Design & Development

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...

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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...

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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...

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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...

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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...

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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...

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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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