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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…
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…
Here are some of the most common cost types you should consider when planning your preclinical study to give your product the best chance of getting to market as swiftly and efficiently as possible focusing on what matters most – clearance from regulatory bodies like the FDA.
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…
As the global COVID-19 pandemic continues to force all of us to find safe paths forward, GCMI continues to remain operational across all service lines including design & development, preclinical services and life cycle advisory. Several states including Georgia are opening businesses and adjusting to life in the COVID-19 era. GCMI remains focused on the…
When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already surmounted significant obstacles. They are nearer to realizing the possibility that their product will enter the market and patient care than ever before. Quality preclinical research begins with a robust preclinical study…
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…