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

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

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…

GCMI Remains Your Resource for Capital Efficient Medtech Design and Development

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?

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…

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

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 1

Innovation in medical technologies is something of a paradox. On one hand, new technologies that drive innovation can manifest at breakneck speed. On the other hand, the pace at which those technologies breed innovations that reach full commercialization and patient impact can be glacial by comparison.   What have been the most significant changes with…

THE Place to Start, And Follow-On, For University-Sourced Medtech Innovation Funding

A dive into the Georgia Research Alliance (GRA) and its funding programs with GRA VP of Venture Development Ashley Cornelison In the first of this short series on medtech innovation funding opportunities, GCMI Director of Scientific Affairs Evan Goldberg stated, “GRA is the first place to go for those trying to commercialize a technology out…

When ROI Gets Squeezed By Market Size, Process In Medtech Innovation Means Even More

Revolutionizing Pediatrics: Innovations in Medical Device Design & Development. A Pediatric Tech Talk Webinar with GCMI, June 21, 2023 – 12:00 p.m. Eastern   “Innovation in pediatric technologies that address unmet clinical needs lags behind innovation for adult populations in large part due to its relatively small market size and ROI (return on investment) prospects…

Moving Beyond Improvisation. Solving a High Volume, High Value Unmet Clinical Need to Advance Patient Care

A “Catheter Gripping Tool” solving an unmet need as GCMI’s grows its roster of collaborative medtech innovations with the Children’s Mercy Kansas City Center for Pediatric Innovation.   Human beings are generally good at improvisation. Assembly calls for a 10mm socket? Try this handy crescent wrench right here and maybe it will do. What happened…

Beware the Unfamiliar Approach: Preclinical Implications for Novel Cell & Gene Therapies

Roughly one decade ago, scientists made significant improvements in viral vectors’ ability to deliver genetic therapeutics. Those therapies use genetic material like DNA to manipulate a patients’ own cells. Cellular (cell) therapies transfer cells into the patient whether they are the patients’ own cells or cells derived from another location or donor cells.    Because…