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.
Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for preclinical work in this early development stage? GCMI Preclinical Program Director Evan Goldberg shares his insights.
Georgia Tech recently completed its Fall 2020 (virtual) Capstone Design Expo. From the project’s website, “The Capstone Design Expo showcases Georgia Tech’s graduating seniors as they present their innovative projects designed and built during the Capstone Design Course. Students work in teams to solve either an industry problem, develop innovative tools to assist researchers, or…
Last month, Georgia Tech named Raghupathy “Siva” Sivakumar inaugural Interim Chief Commercialization Officer. From Georgia Tech Research Horizons: “Sivakumar will bring together commercialization and technology transfer activities from across campus with a goal of moving more intellectual property out into the marketplace to help expand Georgia Tech’s impact on the world. Attaining that goal…
How does medtech design verification and validation “translate” to preclinical testing? GCMI’s Director of Scientific Affairs explains.
Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions. But this type of work is also expensive. The most effective product development strategies use preclinical studies wisely. The most expensive preclinical study is the one you have to repeat. How…
Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash unnecessarily. 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. It is possible to know earlier in the…
Medtech and life science innovation is a complex, costly endeavor. How do you know you are on the right regulatory track? What activities need to happen in which order to achieve key milestones efficiently? Preclinical work is expensive and the most expensive study is the one you have to do twice. GCMI helps…
A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung® Respiratory Assist System (RAS), the world’s first fully-integrated respiratory dialysis system. This system removes carbon dioxide directly from the blood, allowing the patient’s lungs to rest and heal while avoiding…
Innovative medical technologies start with a great idea, novel science and an identified unmet clinical need. The process by which these technologies enter clinical care is as complicated as the science behind it. On October 7th, Georgia Tech Associate Professor of Engineering Christopher Saldana and the team at GCMI shared the impetus, idea, regulatory requirements…