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MEDFlix

Featured Videos

March 29, 2017
Susan Alpert, SFA Consulting, Global Regulatory Strategy

Practical Advice for Your Regulatory Strategy

By MedTech Intelligence Staff

For companies in global markets, consider these three factors.  

March 6, 2017
Matthew Hein, U.S. Department of Commerce

Should I Pursue Emerging Medtech Markets?

By MedTech Intelligence Staff

Many companies go for product approval in smaller markets first. Is that the right decision?  

April 21, 2016

Connecting User Needs with Actionable Product Design Inputs

By MedTech Intelligence Staff

Identifying user needs and actually turning them into actionable inputs during the design process can be a challenge.  

April 11, 2016
FDA, Al Taylor, Risk

FDA Says Consider Device Context, Not Just Intended Use

By MedTech Intelligence Staff

Device companies need to think about how their product interacts with systems and users.  

March 4, 2016
Jon Speer, risk management

MedTech Blunders in Risk Management

By MedTech Intelligence Staff

A look at some common mistakes medical device companies make when approaching risk.  

March 1, 2016
Mark Leimbeck, UL

Consistency Needed in Addressing IEC 60601-1 3rd Edition Risk Management

By MedTech Intelligence Staff

There’s a greater emphasis on being able to demonstrate competence in performing required activities.  

February 12, 2016
ECRI Instiute

Testing Devices Critical Part of Improving Patient Safety

By Maria Fontanazza

This video demonstrates how ECRI Institute tests medical devices.  

February 11, 2016
ECRI, duodenoscopes, endoscopes

Why Duodenoscopes Are So Tough to Clean

By Maria Fontanazza

Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.  

November 6, 2015
Maria Fontanazza and Michael Lohan, IDA Ireland, AdvaMed 2015

Ireland Remains Competitive in Medical Device Sector

By MedTech Intelligence Staff

With an established base of medtech companies and a strong workforce, Ireland remains a key player in the global supply chain.   

November 5, 2015
Joan Koerber-Walker and Maria Fontanazza, economic development in medtech, AdvaMed 2015

Finding the Right Ecosystem for MedTech Innovation

By MedTech Intelligence Staff

In order to keep innovation and manufacturing in the United States, device companies need federal and local support.  

Visit the MEDFlix Archive for more

Featured Articles

July 7, 2026
AI in the EHR

Applying Agentic AI to Healthcare Delivery: The Key to True Transformation

By Jaimon Jose

MTI Viewpoints Insights shared by industry relative to healthcare and...

July 7, 2026
post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness.

June 29, 2026
AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Geethapriya (Priya) Setty

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

June 1, 2026

MedTech In Focus: AI impact in healthcare

By MedTech Intelligence Staff

The most recent AI thought leadership published on MedTechIntelligence.com.

June 1, 2026

If Your AI Can’t Explain Itself, Can FDA Authorize It?

By Lavanya Ramnath, Srividya Narayanan

Why is algorithmic transparency becoming an increasingly important consideration in FDA's review of AI/ML medical devices?

May 20, 2026

Fixing Eligibility at the Point of Care: The Missing Link in Medical Device Reimbursement Integrity

By Peter Justen

MTI Viewpoints Insights shared by industry relative to healthcare and...

May 20, 2026

The failure of the ‘usual suspects’ approach to life science recruitment

By Ivor Campbell

How has AI impacted the way in which companies recruit for senior specialists, particularly in highly niche roles in MedTech, biotech and pharmaceutical development? Finding the right people for these roles has never been harder.

May 20, 2026
Justice scale, healthcare, cost

Value, Focus, and the Future of MedTech: M&A and Divestitures are Rewriting the Strategic Playbook.

By Joan Hinrichs

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients - unlocking their full potential.

View More Combination Products Articles »

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  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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