Alignment and Impact: What the new FDA Quality Management System Regulation final rule means for GCMI and our medtech design and development customers.

Blog, Cardiology & Cardiothoracic, Design & Development, GCMI, News, Pediatric, Physician Innovators

First, the news.   “On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities…

GCMI Experts Help Shape Future Innovators at Children’s Hospital of Philadelphia, Driving Pediatric Medical Device Development

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

By: Emily Blum, MD, Medical Director, GCMI   The Challenge: Innovation Roadblocks in Pediatric Care Hospitals are brimming with brilliant ideas from healthcare providers who have a deep understanding of patient challenges. Innovation directly addressing unmet clinical needs provides a superior foundation for new technologies, increasing the likelihood of improved patient care, positive outcomes, and…

Improving the Human Condition Through Medtech Innovation

Accelerator, Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News

GCMI recently welcomed Georgia Tech President Angel Cabrera for an inside look at our work and its impact. Almost immediately after Angel Cabrera was named President of Georgia Tech in 2019, he led “more than 5,700 members of the Georgia Tech community [who] contributed to a new 10-year strategic plan that launched in November 2020.…

2024: The Year of the Atlanta Healthcare Startup? Count Us In!

Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News

Fact: Atlanta enjoys assets critical to medtech innovation on par with those in hubs like Boston and the Bay Area. In abundance Atlanta has clinicians, hospitals, patients, universities including two medical schools, engineers, entrepreneurs, solutions providers and supporting state and municipal resources. We are also home for the Centers of Disease Control and Prevention.   …

GCMI Remains Your Resource for Capital Efficient Medtech Design and Development

Blog, Design & Development, Digital Health, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Physician Innovators

Medtech and life science innovation is intensely rigorous. It requires high levels of acumen and proficiency in multiple disciplines. It can also be immensely capital intensive.    Tiffany Wilson founded Atlanta’s Global Center for Medical Innovation (GCMI) in 2012 to help medtech innovators de-risk their technologies, increasing their odds of successful commercialization and positive patient…

What’s an “expanded use pathway” and what are its implications for new pediatric technologies?

Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Pediatric, Physician Innovators

New medical technologies for pediatric care face difficult hurdles to commercialization, especially industry investment, due to relatively small market size and the quickly shifting nature of pediatric anatomy. In many cases, compassionate or “expanded use” regulatory pathways are needed to make new technologies available for clinical use in pediatric patients.   In December, GCMI Research…

News: GCMI’s Continuing Medtech Innovation Work (In Light of Veranex’ Acquisition of T3 Labs)

Blog, Design & Development, GCMI, News

T3 Labs, the industry leading preclinical CRO, a wholly owned subsidiary of GCMI has been acquired by Veranex, a multinational preclinical contract research organization and medtech solution provider, effective November 30, 2023.    GCMI will remain a non-profit 501(c)(3) organization and an affiliate of the Georgia Institute of Technology. GCMI will continue to provide medtech…

Venture Funding for New, “University Bred” Medical Technologies: When It’s Time and What to Bring

Accelerator, Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News, Pediatric, Physician Innovators

If you’ve been following our funding series for innovators seeking to spin out new medical technologies from higher ed “environments” like Georgia Tech, you’ll have seen:   The Top 5 Medtech and Life Science Funding Resources for GT Faculty, Researchers and Investigators – at Phase Zero, THE Place to Start, and Follow-On, for University Sourced…

The GCMI 2023 State of Medtech Design and Development Report Part 2

Accelerator, Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News

In part 1 of our 2023 State of Medtech Design and Development Report we discussed sensors, AI and the paradigm shift in regulatory strategy.   Here in part 2, we dive into a persistent need for gap analysis, the importance of focusing on the unmet clinical need, the challenges of manufacturing at scale and investigate…

What to Do, Where to Go and Why for Newly Funded University-Based New Medical Technologies

Blog, Design & Development, GCMI, How GCMI Supports Georgia Tech Innovators, Researchers, PIs and Students, News

You’re a university-based researcher, investigator, faculty member or perhaps even a student who has snagged your first funding for the earliest stage commercialization, design and development activities for your potential medical technology. You might even have completed the first activities with that funding and scored $100,000 or more in follow-on funding from GRA, SBIR, or…