Ortho Innovators: Advance Your Technology, at Any Phase in Its Pathway, by Connecting with GCMI at ORS 2023

If you’re attending ORS 2023 and have a new orthopedic technology in development, including preclinical work that may be on your product development horizon, you have a wonderful chance to connect with our Director of Scientific Affairs Evan Goldberg onsite.   GCMI is the U.S. proving ground for global medical innovation. Our mission is to…

Interdisciplinary Innovation in Action – 2022 Fall Capstone Team Wristy Business Tackles a Standard of Care Treatment Suffering from a 40-70% Failure Rate

The human wrist is a complex arrangement of short, small bones, component joints and ligaments. Especially among young, active people, it is subject to approximately 20,000 instances of scapholunate ligament (SLL) tears, mostly the result of an intense impact to the hand.   Left untreated, SLL tears can degrade quickly, leading to the untreatable scapholunate…

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…

When Stars Align – Stridelink quickens its march to commercialization aligned with new remote monitoring capabilities and CMS CPT codes

Occasionally, even in the medtech innovation industry, stars align for a new technology to quickly, powerfully achieve commercialization and the associated clinical outcomes intended.   Such may well be the case for the team and technology at StrideLink.   As we reported last year, “StrideLink is a new technology venture, a first of its kind…

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…