Christina Bergeron Previews Regulatory Risk Factors in 2026 for Medical Device Targets in Trending Video

Christina Bergeron: I’m Christina Bergeron, a partner in the healthcare group at Ropes & Gray. I advise private equity clients and healthcare companies on healthcare fraud and abuse, and privacy matters, including as it relates to the device industry.

Over the past year, we’ve seen a clear uptick in investment in medical device companies, and we expect the momentum to continue into 2026 for both private equity sponsors and strategic buyers. We are already seeing strong client interest across a broad range of assets, including mature medtech companies, diagnostic platforms, implantables, AI-enabled devices, and contract manufacturing organizations, otherwise known as CMOs.

Our team is working on some of the largest and most complex device deals in the industry—as one example, we recently advised on the Hologic take-private acquisition, and we wanted to share some insights.

Key drivers of investment interest in this industry are device companies that have recurring revenue models, a strong foundation for regulatory compliance, and alignment with broader digital health and technology-enabled trends, including AI. We’re also seeing strong interest in consolidation strategies and spin-off opportunities.

Needless to say, these opportunities carry risk. Recent U.S. enforcement activity in the device space is higher than ever. Overall, we’re seeing increased FDA enforcement, as well as significant DOJ settlements tied to data security failures and marketing conduct—all alongside growing state-level health data and AI regulation.

Our team helps clients assess these nuanced risks in a focused and prioritized way. What distinguishes Ropes is that we represent both investors, as well as device companies operating within this evolving regulatory landscape.

Understanding current False Claims Act and anti-kickback theories is critical for all clients interested in investing in this space. We help clients ask the right diligence questions to understand the true risk profile of a device company, including the growing trend of DOJ and whistleblowers applying defense-contractor-style cybersecurity standards to device manufacturers. We saw this clearly in the Illumina settlement in July 2025, marking a new frontier for FCA enforcement in medtech.

Safeguards around managing and accounting for these risks are essential, particularly for companies developing AI-enabled diagnostics and predictive analytics, where FDA, healthcare regulatory, and privacy considerations intersect. Ropes provides integrated advice across all of those areas.

A second area of focus is state privacy and consumer health data laws, including in states such as Washington, Nevada and Connecticut, that create new compliance obligations and enforcement risk for device companies handling health data.

We also focus on regulatory clarity around HCP engagements, discounting and rebate programs, free goods and samples, and value-based care initiatives, as well as payer acceptance and reimbursement pathways, including coding, coverage, and payment strategy—working closely with our FDA team. And lastly, scalable commercialization strategies, grounded in robust regulatory compliance.

In 2026, device companies are expected to remain an attractive investment area for private equity and strategic buyers alike.

Ropes & Gray helps investors assess and manage these risks while also supporting device companies in navigating this complex regulatory environment.