From Capstone through CREATE-X and on to the precipice of commercialization: Ethos Medical’s medtech journey for its novel spinal guidance system

In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement.   Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance…

The State of Preclinical Studies: A Q&A with GCMI’s Director of Scientific Affairs Evan Goldberg

Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…

Why GCMI for preclinical testing and bioskills training? Commitment to value.

We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice.   Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all…

Why GCMI for preclinical testing and bioskills training? Our scientific acumen.

At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA.    We won’t turn your project away because it’s too hard, or because we haven’t done…

Why GCMI for preclinical testing and bioskills training? Quality, compliance and accreditation.

At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers.   GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services.…

Why GCMI for preclinical or bioskills training? Collaborative accountability.

In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols.   Why choose GCMI for your preclinical testing needs? We are collaborative and accountable. We are committed to meeting your needs on your timeline and on your budget.  …

Why GCMI for your preclinical or bioskills programs? Flexibility.

As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not…

How do you know you are ready for preclinical work? Insights and recording from our latest webinar.

How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg joined Renovo Biomedical’s Anna Fallon on January 14, 2021 to answer that question.

How does our verification and validation phase of medtech development ‘translate’ to preclinical studies?

In section 21 CFR 820.3 of the federal code, FDA defines design verification as “the process of confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Design validation is defined as “the process of establishing by objective evidence that product specifications conform with user needs and intended use(s).”  Medical product…