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Wearable Cloud, Medical Device Connectivity
September 25, 2019
Wearable Cloud, Medical Device Connectivity

Wearables Web Seminar Focuses on Market Trends, Innovative Components and Integrating Data

By MedTech Intelligence Staff

This complimentary event will give attendees insights on the market landscape and potential areas of opportunity.

Continue reading →

Nicholas Zampa
September 23, 2019
Nicholas Zampa
MEDdesign

Making Way for Probability in Human Factors (Part I)

By Nicholas Zampa

This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.

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European Union Flag
September 20, 2019
European Union Flag

Biotronik’s EU MDR Certification a ‘Huge Milestone’, Says GlobalData

By MedTech Intelligence Staff

The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.

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Alert
September 16, 2019
Alert

FDA Monitoring Potential Device Shortage After Atlanta Sterigenics Facility Temporarily Closes

By MedTech Intelligence Staff

Will more medical devices be impacted?

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John Geis, Cresset Partners
September 13, 2019
John Geis, Cresset Partners
Soapbox

What MedTech Product Business Owners Must Know About Private Investments

By John Geis

For founders and owners of privately held medical product businesses, the amount of private investment dollars available is significant.

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Ames Gross, Pacific Bridge Medical
September 11, 2019
Ames Gross, Pacific Bridge Medical
Ameing for Asia

Opportunities for Precision Medicine in Asia

By Ames Gross

It is the pot of gold at the end of the medical rainbow—the promise that, by harnessing data, researchers can tailor drugs, devices, and treatments to the genetic configuration, lifestyle, and environment of individual patients.

Continue reading →

Rachel Shelly, IDA Ireland
September 9, 2019
Rachel Shelly, IDA Ireland
Soapbox

Where MedTech Is Going in the Next Decade, An Irish Perspective

By Rachel Shelly

Medtech decision makers must accurately predict future trends in order to chart the best future directions and identify the most advantageous areas for business investment.

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Sandi Schiable, WuXi AppTec
September 3, 2019
Sandi Schiable, WuXi AppTec
Soapbox

Preparing for MDR: Partner Up

By Sandi Schaible

There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.

Continue reading →

Tissue graft, normal bone
August 8, 2019
Tissue graft, normal bone

Combining Medical Technologies for Predictable Bone Regeneration

By Robert E. Marx, DDS

The first steps into clinically practical tissue engineering are through in-situ tissue engineering of bone.

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magnifying glass
July 17, 2019
magnifying glass

IDMP: Back on Track and Bearing Down with New Urgency—What’s Next?

By Siniša Belina

After a series of delays and false starts, EMA is now progressing its ISO IDMP agenda with firm intent. The first implementation guide is out now for consultation, to be followed by a second actionable version by next year. Life sciences companies targeting Europe will have a year to comply with all the measures—but this will be a lot of work.

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
  • Manufacturing Execution
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