Learn more about: PreClinical CRO, Med Device Design, Development, Prototyping and More with GCMI.

Medtech and life science innovation is a complex, costly endeavor. How do you know you are on the right regulatory track? What activities need to happen in which order to achieve key milestones efficiently?   Preclinical work is expensive and the most expensive study is the one you have to do twice.   GCMI helps…

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

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

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

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…

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

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?

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.

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

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…

Global Center for Medical Innovation Joins Alira Health in Strategic Partnership to Accelerate Innovation Globally

Atlanta, GA & Framingham, MA – June 24, 2020   In response to the unprecedented need for continuous innovation and improving patient outcomes, GCMI (www.gcmiatl.com) the leading accelerator and incubator in the Southeastern United States and Alira Health a leading international healthcare and life sciences advisory firm are pleased to announce their new partnership. With this…

What is a 510(k)? Medtech regulatory expert Grace Powers answers some frequently asked questions about the common, but tricky, regulatory submission and clearance for new medical technologies.

A significant number of innovative medical technologies fall into FDA’s Class II classification, the vast majority of which require an FDA 510(k) submission. What exactly is a 510(k)? What types of products fall into the Class II, 510(k) category?   Grace Powers, principal consultant with Powers Regulatory Consulting, has 20 years of industry experience in…