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 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…

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…

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…

NBC News: “Georgia student, son of 2 first responders, creates lifesaving COVID-19 equipment”

Friends and colleagues, we hope you will enjoy this inspiring story of innovation and collaboration that is helping keep our frontline healthcare professionals safe during this time of desperate need. “I saw nothing better I could do to give back to people like my mom, my dad — who have been working in emergency services…

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

The design and development process can make or break a medical device’s commercial potential. It is dependent on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. Too many promising medtech innovations and early stage companies fail unnecessarily because they run out of funding before achieving milestones required for next-round investments. Medical device…