Our Process: What is Design Freeze and How Does the Design and Development Phase Work at GCMI?
Design and Development for medtech: digging in to complete design tasks, achieving design freeze and ensuring readiness for manufacturing.
“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…
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…
Common costs in preclinical testing programs
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.
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…