Overheating lighting instruments coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to these as “never events” so they should never happen, right? But, data suggests that they occur more than twice a day. This was a red flag for co-founders James Rains and Kamil Makhnejia.…
Earlier this week, the Southeastern Medical Device Association announced several industry leading plenary and keynote speakers set for next month’s 2018 SEMDA Annual Medtech Conference in Greenville, South Carolina. Representing GCMI, and its Design and Development line of service, our Product Development Director, Mike Fisher will serve on a panel led by Paul Snyder, VP of…
In medical product development, correctly identifying and committing to your FDA approval process or pathway can make or break many new projects.
GCMI-T3 Labs will be exhibiting at the Society of Interventional Radiology annual meeting (Booth 833), which will be held March 17-22, 2018 in sunny Los Angeles, CA. This is a great opportunity to learn about the latest clinical and scientific contributions as well as current treatments, needs and future trends in interventional radiology. We look…
Connect with T3 Labs at AAOS 2018 The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of thought leaders, physicians, scientists and academics seeking the latest in injury prevention and disease treatment of the musculoskeletal system. AAOS 2018 will bring the top names in…
We want to begin by wishing you and your team, a joyous and safe holiday season. Thank you for all your support and the opportunities you have sent our way. We hope you all get to enjoy this time with your loved ones. In so many ways, 2017 was a landmark year for GCMI. From…
Grants season is coming up again! Let’s face it, preparing and submitting a biomedical research grant application is a tedious task that requires a lot of planning. We at GCMI-T3 get dozens of requests every year to be collaborators on the preclinical portion of the grant application, often times the night before the grant is…
Michael Fisher, Director of Product Development for GCMI, shares his insights from the IEEE-NIH Healthcare Innovations and Point of Care Technology conference. Recently, GCMI attended and spearheaded a presentation during the IEEE-NIH Healthcare Innovations and Point of Care Technology conference which focuses on innovation and technologies for precision health and their clinical translation, to address…
For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills training services available. Depending on the class and type of submission, not every medical product requires preclinical studies, however, completing preclinical studies is advantageous for proof of concept, when raising capital, applying for reimbursement, and…
Medical technology innovators learn quickly that there is little, if any, flexibility in the FDA approval process. NFANT Labs knew they needed multidisciplinary partners able to build flexibility into an inflexible process, designing and developing their product with a constant eye on efficiency and the FDA approval prize. In the United States, up to 70%…