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 is verification and validation in medical product development?

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…

Our Process: What is the Design and Development Phase at GCMI?

In the context of GCMI’s phase-gated product development process the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase (called “Phase 1” at GCMI). At the completion of project planning, innovators have determined what work is required to take the technology from prototype to product. The Design and…

“What makes a high quality preclinical study final report?” – FREE Webcast

The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not the only study that a reviewer might be working on. How do you make the report detailed, yet easy to read? What elements must be present? What common mistakes should you be certain to avoid?…

GCMI Builds PPE Business in Six Weeks to Help Protect U.S. Healthcare Workers Battling COVID-19 – White Paper

GCMI helps medtech innovators, including physicians, academic researchers and professors, startups and large strategic companies, bring their products to market. Our work to successfully commercialize medtech innovation to date has been almost exclusively as a service provider.   When the need became apparent that we could play a significant role in getting desperately needed PPE…

More Healthcare Shortages Lead to Another Powerful Georgia Tech, GCMI Collaboration: Redefining Hand Sanitizer and Donating 7,000 Gallons to Fight Covid-19 via GT Research Horizons

Following closely on the heels of GCMI’s work with Georgia Tech and others to design, produce and deliver hundreds of thousands of PPE face shields to frontline health workers, Georgia Tech and GCMI have combined their resources to help solve another critical shortage in healthcare: hand sanitizer.    Alarmed to discover a looming shortage 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…

Buyer beware: Common costs in preclinical research: a free webinar from GCMI

All preclinical study estimates are not created equal: they may or may not include line items that can widely influence the total fee. We know preclinical studies are expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but is not always…

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…