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 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…
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…
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…
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…
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…
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…
Medtech innovation is an exciting, yet risky enterprise. The vast majority of venture capital and strategic investors now want to see early investment in de-risking medical innovations. There is simply too much potential for failure in the pathway to commercialization, plus financial risk related to market forces and competitive products. Too many medtech development…
In mid-March 2020, the shortage of personal protective equipment for healthcare providers responding to the COVID-19 outbreak had become a national emergency. By the time the University System of Georgia suspended on-campus instruction and asked students to depart campus by March 13 in response to rapidly increasing numbers of COVID-19 cases, Christopher Saldana, Ph.D., associate…
Preclinical work, especially GLP studies, are costly and critical to the product’s successful regulatory submission. Efficiency and quality in preclinical work begins with a robust preclinical study protocol. Preclinical protocols are the foundation on which reports required by regulatory bodies are built. What elements in a preclinical study protocol give the study the best…