Instructional Materials:
The Basis for Safety Between Users and Medical Devices

By Renée Bailey, BlackHägen Design

Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.

• Engage with MedTech executives and regulators in Washington DC for an in-depth look at trends in advanced manufacturing and supply chain intelligence.
• Trends in Advance Manufacturing Technology for quality improvement & management, speeding time to market, mitigating labor resource issues, and more.
• Supply Chain Intelligence technologies and strategies for building sustainable, resilient supply chains.

Earlybird Pricing of $595 ends September 30.
Seating is limited

The Power of AI to Enhance Clinical Trials

By John Schwope, Simplified Clinical

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.

EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

By Christian Götz and Dr. Jara Brenke, TÜV SÜD Product Service GmbH

Previous EU regulatory acts did not cover products without an intended medical purpose—typically devices with aesthetic indications. This now changes with Annex XVI of the EU Medical Device Regulation (MDR). Notified Bodies can assess these products for their conformity with the regulation. However, responsibility for proactively pursuing the EU certificate of conformity for the products rests with the manufacturers.

Partnering to Support Sustainability in the OR

By MedTech Intelligence Staff

A recent study from Ethicon and the Cleveland Clinic outlined opportunities and barriers to better sustainability practices in operating rooms. We spoke with Vishnu Kalra, President, U.S. Ethicon, to learn more about the study’s findings, Ethicon’s efforts to develop more sustainable products and practices, and how other companies can get started.

Featured Quote

Older infrared analysis tools had long analysis times and only measured the sample cavity, not the entire sample. Newer iterations resolve these issues by using a lattice of parallel infrared beams to irradiate more evenly as well as innovative cooldown mechanisms to speed processing times.

— Emily Newton, Revolutionized Magazine

How redesign can help meet sustainability demands
for medical devices

External environmental influences or improper handling can lead to inaccurate results or poor weighing performance, which are not caused by the balance. To ensure high accuracy during weight measurements and excellent repeatability of the results you need to heed certain basic rules and requirements.

Download to learn more

How to Achieve Optimal Weighing Performance with Lab Balances

Better device outcomes through better data

The Emergence of Lateral Flow Assays in Diagnostics

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Drive Healthcare Transformation with Enterprise-Level Infrastructure

2023 MedTech Regulatory Performance Report