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…

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

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

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

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

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…

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…

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…

It’s About Time! 2023 BME Spring Capstone Team Aims to Reduce 70% Failure Rate of Common Lumbar Punctures

Lumbar punctures are a procedure performed by neurologists to obtain cerebrospinal fluid from a patient’s back, typically from the L3/L4 spinal canal, and are used for diagnosis and treatment of many neurological diseases and cancers. There are more than 8 million conducted worldwide every year, including 370,000 in the United States.   Currently, doctors feel…

Reducing the 90% Recurrence Rate for Glioblastoma Treatment Through an Implantable Device for the Delivery of Stem Cells

GCMI’s Spring 2023 Capstone Spotlight on Team LifeSTEM “Gliomas are brain tumors that come in multiple forms ranging from low-grade, benign tumors to high-grade, malignant tumors including glioblastomas. Glioblastoma treatment involves surgical resection, chemotherapy, and radiation. However, these tumors are typically incompletely resected, so there is a 90% recurrence rate [for a course of treatment,…

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…