Technology

Remote Cardiac Monitoring: The Rhythm of Innovation

By Robert Kowal, M.D., Ph.D., Medtronic

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

Connected Device Development and the Cloud

While the cloud offers high value for medical device manufacturers and device users, it also creates new challenges. Join the complimentary webinar to hear how industry leaders and pioneers of medical devices are tackling the cloud, plus a “sneak preview” of their Consensus Report to AAMI providing the first-ever written industry guidance on this important topic.

Register here

Intellectual Property

Four Key Disciplines for Intellectual Property Protection

By Jeremy Wittkop, InteliSecure

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

Technology

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

By Bret Kevan Purcell, Ph.D., M.D., University of Florida

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

Upcoming Virtual Event

How Computational Modeling & Simulation Brings Medical Devices to Market Faster, Cheaper, Yet Better

By MedTech Intelligence Staff

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.

Regulatory

EU MDR Approval:
Performing the Literature Search

By Catarina Carrão, Ph.D., Kolabtree

Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.

Upcoming Webinar

COVID-19 Requires New Approach to Clinical Trials
and Human Factors Studies

By MedTech Intelligence Staff

An upcoming webinar will discuss the new methods and protocols that have emerged as a result of conducting trials and HF studies during the pandemic.

Featured Quote

Over the last several months, the COVID-19 pandemic has catapulted virtual health to the forefront of care delivery. This giant leap forward in virtual health is punctuating the need for reliable, clinically accurate technologies to advance how virtual medicine is delivered.

— Raj Toleti, Andor Health

Unlocking Medtech’s Future Potential with Connected Devices and Services

Sponsored By S3 Connected Health

How to optimize coatings and substrates for compatible medical devices

Sponsored By KRÜSS

Securing devices so that clinicians and patients connect without fear.

Sponsored By Irdeto

Telemedicine Cybersecurity Report: iOS Patient-Facing Mobile Apps

Sponsored By Irdeto

The engineer’s guide to wearables

Sponsored By 3M

Trends in Medical Device Purchasing, Evaluation of Value, and Advice for Manufacturers

Sponsored By Evidera

The Growing Need for Real-World Evidence in Medical Devices

Sponsored By Evidera

Clinical Trials & Human Factors Studies during a Pandemic

Dec. 7, 12:00 to 1:30 pm EST

What you will learn:

• Study challenges during a pandemic
• FDA guidance on clinical studies during COVID-19
• Strategies and procedures for clinical trials during a pandemic
• Strategies and procedures for human factors studies during a pandemic
• Long-term opportunities for more efficient clinical and human factors research based on lessons from COVID-19

Register Now!

Computer Modeling & Simulation in MedTech Product Development & Submissions

A virtual conference | January 27-28, 2021, 11:00 AM - 4:00 PM ET

What you will learn:

• The uses and limitation of CM&S in med tech product development
• Simulation to support, enhance, or replace clinical studies
• The business case for CM&S
• FDA’s perspective of CM&S
• Standards and validation of modeling data
• Case studies of successful med tech CM&S
• The promise of digital twins, personalized modeling, and 3D printing

Register Now!

EU IVDR Implementation Strategies Virtual Workshop

February 24 – 26, 2021, 11:00 AM - 4:00 PM ET

EU IVDR will profoundly affect the global diagnostics market, requiring new procedures, evidence development, documentation, organizational structures, reporting, data management, and a reassessment of legacy portfolios. Even the largest and best-prepared companies struggle with implementation, which involves strategic thinking and buy-in at the highest levels. This interactive workshop convenes experts from major diagnostics companies, notified bodies, and consulting firms to share strategies, procedures, experiences, and challenges.

Register Now!