This week, we dissect a critical trend impacting the US MedTech landscape: the sustained surge in FDA warning letters. This isn't a random enforcement spike; it's a targeted campaign against systemic weaknesses in Quality Management Systems that many companies mistakenly believe are compliant. We move beyond the headlines to reveal the specific fai…

This week, we dissect a critical, under-the-radar policy shift from the US FDA concerning AI and machine learning medical devices. Regulators are cracking down on Predetermined Change Control Plans (PCCPs), demanding a level of detail that many companies are unprepared for. This change fundamentally alters the roadmap for getting self-improving alg…

This week, MedTech Global Insights dives into the US FDA's groundbreaking new final guidance on Predetermined Change Control Plans (PCCPs) for AI-enabled medical devices. This policy promises to accelerate innovation by allowing pre-approval for future algorithm updates, but it also introduces significant strategic complexities that could trap unpr…

In this episode, we dissect the recent FDA De Novo approval of a revolutionary AI diagnostic tool for oncology. While the industry celebrates this milestone, we look beyond the headlines to uncover the complex and demanding post-market challenges that await, from stringent real-world data collection to cybersecurity vigilance.Imagine a startup that…

Allen and Joel are joined by Nathan Davies from Lloyd Warwick to discuss the world of wind energy insurance. Topics include market cycles, the risks of insuring larger turbines, how critical spares can reduce downtime and costs, why lightning claims often end up with insurers rather than OEMs, and how AI may transform claims data analysis. Sign up …

This week, MedTech Global Insights dives into the FDA's game-changing final rule to regulate Laboratory Developed Tests (LDTs) as medical devices. We unpack the agency's rationale behind this historic policy shift, ending decades of enforcement discretion that allowed thousands of labs to develop tests without direct FDA oversight. This episode exp…

The FDA just dropped a bombshell on the AI medical device world. On January 2nd, they unveiled the 'AI-Driven SaMD Pre-Certification Excellence Program,' or AIPEP. This new pilot program promises a fast track for AI-powered software, but it comes with a catch: a mountain of new requirements for data transparency and algorithm validation.This move c…

Allen, Joel, and Yolanda examine TPI Composites’ Chapter 11 proceedings, including the Oaktree Capital secured debt controversy and Vestas’ acquisition of two Mexican factories. With remaining assets heading to auction in January, they discuss what operators should consider as blade supply uncertainty grows. Sign up now for Uptime Tech News, our we…

In the final days of 2025, the U.S. FDA unveiled a pivotal shift in policy, now allowing broader use of Real-World Data (RWD) in medical device submissions. This episode of MedTech Global Insights unpacks what this means for the industry, from startups to global enterprises. We explore the immense opportunities this presents for accelerating innova…

Allen covers the Trump administration’s suspension of five East Coast offshore wind leases on national security grounds, and the wave of lawsuits from developers like Equinor and Ørsted calling the reasoning pretextual. Plus Bill Gates-backed startup Airloom showcases its low-profile turbine design at CES 2026, and Brazil opens consultation on curt…

In the final days of 2025, the medical device world felt the full force of the U.S. FDA's new cybersecurity mandate. With the 'Refuse to Accept' policy now in effect, the agency is turning away submissions that fail to meet stringent new security requirements before they are even reviewed.This is not a minor checklist item; it's a fundamental shift…

In the final days of 2025, EU regulators issued a surprise mandate that reshapes the landscape for AI-driven medical devices. A new guidance requires the use of Real-World Evidence (RWE) for continuous, post-market validation of AI/ML algorithms, impacting all companies planning to enter or remain in the European market. This episode of MedTech Glo…

In the final days of 2025, the US FDA made a pivotal change to how it evaluates medical devices, opening the door for Real-World Data (RWD) to take center stage in regulatory submissions. This episode breaks down what this policy shift means for the MedTech industry, moving beyond the traditional reliance on expensive clinical trials.We explore the…

Allen and Joel are joined by Jeremy Heinks of CICNDT to discuss the critical need for pre-installation blade inspections, especially as safe-harbored blades from years past are rushed into service. They cover advanced NDT technologies including robotic CT scanning, blade bolt inspection for cracking issues, and how operators can extend turbine life…

Allen, Joel, and Rosemary break down the Trump administration’s sudden halt of five major offshore wind projects, including Coastal Virginia Offshore Wind and parts of Vineyard Wind, over national security claims the hosts find questionable. They also cover the FCC’s ban on new DJI drone imports and what operators should do now, plus Fraunhofer’s l…

Allen delivers the 2025 state of the wind industry. For the first time, wind and solar produced more electricity than coal worldwide. The US added 36% more wind capacity than last year, Australia’s market hit $2 billion, and China extended its 25-year streak of double-digit growth. But 2025 also brought challenges: the Trump administration froze of…

