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. …
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…
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…
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…
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,…
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…
With mixed emotions, I have made the decision to leave Global Center for Medical Innovation (GCMI) and to start an exciting new chapter in my career. I am leaving GCMI to join the University City Science Center in Philadelphia as President and CEO effective October 1. The decision to leave GCMI has not been an…
Atlanta, GA & Framingham, MA – June 24, 2020 In response to the unprecedented need for continuous innovation and improving patient outcomes, GCMI (www.gcmiatl.org) 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…
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…
Medical product design verification and validation activities (called “Phase 3” and “Phase 4” at GCMI) typically come after a design phase (called “Phase 2” at GCMI). At the completion of the design phase, a product will have well-defined design inputs, plus fully described design features and manufacturing methods. Design verification and validation then takes this…