RAPS Convergence 2026: Navigating Regulatory Change, Real-World Evidence and AI in MedTech
Last week, Purdie Pascoe's Associate Director, Chris Webb, and Commercial Director, Ellie Baker, attended RAPS Convergence 2026 in Charlotte, North Carolina. Bringing together regulators, manufacturers, Notified Bodies and industry experts, the event provided valuable insight into the challenges and opportunities shaping the future of MedTech. While topics ranged from regulatory reform and accelerated pathways to market through to artificial intelligence, one message consistently emerged throughout the conference: high-quality evidence generation is becoming more important than ever.
An Industry in Transition
If there was one word that defined this year's event, it was change.
Across multiple sessions, discussions focused on evolving regulatory frameworks and the increasing pace of transformation across the MedTech industry. In the United States, the FDA has experienced what many described as a "year in flux", following leadership transitions and ongoing capacity challenges after workforce reductions in 2025. Despite this uncertainty, discussions remained largely positive, particularly regarding the Centre for Devices and Radiological Health (CDRH) and its implementation of the Quality Management System Regulation (QMSR) earlier this year.
Europe was also a key focus. The European Commission's proposed updates to the MDR and IVDR continue to generate debate across the sector. While there was broad agreement that aspects of both regulations require refinement, discussions emphasised that the objective is not to lower standards, but to create a framework that is more predictable, proportionate and supportive of innovation while maintaining patient safety.
Why Real-World Evidence Matters More Than Ever
Alongside regulatory change, the growing importance of Real-World Data (RWD) and Real-World Evidence (RWE) was one of the strongest themes throughout the conference.
Whether discussing lifecycle evidence generation, proactive post-market surveillance or risk-based PMCF programmes, speakers consistently highlighted that regulators are increasingly concerned not just with the quantity of data collected, but its quality. Evidence must be robust, relevant, representative, traceable and methodologically sound if it is to support ongoing assessments of safety, performance and clinical benefit.
As expectations continue to evolve, manufacturers will need to ensure that data collection activities are designed with clear objectives, endpoints and analysis plans from the outset. Poorly planned datasets risk providing limited value during regulatory review. These discussions reinforced the importance of collecting high-quality post-market feedback through well-designed studies, an approach that underpins the PMCF and post-market survey programmes we deliver at Purdie Pascoe.
Faster Pathways Demand Smarter Evidence Generation
This focus on evidence becomes even more important as pathways to market continue to accelerate.
Across several sessions, speakers explored mechanisms designed to bring innovative technologies to patients more quickly, including De Novo authorisations, accelerated review pathways and reduced predicate requirements. While these approaches can speed access to innovation, they can also mean less evidence is available at the point of market entry.
The session FemTech and Beyond: Addressing Sex-based Disparities in Medical Devices and Pharmaceuticals highlighted this challenge through examples of technologies that performed well against aggregate measures but later revealed important differences within specific patient groups once used in real-world settings.
The message was clear: post-market evidence generation cannot be treated as a regulatory checkbox. Well-designed PMCF activities and real-world evidence programmes play a critical role in generating the longer-term follow-up data, subgroup analyses and performance insights needed throughout a product's lifecycle.
The Foundation Is Robust Study Design
One theme connected many of the discussions throughout the conference: robust study planning.
Speakers repeatedly emphasised that defining clear objectives, meaningful endpoints and evidence requirements before data collection begins is essential for generating regulatory-grade evidence. Increasingly, success depends less on collecting more data and more on collecting the right data.
It is a principle that closely aligns with how we design post-market survey programmes at Purdie Pascoe, helping manufacturers generate evidence that is meaningful, defensible and fit for regulatory purposes.
AI's Role Is Becoming Clearer
Artificial intelligence was another recurring topic throughout the event. What stood out was how the conversation has evolved beyond whether AI should be used and towards where it can create the most value.
Examples ranged from analysing imaging datasets and refining surgical planning through to supporting literature surveillance, evidence synthesis and first-pass report drafting. By reducing the burden of repetitive and time-consuming activities, AI can help professionals focus more of their time on scientific judgement, identifying evidence gaps and understanding the wider context behind the data.
Rather than replacing human expertise, discussions throughout the conference suggested the greatest opportunity lies in combining AI-enabled efficiency with experienced professional oversight.
Final Thoughts
RAPS Convergence 2026 showcased an industry navigating significant change. Regulatory frameworks are evolving, pathways to market are accelerating and AI continues to reshape how information is generated and used.
Yet despite these developments, one theme consistently connected almost every discussion throughout the conference: the need for high-quality evidence. As regulatory expectations continue to evolve, organisations that invest in thoughtful study design and meaningful real-world evidence generation will be best positioned to adapt with confidence.