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Remco Munnik, Iperion
May 15, 2020
Remco Munnik, Iperion
Soapbox

Essential Data Preparations for AI

By Remco Munnik, Steve Gens

Smart process automation promises to cut complexity and transform product traceability in the medical device industry. However, its potential relies 100% cent on having good, reliable data on which to draw.

Continue reading →

Medtech, innovation
April 10, 2020
Medtech, innovation
Soapbox

Compliance Date Approaching for FDA Unique Device Identifiers

By Amy Scanlin

Timely compliance will ensure that your products will not be considered misbranded.

Continue reading →

Ames Gross, Pacific Bridge Medical
April 8, 2020
Ames Gross, Pacific Bridge Medical
Ameing for Asia

Amid Pandemic, Augmented and Virtual Reality Offer Promise in Asian Markets

By Ames Gross

With the Covid-19 pandemic increasingly forcing healthcare testing, diagnosis and treatment online, the promise of augmented and virtual reality is drawing deepening interest in Asia’s medtech market.

Continue reading →

Mark Wasmuth, GMDN Agency
March 25, 2020
Mark Wasmuth, GMDN Agency
Soapbox

We Need Better Data to Make Better Decisions

By Mark Wasmuth

Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.

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N95 respiratory mask
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.

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Charlie Kim, Soom
March 11, 2020
Charlie Kim, Soom
Soapbox

How to Get More Mileage Out of Your Electronic IFU

By Charlie Kim

Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with greater confidence and clarity in medical devices.

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Coronavirus, COVID-19
February 26, 2020
Coronavirus, COVID-19

U.S. Companies Donate Nearly $27 Million in Medical Products to Aid in COVID-19 Outbreak in China

By MedTech Intelligence Staff

AdvaMed has reported that its member companies have provided $26.8 million in medical supplies, along with $4.1 million in cash donations.

Continue reading →

FDA
February 18, 2020
FDA

FDA Operation Prevented Illegal Shipments of Products from Entering U.S. Market

By MedTech Intelligence Staff

The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.

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gavel
February 3, 2020
gavel

J&J Must Pay $344 Million for Marketing of Pelvic Mesh in California Case

By MedTech Intelligence Staff

The state’s attorney general said J&J put its profits “ahead of the health of millions of women”.

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Remco Munnik, Iperion
January 29, 2020
Remco Munnik, Iperion
Soapbox

Capitalizing on Standardized International Product Data

By Remco Munnik

The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.

Continue reading →

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Columns

November 27, 2024

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

By Alex Fong
sustainable design

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

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

By Laura Housman
LDT Development

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

Instilling Trust in AI

Rama Chellappa

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.

November 11, 2020
MEDdesign

Designing the Worst-Case Test to Get Best Case Results

By Dan Fowler
Dan Fowler, WuXi AppTec

To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.

November 4, 2020
Soapbox

How the COVID-19 Response Is Revealing Potential of IDMP

By Lise Stevens
Lise Stevens, Iperion

The pandemic is helping realize the potential of ISO IDMP data standards in relation to adverse event reporting, electronic prescribing and medicines control in the supply chain.

October 12, 2020

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza
Arlen Ward, System Insight Engineering

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

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

By MedTech Intelligence Staff
Checkbox

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.

August 4, 2020
Ameing for Asia

Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge

By Ames Gross
Ames Gross, Pacific Bridge Medical

In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.

  • Digital Health
  • MedTech Economics
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