AI Through 2030: Scenarios, Uncertainty, and Regulatory Signal

MedTech Leading Voice | Issue 151

This week’s update focuses on projected AI trajectories through 2030, regulatory adoption of patient preference science, LLM risk management pitfalls, evolving biocompatibility expectations, documentation structure, and cross-functional integration shaping regulatory execution.

📝 From the Editor

Danny Van Roijen highlighted the OECD’s latest paper exploring possible AI trajectories through 2030, outlining four scenarios for how AI progress may evolve.

🔥 MLV100 Launch Party: Join us this Friday, Feb. 20, for the new MLV100 for 2026, featuring more than 100 MedTech experts worth following on LinkedIn on an all-new AI-forward MLVx platform.

This issue centers on how forward-looking AI projections intersect with regulated product development, documentation discipline, safety expectations, and governance through 2030.

— Sean Smith, Publisher

🎯 Featured Post

AI Through 2030 — OECD Scenarios for Progress

Danny Van Roijen outlined the OECD’s four projected AI trajectories through 2030, examining how innovation could stall, slow, continue, or accelerate depending on technical and economic constraints.

The paper examines:

• Defined AI capability indicators across language, reasoning, creativity, memory, and physical interaction
• Uncertainties around scaling performance gains and reinforcement learning advances
• Limits in robust agentic behavior and metacognition
• Comparative benchmarking of AI performance against human capabilities

For MedTech teams, the framework provides context for planning governance models, validation strategy, and long-term risk management as AI capabilities evolve.

View the post >>

📌 This Week’s Top Posts (In no special order)

• The OECD’s latest paper on AI trajectories through 2030 was highlighted by Danny Van Roijen.
• Angelina Lisandrelli announced a new FDA draft guidance adopting ICH E22 on patient preference studies across CDER and CDRH products.
• Sigrid Berge van Rooijen outlined 5 common LLM risk management pitfalls in healthcare, from hallucinations and bias to privacy and explainability.
• Updated expectations under ISO 10993-1:2025 focussing on implants, indirect contact, and intended use were outlined by MedCore by Marina Daineko.
• In her latest Monday News, Marina Daineko covered EMA’s tougher impurity expectations, an FDA Class I recall, and EU moves to harmonise MDR and IVDR oversight.
• René Drost explained the expectations around references and related standards under Technical Specification 5137.
• MDR language requirements for professional-use IFUs and eIFUs across EU Member States, was overviewed by Matrix One.
• Tibor Zechmeister compared DHF vs DMR vs DHR vs Technical Documentation, and their alignment under FDA and EU MDR requirements.
• Michelle Lott discussed the importance of effective CAPA programs when treated as a data-driven, cross-functional system.
• The concept of substantial equivalence and its alignment with intended use were defined by Danny Syring.
• Bastian Krapinger-Ruether shared key PSUR requirements under EU MDR and its importance for PMS audits.
• The impact of the Cyber Resilience Act on medical devices and connected systems was flagged by Eylon Gushpantz.
• Erik van Dijk explored the importance of integration across disciplines in accelerating medical device submissions.
• Beat Keller cautioned against inconsistent definitions of “patient” across IEC, ISO, MDR, and FDA frameworks, warning of potential scope gaps.

