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,…

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…

What does the Project Planning process for medtech innovation look like?

Where does Medtech Project Planning fit in with Product Development and why is it important? Let’s review the basic steps for successful Project Planning.   What is Project Planning? Project planning, also referred to as “Phase 1” at GCMI, follows directly after the feasibility phase, “Phase Zero.”  Phase 1 is the beginning of the formal…

Watch: Medical Device Innovation: A one-on-one with ATDC Lead Entrepreneur in Residence Frank Tighe and GCMI CEO Tiffany Wilson

Tiffany Wilson, CEO of The Global Center for Medical Innovation (GCMI), and Frank Tighe, Lead Entrepreneur in Residence at The Advanced Technology Development Center (ATDC), discussed the medical product development process for early stage innovators. Learn from their experiences by watching.       Too many promising medtech innovations and early stage companies fail unnecessarily…

Ares Health Systems’ learnings and next steps after 12 months in GCMI’s accelerator program

Last year, Ares Health Systems became the first digital health company to enter GCMI’s accelerator, accessing our digital health commercial development expertise and health system relationships to further validate the value of Ares’ MPower care management platform and commence market penetration. “Our confidence in our value proposition has increased since we’ve last talked,” says Ares…