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FEATURE ARTICLE
How is AI Enabling Darwinian growth for Life Science Professionals?
By Ivor Campbell
The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.
FEATURED CONTENT
R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?
By Venkatesan (Venkat) Muthukrishnan
How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.
The Hidden Complexities of Medical Needle Design
By Kelly Peterson
Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.
Using AI and LLMs to fill in fragmented data gaps within complex critical care
By Dimitar Baronov, PhD
AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or de-escalation of treatment and enhances patient outcomes. These technologies also help reduce staffing issues and prevent clinician burnout by continuously monitoring patient risk and supporting decision-making in busy ICU settings.
Digital Companion for the Perioperative Surgical Phases
By Partha Anbil
A digital companion, purpose-built for surgical patients’ pre- and post-operative journeys, is now an imperative for providers, payers, and medtech leaders aiming to achieve competitive differentiation, clinical excellence, and sustainable business value.
Navigating U.S.-EU Medical Device Regulation: Innovative Strategies for Global Compliance
By Holger Wagner
The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation (MDR) and the FDA’s Quality Management System Regulation (QMSR) setting new benchmarks.
The Overlooked Role of Family Caregivers in Home-Based Care: Addressing Challenges and Leveraging Technology
By Jiang Li
Examines the increasing strain on caregivers in home-based care models, the level of support they need for various stages of care, and how improved technological devices and infrastructure can help alleviate their burden.
Beyond Batteries: The Urgent Case for RF-Powered Medical Devices in Modern Healthcare
By Dr. Charles Greene
Hospitals are adding more connected devices than ever before—from patient wearables to asset tracking systems. Yet this digital transformation is being bottlenecked by an antiquated power infrastructure dependent on single-use batteries that create waste, demand constant maintenance, and compromise device reliability.
Disruptive Innovation in MedTech: Evolving Characteristics and Modern Realities
By Partha Anbil
Converting promising technologies into durable outcomes, experience, and cost at scale with evolving technologies and disruptive innovation.
MEDTECH VIEWPOINT
How is AI Enabling Darwinian growth for Life Science Professionals?
By Ivor Campbell
The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.
AI and Functional Precision Medicine: A Defining Moment for Pediatric Cancer Care
President Trump’s 2025 executive order establishing artificial intelligence (AI) in pediatric cancer as a national priority marks a turning point in medicine. For decades, childhood cancer treatments have advanced slowly, constrained by limited data, small clinical trials, and therapies designed for adults. The convergence of AI and Functional Precision Medicine (FPM) now offers a path to faster, more accurate, and more personalized treatments for children, one that replaces population-based best guesses with evidence-driven precision care.
What is a Service+Tech Model?
By Lakshmeenarayana Goundalkar (LGG)
The Service+Tech model embeds AI into the workflow of regulatory experts rather than treating technology as a standalone tool; an approach allowing organizations to adopt AI immediately, with no risk and no R&D investment, while keeping full confidence in the accuracy and regulatory readiness of submissions.
Physician Investment in MedTech Startups Can Be a Tricky Topic
By Scott Nelson
The physician has a unique perspective that non-clinical investors don’t: they know firsthand whether a technology will be adopted. They deeply understand if it truly is better for them and their patients.
ASK THE EXPERT
Product Development Outsourcing Needs Speed, Safety & Certainty
Seek partners who can see your vision — the full picture, anticipate challenges, and help you navigate complexity with confidence.
4 FAQs to Notified Bodies
Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.
Managing MedTech Cost Pressures With Data-Driven Lifecycle Intelligence
To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.
NEWS
* MTI Regulatory Roundup: global medical device regulatory update
* FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies
* EndoQuest to Advance Next-Generation Surgical Robotics powered by NVIDIA IGX Thor
* AtriCure Announces the First Patient Treated in the BoxX-NoAF Clinical Trial
* Thermo Fisher Scientific to Acquire Clario to Provide Deeper Clinical Insights
* Hologic to be Acquired by Blackstone and TPG for up to $79 per Share
* AAMI and TechNation Collaborate to Survey Healthcare Technology Field
* AMA Launches Center for Digital Health and AI Innovation
* Merit Medical to Purchase Pentax Medical C2 CryoBalloon Technology
* Nalu Medical PNS System Acquired by BSCI
* Seelos Therapeutics, Inc. Assets, Acquired through Bankruptcy
* Sunrise Labs Rebrands as Suntra MedTech Solutions™
* Expanded approval for Navitor TAVR system – CE Mark in Europe
* Philips launches smart telemetry platform for cardiac connectivity beyond the bedside
* Globe® Pulsed Field System receives FDA approval
Upcoming Events & Webinars
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On Demand Events & Webinars
December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?
Join the MedTech Intelligence Community
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TOPICS
* Digital Health
* MedTech Economics
* Manufacturing Execution
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* Quality/Regulatory
Upcoming Events & Webinars
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Boost Product Quality with Integrated ALM and PLM
Whether you’re managing complex product portfolios, navigating regulatory pressures, or striving to deliver higher customer satisfaction, this guide will help you understand the tangible benefits of integrating ALM and PLM.
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