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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.

Continue reading →

Medtronic, drug coated balloon, peripheral artery disease
December 16, 2015
Medtronic, drug coated balloon, peripheral artery disease

Medtronic Takes Manufacturing to Galway

By MedTech Intelligence Staff

The company will invest €13 million in the facility, which will make drug-coated balloons for peripheral artery disease.

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December 15, 2015

Transdermal Ibuprofen Patch to be Available in Two Years

By MedTech Intelligence Staff

Researchers say the technology enables a high drug load and consistent drug release profile.

Continue reading →

December 15, 2015
Ameing for Asia

Are Clinical Trials Needed to Register Your Device in China?

In lieu of trials, some companies may be able to submit a CER.

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Combination product, drug, device and biologic
November 2, 2015
Combination product, drug, device and biologic

Two Key Processes You Must Know as a Combination Product Manufacturer

By David Amor

When preparing a regulatory submission, there are a couple of critical elements to consider.

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October 30, 2015
MEDdesign

Science Fiction Meets Nano-Robots

By Klaus Jopp

A peek at the latest miniaturization trends, including nano-robots that transport therapeutics to tumors.

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October 13, 2015

CDRH’s Shuren: Future is Bright, We Need to Take Risks

By Maria Fontanazza

As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.

Continue reading →

Robert Califf, FDA
September 16, 2015
Robert Califf, FDA

President Obama Nominates Robert Califf as Next FDA Commissioner

By Maria Fontanazza

Industry doesn’t anticipate roadblocks from the Senate, expects confirmation.

Continue reading →

August 19, 2015

How to CE Mark a Medical Device that Incorporates a Drug

By Paula McCarthy

An awareness of the European regulations and the definitions is essential when pursuing a CE Mark for a combination product.

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Columns

September 2, 2025

Impact of Combination Products on the Medical Devices Industry

By Partha Anbil
combination devices

A comprehensive update on the combination products market shows significant industry partnerships, development challenges, and strategic imperatives for success in the sector characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes.

August 26, 2025

Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)

By Celegence
combination products

Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations.

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.

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