Allen, Joel, Rosemary, and Yolanda break down the TPI Composites bankruptcy fallout. Vestas is acquiring TPI’s Mexico and India operations while a UAE company picks up the Turkish factories. That leaves GE in a tough spot with no clear path to blade manufacturing. Plus the crew discusses blade scarcity, FSA availability floors, and whether a new bl…

Brazil has just opened a regulatory fast-track for AI medical devices, promising market approval in just 90 days. This is a massive opportunity for MedTech companies looking to expand into Latin America, but a hidden challenge is causing significant delays and unexpected costs for even the most prepared firms.This episode of MedTech Global Insights…

Allen covers forecasts for 46 GW of new US wind capacity by 2029, driven by data centers and reshoring. Plus Equinor’s Empire Wind project stays on track for late 2026, RWE gets approval for the Five Estuaries offshore wind farm in the UK, and a Scottish startup raises funding for modular multi-rotor turbines. Sign up now for Uptime Tech News, our …

Brazil's health authority, ANVISA, recently announced an exciting fast-track approval pathway for AI and machine learning medical software. This move promises to accelerate market access in one of Latin America's biggest markets, creating a massive opportunity for MedTech innovators worldwide.However, this golden opportunity comes with hidden compl…

Last week, the European Commission extended the challenging IVDR transition deadlines, giving diagnostic manufacturers more time. While this seems like a reprieve, it introduces significant strategic complexity and the dangerous risk of complacency. We dissect the new tiered deadlines and analyze what this major regulatory shift truly means for the…

The European Commission has ended years of uncertainty by announcing a mandatory deadline for EUDAMED. As of May 28, 2026, medical device and IVD companies must comply with the database's core modules. This isn't just a new database; it's a new era of regulatory transparency that demands immediate and strategic action from everyone in the MedTech i…

Allen and Joel are joined by Gregory Kocsis, lifting technology expert, to discuss the gap between European and US crane operations. They cover multi-brand blade handling tools, up-tower cranes, and why the aftermarket service sector is driving innovation in major component replacements. Sign up now for Uptime Tech News, our weekly email update on …

This week, we unpack the major implications of the UK MHRA's landmark approval of GSK's new twice-yearly asthma treatment. This is more than a product launch; it's a crucial signal for the global MedTech industry on how to successfully navigate the complex and independent post-Brexit regulatory landscape. We explore why the UK is re-emerging as a v…

Last week, the FDA unveiled a game-changing fast-track for AI diagnostics, but a hidden challenge is already causing chaos for unprepared companies. We break down the new 'Agile PMS' framework and what it means for your market access strategy.This new rule isn't just theory. We explore the real-world case of CardiaAI, a leading Boston-based startup…

The US FDA is making its biggest change to quality system regulations in a generation, harmonizing with the global ISO 13485 standard. This shift, mandated by the new Quality Management System Regulation (QMSR), presents both opportunities for streamlined global compliance and significant hidden risks for unprepared manufacturers.Many global compan…

Allen, Joel, and Yolanda recap the UK Offshore Wind Supply Chain Spotlight in Edinburgh and Great British Energy’s £1 billion manufacturing push. Plus Ørsted’s European onshore wind sale, Xocean’s unmanned survey tech at Moray West, and why small suppliers must scale or risk being left behind. Sign up now for Uptime Tech News, our weekly email upda…

The promise of AI in MedTech is undeniable, but a major regulatory storm is brewing in the European Union. A new, complex dual-compliance framework now requires AI-driven medical devices to satisfy both the rigorous Medical Device Regulation (MDR) and the brand-new EU AI Act. This episode of MedTech Global Insights dives deep into what this means f…

Allen covers a federal judge striking down the US wind energy moratorium, calling it arbitrary and capricious. Plus Maryland opens offshore wind bids for 8.5 gigawatts, Great British Energy announces a £1 billion supply chain investment, and Nordex lands its largest US turbine deal in 25 years with Alliant Energy in Iowa. Sign up now for Uptime Tec…

The explosion of AI in MedTech is met with a tangled web of new global regulations. This week, we dissect the latest guidance from the IMDRF and explore the growing divide between regulatory bodies in the US, Europe, and beyond. For AI device makers, the path to market is now filled with more hidden risks than ever.We explore the critical case of "…

In this episode of MedTech Global Insights, we dissect the FDA's newly finalized guidance on using Digital Health Technologies (DHTs) for remote data collection in clinical trials. This pivotal update opens the door for more decentralized and patient-centric studies but introduces stringent new requirements for verification, validation, and data in…

The European Union has rolled out tough new cybersecurity regulations for medical devices, forcing manufacturers to rethink their entire approach to product security. This episode dives into the practical challenges companies are facing, from securing legacy products to meeting intensive new documentation and surveillance demands.We explore the cas…

Morten Handberg, Principal Consultant at Wind Power LAB, returns to discuss blade damage categorization. From transverse cracks and leading edge erosion to carbon spar cap repairs, he explains what severity levels really mean for operators and why the industry still lacks a universal standard. Sign up now for Uptime Tech News, our weekly email upda…

