News

An Interview with Gilero’s Director of Human Factors & Design

[embed]https://vimeo.com/461522190[/embed] Human-centered design is a core part of the Gilero process.  We strongly believe that by bringing user needs into focus early within the medical device design and development process, we can deliver products that users readily embrace and can be operated safely in real-world conditions.  The...

27 Oct, 2020

7 Tips for Successful Medical Device Manufacturing

Transferring a medical device into manufacturing can be challenging. There is a high demand to manufacture devices efficiently, affordably and with a faster time-to-market than ever before. Medical device manufacturers must find innovative solutions to meet these needs while following best practices and regulatory guidelines to ensure...

12 Oct, 2020

Combination Products – Definition & Overview

What is a Combination Product? A combination product is a therapeutic or diagnostic product that combines drugs, medical devices, and/or biological products. A combination product will combine at least two of these product categories and sometimes combines all three. Some of the most common types include traditional...

07 Oct, 2020

What is a Cleanroom & What Happens in One?

What is a Cleanroom? A cleanroom is a controlled environment in which the number of airborne particles is kept to a minimum. These particles could include contaminants such as dust, airborne microbes, aerosol particles and chemical vapors. The contamination level in a cleanroom is specified by the...

29 Sep, 2020

Vascugenix Prepares to Launch Speed-Torque Device

LITTLE ROCK, Ark., September 15, 2020 - Vascugenix, a medical device company focused on developing innovative products to improve interventional cardiovascular procedures, is preparing to launch its first developed device, the Speed-Torque, in the U.S. market. The Speed-Torque is specially designed to improve the process of guidewire...

15 Sep, 2020

UNC-Chapel Hill Startup Develops ‘Error-Free’ Dose Measurement for Pediatric Patients

This is an excerpt from the article UNC-Chapel Hill startup develops 'error-free' dose measurement for pediatric patients, written by Shellie Edge and published by WRAL TechWire on Aug. 11, 2020. The full article can be found here. CHAPEL HILL, NC – As a patient undergoing chemotherapy, the...

26 Aug, 2020

FDA 510(k) Submission Process: An Introduction & How-To Guide

What is a 510(k) submission? A 510(k) submission is a type of regulatory submission made to FDA called a Premarket Notification. In a 510(k), substantial equivalence to a predicate device on the market must be demonstrated. In other words, the medical device in question must be at...

17 Aug, 2020

Medical Device Design & Development: An Informative Guide

Medical devices make medical intervention easier and more successful. They range from tongue depressors and catheters to pacemakers and medical lasers. Medical devices have been used by clinicians for as long as medical intervention has existed, but within the last several decades, advances in medical device design...

30 Jul, 2020