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…

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…

What do pediatric innovators need to know about risk, regulatory, IP and more for new pediatric technologies? A Pediatric Tech Talk recording.

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 for industry, continuously changing anatomies of children, and limited populations for testing and clinical trials.   Activity sequence and process matters a great deal…

Funding Support for GT Innovators and Researchers with Promising Medical Technologies

Funding varies in specific levels from fiscal year to fiscal year, specifically supports projects with high potential for successful commercialization, follow on funding and improved patient outcomes. Projects are selected by GCMI leadership in consultation with the board of directors. These funds are not for staff / salary or lab support. 

You’re a researcher or engineer who has found a solid unmet clinical need. Excellent! Now the rigorous work begins.

You’re a researcher or engineer who has found a clinician with a strong unmet clinical need your technology might solve.   Outstanding! Too many technologies go looking for problems to solve instead of finding the clinically stated problem first and fitting your technology to meet it in a way that truly works in the clinical…

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…

Preclinical Implications for 3D Printed and Bioresorbable Medical Technologies

The phrase “personalized medicine” has been thrown about by so many for so long in healthcare as to defy definition: or require post graduate work in any one of dozens of specific clinical or technological fields.   For the sake of brevity, 3D printing and bioresorbable material technologies are actively realizing personalized medicine in the…

High Demand, Regulatory Support and Importance of Advance Planning Highlight the 2022 State of the Preclinical Ecosystem

As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to travel for business, medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost…