News

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

How to Prepare a 510(k) Submission

What is a 510(k)? A 510(k) 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 least as...

17 Aug, 2020

A Guide to Medical Device Design & Development

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

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...

02 Jul, 2020

Drug Delivery: An Overview

For centuries, drugs have been used to treat ailments, improve health and extend the lives of both humans and animals. The substances used as drugs have evolved greatly from the mixtures of medicinal plants and other ingredients found in ancient times. As the science of drugs and...

25 Jun, 2020

Gilero Scales Up Face Shield Production

Since the World Health Organization characterized COVID-19 as a pandemic in March 2020, Gilero has been working on a number of initiatives to help alleviate shortages of necessary medical equipment. Utilizing our experienced team of design engineers and deep knowledge of the medical device industry, we began...

14 May, 2020

North Carolina Working with Local Manufacturers to Make Critical Supplies

RALEIGH, N.C. - North Carolina is working with local manufacturers to shift their production to make critical medical supplies.   In March, Governor Roy Cooper established the state’s Task Force for Emergency Repurposing of Manufacturing (TFERM) to increase the amount of protective gear made here at home....

13 May, 2020

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,...

17 Apr, 2020

Gilero’s Pittsboro, NC Facility Shifts to Face Shield Manufacturing

This article was written by Zachary Horner, Chatham News + Record Staff, and published in Chatham News + Record. The full article can be found here. PITTSBORO — As companies and businesses around the world shift their production focus to making products designed to help fight the...

15 Apr, 2020

The Importance of Human Factors & Usability Testing of Medical and 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 devices before they hit the market.  Anyone using a medical device, whether clinician or patient, should be able to do so without making...

10 Apr, 2020

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...

26 Mar, 2020

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...

25 Mar, 2020

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...

28 Jan, 2020

Gilero Opens New Design Center in Southern California

MORRISVILLE, N.C., Dec. 6, 2019 -- Gilero, a contract design, development and manufacturing firm specializing in medical and drug delivery devices, has announced the opening of a new Design Center in Carlsbad, California. The new location serves as Gilero’s second Design Center and will be led by Rob...

06 Dec, 2019

Gilero’s Director of Quality & Operations Delivers Guest Lectures at Virginia Tech

Over the past few months, Gilero’s Director of Quality & Operations, Kristin Benokraitis, has traveled to Virginia Tech’s campus twice, speaking to both graduate and undergraduate students in the Biomedical Engineering and Mechanics department.  Like many colleges and universities, Virginia Tech understands the importance of preparing students...

15 Nov, 2019

Delivering the Goods: The Evolving World of Combination Products

This is an excerpt from the article Delivering the Goods: The Evolving World of Combination Products, written by Sam Brusco, Associate Editor of Medical Product Outsourcing. The full article can be found here. The drug delivery and combination products market is technically made up of several different...

06 Nov, 2019

Ernie Green Industries And Gilero Announce Business Realignment

COLUMBUS, OH and MORRISVILLE, N.C., Nov. 4, 2019 -- Ernie Green Industries and Gilero announced today that they have made the strategic decision to end their equity partnership, known as EG-GILERO, allowing each company to refocus on their respective core offerings. Going forward, Gilero and Ernie Green Industries will operate as...

04 Nov, 2019

Tony Stark, Ironman & Medical Device Design

I always thought that everything I needed to learn I could learn from The Simpson’s but recently I have had to turn to comics and superheroes to learn about designing a battery powered medical device. In this case I’m referring to Ironman. Tony Stark had an electromagnet...

01 Apr, 2019

IEC 60601-1-2 4th Edition

By: Genine Grant, Program and Quality Manager for Integrated Systems at Gilero IEC 60601-1-2 Ed 4:2014 is now in full force.  The initial reaction to a change in regulatory requirements, significant or otherwise, is usually “DARN IT! Just when I finally got the hang of this thing...

29 Mar, 2019

When Work and Life Cross Paths: Putting Your Best Foot Forward (In Design)

By: Kristin Benokraitis, Director of Quality and Operations at Gilero For the past 12 years I have worked in the medical device industry where I have developed new and exciting products which help to improve patient care, and in many cases, save lives. It’s the kind of...

08 Mar, 2019

The Importance of User Feedback – 3 Misuses of Pen Devices

By: David Orenstein, Product Development Engineer for Gilero It can be difficult sometimes to see the value in usability testing. As devices are developed they seem so simple to the engineering team developing them; or the complexities are so justified it wouldn’t make sense to do it...

19 Feb, 2019

User Research: It Doesn’t Need to be Expensive

By: Thomas Stokes, PhD When it comes right down to it, if you are making medical devices, performing good user research and formative studies in addition to validation studies is the smart choice. User research and formative studies provide valuable insights about users, their tasks, the environment...

15 Jan, 2019

A Case for Placing a Higher Priority on Human Factors in the Medical Device Design Process

I may be a new engineer to the medical device field, but the discussion I’ve observed in the industry over the past few years indicates the landscape is changing quickly. Some examples of recent changes that we’ve already seen include the emergence of digital medicine, robotically assisted...

29 Dec, 2018