Medical device manufacturers shouldn’t expect a lighter regulatory touch despite staffing changes at the US Food and Drug Administration, former FDA leader Sean Boyd says.
Speaking on the latest episode of “Quality in the Boardroom,” Boyd, now Corporate VP at QualityHub after a 31-year FDA career, said the agency experienced considerable disruption but continues to meet its medical device review goals.
“It was a very disruptive time at the agency about a year ago,” said Boyd, who was caught up in an early round of staff reductions in 2025 when he was Director of the FDA’s Office of Regulatory Programs in the Office of Product Evaluation and Quality (OPEQ), within the Center for Devices and Radiological Health (CDRH).
“The reductions in staffing … may have changed industry’s lead reviewer, may have changed the makeup of their review team, [may have changed] the supervisors and managers that were responsible for reviewing some of those decisions – and even executive leadership,” he said. “I think that had a huge impact on the [FDA] and … on the industry.”
Still, Boyd said, the FDA’s review performance has remained remarkably resilient.
“If you look at the MDUFA performance reports, all metrics are being met or are on target to be met,” he said. “That’s really impressive and a testament to the review teams and the leadership at the agency.” (Related Story: “1 Year After Layoffs, FDA Stable but Faces Long Road to Rebuild Lost Expertise, Says Device Center Vet,” QualityHub, April 20, 2026.)
The discussion, hosted by Quality Means Business CEO Michel Moravia and moderated by Kwame Ulmer of MedTech Impact Partners, focused on how manufacturers can navigate an evolving FDA on a variety of fronts, including pre- and post-market submissions, AI, facility inspections, and more.
‘Storytelling’ Matters More Than Ever
An area where Boyd believes manufacturers can improve immediately is how they communicate with FDA reviewers.
“One of the most important things to keep in mind is the importance of storytelling, regardless of the submission type that you’re preparing,” he said.
Rather than presenting submissions as collections of technical documents, Boyd encouraged companies to provide FDA reviewers with the broader context behind a product.
“It’s really important to put in context, what is the product, what is the benefit to the patient, [and] what are the risks that have been identified and mitigated so [the reviewers] can look at it from a benefit-risk perspective holistically,” Boyd said.
He noted that this is particularly important for Premarket Approvals (PMAs), De Novo submissions, and other novel technologies where review teams may be encountering a product or manufacturing approach for the first time.
AI’s Biggest Opportunity is Finding Patterns
Artificial intelligence also featured prominently during the conversation, with Boyd, Moravia, and Ulmer pointing to its potential to improve regulatory decision-making rather than simply automate documentation.
“AI is going to be a huge contributor and enabler for industry and the agency in gathering large amounts of information,” Boyd said.
He suggested companies could use AI to analyze years of FDA warning letters and identify common reasons agency responses are considered inadequate.
“If you could use AI to look at [a year’s] worth of warning letters and ask it … ‘Why were those responses inadequate?’ – industry could learn from that,” Boyd said. “You’re providing a more comprehensive and holistic response to get to a systemic fix.”
Ulmer said AI could also improve interactions between sponsors and regulators by helping both sides identify patterns from previous reviews.
“I’m thinking about organizations – companies of all sizes, particularly large ones – that could potentially say, ‘We used AI to look at the last 10 questions or last 10 conversations we had with [the FDA], and here’s what [it] told us about human factors testing. Is this still the case, FDA?’” Ulmer said. “And maybe the FDA could say, ‘Well, we not only looked at your question [and] your issues with HF, but we’ve looked at all the other similar devices with HF questions, and here’s our current thinking.’ Maybe that’s how AI could make that conversation more efficient.”
Meanwhile, Moravia argued that AI’s greatest value lies in converting historical information into actionable insight.
“Over and over, we’re hearing ‘data.’ Data is at the crux of it. The pattern that comes with the data is becoming very important,” he said. “It could potentially bridge a conversation toward the future.”
Inspection Activity Remains Strong
While device makers may have expected FDA inspection activity to decline following workforce reductions, Boyd said the numbers tell a different story.
“Inspection numbers are on par over the past couple of years,” he said.
At the same time, Boyd said enforcement activity appears to be increasing as the FDA returns to pre-pandemic inspection levels and strengthens coordination between compliance personnel and field investigators.
“Your people … need to understand how their day-to-day job – from the C-suite down to the production floor – impacts the quality of the product or service that you’re delivering.” – Sean Boyd
He stressed that companies should continue investing in inspection readiness programs built on internal audits, mock inspections, employee training, and documented response procedures.
“There is no replacement for a strong quality culture within the organization,” Boyd said, noting that every company should have an inspection readiness plan “just to be ready for when that investigator shows up at the door.” (Related Expert White Paper: “Building a Culture of Quality in Medical Device Organizations: Best Practices for QMSR Compliance,” QualityHub, March 2026.)
QMSR Raises the Importance of Data Strategy
The panel also discussed the FDA’s implementation of the Quality Management System Regulation (QMSR), which aligns the agency’s quality system requirements with international quality systems standard ISO 13485:2016.
Moravia said the regulation represents a broader shift toward lifecycle risk management and harmonization with international standards. Boyd agreed, adding that organizations should already be planning how quality data will flow across the product lifecycle.
“Planning for how you’re going to use data across the product lifecycle and across the systems … within your company is imperative,” he said.
Boyd cautioned, however, that AI should augment experienced quality and regulatory professionals rather than replace them.
Manufacturers need to “understand not only the outputs that [AI] generates, but [that] you’re feeding it the right questions, you’re feeding it the right sources of data up front so it’s an enabler for … your in-house quality staff to augment what they do on a day-to-day basis,” he said.
Quality Protects More Than Compliance
Asked for his final takeaway after more than three decades at the FDA, Boyd said quality should be viewed as a strategic business asset rather than simply a regulatory obligation.
“When I think about brand reputation,” he said, “that really begins with quality.”
Boyd added that companies build lasting reputations by empowering employees, establishing consistent processes, and delivering products that meet or exceed customer expectations.
“Your people need to be motivated by the mission of the organization, they need to understand how their day-to-day job – from the C-suite down to the production floor – impacts the quality of the product or service that you’re delivering,” Boyd said. “The worst thing you can do is ask for feedback and ignore it, not act on it, or even worse, kind of penalize it.
“That’s one aspect of quality driving brand reputation through your people.”
