News

Understanding Human-Centered Design

“If you think good design is expensive, you should look at the cost of bad design,” said Dr. Ralf Speth, CEO of Jaguar Land Rover. While the medical device industry is not the same as the automobile industry, the sentiment still applies. Not only can a bad...

24 Mar, 2021

Connected Medical Devices: The Rise of Smart Health Solutions

Innovation is a hallmark of the medtech industry. As connected technology becomes more intertwined in our daily lives, it only makes sense that more medical products capable of internet connectivity will enter the market. The number of connected medical devices in the market is expected to increase...

15 Feb, 2021

The Difference Between Medical Device Quality Control & Quality Assurance

The last thing a medical device manufacturer wants is for a piece of equipment to malfunction once it gets into the hands of a clinician, patient or caregiver. With such high stakes, the emphasis on quality when it comes to this form of design and manufacturing is...

20 Jan, 2021

Yukon Medical Receives NIH Funding for ClearTip™ Collection Swabs

DURHAM, N.C., January 12, 2021 - Yukon Medical today announced it has been awarded up to $9.4 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company’s non-absorbent, injection-molded ClearTip™ swabs used for the collection of...

17 Jan, 2021

The Importance of a Manufacturing Quality Plan

What is a Manufacturing Quality Plan? The importance of a manufacturing quality plan can’t be understated in any field, but it’s particularly important in the medical device industry. A quality plan for medical device design and manufacturing is required by the FDA and the ISO 13485 framework....

03 Jan, 2021

SCONE Medical Solutions Inc. Receives EUA for Self-Contained Negative Pressure Environment

MORRISVILLE, N.C., December 21, 2020 - SCONE Medical Solutions Inc. announced today that their product, the Self-Contained Negative Pressure Environment (SCONE™) has been cleared by FDA and is available for sale to hospitals in the United States. The SCONE™ uses negative pressure technology to create "active" barrier...

21 Dec, 2020

An End-of-Year Interview with Gilero’s CEO

It’s safe to say that 2020 did not go the way any of us planned.  I sat down (virtually, of course) with Ted Mosler, Founder and Chief Executive Officer of Gilero, to discuss the state of the company and plans for the future as this year finally...

17 Dec, 2020

Governor of North Carolina Visits Gilero Manufacturing Facility

Yesterday, North Carolina Governor Roy Cooper visited Gilero’s manufacturing facility in Pittsboro, NC. As a medical device company, Gilero felt compelled to find a way to help during the early days of the pandemic.  This past spring, Gilero quickly designed, developed, and began manufacturing a protective face...

04 Dec, 2020

5 Ways to Ensure a Smooth Design Transfer Process

An effective design transfer is critical for medical device manufacturing. When done well, the process is faster, the cost is more economical, and the final product is more likely to meet all design specifications. Done poorly, production is likely to be slowed down, unexpected costs arise, there...

30 Nov, 2020

Could Grant Money Help Pay for Your Medical Device Project?

The design and development process for a new medical device can be costly. For companies and projects that meet certain criteria, applying for a grant may be a viable option to secure the funding needed for these medical device projects. In its most basic sense, a grant...

09 Nov, 2020

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? As defined by the FDA, 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...

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

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