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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

November 27, 2024
sustainable design

From design to disposal:
Reducing the footprint of single-use drug delivery devices

By Alex Fong

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024
LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023
Rama Chellappa

Instilling Trust in AI

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff

The FreeStyle Libre 2 now has indications for children ages four and older.

May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

View More Combination Products Articles »

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

Upcoming Events & Webinars

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On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

Combination Products

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