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October 3, 2016

4 Facts about Industry 4.0 Medical Device Manufacturers Can’t Ignore

By John Dzelme

How advanced software, technology and manufacturing processes will help companies stay competitive.

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September 26, 2016

Special Problems and Disconnects for Combination Products

By Alberto Velez

Some insights on integrating stability testing requirements into a device organization’s plan to make combination products.

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3D printing
September 21, 2016

Growth of Medical 3-D Printing in Asia

By Ames Gross
3D printing

With the largest patient population in the world, the region has high growth potential over the next few years.

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Acceptance criteria, formula
September 19, 2016

Deriving Validation Acceptance Criteria

By William Brown
Acceptance criteria, formula

An important yet often mysterious part of validation.

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User-centered design
September 12, 2016

Challenging the Assumption of “The Fewer Steps the Better”

By Charlotte Lux, Ed Geiselhart
User-centered design

Why this sentiment can cause more harm than good.

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Product Development, Human factors engineering
September 6, 2016

HFE Practice Models: How Manufacturers Establish and Maintain HFE Competency

By Allison Strochlic, Michael Wiklund
Product Development, Human factors engineering

Manufacturers can rely upon internal human factors engineers and/or external consultants to apply HFE effectively during device development.

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Barcode, UDI
September 1, 2016

Preparing for UDI in Europe

By Steve Cottrell, Madris Tomes
Barcode, UDI

The United States paves the way for seamless compliance.

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Intuitive Surgical, robotic assisted surgery
August 23, 2016

The Transformation of Robotics in Asia

By Ames Gross
Intuitive Surgical, robotic assisted surgery

Several technologies that can streamline procedures for surgeons in the OR are in development.

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Heart
July 27, 2016

Update on the Cardiovascular Market in Asia

By Ames Gross
Heart

As CVD rates rise, so does the demand for devices that improve heart function and blood flow.

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Checkbox
July 14, 2016

Eight Things You Need to Know about Unique Device Identification

By Steve Cottrell, Madris Tomes
Checkbox

Are you UDI-ready? Get the facts to achieve compliance fast.

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Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle


On Demand Events & Webinars

December 1, 2025
From Silos to Synergy: Building the Intelligent MedTech Lifecycle
September 17, 2025
Japan Medical Device Reimbursement Strategy
February 26, 2025
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery
September 26, 2024
Adopting a RIM Platform in MedTech: Myths vs. Reality
August 27, 2024
Decoding global regulatory pathways: How to classify your Medical Device
July 31, 2024
Managing global regulatory strategy and compliance: assessing status, gaps, and needs.
July 18, 2024
Now that the EU MDR deadline is passed, how do you sell your device abroad?





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

Upcoming Events & Webinars

September 23, 2026 – 11:00 am – 12:00 pm
Managing Cybersecurity Across the MedTech Lifecycle

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