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Manufacturing Execution

Featured Articles

February 3, 2026
Safety of AI in Medical Devices

AI in Medical Devices: Safety Questions the Industry Can’t Afford to Ignore

By Pujitha Gourabathini

Artificial intelligence is moving quickly into mainstream medical devices, and the industry has become fluent in a familiar set of concerns: bias, transparency, and cybersecurity. These topics matter, but they don’t capture the risks most likely to shape patient safety in the coming decade. The deeper challenges lie in the interactions between algorithms, clinical workflows, data pipelines, and human decision making. Those interactions are where safety is won or lost, and they remain the least examined part of AI adoption.

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

By Randy Knotts

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026
Medical Device R&D Bottleneck

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.

December 4, 2025

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.

December 4, 2025
Smart Critical Care

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.

December 4, 2025

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.

November 17, 2025
Aligning MedTech Compliance

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.

October 28, 2025
Battery-Powered Medtech

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.

View More Operations Articles »

News & Views

  • FDA Launches Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Chronic Disease Technologies

  • AI and Functional Precision Medicine: A Defining Moment for Pediatric Cancer Care

  • Significance of Harmonized standards

  • Why Your Regulatory Compliance Strategies Aren’t Keeping Pace

  • Top MedTech Trends in 2025

  • Streamlining Compliance for Quicker MedTech Market Entry

  • GeniPhys receives FDA clearance for self-assembling collagen scaffold

  • Medtronic Acquires Nano Surface Technology Assets from Nanovis

  • AAMI Updates Materials Compatibility Guidance for EO, Other Modalities

  • APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare

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






Operations Archive

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  • Manufacturing Execution
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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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