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gavel
July 5, 2016
gavel

Mesh Lawsuits Shine Light on Material Sourcing and Selection

By Maria Fontanazza

Having the right internal material science expertise, along with aligning material specs with device outcomes is essential.

Continue reading →

June 13, 2016

Medtronic, IBM Unveil SugarWise Diabetes App

By MedTech Intelligence Staff

The cognitive app that aims to make daily diabetes management easier and more informative is in the final development stage.

Continue reading →

May 27, 2016

Help! How Do I Identify User Needs and Get My Product to Market Now?

By MedTech Intelligence Staff

A roundtable discussion on key issues that medtech companies face in product development.

Continue reading →

Injectable Device, UL, combination product
May 23, 2016
Injectable Device, UL, combination product

Human Factors Perspective: Safety Lessons Learned Using Injectable Devices

By Allison Strochlic, Michael Wiklund

Conducting usability tests will help manufacturers reduce the risk of harmful use errors and enhance device effectiveness.

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April 26, 2016

New Ventral Hernia Mesh Shoots to Kill Bacteria

By Maria Fontanazza

Start-up Ariste Medical has developed technology to reduce surgical site infections and transform implants into combination products.

Continue reading →

Robert Califf, FDA
February 29, 2016
Robert Califf, FDA

Califf Confirmed to Head FDA, Opposition Remains

By MedTech Intelligence Staff

Although the U.S. Senate vote to appoint the new agency commissioner was overwhelming, it was not without critics.

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Dollar, money
February 12, 2016
Dollar, money

Combination Products to Get Part of $5.1 Billion Requested FDA Budget

By MedTech Intelligence Staff

The agency is creating a virtual center of excellence to expedite the development of combination products.

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February 9, 2016

Human Factors, Combination Products Focus of Latest FDA Guidances

By MedTech Intelligence Staff

The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.

Continue reading →

Insulet, OmniPod
February 8, 2016
Insulet, OmniPod

Beyond Diabetes, Insulet Explores Viable Smart Drug Delivery

By Maria Fontanazza

Via partnerships with pharmaceutical companies, Insulet expands its platform technology past insulin delivery.

Continue reading →

Regenerative Medicine, microencapsulation
January 14, 2016
Regenerative Medicine, microencapsulation

Infographic: Opportunity and Innovation in Regenerative Medicine

By MedTech Intelligence Staff

The rise in chronic disease and the effort to reduce healthcare costs presents a large opportunity for the field of regenerative medicine.

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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.

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