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Product Design & Development

Shady Hassan, Vocalis Health
December 9, 2020
Shady Hassan, Vocalis Health
MEDdesign

Returning to ‘Normal’: Non-Invasive Screening Via Vocal Analysis

By Shady Hassan, M.D.
No Comments

A return to normalcy requires us to address the limits of current testing approaches and broadly deploy reliable screening tools that facilitate early detection and encourage more focused testing of those at high-risk of spreading the coronavirus.

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Wearable Cloud, Medical Device Connectivity
December 8, 2020
Wearable Cloud, Medical Device Connectivity

Medical Devices and the Cloud: What Does It Mean to Product Design?

By MedTech Intelligence Staff
2 Comments

Although the cloud offers great value for medtech manufacturers and device users, it also creates new challenges.

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Combination product, drug, device and biologic
December 7, 2020
Combination product, drug, device and biologic

Quality Considerations for Drug-Device Combination Products

By Amy Scanlin
1 Comment

Understanding the GMP requirements of each component is critical to product and compliance success.

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Suzanne Clark, Ken Block Consulting
December 2, 2020
Suzanne Clark, Ken Block Consulting
CAPA Corner

Considering CAPA: Maybe It’s Not a Monster After All

By Suzanne E. Clark
No Comments

It’s time to consider CAPAs as opportunities rather than just other issues to tackle.

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Jennifer S. Geetter, McDermott
November 30, 2020
Jennifer S. Geetter, McDermott
Soapbox

Digital Health as Healthcare Delivery: A Path to Transform Care Delivery Post-Pandemic

By Jennifer S. Geetter
No Comments

The challenge for the digital health community will be to bring the same high standards for care in the physical world to their digital interactions.

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Bret Kevan Purcell
November 25, 2020
Bret Kevan Purcell
MEDdesign

Managing COVID-19: How Medical Advancements Bring More Options for Patients and Doctors

By Bret Kevan Purcell, Ph.D., M.D., COL (Ret.), Medical Corps., U.S. Army
No Comments

A review of new, successful treatment options for the novel coronavirus.

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Robert Kowal, M.D., Medtronic
November 23, 2020
Robert Kowal, M.D., Medtronic
MEDdesign

Remote Cardiac Monitoring: The Rhythm of Innovation

By Robert Kowal, M.D., Ph.D.
No Comments

The technology behind remote cardiac device monitoring is becoming more convenient, responsive and connected across the digital ecosystem—including a new smartphone app.

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Jeremy Wittkop, InteliSecure
November 20, 2020
Jeremy Wittkop, InteliSecure
MEDdesign

Four Key Disciplines for Intellectual Property Protection

By Jeremy Wittkop
No Comments

The absence of any of these disciplines can lead to blind spots that can introduce risk, but they are not all created equal.

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MedTech Intelligence
November 20, 2020
MedTech Intelligence

Six FDA Experts to Weigh in on Computational Modeling & Simulation in MedTech Product Development

By MedTech Intelligence Staff
No Comments

No longer just “the big company advantage,” CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

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Josh Turpen, Jama Software
November 17, 2020
Josh Turpen, Jama Software
Soapbox

The Top Trend for Medical Devices in 2021? Putting Quality First

By Josh Turpen
1 Comment

Moving too quickly in the product development process can lead to mistakes.

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