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…

Consolidation, Planning and Due Diligence: Our Annual Spotlight on the State of Preclinical for 2023

GCMI and our preclinical arm also known as T3 Labs is a trusted, proven industry-leading preclinical CRO for medical devices and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, feasibility, and safety and efficacy GLP medical device testing for studies in any therapeutic area and in small and large…

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…

Who brings what to the table? Artivion’s Deepal Stevenson, M.S. shares her insights on the client / CRO relationship for effective, efficient preclinical studies and reports.

Life science companies of all shapes and sizes rely on preclinical contract research organizations (CROs) to generate the data and reports required to bring their innovations to market.   To do this effectively, and in a capital efficient manner, each entity needs to understand what they need from the other, when they need it, why…

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…

Orthopaedic Innovators: Do Not Underestimate the Importance of Process in “Medtech Innovation: From Unmet Clinical Needs to Clinical Solutions”

Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022   “For over 60 years, the Orthopedic Research Society (ORS) has been the leading research society supporting engineers, orthopaedic surgeons, biologists, veterinarians, and clinicians in pursuit of a world without musculoskeletal limitations.”   GCMI and…

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…

Recording & Insights: An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE)

Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study are first in human devices, devices that require Class III premarket approvals, some Class II devices, or a de novo device or…

Are you a life science innovator seeking funding in the next 12 months? Applications are open for PitchRounds at AdvanSE 2022.

Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022.   They’re seeking the southeast’s most promising life science innovators across multiple life science categories including biopharma, medtech, diagnostic, digital health and agriculture biotechnology technologies.   Along with Southeast Life Sciences, we encourage those seeking early rounds of six figures…

An Introduction to the U.S. FDA’s Investigational Device Exemption (IDE): A GCMI Webinar

Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization success.   Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study…