Design & Development

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...

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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...

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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...

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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...

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An Interview with Gilero’s Director of Integrated Systems

The Integrated Systems team at Gilero is dedicated to designing, developing and manufacturing electromechanical medical devices and electromechanical drug delivery systems. While Gilero has been providing design & development services since its inception in 2002, and later added manufacturing services, the addition of a dedicated team for...

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Charles Barkley Invests in Cary Medtech Startup NeuroVice

This is an excerpt from the article NBA legend Charles Barkley invests in Cary medtech startup, written by Chantal Allam and published by WRAL TechWire.  The full article can be found here. CARY, NC – NeuroVice, a fledgling startup that’s developed a tongue protector for seizure sufferers,...

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The Importance of Human Factors for Medical & Drug Delivery Devices

As medical and drug delivery devices grow increasingly complex, regulatory agencies continue to place a greater emphasis on ensuring the safety and effectiveness of these devices through user research and human factors testing.  Anyone using a medical device, whether clinician or patient, should be able to do...

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Improvised Cotton Facemask and 3D Printed Face Shield: Step-by-Step Instructions

As COVID-19 continues to overwhelm communities on a global scale, PPE for healthcare workers and caregivers is in short supply.  Gilero has developed designs for an improvised cotton facemask and a 3D printed face shield that can be used when medical grade PPE is not available.  We...

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Gilero’s Response to COVID-19

In response to the current COVID-19 pandemic, we at Gilero feel compelled to help.  As a company that designs, develops and manufactures medical devices, we have the opportunity to make an impact by relieving some of the shortages of essential medical equipment. Gilero’s response to the situation...

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Medical Device Concept to Commercialization in Seven Steps

Turning an idea for a medical device into a successful commercialized product is no easy task. It requires time, funding, foresight and creative solutions to take these products from concept to commercialization. Gilero has been providing design, development and manufacturing services in the medical and drug delivery...

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