, privacy, cybersecurity, website tracking, and AI use are increasingly part of broader product, regulatory, and commercial planning.

Commercialization and Compliance

Mike Pisetsky brought an in-house perspective to the program with a discussion of medtech commercialization, market development, FDA strategy, reimbursement, physician relationships, transparency reporting, and compliance controls.

The session highlighted how regulatory strategy, clinical evidence, reimbursement, market education, field activity, physician engagement, and compliance infrastructure need to evolve together as products and markets develop.

Pisetsky discussed the importance of managing off-label issues, tracking physician behavior, understanding changing clinical practice patterns, and working with FDA to update labeling when evidence supports expanded indications.

The session also addressed physician investors, consulting arrangements, stock options, physician-owned distributor concerns, CPT code transitions, grants, sponsorships, field-based promotion, meal limits, and market-building activities.

As Pisetsky emphasized:

“As a market develops, the compliance program has to develop with it. Regulatory strategy, reimbursement, physician engagement, field activity, and market education all need to move together.”
Mike Pisetsky, Chief Business & Legal Affairs Officer, SI-BONE

The broader point was that compliance programs need clear rules, practical training, monitoring, escalation paths, and remediation. Compliance controls need to be understandable and workable for the people operating in the field.

Key Takeaways

Ski-LE 2026 reinforced several practical lessons for medical products companies:

• FDA’s approach to AI/ML, clinical decision support, and general wellness technologies continues to evolve
• Claims, user interpretation, and clinical context can drive regulatory status
• FDA engagement should be strategic and carefully planned
• Advertising and promotion scrutiny is increasing, especially for DTC, compounded GLP-1, and net impression issues
• AKS and FCA risk now reaches pricing, contracting, physician relationships, patient support, data reporting, cybersecurity, and documentation
• Privacy, website tracking, and AI use should be addressed as part of broader product and commercial strategy
• Commercialization and compliance should be built together, not treated as separate workstreams

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