Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time to attend a webinar! The team at GCMI is excited to announce that we will be hosting a series of webinars starting next week. Our first webinar focuses on good laboratory practice (GLP) preclinical…
To our GCMI clients, experts, and friends – From the beginning of the COVID-19 crisis, my team and I have been focused on how GCMI can lend a hand. Today, I am asking you to help us accelerate our efforts. We are on the frontline of the COVID-19 relief effort. We are part of a…
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…
Fast track answers to critical questions that de-risk medtech innovations When an innovator has identified a medical problem, taking an efficient approach to minimize risk and identify the viability of potential solutions is key. Our Phase Zero focuses on evaluating critical product elements early, minimizing risk, cost and effort. Key questions: What is…
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…
Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous, are conducted in compliance with a legally bound code of federal regulations (21 CFR Part 58) and should be conducted by qualified scientists and staff of an accredited contract research organization (CRO). They are also…
In October 2018, GCMI and Rambam Medical Center announced the formation of a partnership to help Israeli medtech innovators commercialize their products in the U.S. healthcare market. Earlier this year, Georgia Bio and the Atlanta Chamber of Commerce recognized our work with a 2019 Phoenix Award recognizing leaders who have forged academic and industry relationships…
Welcome to the third episode in our series about what it takes to get from an idea to a new medical device. We started the series recommending you consider how invested you are in your medtech idea and then get input to find out if your idea really fulfills an unmet clinical need. In the…
Your innovative medtech or medical device idea may solve a problem that you face on a regular basis, but that doesn’t always make it a good candidate for commercialization. It’s not just your idea that matters, but also others’ need for your idea because you’re not the only person that’s going to be using your product.…
So you have an idea for a new medical device. Now what? Coming up with a concept for a new medical device is an exciting moment. The possibility of solving a real unmet clinical need can seem so promising that you may overlook the myriad process challenges that go along with bringing this idea to…