ALung Technologies granted Emergency Use Authorization by the FDA for their Hemolung® Respiratory Assist System for the Treatment of COVID-19

Accelerator, Blog, Cardiology & Cardiothoracic, GCMI, News, Preclinical CRO Excellence, T3, Uncategorized

A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung® Respiratory Assist System (RAS), the world’s first fully-integrated respiratory dialysis system. This system removes carbon dioxide directly from the blood, allowing the patient’s lungs to rest and heal while avoiding…

Recording & Takeaways: Lessons Learned from Rapid Commercialization and Collaboration in Response to PPE Shortages

Accelerator, Blog, Design & Development, GCMI, News, Physician Innovators

Innovative medical technologies start with a great idea, novel science and an identified unmet clinical need. The process by which these technologies enter clinical care is as complicated as the science behind it. On October 7th, Georgia Tech Associate Professor of Engineering Christopher Saldana and the team at GCMI shared the impetus, idea, regulatory requirements…

Critical questions to answer that determine if your idea has commercial potential in healthcare

Accelerator, Blog, Design & Development, GCMI, News, Physician Innovators

From our colleagues at the Children’s Healthcare of Atlanta Pediatric Technology Center – “We knew that we had an innovative concept, but [we] needed to ensure that we were taking the correct steps that would help us reach commercialization in a timely and cost-efficient manner.” Professor James Rains and Georgia Tech Alumnus Mr. Kamil Mahknejia…

Behind the scenes: what it takes to keep an industry leading preclinical CRO running right

Bio-skills and medical device training, Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, News, orthopedic, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards  for our medtech and life science customers. …

Webcast Oct 21., 12pm: Building a foundation for growth: How Georgia Tech “born” Jackson Medical used Phase Zero to try to end “never events” in the operating room.

Blog, Design & Development, Events, GCMI, News, Webinar

Overheating lighting instruments coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to these as “never events” so they should never happen, right? But, data suggests that they occur more than twice a day. This was a red flag for Jackson Medical co-founders James Rains and…

GCMI’s Design and Development Process Phase 5: Transfer to Production

Accelerator, Blog, Design & Development, GCMI, Physician Innovators

At the end of verification and validation, a medical product is ready for regulatory submission or marketing, depending on the product’s regulatory classification. The manufacturing transfer phase typically follows, ensuring that high quality products can be made at sufficient product volumes.    Note: Industry uses “manufacturing transfer” and “transfer to production” interchangeably as you may…

Medtech IP legalese 101: What is a patent landscape review, what is a patent, what is freedom to operate?

Accelerator, Blog, Design & Development, GCMI, News, Physician Innovators

All types of innovators need to carefully protect their intellectual property (IP) from those who may infringe on their ideas and products, and themselves from inadvertently infringing on others’. Medtech innovation is no exception and the landscape is rife with pitfalls. Smith, Gambrell and Russell’s Matthew Warenzak shares his insights on patent landscape reviews, patents…

Commercialization During the COVID-19 Crisis: Lessons Learned in a 60 Minute Webcast.

Accelerator, Blog, Design & Development, Digital Health, Events, GCMI, News, Physician Innovators, Webinar

The vast majority of novel ideas from academia never make it into clinical use. Together we can change that. Innovative medical technologies start with a great idea, novel science and an identified unmet clinical need. The process by which these technologies enter clinical care is as complicated as the science behind it. On October 7th,…

Sherry Farrugia Named GCMI Interim CEO

Accelerator, Blog, GCMI, New, News

Global Center for Medical Innovation’s Board of Directors has announced Sherry Farrugia will serve as the organization’s interim CEO, effective immediately. Ms. Farrugia comes to GCMI from the Children’s Healthcare of Atlanta, Pediatric Technology Center at the Georgia Institute of Technology, where she was Chief Operating and Strategy Officer spending the past 10 years focused…