Medical Design & Outsourcing: FDA issues FAQ on 3D-printed equipment against coronavirus

Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing COVID-19 pandemic. “University research teams and others have been racing to develop DIY ventilators to help patients whose breathing is restricted by COVID-19. Those seeking to 3D-print accessories or parts…

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

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?

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.

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.

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…