Regulatory

Q3 Medical Device Recalls Fall Nearly 30%,
but Still on Track to Exceed 2019

By MedTech Intelligence Staff

Top reasons for recalls include software, quality and parts issues.

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

Technology

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

By Jennifer S. Geetter, McDermott Will & Emery

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.

Operations

Post-COVID Era of Product Safety:
Recall Risks During and After a Pandemic

By Chris Harvey, Stericycle

The medical device industry is pressured to aid those stricken by the pandemic, while at the same time working to mitigate increased risks usually associated with hurried manufacturing and quality control procedures.

Quality

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

By Suzanne E. Clark, Ken Block Consulting, LLC

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

NEXT WEEK: 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.

Product Development

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza, Editor-in-Chief

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.

Technology

Remote, Telehealth-Driven World Poses New Concerns
for Medical Device Security

By Bill Enos, MSI Americas

Medical device security needs to address the cyber-physical threats, not just patient health information risk.

Featured Quote

Right now, digital medical technology is at a “show me” point where physicians are demanding to see the data proving they can deliver better care with it than without it.

— Justin Williams, Noteworth

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!