News

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? 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 most common types include traditional...

07 Oct, 2020