Design & Development

An Introduction to Human Factors Engineering

Human factors engineering is a design approach focused on optimizing the interactions between users and devices. Also known as ergonomics or usability engineering, human factors engineering (HFE) can be applied to hardware, software, and a variety of complex systems. This aspect of design development is meant to...

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An Interview with Gilero’s Vice President of Technical Operations

Eli Nichols is the VP of Technical Operations at Gilero, where he uses his extensive engineering background and breadth of medical device knowledge to oversee Gilero’s design transfer team. Learn more about why Gilero has a dedicated team for transferring designs into manufacturing, and Eli’s role in...

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Medical Device Design UX Workflow

UX workflows for medical devices are changing the healthcare industry. Adhering to a workflow that is user-focused is critical to maintaining this level of healthcare innovation. So what should a UX design workflow include, and how can designers keep users at the forefront? Let’s walk through how...

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623 Medical Announces the Launch of Nüm, a Novel Sterile Topical Anesthetic Spray

MORRISVILLE, N.C., June 1, 2021 - 623 Medical has announced that their first commercial product, nüm, has been cleared by the FDA and is now available for sale in the US market. Nüm is a sterile topical anesthetic spray used to numb the skin prior to needle...

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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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