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Product Design & Development

Featured Articles

May 10, 2026
Trust in AI

Maintaining trust in medical AI: Monitoring and managing model lifecycle

By Anna Vuolo

Healthcare environments are dynamic with patient populations, clinical practices and data collection methods continuously evolving. Similarly, effective AI systems depend on more than performance at initial deployment. They must be monitored and managed throughout their lifecycle to remain reliable, clinically relevant, and safe.

April 30, 2026

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

April 1, 2026

The Human Side of AI Medical Devices: Why Safety Depends on Design, Not Just Algorithms

By Shreya Sridhar

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.

March 27, 2026

HL7 Launches Real‑Time Medical Device Interoperability Accelerator

By MedTech Intelligence Staff

New implementation community builds on global collaboration to improve real-time device data exchange for AI-enabled care.

February 26, 2026
MedTech Commercialization

Decision Criteria for Technology Commercialization of Medical Devices in 2026

By Partha Anbil

Commercialization strategy in 2026 and beyond is more than a checklist. It requires a new mindset where cybersecurity is seen as a patient safety imperative, data is treated as a critical strategic asset, and product lifecycle is an intelligent process.

February 23, 2026

Mastering MedTech Intelligence: The Intelligent Product Lifecycle at Fresenius Medical Care

By MedTech Intelligence Staff

Rene Zoelfl, Global Industry Advisor for PTC's MedTech practice, shares how intelligent product lifecycle at Fresenius Medical Care connects cross-discipline teams through a digital fabric built on a shared data foundation.

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 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.

View More Product Development Articles »

News & Views

  • FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

  • FDA Expands AI Capabilities: Launches ELSA and Completes HALO Data Platform Consolidation

  • Roche acquires PathAI to transform AI-driven diagnostics

  • Trump Planning to Fire FDA Commissioner Marty Makary

  • Why Gen AI is a Win for MedTech: And, How to Unlock its Potential with the Right Policies

  • Medtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval

  • Sonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided HIFU Therapy for Pancreatic Cancer

  • Edwards Lifesciences Shares Ten-Year Pivotal Data Supporting Long-Term Durability of Resilia Tissue

  • Johnson & Johnson Enters Agreement to Acquire Atraverse Medical

  • enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve

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






Product Development 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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