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

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.

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

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…

Free webcast: Importance of gross pathology and histopathology in a preclinical study

Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols…

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…