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…
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.
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…
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA – March 24, 2020 – Global Center for Medical Innovation (GCMI), the Southeast’s first and only comprehensive medical device innovation center, today announced a collaboration that addresses the severe shortage of personal protective equipment (PPE) for…
Based on decades of collective experience conducting preclinical studies and writing preclinical final reports (both GLP and Non-GLP), our team of subject matter experts has outlined what makes a good preclinical study final report.
In mid-November 2019, six student-led Georgia Tech Capstone teams put their medical device ideas to the test at GCMI. These are five of their stories.
Georgia Tech biomedical engineering students Oscar Gutierrez, Ahmed Alnamos, Nishani Kanthasamy and Sondos Alnamos make up the team ‘Bullseye’ for the Fall 2019 edition of the Capstone Program. Their device seeks to provide a solution for patients who are at risk of aspiration but do not otherwise require general anesthesia during Esophagogastroduodenoscopy, or EGD, procedures
Aprons of Shield set out to design a device that achieves full-body shielding from radiation for clinicians while still giving them the ability to use their hands without being weighed down by aprons or increasing exposure.
As the year comes to a close and many of us look forward to a holiday respite, I find myself full of enthusiasm having recently returned from Israel advancing our accelerator program with Rambam Health Center and participating in the mHEALTH Israel Women’s Meetup at Google for Startups Campus in Tel Aviv. We live in…