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Anura Fernando, UL
December 31, 2019
Anura Fernando, UL
Soapbox

How We Created an Orchestrated Approach to Healthcare Cybersecurity Assurance

By Anura Fernando, Marc Wine

The goal is to establish a baseline of cybersecurity hygiene and assurance for devices that are part of the national critical infrastructure software supply chain.

Continue reading →

Jon Speer, Greenlight Guru
December 27, 2019
Jon Speer, Greenlight Guru
Soapbox

4 Keys to Funding Your Medical Device

By Jon Speer

How will you make your company more attractive to investors?

Continue reading →

Sue Spencer, IVD, EU MDR, Qserve
December 24, 2019
Sue Spencer, IVD, EU MDR, Qserve
Soapbox

IVDR: Go with the Flow

By Sue Spencer

When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.

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Medtech, innovation
December 23, 2019
Medtech, innovation

A New Approach to the FDA’s Special 510(k) Program

By Tara Lysechko

The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.

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December 20, 2019

Home Monitoring Tech to Continue to Gain Steam in 2020

By MedTech Intelligence Staff

Technology will continue to evolve to allow patients greater control over their healthcare.

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Bill Oldham, Thought Leadership & Innovation Foundation
December 19, 2019
Bill Oldham, Thought Leadership & Innovation Foundation
MEDdesign

Regenerative Medicine: Innovative Approach Reduces Burn and Diabetic Wound Complications

By Bill Oldham, Robin Robinson, Ph.D.

The idea of harnessing the body’s response to heal and defend is no longer the stuff of science fiction.

Continue reading →

Sandi Schiable, WuXi AppTec
December 17, 2019
Sandi Schiable, WuXi AppTec

Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears

By Maria Fontanazza

With May 26, 2020 quickly approaching, every day counts.

Continue reading →

Justice scale, healthcare, cost
December 9, 2019
Justice scale, healthcare, cost

The Convergence in Healthcare and How Small and Large MedTech Companies Must Adjust

By Maria Fontanazza

Peter Micca of Deloitte discusses the changes that are happening within the healthcare ecosystem as a whole.

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3M Microfluidic components
December 6, 2019
3M Microfluidic components

Take a Closer Look at the Components in Microfluidic Devices

Manufacturing microfluidic devices requires sophisticated techniques.

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FDA
November 25, 2019
FDA

FDA Launches EtO Sterilization Master File Pilot Program

By MedTech Intelligence Staff

The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.

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

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