🗓️ Upcoming Events & Webinars

• Tuesday, February 17, 2026 | 10:00 AM ET / 4:00 PM CET — ISO/DIS 18969: Introducing a Process-Based Approach to Clinical Evaluation, featuring Danielle Giroud (CEO, MD-CLINICALS SA, Chair of the ISO 18969 Working Group) and Maria E. Donawa, MD (Founder & President, Donawa Lifescience, Member of the ISO 18969 Working Group). Register Now >>
• Friday, February 20, 2026 | 11:00 AM ET — 🔥MLV100 2026: AI Edition Launch Party, a live session featuring Sean Smith (Founder & Publisher, MedTech Leading Voice) and Jose Bohorquez (President, CyberMed / Bold Type), introducing the MLV100 2026 list and unveiling the new AI-powered MLVx platform delivering expert-backed regulatory answers with clear attribution. Register Now >>
• Tuesday, February 24, 2026 | 10:00 AM ET / 4:00 PM CET — Global Human Factors Strategy for MedTech, featuring Jessica Parry (Senior Human Factors Consultant & Manager, Site Lead – UK, ClariMed) and Jenny Collinson (Director of Human Factors Strategy & Advisory, ClariMed), focused on human factors strategy across the U.S., EU, and UK. Register Now >>
• Thursday, February 26, 2026 | 10:00 AM ET / 4:00 PM CET — EU Regulatory Roadmap Part 2: Avoiding Liability Pitfalls, featuring Bassil Akra (CEO, AKRA TEAM) and Erik Vollebregt (Partner, Axon Lawyers), focused on liability exposure and risk management under EU MDR and IVDR. Register Now >>
• Friday, February 27, 2026 | 11:00 AM ET — The MedTech Employment Outlook for 2026, a Friday In-Focus session featuring Elena Kyria (Founder & CEO, Elemed), focused on how hiring, evaluation, and career signals are shifting in MedTech. Register with one click >>

💥 Weekly 510(k) Roundup

February 09, 2026 | From Marcus Engineering, LLC

45 total clearances across multiple categories, including 9 first-time clearances (🚀)

• Kneevoice, Inc. — Kneevoice Cartilage Evaluation System (🚀): Cleared within cardiovascular classification, the Kneevoice system captures acoustic and vibrational signals generated during knee movement and converts them into a reproducible cartilage health score, supporting objective assessment and longitudinal tracking of joint condition.
• Augmented Reality Software S.L. — LAIA XR (🚀): Cleared for radiology use, LAIA XR transforms CT and MRI datasets into interactive three-dimensional visualizations, enabling clinicians to explore anatomy in extended reality to support procedural planning and spatial orientation.
• Encora, Inc. — Encora Pulse (🚀): Cleared for neurological use, Encora Pulse is a wrist-worn device designed to support tremor management during daily activities, offering a non-pharmacological approach intended to improve functional stability and patient independence.

Explore the full list of this week’s clearances on the 510(k) Roundup page.

📋 Regulatory Roundup

February 09, 2026 Issue | By Martin King

This week’s regulatory activity reinforces a clear direction: compliance is a living system. Authorities are embedding continuous accountability, digital oversight, and evidence-driven lifecycle control into everyday regulatory practice, with updates from the 📌 FDA (CDRH), 📌 European Commission, 📌 European Medicines Agency (EMA), 📌 Swissmedic, 📌 Health Canada, 📌 Medical Device Authority Malaysia, 📌 Department of Health – HKSAR (Hong Kong), and 📌 IMDRF.

Across regions, regulators are strengthening lifecycle resilience through cybersecurity enforcement and vigilance inspections, advancing harmonisation through shared audit models, expanding digital submissions and risk-based software validation, and centering oversight on real-world performance, data integrity, traceability, cybersecurity, and AI governance within connected regulatory ecosystems such as EUDAMED and EudraVigilance.

Explore the Issue >>

In Case You Missed It

Friday, February 13, 2026 | 11:00 AM ET — RegTech 2026: State of the Art in Medical Devices, an interactive Friday In-Focus session featuring Rhys Williams, PhD (RegTech founder, former Meta AI product leader) and Umer Iftikhar (Co-founder and Technical Lead), focused on the real capabilities, limits, and accountability expectations of RegTech and AI in medical device regulation. Watch the replay >>

🔥 Postscript

More than 925 professionals have already registered for Tuesday’s session on ISO/DIS 18969: Introducing a Process-Based Approach to Clinical Evaluation, featuring Danielle Giroud and Maria E. Donawa, MD.

If clinical evaluation planning, MDR alignment, and lifecycle evidence strategy are on your 2026 agenda, this conversation belongs on your calendar. Don’t miss it >>