This week, we dive into a major regulatory challenge brewing in the European Union. MedTech Europe has officially called on the European Commission to resolve the long-standing conflict between the Medical Device Regulation (MDR) and the WEEE directive on electronic waste. This move could reshape compliance for any company selling electronic medica…

The first week of December saw Artificial Intelligence take center stage in MedTech, but not always for the right reasons. While new systems promise to revolutionize patient triage in Greece and reduce physician burnout in the US, a more alarming trend has emerged. Major health insurers are now using AI to automatically deny patient claims, raising…

Last week, the US FDA's new digital health pilot program sent ripples through the MedTech industry. This is more than a simple regulatory update; it's a pivotal shift that moves cybersecurity from a compliance task to a major commercial and contractual battleground, fundamentally changing the rules for market access.This episode breaks down how the…

Allen, Joel, Rosemary, and Yolanda discuss a German study finding 99.8% of birds avoid wind turbines, challenging long-standing collision risk models. They also cover Pattern Energy’s SunZia project nearing completion as the Western Hemisphere’s largest renewable project, lightning monitoring strategies for large-scale wind farms, and offshore flan…

Traditional MedTech global expansion is broken, defined by premium consulting fees, opaque processes, and frustrating delays. This episode of MedTech Global Insights unpacks the new playbook for international market access, revealing how companies are finally breaking free from the old model.We explore how the strategic fusion of advanced AI and on…

Allen covers Ecowende’s first monopile installation in the Netherlands, designed to be the most ecological offshore wind farm ever built. Plus Ireland’s offshore potential proves far smaller than hoped, Australia cancels its third offshore project in recent months, LiveLink Aerospace solves radar clutter in Scotland, GE Vernova secures a Romanian t…

In this episode of MedTech Global Insights, we tackle the silent killer of speed-to-market: regulatory documentation bottlenecks. As companies expand globally, the sheer volume and complexity of preparing submissions for different health authorities can lead to costly delays and divert expert teams to low-value administrative work.We explore how cu…

In the fast-paced world of MedTech, falling behind on regulatory changes isn't just a risk; it's a guarantee of costly delays and missed opportunities. The sheer volume of updates from global health authorities has made manual tracking an impossible task, leaving even the most diligent teams vulnerable to compliance gaps.This episode of MedTech Glo…

Are you ready to accelerate your MedTech or IVD product's global launch by 75%? In this episode of MedTech Global Insights, we explore how Pure Global's advanced AI platform is dismantling the traditional barriers to international market access, transforming a multi-year ordeal into a matter of months.We dive into how this technology provides real-…

In an industry where regulatory costs and complexities can stifle innovation, Pure Global's AI platform emerges as a game-changer. This episode of MedTech Global Insights delves into the five strategic advantages of leveraging their free, powerful AI agents to navigate the intricate world of global medical device registration. We explore how this t…

Allen and Joel sit down with Dan Fesenmeyer of Windquest Advisors to discuss turbine supply agreement fundamentals, negotiation leverage, and how tariff uncertainty is reshaping contract terms. Dan also explains why operators should maximize warranty claims before service agreements take over. Sign up now for Uptime Tech News, our weekly email upda…

In this episode of MedTech Global Insights, we explore the number one hurdle for ambitious medical device and IVD companies: navigating the fragmented and complex world of international regulations. We unpack why the traditional, country-by-country approach to market entry is inefficient and costly in today's fast-paced environment.We then break do…

In this episode of MedTech Global Insights, we explore the paradigm shift in global market access strategy. We move beyond the traditional, fragmented approach of managing regulatory hurdles country by country and dive into the rise of integrated, technology-driven consulting firms. These firms are not just advisors; they are end-to-end partners wi…

Allen and Yolanda discuss Statkraft’s workforce cuts and sale of its Swedish offshore wind projects. They also cover ORE Catapult’s partnership with Bladena to conduct torsional testing on an 88-meter blade, and the upcoming Wind Energy O&M Australia conference. Register for ORE Catapult’s Offshore Wind Supply Chain Spotlight event! Visit CICNDT to…

Navigating the complex, ever-changing web of global MedTech regulations is a primary barrier to market entry. The traditional, manual approach is notoriously slow, costly, and fraught with risks of rejection, delaying access to critical innovations for patients worldwide.This episode of MedTech Global Insights explores a new, technology-driven para…

Allen covers the debate over Chinese wind turbines in Europe, from data security concerns and unfair subsidies to the risk of trading one energy dependency for another. Sign up now for Uptime Tech News, our weekly email update on all things wind technology. This episode is sponsored by Weather Guard Lightning Tech. Learn more about Weather Guard’s …

The global MedTech regulatory landscape is a maze of constantly changing rules and fragmented information. Relying on static guides or old webinars leads to costly delays and rejected submissions. This episode explores a modern solution: a "living library" of expert global insights that converts complex knowledge into simple, actionable checklists …