Breakthrough Initiative Addresses Shortage of Personal Protective Equipment for Nation’s Healthcare Workers in Wake of COVID-19 Pandemic

Accelerator, Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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…

What do you get out of GCMI’s Phase Zero?

Accelerator, Blog, Design & Development, GCMI, News, Physician Innovators

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…

The most expensive study is one you have to repeat. 10 things to know before you start your GLP study.

Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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…

GCMI and Rambam Medical Center Accelerator Evaluating 12 Israeli Startups for U.S. Commercialization.

Accelerator, Blog, GCMI, News, Physician Innovators, T3

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…

Engaging a flexible third party medical product development firm to help you tackle an inflexible process

Blog, Design & Development, GCMI, Physician Innovators

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%…